NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
1
ANASTROZOLO -Carcinoma della mammella indonne in post-menopausa
-Trattamento adiuvante negli stadiprecoci, estrogeno-positivi
-Trattamento del tumore della mammellamaschile
-Trattamento neoadiuvante delle formelocalmente avanzate del carcinoma dellamammella
Trattamento neoadiuvante nelle forme localmenteavanzate del carcinoma della mammella
Viola G et al. Neoadjuvant endocrine therapy for locallyadvanced breast cancer. Clin Ter 2007;158:441-452
Freedman OC et al. Using aromatase inhibitors in theneoadjuvant setting: evolution or revolution? Cancer Treat Rev2005;31:1-17
Dixon JM et al. Neoadjuvant endocrine therapy of breast cancer:a surgical perspective. Eur J Cancer 2002;38:2214-2221
ARSENICOTRIOSSIDO
-Leucemia promielocitica acuta -Mieloma multiplo refrattario o recidivante
-Sindromi mielodisplastiche
-Leucemia/Linfomi a cellule T
Mieloma multiplo refrattario o recidivante
Berenson JR et al. Efficacy and safety of melphalan, arsenictrioxide and ascorbic acid combination therapy in patients withrelapsed or refractory multiple myeloma: a prospective,multicentre, phase II, single-arm study. Br J Haematol2006;135:174-183
Berenson JR et al. A phase I/II study of arsenictrioxide/bortezomib/ascorbic acid combination therapy for thetreatment of relapsed or refractory multiple myeloma. ClinCancer Res 2007;13:1762-1768
Wu KL et al. Phase II multicenter study of arsenic trioxide,ascorbic acid and dexamethasone in patients with relapsed orrefractory multiple myeloma. Haematologica 2006;91:1722-1723
Sindromi mielodisplastiche
Schiller GJ et al. Phase II multicenter study of arsenic trioxide inpatients with myelodysplastic syndromes. J Clin Oncol2006;24:2456-2464
Vey N et al. Arsenic trioxide in patients with myelodysplasticsyndromes: a phase II multicenter study. J Clin Oncol2006;24:2465-2471
Leucemia/Linfomi a cellule T
Ishitsuka K et al. Therapeutic potential of arsenic trioxide withor without interferon-alpha for relapsed/refractory adult T-cellleukemia/lymphoma. Haematologica 2007;92:719-720
Hermine O et al. Phase II trial of arsenic trioxide and alphainterferon in patients with relapsed/refractory adult T-cell
Allegato A
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BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
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leukemia/lymphoma. Hematol J 2004;5:130-134
BLEOMICINA Attività metaplastiche di alcunitessuti (epiteli malpighiani ad altacheratinizzazione)
-In regimi di associazione nel linfoma diHodgkin
-Da solo o in associazione, nei tumori solidi
-Cicli di combinazione per linfomi nonHodgkin
-Tumore dell’ovaio a cellule germinali
-Carcinoma squamoso della cerviceuterina
-Neoplasie non melanomatose della cute
Cicli di combinazione per linfomi non-Hodgkin
Gobbi PG et al. The role of dose size in a chemotherapy regimen(ProMECE-CytaBOM) for the first-line treatment of large B-celllymphomas: a randomized trial by the Gruppo Italiano StudioLinfomi (GISL). Ann Oncol 2006;17:676-682
Tumore dell’ovaio a cellule germinali
Pectasides D et al. Granulosa cell tumor of the ovary. CancerTreat Rev 2007 [Epub ahead of print]
Lu KH et al. Update on the management of ovarian germ celltumors. J Reprod Med 2005;50:417-425
Carcinoma squamoso della cervice uterina
Vermorken JB et al. Randomized phase III trial of bleomycin,vindesine, mitomycin-C, and cisplatin (BEMP) versus cisplatin(P) in disseminated squamous-cell carcinoma of the uterinecervix: an EORTC Gynecological Cancer Cooperative Groupstudy. Ann Oncol 2001;12:967-974
Smith HO et al. Treatment of advanced or recurrent squamouscell carcinoma of the uterine cervix with mitomycin-C,bleomycin, and cisplatin chemotherapy. Gynecol Oncol1993;48:11-15
Neoplasie della cute non melanomatose
Mishima Y et al. Effect of bleomycin on benign and malignantcutaneous tumours. Acta Derm Venereol 1972;52:211-215
BORTEZOMIB -Mieloma multiplo -Linfoma non-Hodgkin indolente
-Linfoma non-Hodgkin mantellare
-Sindromi mielodisplastiche
Linfoma non-Hodgkin indolente e mantellare
O'Connor OA et al. Phase II clinical experience with the novelproteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol2005;23:676-684
Fisher RI et al. Multicenter phase II study of bortezomib inpatients with relapsed or refractory mantle cell lymphoma. JClin Oncol 2006;24:4867-4874
Kane RC et al. Bortezomib for the treatment of mantle celllymphoma. Clin Cancer Res 2007;13:5291-5294
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BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
3
Chen CI et al. Bortezomib is active in patients with untreated orrelapsed Waldenstrom's macroglobulinemia: a phase II study ofthe National Cancer Institute of Canada Clinical Trials Group. JClin Oncol 2007;25:1570-1575
Treon SP et al. Multicenter clinical trial of bortezomib inrelapsed/refractory Waldenstrom's macroglobulinemia: results ofWMCTG Trial 03-248.Clin Cancer Res 2007;13:3320-3325
Goy A et al. Phase II study of proteasome inhibitor bortezomibin relapsed or refractory B-cell non-Hodgkin's lymphoma. J ClinOncol 2005;23:667-675
Sindromi mielodisplastiche
Terpos E et al. Bortezomib is an effective agent for MDS/MPDsyndrome with 5q- anomaly and thrombocytosis. Leuk Res2007;31:559-562
CAPECITABINA -Carcinoma del colon e del retto:adiuvante nello stadio III o inmonoterapia nelle formemetastatiche
-Tumore della mammella localmenteavanzato o metastatico
-Tumore dello stomaco avanzato
-Carcinomi del colon-retto in fase avanzatao metastatica da sola o in associazione adaltri farmaci antitumorali registrati perquesta patologia
-Alternativa al fluorouracile dove non siritenga opportuno o indicato un trattamentoinfusionale
-Carcinoma della mammella localmenteavanzato o metastatico in associazione adaltri farmaci antineoplastici registrati in talepatologia
-Carcinoma del pancreas localmenteavanzato o metastatico
-Carcinoma a cellule renali metastatico inmonoterapia
-Carcinoma dello stomaco
Carcinoma del pancreas localmente avanzato ometastatico
Boeck S et al. Capecitabine plus oxaliplatin (CapOx) versuscapecitabine plus gemcitabine (CapGem) versus gemcitabineplus oxaliplatin (mGemOx): final results of a multicenterrandomized phase II trial in advanced pancreatic cancer. AnnOncol 2007 [Epub ahead of print]
Park BB et al. A phase II trial of gemcitabine plus capecitabinefor patients with advanced pancreatic adenocarcinoma. CancerChemother Pharmacol 2007;60:489-494
Herrmann R et al. Gemcitabine plus capecitabine compared withgemcitabine alone in advanced pancreatic cancer: a randomized,multicenter, phase III trial of the Swiss Group for ClinicalCancer Research and the Central European CooperativeOncology Group. J Clin Oncol 2007;25:2212-2217
Carcinoma a cellule renali metastatico in monoterapia
Oevermann K et al. Capecitabine in the treatment of metastaticrenal cell carcinoma. Br J Cancer 2000;83:583-587
Pagliaro LC et al. Phase II study of capecitabine single-agenttherapy in patients with metastatic renal cell carcinoma. UrolOncol 2006;24:487-491
Carcinoma dello stomaco
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a sostegno dell’estensione dell’indicazione
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-Carcinoma del colon e del retto (DukesB/stadio II) per i quali non si ritengaopportuno un trattamento infusionale confluorouracile o fluorouracile in bolo inassociazione con leucovorin
-Colangiocarcinoma
Ajani J. Review of capecitabine as oral treatment of gastric,gastroesophageal, and esophageal cancers. Cancer2006;107:221-231
Carcinoma del colon e del retto (Dukes B/stadio II)
Figueredo A et al. Adjuvant therapy for stage II colon cancerafter complete resection. Provincial Gastrointestinal Disease SiteGroup. Cancer Prev Control 1997;1:379-392
Feliu J et al. XELOX (capecitabine plus oxaliplatin) as first-linetreatment for elderly patients over 70 years of age with advancedcolorectal cancer. Br J Cancer 2006;94:969-975
Colangiocarcinoma
Iyer RV et al. A phase II study of gemcitabine and capecitabinein advanced cholangiocarcinoma and carcinoma of thegallbladder: a single-institution prospective study. Ann SurgOncol 2007;14:3202-3309
CARBOPLATINO -Carcinoma epiteliale avanzatodell’ovaio
-Carcinoma epidermoide deldistretto cervico-facciale
-Carcinoma del polmone a piccolecellule
-Teratoma
-Alternativa al cisplatino quando questo ècontroindicato oppure quando, a parità diefficacia, carboplatino risulti essere menotossico
-Tumori ovarici e polmonari (associato atassani)
-Seminoma
-Mesotelioma pleurico
-Carcinoma della mammella (da solo o inassociazione)
-Ad alte dosi nei regimi di condizionamentonel trapianto di cellule staminaliemopoietiche
-In sostituzione al cisplatino ed inassociazione nel salvataggio di linfomi
Carcinoma della cervice uterina
Tangjitgamol S et al. Paclitaxel and carboplatin for large cellneuroendocrine carcinoma of the uterine cervix. J ObstetGynaecol Res 2007;33:218-224
Lee MY et al. Concurrent radiotherapy withpaclitaxel/carboplatin chemotherapy as a definitive treatment forsquamous cell carcinoma of the uterine cervix. Gynecol Oncol2007;104:95-99
Kim K et al. Efficacy of paclitaxel and carboplatin as a regimenfor postoperative concurrent chemoradiotherapy of high riskuterine cervix cancer. Gynecol Oncol 2006;101:398-402
Glioblastoma multiforme
Aoki T et al. Phase II study of nimustine, carboplatin,vincristine, and interferon-beta with radiotherapy forglioblastoma multiforme: experience of the Kyoto Neuro-Oncology Group. J Neurosurg 2006;105:385-391
Nakagawa T et al. The combined effects of multiplechemotherapeutic agents for malignant glioma cells. JNeurooncol 2007;84:31-37
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
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BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
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Hodgkin e non-Hodgkin
-Carcinoma della cervice uterina
-Glioblastoma multiforme
-Rabdomiosarcoma
-Neoplasie a sede primitiva ignota
Kim JW et al. Current management strategies for intraocularretino-blastoma. Drugs 2007;67:2173-2185
Rabdomiosarcoma
Chisholm JC et al. Children's Cancer and Leukaemia Group(CCLG; formerly United Kingdom Children's Cancer StudyGroup). Efficacy of carboplatin given in a phase II windowstudy to children and adolescents with newly diagnosedmetastatic soft tissue sarcoma. Eur J Cancer 2007;43:2537-2544
Van Winkle P et al. Ifosfamide, carboplatin, and etoposide (ICE)reinduction chemotherapy in a large cohort of children andadolescents with recurrent/refractory sarcoma: the Children'sCancer Group (CCG) experience. Pediatr Blood Cancer2005;44:338-347
Neoplasie a sede primitiva ignota
Schneider BJ et al. Phase II trial of carboplatin, gemcitabine, andcapecitabine in patients with carcinoma of unknown primary site.Cancer 2007;110:770-775
Pittman KB et al. Gemcitabine and carboplatin in carcinoma ofunknown primary site: a phase 2 Adelaide Cancer Trials andEducation Collaborative study. Br J Cancer 2006;95:1309-1313
CARMUSTINA -Mieloma multiplo
-Linfomi non Hodgkin
-Tumori cerebrali
-Glioma maligno di grado elevato
-Condizionamento pre-trapianto Condizionamento pre-trapianto
Buser AS et al. High-dose chemotherapy using BEAM withoutautologous rescue followed by reduced-intensity conditioningallogeneic stem-cell transplantation for refractory or relapsinglymphomas: a comparison of delayed versus immediatetransplantation. Bone Marrow Transplant 2007;39:335-340
Josting A et al. Dexamethasone, carmustine, etoposide,cytarabine, and melphalan (dexa-BEAM) followed by high-dosechemotherapy and stem cell rescue-a highly effective regimenfor patients with refractory or relapsed indolent lymphoma. LeukLymphoma 2000;37:115-123
Faulkner RD et al. BEAM-alemtuzumab reduced-intensityallogeneic stem cell transplantation for lymphoproliferativediseases: GVHD, toxicity, and survival in 65 patients. Blood2004;103:428-434
CISPLATINO -Tumore del testicolo -Carcinoma della mammella Carcinoma squamoso dell’ano
Hung A et al. Cisplatin-based combined modality therapy for
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
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a sostegno dell’estensione dell’indicazione
6
-Carcinoma dell’ovaio
-Carcinoma del distretto cervico-facciale
-Carcinoma della vescica
-Carcinoma della prostata
-Tumore dell’endometrio
-Linfomi
-Alcune neoplasie dell'infanzia
-Sarcomi
-Linfomi
-Tumore del polmone
-Tumore dell’esofago
-Tumore della tiroide
-Neuroblastoma
-Melanoma maligno
-Mesotelioma pleurico
-Carcinoma dello stomaco
-Carcinoma spinocellulare della cute
-Carcinoma del pancreas
-Neoplasie cerebrali
-Carcinoma della cervice uterina
-Neoplasie a sede primitiva ignota
-Colangiocarcinoma e carcinomi delle viebiliari
-Regimi di associazione nel trattamento disalvataggio dei linfomi Hodgkin e non-Hodgkin
-Carcinoma squamoso dell’ano
-Regimi terapeutici per mobilizzazione dicellule staminali periferiche
-Mieloma multiplo
anal carcinoma: a wider therapeutic index. Cancer2003;97:1195-1202
Regimi terapeutici per mobilizzazione di cellulestaminali periferiche
Watts MJ et al. ESHAP and G-CSF is a superior blood stem cellmobilizing regimen compared to cyclophosphamide 1.5 g m(-2)and G-CSF for pre-treated lymphoma patients: a matched pairsanalysis of 78 patients. Br J Cancer 2000;82:278-282
Lee JL et al. ESHAP plus G-CSF as an effective peripheralblood progenitor cell mobilization regimen in pretreated non-Hodgkin's lymphoma: comparison with high-dosecyclophosphamide plus G-CSF. Bone Marrow Transplant2005;35:449-454
De Latour RP et al. Mobilization of peripheral blood progenitorcells after DHAP regimen with or without rituximab: a largemulticenter comparative study in patients with malignantlymphoma. Leuk Lymphoma 2007;48:897-904
Mieloma multiplo
Corso A et al. The VAD-DCEP sequence is an effective pre-transplant therapy in untreated multiple myeloma. Haematologica2004;89:1124-1127
D'Sa S et al. Etoposide, methylprednisolone, cytarabine andcisplatin successfully cytoreduces resistant myeloma patients andmobilizes them for transplant without adverse effects. Br JHaematol 2004;125:756-765
CITARABINA -Leucemia acuta mieloide dell’adulto e del bambino
-Altre forme proliferative della seriebianca
-Ad alte dosi nelle leucemie acute, neilinfomi non-Hodgkin, e in regime dicondizionamento nel trapianto di cellulestaminali emopoietiche
-Linfoma di Hodgkin
Linfoma di Hodgkin
Schütt P et al. Ifosfamide, etoposide, cytarabine, anddexamethasone as salvage treatment followed by high-dosecyclophosphamide, melphalan, and etoposide with autologousperipheral blood stem cell transplantation for relapsed orrefractory lymphomas. Eur J Haematol 2007;78:93-101
Olivieri A et al. Salvage therapy with an outpatient DHAPschedule followed by PBSC transplantation in 79 lymphomapatients: an intention to mobilize and transplant analysis. Eur JHaematol 2004;72:10-17
CLADRIBINA -Leucemia a cellule capellute -Linfoma non-Hodgkin indolente Linfoma non-Hodgkin indolente
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BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
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-Leucemia linfatica cronica Bresistente a terapia alchilante
-Macroglobulinemia di Waldenström Blum KA et al. Prolonged follow-up after initial therapy with 2-chlorodeoxyadenosine in patients with indolent non-Hodgkinlymphoma: results of Cancer and Leukemia Group B Study9153. Cancer 2006;107:2817-2825
Robak T et al. Rituximab combined with cladribine or withcladribine and cyclophosphamide in heavily pretreated patientswith indolent lymphoproliferative disorders and mantle celllymphoma. Cancer 2006;107:1542-1550
Robak T et al. Cladribine combined with cyclophosphamide andmitoxantrone is an active salvage therapy in advanced non-Hodgkin's lymphoma. Leuk Lymphoma 2007;48:1092-1101
Macroglobulinemia di Waldenström
Weber DM et al. 2-Chlorodeoxyadenosine alone and incombination for previously untreated Waldenstrom'smacroglobulinemia. Semin Oncol 2003;30:243-247
Gertz MA et al. Treatment recommendations in Waldenstrom'smacroglobulinemia: consensus panel recommendations from theSecond International Workshop on Waldenstrom'sMacroglobulinemia. Semin Oncol 2003;30:121-126
Treon SP et al. Update on treatment recommendations from theThird International Workshop on Waldenstrom'smacroglobulinemia. Blood 2006;107:3442-3446
DACARBAZINA -Melanoma metastatico
-Sarcomi dei tessuti molli
-Linfoma di Hodgkin
-Carcinomi neuroendocrini
-Tumori desmoidi
Carcinomi neuroendocrini
Bajetta E et al. 5-Fluorouracil, dacarbazine, and epirubicin in thetreatment of patients with neuroendocrine tumors. Cancer1998;83:372-378
Nocera M et al. Treatment of advanced medullary thyroid cancerwith an alternating combination of doxorubicin-streptozocin and5 FU-dacarbazine. Groupe d'Etude des Tumeurs à Calcitonine(GETC). Br J Cancer 2000;83:715-718
Orlandi F et al. Chemotherapy with dacarbazine and 5-fluorouracil in advanced medullary thyroid cancer. Ann Oncol1994;5:763-765
Tumori desmoidi
Gega M et al. Successful chemotherapeutic modality ofdoxorubicin plus dacarbazine for the treatment of desmoidtumors in association with familial adenomatous polyposis. J
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BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
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Clin Oncol 2006;24:102-105
DOCETAXEL -Tumore della mammella
-Tumore del polmone non a piccolecellule
-Carcinoma della prostata
-Adenocarcinoma dello stomaco
-Tumori del distretto cervico-facciale
-Carcinoma della mammella, in trattamentoneoadiuvante
-Carcinoma avanzato dell’ovaioprecedentemente trattato
-Carcinoma del pancreas
-Carcinoma del polmone a piccole cellule
-Sarcomi
-Carcinoma della vescica
-Carcinoma dell’esofago
Trattamento neoadiuvante del carcinoma dellamammella
Estévez LG et al. Evidence-based use of neoadjuvant taxane inoperable and inoperable breast cancer. Clin Cancer Res2004;10:3249-3261
Jørgensen J et al. Primary inoperable breast cancer. UgeskrLaeger 2007;169:3091-3093
Carcinoma avanzato dell’ovaio
Ferrandina G et al. Docetaxel and oxaliplatin in the second-linetreatment of platinum-sensitive recurrent ovarian cancer: a phaseII study. Ann Oncol 2007;18:1348-1353
Strauss HG et al. Phase II trial of docetaxel and carboplatin inrecurrent platinum-sensitive ovarian, peritoneal and tubal cancer.Gynecol Oncol 2007;104:612-616
Vasey PA et al. Phase III randomized trial of docetaxel-carboplatin versus paclitaxel-carboplatin as first-linechemotherapy for ovarian carcinoma. J Natl Cancer Inst2004;96:1682-1691
Carcinoma del pancreas
Burtness B et al. Phase II trial of weekly docetaxel/irinotecancombination in advanced pancreatic cancer. Cancer J2007;13:257-262
Fine RL et al. The gemcitabine, docetaxel and capecitabine(GTX) regimen for metastatic pancreatic cancer: a retrospectiveanalysis. Cancer Chemother Pharmacol 2008;61:167-175
Carcinoma del polmone a piccole cellule
Pallis AG et al. A multicenter phase II study of the combinationof gemcitabine and docetaxel in previously treated patients withsmall cell lung cancer. Lung Cancer 2004;43:329-333
Skarlos DV et al. Docetaxel and gemcitabine combination, asfirst-line treatment, in patients with extensive disease small-celllung cancer. A phase II study of the Hellenic CooperativeOncology Group. Lung Cancer 2003;41:107-111
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Sarcomi
Bay JO et al. Docetaxel and gemcitabine combination in soft-tissue sarcomas treatment. Bull Cancer 2007;94:S122-S126
Maki RG. Gemcitabine and docetaxel in metastatic sarcoma:past, present and future. Oncologist 2007;12:999-1006
Carcinoma della vescica
Galsky MD. The role of taxanes in the management of bladdercancer. Oncologist 2005;10:792-798
Carcinoma dell’esofago
Tanaka T et al. Second-line combination chemotherapy withdocetaxel for cisplatin-pretreated refractory metastaticesophageal cancer: a preliminary report of initial experience.Chemotherapy 2007;53:449-453
Albertsson M et al. Phase II studies on docetaxel alone everythird week, or weekly in combination with gemcitabine inpatients with primary locally advanced, metastatic, or recurrentesophageal cancer. Med Oncol 2007;24:407-412
Ajani JA. Chemotherapy for advanced gastric orgastroesophageal cancer: defining the contributions of docetaxel.Expert Opin Pharmacother 2006;7:1627-1631
DOXORUBICINA -Sarcoma dei tessuti molli eosteosarcoma
-Linfoma di Hodgkin e non Hodgkin
-Lucemia linfoblastica acuta
-Leucemia mieloblastica acuta
-Carcinoma della tiroide
-Carcinoma della mammella
-Carcinoma dell'ovaio
-Mieloma multiplo, in regimi di associazione
- Sarcomi (tutti gli istotipi)
-Carcinoma dell’endometrio
-Carcinoma della cervice uterina
-Tumori maligni del timo
Carcinoma dell’endometrio
Kodama J et al. Chemotherapy for high-risk early-stageendometrial cancer. Curr Opin Obstet Gynecol 2007;19:42-47
Carcinoma della cervice uterina
Papadimitriou CA et al. A phase II trial of methotrexate,vinblastine, doxorubicin, and cisplatin in the treatment ofmetastatic carcinoma of the uterine cervix. Cancer1997;79:2391-2395
Tumori maligni del timo
Yokoi K et al. Multidisciplinary treatment for advanced invasivethymoma with cisplatin, doxorubicin, and methylprednisolone. JThorac Oncol 2007;2:73-78
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a sostegno dell’estensione dell’indicazione
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-Carcinoma della vescica
-Carcinoma polmonare
-Neuroblastoma
-Tumore di Wilms
-Tumori superficiali della vescica
-Carcinoma dello stomaco
-Carcinoma del fegato
-Carcinoma del pancreas
-Carcinoma del sigma retto
-Carcinoma del distretto cervico-facciale
-Carcinoma della prostata ormono-refrattario
DOXORUBICINALIPOSOMIALE
-Tumore della mammellametastatico
-Tumore dell’ovaio
-Sarcoma di Kaposi AIDS- correlato
-Carcinoma della mammella localmenteavanzato
-Rabdomiosarcoma
-Sarcoma di Ewing
-Mieloma multiplo
-Linfomi Hodgkin e non-Hodgkin
-Tumori maligni della tiroide
Carcinoma della mammella localmente avanzato
Ulrich-Pur H et al. Phase II trial of pegylated liposomaldoxorubicin (Caelyx) plus gemcitabine in chemotherapeuticallypretreated patients with advanced breast cancer. Acta Oncol2007;46:208-213
Ardavanis A et al. Pegylated liposomal doxorubicin incombination with vinorelbine as salvage treatment in pretreatedpatients with advanced breast cancer: a multicentre phase IIstudy. Cancer Chemother Pharmacol 2006;58:742-748
Alexopoulos A et al. Phase II study of pegylated liposomaldoxorubicin (Caelyx) and docetaxel as first-line treatment inmetastatic breast cancer. Ann Oncol 2004;15:891-895
Rabdomiosarcoma e Sarcoma di Ewing
Nielsen OS et al. Phase 1 European Organisation for Researchand Treatment of Cancer study determining safety of pegylatedliposomal doxorubicin (Caelyx) in combination with ifosfamide
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in previously untreated adult patients with advanced ormetastatic soft tissue sarcomas. Eur J Cancer 2006;42:2303-2309
Skubitz KM. Phase II trial of pegylated-liposomal doxorubicin(Doxil) in sarcoma. Cancer Invest 2003;21:167-176
Mieloma multiplo
Rifkin RM et al. Pegylated liposomal doxorubicin, vincristine,and dexamethasone provide significant reduction in toxicitycompared with doxorubicin, vincristine, and dexamethasone inpatients with newly diagnosed multiple myeloma: a Phase IIImulticenter randomized trial. Cancer 2006;106:848-858
Orlowski RZ et al. Randomized phase III study of pegylatedliposomal doxorubicin plus bortezomib compared withbortezomib alone in relapsed or refractory multiple myeloma:combination therapy improves time to progression. J Clin Oncol2007;25:3892-3901
Zervas K et al. Greek Myeloma Study Group. Primary treatmentof multiple myeloma with thalidomide, vincristine, liposomaldoxorubicin and dexamethasone (T-VAD doxil): a phase IImulticenter study. Ann Oncol 2004;15:134-138
Linfomi Hodgkin e non-Hodgkin
Macpherson N et al. Liposomal encapsulated doxorubicin(Caelyx) in the treatment of relapsed aggressive non-Hodgkin'slymphoma: a phase II study. Leuk Lymphoma 2006;47:1327-1332
Di Bella NJ et al. Pegylated liposomal doxorubicin as single-agent treatment of low-grade non-Hodgkin's lymphoma: a phaseII multicenter study. Clin Lymphoma 2003;3:235-240
Orlowski RZ et al. Phase 1 trial of the proteasome inhibitorbortezomib and pegylated liposomal doxorubicin in patients withadvanced hematologic malignancies. Blood 2005;105:3058-3065
Tumori maligni della tiroide
Moscetti L et al. A partial response in anaplastic carcinoma ofthe thyroid with liposomal doxorubicin. J Exp Clin Cancer Res2005;24:151-154
Tennvall J et al. Anaplastic thyroid carcinoma: three protocols
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a sostegno dell’estensione dell’indicazione
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combining doxorubicin, hyperfractionated radiotherapy andsurgery. Br J Cancer 2002;86:1848-1853
EPIRUBICINA -Carcinoma della mammella
-Sarcomi delle parti molli
-Carcinoma dello stomaco
-Carcinoma del fegato
-Carcinoma del pancreas
-Carcinoma del sigma-retto
-Carcinoma del distretto cervico-facciale
-Carcinoma del polmone
-Carcinoma dell’ovaio
-Leucemie
-Linfomi
-Carcinoma della vescicasuperficiale
-Profilassi delle recidive dopointervento di resezione transuretrale
Può essere utilizzata al posto delladoxorubicina da sola od in associazione neltrattamento dei tumori solidi, sia in faseprecoce che avanzata
-Tumori neuroendocrini
-Carcinoma dell’esofago
-Carcinoma della prostata
-Carcinoma della cervice uterina
Tumori neuroendocrini
Bajetta E et al. 5-Fluorouracil, dacarbazine, and epirubicin in thetreatment of patients with neuroendocrine tumors. Cancer1998;83:372-378
Bajetta E et al. Efficacy of a chemotherapy combination for thetreatment of metastatic neuroendocrine tumours. Ann Oncol2002;13:614-621
Carcinoma dell’esofago
Choi IK et al. Epirubicin, cisplatin, oral UFT, and leucovorincombination chemotherapy in advanced and metastaticesophageal cancer. Med Oncol 2007;24:33-37
Ross P et al. Prospective randomized trial comparing mitomycin,cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU)with epirubicin, cisplatin, and PVI 5-FU in advancedesophagogastric cancer. J Clin Oncol 2002;20:1996-2004
Carcinoma della prostata
Petrioli R et al. Weekly docetaxel and epirubicin in treatment ofadvanced hormone-refractory prostate cancer. Urology2007;69:142-146
Carcinoma della cervice uterina
D'Agostino G et al. Neoadjuvant treatment of locally advancedcarcinoma of the uterine cervix with epirubicin, paclitaxel andcisplatin. Cancer Chemother Pharmacol 2002;49:256-260
ETOPOSIDE -Tumori del polmone a piccolecellule
-Carcinoma del testicolo nonseminomatoso resistente
-Linfoma di Hodgkin
-Linfomi non Hodgkin
-Terapie ad alte dosi sequenziali nelcondizionamento pre-trapianto
-In associazione nella leucemia linfatica acutae nel mieloma multiplo
-Sarcomi
-Tumori a cellule germinali
Tumori a cellule germinali
Marwaha S et al. The importance of the dose of etoposide in theinitial treatment of metastatic germ cell tumors and advances inmanagement of patients that relapse. Can J Urol 2007;14:3692-3696
Kondagunta V et al. Germ-cell tumors. N Engl J Med2007;357:1773
Carcinoma dello stomaco e dell’esofago
Lokich JJ et al. Combined paclitaxel, cisplatin, and etoposide for
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
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(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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a sostegno dell’estensione dell’indicazione
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-Leucemie acute
-Coriocarcinoma gestazionale
-Carcinoma dello stomaco e dell’esofago
-Carcinoma del testicolo
-Tumori maligni intracranici
-Tumori del distretto cervicale
-Tumori neuroendocrini
patients with previously untreated esophageal andgastroesophageal carcinomas. Cancer 1999;85:2347-2351
Chiou TJ et al. Treatment of advanced gastric cancer with amodified regimen of etoposide/leucovorin/5-fluorouracil. CancerInvest 1996;14:197-201
Carcinoma del testicolo
Bamias A et al. Two cycles of etoposide/cisplatin cured allpatients with stage I testicular seminoma: risk-adapted protocolof the Hellenic Cooperative Oncology Group. Urology2007;70:1179-1183
Tumori maligni intracranici
López-Aguilar E et al. Preirradiation ifosfamide, carboplatin, andetoposide for the treatment of anaplastic astrocytomas andglioblastoma multiforme: a phase II study. Arch Med Res2000;31:186-190
Tumori del distretto cervicale
Tanaka T et al. Optimal combination chemotherapy andchemoradiotherapy with etoposide for advanced cervicalsquamous cancer cells in vitro. Oncol Rep 2006;15:939-947
Tumori neuroendocrini
Hainsworth JD et al. Phase II trial of paclitaxel, carboplatin, andetoposide in advanced poorly differentiated neuroendocrinecarcinoma: a Minnie Pearl Cancer Research Network Study. JClin Oncol 2006;24:3548-3554
FLUOROURACILE -Trattamento palliativo delcarcinoma della mammella, delcolon, del retto, dello stomaco e delpancreas
-Tumori del fegato
-Tumori dell’utero
Può essere utilizzato, da solo o in associazione,nei tumori solidi (*)
-Carcinoma del colon (adiuvante)
-Carcinoma dell’esofago
-Carcinoma del pancreas (adiuvante)
Carcinoma del colon (adiuvante)
Chung KY and Saltz LB. Adjuvant therapy of colon cancer:current status and future directions. Cancer J 2007;13:192-197
Kuebler JP et al. Oxaliplatin combined with weekly bolusfluorouracil and leucovorin as surgical adjuvant chemotherapyfor stage II and III colon cancer: results from NSABP C-07. JClin Oncol 2007;25:2198-2204
De Gramont A et al. Targeted agents for adjuvant therapy of
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a sostegno dell’estensione dell’indicazione
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-Tumori dell’ovaio
-Tumori della vescica
-Trattamento profilattico dellerecidive di tumore del colon-rettodopo chirurgia
-Tumori maligni a cellule di Langerhans
-Carcinoma del pene
-Carcinoma della prostata
-Carcinoma gastrico (adiuvante e neo-adiuvante)
-Tumori del distretto cervico-facciale
-Tumori maligni nasofaringei
-Tumore dell’ano
(*) La Commissione Terapeutica ha ritenutoopportuno documentare meglio alcuneindicazioni già presenti nella lista AIFA
colon cancer. Semin Oncol 2006; 33:42-45
Carcinoma dell’esofago
Lin CC et al. Multifractionated paclitaxel and cisplatin combinedwith 5-fluorouracil and leucovorin in patients with metastatic orrecurrent esophageal squamous cell carcinoma. Anticancer Drugs2007,18:703-708
O'Connor BM et al. Concurrent oxaliplatin, 5-fluorouracil, andradiotherapy in the treatment of locally advanced esophagealcarcinoma. Cancer J 2007;13:119-124
Sasamoto R et al. Long-term results of chemoradiotherapy forlocally advanced esophageal cancer, using daily low-dose 5-fluorouracil and cis-diammine-dichloro-platinum (CDDP). Int JClin Oncol 2007;12:25-30
Carcinoma del pancreas (adiuvante)
Ghaneh P et al. Neoadjuvant and adjuvant strategies forpancreatic cancer. Eur J Surg Oncol 2007 [Epub ahead of print]
Aung KL et al. Adjuvant therapy for pancreatic cancer. ExpertOpin Pharmacother 2007;8:2533-2541
Cantore M et al. Adjuvant intra-arterial 5-fluoruracil, leucovorin,epirubicin and carboplatin with or without systemic gemcitabineafter curative resection for pancreatic adenocarcinoma. CancerChemother Pharmacol 2006;58:504-508
Tumori maligni a cellule di Langerhans
Strosberg J et al. Effective treatment of locally advancedendocrine tumors of the pancreas with chemoradiotherapy.Neuroendocrinology 2007;85:216-220
Carcinoma del pene
Culkin DJ and Beer TM. Advanced penile carcinoma. J Urol2003;170:359-365
Roth AD et al. Intra-arterial chemotherapy in locally advanced orrecurrent carcinomas of the penis and anal canal: an activetreatment modality with curative potential. Br J Cancer2000;83:1637-1642
Eisenberger MA, Chemotherapy for carcinomas of the penis andurethra. Urol Clin North Am 1992;19:333-338
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
15
Carcinoma della prostata
Lin CC et al. Weekly paclitaxel and high-dose 5-fluorouracil plusleucovorin in hormone-refractory prostate cancer: in vitrocombined effects and a phase II trial. Urol Oncol 2007;25:207-213
Swanson GP et al. Locally advanced prostate cancer treated withconcomitant radiation and 5-fluorouracil: Southwest OncologyGroup Study 9024. J Urol 2006;176:548-553
Birtle AJ et al. Epirubicin carboplatin and 5-fluorouracil(ECarboF) chemotherapy in metastatic hormone refractoryprostate cancer. Br J Cancer 2004;91:1472-1476
Carcinoma gastrico (adiuvante e neo-adiuvante)
Ng K et al. Adjuvant and neoadjuvant approaches in gastriccancer. Cancer J 2007;13:168-174
Saletti P et al. Adjuvant chemotherapy (ECF regimen) forpatients with gastric adenocarcinoma. Hepatogastroenterology2007;54:969-972
Koo DH et al. Adjuvant chemotherapy with 5-fluorouracil,doxorubicin and mitomycin-C (FAM) for 6 months after curativeresection of gastric carcinoma. Eur J Surg Oncol 2007;33:843-848
Tumori del distretto cervico-facciale
Tulunay OE et al. Pilot study of intraoperative chemotherapywith cisplatin and 5-fluorouracil in patients with advancedsquamous cell carcinoma of the head and neck. Head Neck2007;29:267-271
Baghi M et al. Adjuvant docetaxel, cisplatin and 5-fluorouracil(TPF) in locally advanced squamous cell carcinoma of the headand neck. Anticancer Res 2006;26:559-563
Faivre S et al. Preoperative sequential chemotherapy in locallyadvanced squamous cell carcinoma of the head and neck. HeadNeck 2005;27:311-319
Tumori maligni nasofaringei
Fuwa N et al. Treatment results of alternating chemoradiotherapyfor nasopharyngeal cancer using cisplatin and 5-fluorouracil--a
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phase II study. Oral Oncol 2007;43:948-955
Yau TK et al. Treatment of Stage IV(A-B) nasopharyngealcarcinoma by induction-concurrent chemoradiotherapy andaccelerated fractionation: impact of chemotherapy schemes. Int JRadiat Oncol Biol Phys 2006;66:1004-1010
Wong AS et al. Paclitaxel, 5-fluorouracil and hydroxyureaconcurrent with radiation in locally advanced nasopharyngealcarcinoma. Ann Oncol 2006;17:1152-1157
Tumore dell’ano
Das P et al. Current treatment for localized anal carcinoma. CurrOpin Oncol 2007;19:396-400
Hatfield P et al. Involved-field, low-dose chemoradiotherapy forearly-stage anal carcinoma. Int J Radiat Oncol Biol Phys2008;70:419-24
Charnley N et al. Effective treatment of anal cancer in the elderlywith low-dose chemoradiotherapy. Br J Cancer 2005;92:1221-1225
GEMCITABINA -Carcinoma polmonare non apiccole cellule localmente avanzatoo metastatico
-Adenocarcinoma del pancreaslocalmente avanzato o metastatico
-Carcinoma della vescica
-Carcinoma della mammella nonresecabile localmente ricorrente ometastatico
-Carcinoma ricorrente dell'epiteliodell'ovaio
-Terapia di salvataggio della neoplasiagerminale del testicolo
-Sarcomi dei tessuti molli
-Colangiocarcinoma e carcinomi delle vie biliari
-Neoplasie del distretto cervico-facciale
-Linfomi di Hodgkin e non Hodgkin
-Carcinoma del colon e del retto
-Mesotelioma maligno
-Carcinoma del polmone a piccole cellule
-Sarcoma (tutti gli istotipi)
-Tumori a cellule germinali
Carcinoma del colon e del retto
Ziras N et al. Multicenter phase II study of gemcitabine andoxaliplatin (GEMOX) as second-line chemotherapy in colorectalcancer patients pretreated with 5-fluorouracil plus irinotecan.Oncology 2006;70:106-114
Correale P et al. Chemo-immunotherapy of metastatic colorectalcarcinoma with gemcitabine plus FOLFOX 4 followed bysubcutaneous granulocyte macrophage colony-stimulating factorand interleukin-2 induces strong immunologic and antitumoractivity in metastatic colon cancer patients. J Clin Oncol2005;23:8950-8958
Correale P et al. A novel biweekly multidrug regimen ofgemcitabine, oxaliplatin, 5-fluorouracil (5-FU), and folinic acid(FA) in pretreated patients with advanced colorectal carcinoma.Br J Cancer 2004;90:1710-1714
Mesotelioma maligno
Kalmadi SR et al. Gemcitabine and cisplatin in unresectablemalignant mesothelioma of the pleura: A phase II study of theSouthwest Oncology Group (SWOG 9810). Lung Cancer 2007,
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(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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a sostegno dell’estensione dell’indicazione
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[Epub ahead of print]
Lucchi M et al. Four-modality therapy in malignant pleuralmesothelioma: a phase II study. J Thorac Oncol 2007;2:237-242
Utkan G et al. Divided dose of cisplatin combined withgemcitabine in malignant mesothelioma. Lung Cancer2006;53:367-374
Carcinoma del polmone a piccole cellule
Ohyanagi F et al. Phase II trial of gemcitabine and irinotecan inpreviously treated patients with small-cell lung cancer. CancerChemother Pharmacol 2007 [Epub ahead of print]
Hesketh PJ et al. Phase II study of gemcitabine and cisplatin inpatients with previously untreated extensive stage small cell lungcancer: Southwest Oncology Group Study 9718. J Thorac Oncol2007;2:440-444
Schuette W et al. Phase II trial of gemcitabine/irinotecan inrefractory or relapsed small-cell lung cancer. Clin Lung Cancer2005;7:133-137
Sarcoma
Maki RG. Gemcitabine and docetaxel in metastatic sarcoma:past, present, and future. Oncologist 2007;12:999-1006
Maki RG et al. Randomized phase II study of gemcitabine anddocetaxel compared with gemcitabine alone in patients withmetastatic soft tissue sarcomas: results of sarcoma alliance forresearch through collaboration study 002. J Clin Oncol2007;25:2755-2763
Dileo P et al. Gemcitabine and vinorelbine combinationchemotherapy for patients with advanced soft tissue sarcomas:results of a phase II trial. Cancer 2007;109:1863-1869
Tumori a cellule germinali
Einhorn LH et al. Phase II study of paclitaxel plus gemcitabinesalvage chemotherapy for germ cell tumors after progressionfollowing high-dose chemotherapy with tandem transplant. J ClinOncol 2007;25:513-516
De Giorgi U et al. Phase II study of oxaliplatin and gemcitabinesalvage chemotherapy in patients with cisplatin-refractory
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BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
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nonseminomatous germ cell tumor. Eur Urol 2006;50:1032-1038
Pectasides D et al. Gemcitabine and oxaliplatin (GEMOX) inpatients with cisplatin-refractory germ cell tumors: a phase IIstudy. Ann Oncol 2004;15:493-497
IDARUBICINA -Leucemia acuta non linfoblastica
-Cancro della mammella in stadioavanzato
-Leucemia acuta linfociticanell'adulto e nel bambino
-Linfomi non-Hodgkin in prima linea opretrattati, in combinazione con altrichemioterapici
Linfomi non-Hodgkin in prima linea o pretrattati, incombinazione con altri chemioterapici
Zinzani PL et al. Effectiveness of fludarabine, idarubicin andcyclophosphamide (FLUIC) combination regimen for youngpatients with untreated non-follicular low-grade non-Hodgkin'slymphoma. Leuk Lymphoma 2004;45:1815-1819
Morra E et al. Treatment of patients with high-grade non-Hodgkin's lymphoma aged over 70 years with an all-oral regimencombining idarubicin, etoposide and alkylators. Crit Rev OncolHematol 2000;35:95-100
Oyan B et al. Ifosfamide, idarubicin, and etoposide inrelapsed/refractory Hodgkin disease or non-Hodgkin lymphoma:a salvage regimen with high response rates before autologousstem cell transplantation. Biol Blood Marrow Transplant2005;11:688-697
IDROSSIUREA Leucemia mieloide cronica -Mielofibrosi
-Trombocitemia essenziale
-Policitemia vera
Mielofibrosi, trombocitemia essenziale, policitemiavera
Cervantes F et al. New and old treatment modalities in primarymyelofibrosis. Cancer J 2007;13:377-383
Finazzi G et al. Expertise-based management in essentialthrombocythemia and polycythemia vera. Cancer J 2007;13:372-376
Barbui T et al. Therapy for polycythemia vera and essentialthrombocythemia is driven by the cardiovascular risk. SeminThromb Hemost 2007;33:321-329
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
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IFOSFAMIDE-Carcinoma bronchiale
-Carcinoma dell’ovaio
-Tumori del testicolo
-Sarcomi delle parti molli
-Carcinoma della mammella
-Carcinoma del pancreas
-Ipernefroma
-Carcinoma dell’endometrio
-Linfomi maligni
-Può essere utilizzato, da solo o in associazione,nei tumori solidi sulla base delle evidenzescientifiche presenti in letteratura ed inparticolare:
-Sarcomi (tutti gli istotipi)
-Regime di condizionamento pretrapianto dicellule staminali emopoietiche
-Tumore a cellule germinali dell’ovaio
-Carcinoma del polmone a piccole cellule
-Tumori del distretto cervico-facciale
-Carcinoma nasofaringeo
-Tumori maligni del timo
-Tumore a cellule germinali
-Carcinoma della cervice uterina
Tumore a cellule germinali dell’ovaio
Popadiuk S et al. Ovarian malignant tumours. Efficacy of germcell and sex cord tumour treatment protocol in Poland. MedWieku Rozwoj 2006;10:803-810
Balat O et al. Remission of recurrent mixed germ cell tumor ofthe ovary after treatment with vincristine, carboplatin,fluorouracil, and ifosfamide: a case report and review of theliterature. Eur J Gynaecol Oncol 1996;17:342-344
Gershenson DM. Update on malignant ovarian germ cell tumors.Cancer 1993;71:1581-1590
Carcinoma del polmone a piccole cellule
Thatcher N et al. Ifosfamide, carboplatin, and etoposide withmidcycle vincristine versus standard chemotherapy in patientswith small-cell lung cancer and good performance status: clinicaland quality-of-life results of the British Medical ResearchCouncil multicenter randomized LU21 trial. J Clin Oncol2005;23:8371-8379
Iwasaki Y et al. Double-cycle, high-dose ifosfamide, carboplatin,and etoposide followed by peripheral blood stem-celltransplantation for small cell lung cancer. Chest 2005;128:2268-2273
Marangolo M and Giovanis P. Ifosfamide in small cell lungcancer. Oncology 2003;65:46-49
Tumori del distretto cervico-facciale
Pai VR et al. Two- vs three-drug combination chemotherapy inadvanced or recurrent head and neck cancer: a single institutionexperience of 361 patients. Med Oncol 2004;21:305-308
Airoldi M et al., Ifosfamide in the treatment of head and neckcancer. Oncology 2003;65:37-43
Shin DM et al. Phase II study of induction chemotherapy withpaclitaxel, ifosfamide, and carboplatin (TIC) for patients withlocally advanced squamous cell carcinoma of the head and neck.Cancer 2002;95:322-330
Carcinoma nasofaringeo
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BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
20
Chua DT et al. A phase II study of ifosfamide, 5-fluorouracil andleucovorin in patients with recurrent nasopharyngeal carcinomapreviously treated with platinum chemotherapy. Eur J Cancer2000;36:736-741
Tumori maligni del timo
Iwasaki Y et al. Multidisciplinary therapy including high-dosechemotherapy followed by peripheral blood stem celltransplantation for invasive thymoma. Chest 2002;122:2249-2252
Geffen DB et al. Multimodal treatment of metastatic thymiccarcinoma including high-dose chemotherapy with autologousstem cell transplantation: report of a case with more than 4-yeardisease-free survival. Am J Clin Oncol 2001;24:566-569
Highley MS et al. Treatment of invasive thymoma with single-agent ifosfamide. J Clin Oncol 1999;17:2737-2744
Tumore a cellule germinali
Einhorn LH et al. High-dose chemotherapy and stem-cell rescuefor metastatic germ-cell tumors. N Engl J Med 2007;357:340-348
Lorch A et al. Single versus sequential high-dose chemotherapyin patients with relapsed or refractory germ cell tumors: aprospective randomized multicenter trial of the GermanTesticular Cancer Study Group. J Clin Oncol 2007;25:2778-2784
Kondagunta GV et al. Paclitaxel plus ifosfamide followed byhigh-dose carboplatin plus etoposide in previously treated germcell tumors. J Clin Oncol 2007;25:85-90
Carcinoma della cervice uterina
Serkies K et al. Chemotherapy with mitomycin C, ifosfamide andcisplatin for recurrent or persistent cervical cancer. Int J GynecolCancer 2006;16:1152-1156
Buda A et al. Randomized trial of neoadjuvant chemotherapycomparing paclitaxel, ifosfamide and cisplatin with ifosfamideand cisplatin followed by radical surgery in patients with locallyadvanced squamous cell cervical carcinoma: the SNAP01 (StudioNeo-Adjuvante Portio) Italian Collaborative Study. J Clin Oncol2005;23:4137-4145
Buda A et al. Role of ifosfamide in cervical cancer: an overview.Oncology 2003;65:63-66
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
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IMATINIB -Leucemia mieloide cronica
Philadelphia positiva
-Leucemia linfoblastica acuta
-Malattie mielodisplastiche emieloproliferative
-Sindrome ipereosinofila avanzata
-Tumori stromali del tratto gastro-intestinale maligni
-Dermatofibrosarcoma protuberans
-Sindrome ipereosinofila
-Mastocitosi sistemica
Sindrome ipereosinofila
Baccarani M et al. The efficacy of imatinib mesylate in patientswith FIP1L1-PDGFRalpha-positive hypereosinophilic syndrome.Results of a multicenter prospective study. Haematologica2007;92:1173-1179
Fletcher S et al. Diagnosis and treatment of hypereosinophilicsyndromes. Curr Opin Hematol 2007;14:37-42
Peros-Golubici� T et al. Hypereosinophilic syndrome: diagnosisand treatment. Curr Opin Pulm Med 2007;13:422-427
Mastocitosi sistemica
Pardanani A. Systemic mastocytosis: bone marrow pathology,classification, and current therapies. Acta Haematol 2005;114:41-51
Droogendijk HJ et al. Imatinib mesylate in the treatment ofsystemic mastocytosis: a phase II trial. Cancer 2006;107:345-351
Pardanani A et al. Imatinib for systemic mast-cell disease. Lancet2003;362:535-536
INTERFERONE alfa -Leucemia a cellule capellute
-Leucemia mieloide cronica
-Mieloma multiplo
-Linfoma follicolare
-Tumore carcinoide
-Melanoma maligno
-Terapia di prima linea della trombocitemiaessenziale in gravidanza e in pazienti di etàminore a 40 anni
-Terapia di seconda linea della trombocitemiaessenziale in pazienti tra 40 e 60 anni a bassorischio di complicanze tromboemboliche
-Carcinoma a cellule renali
Carcinoma a cellule renali
Ryan CW et al. Sorafenib with interferon alfa-2b as first-linetreatment of advanced renal carcinoma: a phase II study of theSouthwest Oncology Group. J Clin Oncol 2007;25:3296-3301
Gollob JA et al. Phase II trial of sorafenib plus interferon alfa-2bas first- or second-line therapy in patients with metastatic renalcell cancer. J Clin Oncol 2007;25:3288-3295
Tannir NM et al. Improved tolerability and quality of life withmaintained efficacy using twice-daily low-dose interferon-alpha-2b: results of a randomized phase II trial of low-dose versusintermediate-dose interferon-alpha-2b in patients with metastaticrenal cell carcinoma. Cancer 2006;107:2254-2261
IRINOTECANO -Carcinoma avanzato del colon e delretto, in combinazione con 5-fluorouracile e acido folinico (primalinea); in monoterapia dopo 5-
-Trattamento di seconda linea dei carcinomiavanzati del tratto gastroenterico (esofago,stomaco e pancreas)
Tumore a piccole cellule del polmone
Spigel DR et al. Irinotecan, carboplatin and imatinib in untreatedextensive-stage small-cell lung cancer: a phase II trial of theMinnie Pearl Cancer Research Network. J Thorac Oncol2007;29:854-861
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
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a sostegno dell’estensione dell’indicazione
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fluorouracile (seconda linea)
-Carcinoma metastatico del colon edel retto EGFR positivo dopofallimento di terapia citotossicacontenente irinotecano, inassociazione a cetuximab
-Tumore a piccole cellule del polmone
-Carcinoma della cervice uterina
Bae SH et al. A phase II study of biweekly irinotecan andcisplatin for patients with extensive stage disease small cell lungCancer. Lung Cancer 2007, [Epub ahead of print]
Fennell DA et al. Phase II trial of irinotecan, cisplatin andmitomycin for relapsed small cell lung cancer. Int J Cancer2007;121:2575-2577
Carcinoma della cervice uterina
Umesaki N et al. Phase II study of irinotecan combined withmitomycin-C for advanced or recurrent squamous cell carcinomaof the uterine cervix: the JGOG study. Gynecol Oncol2004;95:127-132
Tsuda H et al. Phase I-II study of irinotecan (CPT-11) plusnedaplatin (254-S) with recombinant human granulocyte colony-stimulating factor support in patients with advanced or recurrentcervical cancer. Br J Cancer 2004;91:1032-1037
Verschraegen CF. Irinotecan for the treatment of cervical cancer.Oncology (Williston Park) 2002;16:32-34
MEGESTROLOACETATO
-Carcinoma della mammella odell'endometrio in fase avanzata
-Anoressia e perdita di pesosecondarie a neoplasie
Trattamento del tumore della mammellamaschile
-Carcinoma dell’ovaio
Carcinoma dell’ovaio
Wilailak S et al. Phase II study of high-dose megestrol acetate inplatinum-refractory epithelial ovarian cancer. Anti-Cancer Drugs2001;12:719-724
Markman M et al. Phase I trial of paclitaxel plus megestrolacetate in patients with paclitaxel-refractory ovarian cancer. ClinCancer Res 2000;6:4201-4204
Wiernik PH et al. High-dose megestrol acetate in the treatment ofpatients with ovarian cancer who have undergone previoustreatment: Eastern Cooperative Oncology Group Study PD884.Am J Clin Oncol 1998;21:565-567
METOTRESSATO -Coriocarcinoma
-Corionadenoma destruente
-Mola vescicolare o idatiforme
-Sarcomi
-Carcinoma della vescica
-Leucemie acute e linfomi non Hodgkin (ad altedosi)
-In associazione a ciclosporina nella profilassidella Graft Versus Host Disease in pazienti
Carcinoma del pene
Sheen MC et al. Penile verrucous carcinoma successfully treatedby intra-aortic infusion with methotrexate. Urology 2003;61:1216-1220
Sklaroff RB and Yagoda A. Methotrexate in the treatment ofpenile carcinoma. Cancer 1980; 45:214-216
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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a sostegno dell’estensione dell’indicazione
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-Linfomi
-Carcinomi cervico-facciali
-Carcinoma della mammella
-Carcinoma del polmone
-Carcinoma della cervice uterina
-Leucemie acute
-Leucemia linfoblastica del bambino
-Linfosarcoma del bambino (III e IVstadio
sottoposti a trapianto di cellule staminaliemopoietiche
-Carcinoma del pene
Kattan J et al. Penile cancer chemotherapy: twelve years'experience at Institut Gustave-Roussy. Urology 1993; 42:559-562
MITOMICINA C -Carcinoma dello stomaco
-Carcinoma del pancreas
-Carcinoma dell’utero
-Carcinoma della mammella
-Adenocarcinoma polmonare
-Carcinosi peritoneale
-Tumori del colon e del retto
-Tumori della vescica
-Tumori della cute
-Sarcomi
-Epatocarcinomi
-Leucemie acute e croniche
-Carcinoma dell’ano
-Carcinoma dell’esofago
-Carcinoma delle vie biliari
Carcinoma dell’esofago
Stewart FM et al. Cisplatin, 5-fluorouracil, mitomycin C andconcurrent radiation therapy with and without esophagectomy foresophageal carcinoma. Cancer 1989; 64:622-628
Anderson SE et al. Combined modality chemoradiation in elderlyoesophageal cancer patients. Br J Cancer 2007;96:1823-1827
Coia LR et al. Long-term results of infusional 5-FU, mitomycin-C and radiation as primary management of esophagealcarcinoma. Int J Radiat Oncol Biol Phys 1991;20:29-36
Carcinoma delle vie biliari
Kornek GV et al. Mitomycin C in combination with capecitabineor biweekly high-dose gemcitabine in patients with advancedbiliary tract cancer: a randomised phase II trial. Ann Oncol2004;15:478-483
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
BIBLIOGRAFIA
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24
-Linfoma di Hodgkin
OXALIPLATINO -Trattamento adiuvante del cancrodel colon di stadio III (C di Duke)dopo resezione completa del tumoreprimario in associazione con 5-FU eacido folinico
-Cancro del colon e del rettometastatico
-Carcinoma del pancreas e delle vie biliari inassociazione a gemcitabina
-Tumori del colon e del retto metastatici inassociazione a farmaci alternativi al 5-FU
-Tumore dell’ovaio
-Carcinoma dello stomaco avanzato ometastatico
-Tumore a cellule germinali
-Carcinoma della mammella metastatico dopofallimento di chemioterapia con taxani eantracicline
-Linfomi non-Hodgkin
Tumore dell’ovaio
Germano D et al. Gemcitabine combined with oxaliplatin(GEMOX) as salvage treatment in elderly patients with advancedovarian cancer refractory or resistant to platinum: a singleinstitution experience. J Chemother 2007;19:577-581
Ferrandina G et al. Docetaxel and oxaliplatin in the second-linetreatment of platinum-sensitive recurrent ovarian cancer: a phaseII study. Ann Oncol 2007;18:1348-1353
Raspagliesi F et al. Gemcitabine combined with oxaliplatin(GEMOX) as second-line chemotherapy in patients withadvanced ovarian cancer refractory or resistant to platinum andtaxane. Oncology 2004;67:376-381
Carcinoma dello stomaco avanzato o metastatico
Chao Y et al. Phase II study of weekly oxaliplatin and 24-hinfusion of high-dose 5-fluorouracil and folinic acid in thetreatment of advanced gastric cancer. Br J Cancer 2004; 91:453-458
Al-Batran SE et al. Phase II trial of biweekly infusionalfluorouracil, folinic acid, and oxaliplatin in patients withadvanced gastric cancer. J Clin Oncol 2004; 22:658-663
Kim JG et al. Multicenter phase II study of docetaxel plusoxaliplatin combination chemotherapy in patients with advancedgastric cancer: Daegu Gyeongbuk Oncology Group. Br J Cancer2008 [Epub ahead of print]
Tumore a cellule germinali
Kollmannsberger C et al. Activity of oxaliplatin in patients withrelapsed or cisplatin-refractory germ cell cancer: a study of theGerman testicular cancer study group. J Clin Oncol 2002;20:2031-2037
Pectasides D et al. Gemcitabine and oxaliplatin (GEMOX) inpatients with cisplatin-refractory germ cell tumors: a phase IIstudy. Ann Oncol 2004;15:493-497
Carcinoma della mammella metastatico dopofallimento di chemioterapia con taxani e antracicline
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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25
Delozier T et al. A phase II study of an oxaliplatin/vinorelbine/5-fluorouracil combination in patients with anthracycline-pretreatedand taxane-pretreated metastatic breast cancer. Anticancer Drugs2006;17:1067-1073
Martín M. Platinum compounds in the treatment of advancedbreast cancer. Clin Breast Cancer 2001;2:190-208
Pectasides D et al. Oxaliplatin plus high-dose leucovorin and 5-fluorouracil in pretreated advanced breast cancer: a phase IIstudy. Ann Oncol 2003;14:537-542
Linfomi non-Hodgkin
Chau I et al. An oxaliplatin-based chemotherapy in patients withrelapsed or refractory intermediate and high-grade non-Hodgkin'slymphoma. Br J Haematol 2001;115:786-792
PACLITAXEL -Carcinoma ovarico
-Carcinoma della mammella
-Carcinoma del polmone non apiccole cellule in stadio avanzato, incombinazione con cisplatino
-Sarcoma di Kaposi correlatoall'AIDS avanzato
-Carcinoma del distretto cervico-facciale
-Carcinoma dell'endometrio e della cerviceuterina
-Neoplasia germinale del testicolo
-Carcinoma della vescica
-Sarcomi dei tessuti molli
-Carcinoma delle tube di Falloppio
-Carcinoma dello stomaco
-Glioma maligno
-Melanoma maligno
-Carcinoma del polmone non a piccole cellulein monoterapia o combinato con agenti diversida cisplatino
Carcinoma delle tube di Falloppio
Gemignani ML et al. Paclitaxel-based chemotherapy incarcinoma of the fallopian tube. Gynecol Oncol 2001;80:16-20
Carcinoma dello stomaco
Kang HJ et al. A phase II study of paclitaxel and capecitabine asa first-line combination chemotherapy for advanced gastriccancer. Br J Cancer 2008;98:316-322
Yamaguchi K et al. Combination chemotherapy with 5-fluorouracil, cisplatin and paclitaxel for pretreated patients withadvanced gastric cancer. Anticancer Res 2007;27:3535-3539
Ajani JA et al. Phase II study of taxol in patients with advancedgastric carcinoma. Cancer J Sci Am 1998;4:269-274
Glioma maligno
Prados MD et al. Phase II study of paclitaxel in patients withrecurrent malignant glioma. J Clin Oncol 1996;14:2316-2321
Melanoma maligno
Einzig AI et al. A phase II study of taxol in patients withmalignant melanoma. Invest New Drugs 1991;9:59-64
Rao RD et al. Combination of paclitaxel and carboplatin assecond-line therapy for patients with metastatic melanoma.
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ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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Cancer 2006;106:375-382
Walker L et al. Phase II trial of weekly paclitaxel in patients withadvanced melanoma. Melanoma Res 2005;15:453-459
Carcinoma del polmone non a piccole cellule inmonoterapia o combinato con agenti diversi dacisplatino
Androulakis N et al. Salvage treatment with paclitaxel andgemcitabine for patients with non-small-cell lung cancer aftercisplatin- or docetaxel-based chemotherapy: a multicenter phaseII study. Ann Oncol 1998;9:1127-1130
Hainsworth JD et al. One-hour paclitaxel plus carboplatin in thetreatment of advanced non-small cell lung cancer: results of amulticentre, phase II trial. Eur J Cancer 1998;34:654-658
Scagliotti GV et al. Randomized study of adjuvant chemotherapyfor completely resected stage I, II, or IIIA non-small-cell lungcancer. J Natl Cancer Inst 2003;95:1453-1461
PEMETREXED -Mesotelioma pleurico maligno nonresecabile non pretrattato
-Carcinoma polmonare non apiccole cellule localmente avanzatoo metastatico
Altri mesoteliomi maligni (tutti gli istotipi) Altri mesoteliomi maligni
Vogelzang NJ et al. New agents in the management of advancedmesothelioma. Semin Oncol 2005;32:336-350
RITUXIMAB -Linfoma non Hodgkin
-Linfoma follicolare in III-IV stadio,in recidiva o refrattario
-Linfoma non Hodgkin CD20positivo
- Linfomi non Hodgkin a cellule B: tutti gliistotipi CD 20- positivi in prima linea, in cicli disalvataggio, inclusi i regimi di condizionamento
-Leucemia linfatica cronica
-Disordini linfoproliferativi EBV-correlati insoggetti trapiantati
-Terapia della Graft Versus Host Disease acuta ecronica steroido-resistente
-Macroglobulinemia di Waldenström
Macroglobulinemia di Waldenström
Dimopoulos MA et al. Primary treatment of Waldenströmmacroglobulinemia with dexamethasone, rituximab, andcyclophosphamide. J Clin Oncol 2007;25:3344-3349
Treon SP et al. Novel agents in the treatment of Waldenström'smacroglobulinemia. Clin Lymphoma Myeloma 2007;7:199-206
Treon SP et al. Extended rituximab therapy in Waldenström'smacroglobulinemia. Ann Oncol 2005;16:132-138
Leucemia a cellule capellute
Else M et al. The role of rituximab in combination withpentostatin or cladribine for the treatment of recurrent/refractoryhairy cell leukemia. Cancer 2007;110:2240-2247
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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a sostegno dell’estensione dell’indicazione
27
-Leucemia a cellule capellute Robak T. Current treatment options in hairy cell leukemia andhairy cell leukemia variant. Cancer Treat Rev 2006;32:365-376
TAMOXIFENE -Carcinoma mammario
-Tumore della mammella maschile
-Fibromatosi aggressive
-Carcinoma ovarico avanzato
Carcinoma ovarico avanzato
Perez-Gracia JL and Carrasco EM: Tamoxifen therapy forovarian cancer in the adjuvant and advanced settings: Systemicreview of the literature and implications for future research.Gynecol Oncol 2002;84:201-209
Hatch KD et al. Responsiveness of patients with advancedovarian carcinoma to tamoxifen. Cancer 1991;68:269-271
van der Vange N et al. Experience with hormonal therapy inadvanced epithelial ovarian cancer. Acta Oncol 1995;34:813-820
TEMOZOLOMIDE -Glioblastoma multiforme
-Gliomi maligni
-Melanoma maligno quando non si ritengaopportuno un trattamento con dacarbazina
-Linfomi primitivi del sistema nervosocentrale
Linfomi primitivi del sistema nervoso centrale
Santisteban M et al. Primary central nervous system lymphomatreated with rituximab plus temozolomide in a second lineschedule. Clin Transl Oncol 2007;9:465-467
Reni M et al. Temozolomide as salvage treatment in primarybrain lymphomas. Br J Cancer 2007;96:864-867
Pitini V et al. Salvage therapy for primary central nervous systemlymphoma with (90)Y-Ibritumomab and temozolomide. JNeurooncol 2007;83:291-293
TENIPOSIDE -Linfomi maligni
-Tumori del SNC
-Tumori della vescica
-Mieloma multiplo Mieloma multiplo
Leoni F et al. Continuous-infusion cyclophosphamide incombination with teniposide and dexamethasone in refractorymyeloma. Leuk Lymphoma 1992;7:481-487
Tirelli U et al. Phase II study of teniposide (VM-26) in multiplemyeloma. Am J Clin Oncol 1985;8:329-331
TOPOTECANO -Carcinoma metastatizzatodell’ovaio (in seconda linea osuccessive)
-Carcinoma polmonare a piccolecellule recidivante (in seconda linea)
-Carcinoma della cervice uterinarecidivante dopo radioterapia e nelle
-Carcinoma del polmone a piccole cellule inprima linea e/o in pazienti non candidati allaterapia con cisplatino
-Carcinoma della cervice uterina:monoterapia nello stadio IVB recidivato oresistente
-Neuroblastoma resistente alla terapia di
Carcinoma del polmone a piccole cellule in prima lineae/o in pazienti non candidati alla terapia con cisplatino
Schiller JH. Topotecan in small cell lung cancer. Semin Oncol1997;24:27-33
Eckardt JR et al. Open-label, multicenter, randomized, phase IIIstudy comparing oral topotecan/cisplatin versusetoposide/cisplatin as treatment for chemotherapy-naive patientswith extensive-disease small-cell lung cancer. J Clin Oncol
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
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(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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28
pazienti allo stadio IVB dellamalattia (in associazione concisplatino)
prima linea
-Sarcoma di Ewing resistente alla terapia diprima linea
-Rabdomiosarcoma resistente alla terapia di
prima linea
-Leucemia acuta
-Sindromi mielodisplastiche
2006;24:2044-2051
O'Brien ME et al. Phase III trial comparing supportive care alonewith supportive care with oral topotecan in patients with relapsedsmall-cell lung cancer. J Clin Oncol 2006; 24:5441-5447
Carcinoma della cervice in monoterapia nello stadioIVB recidivato o persistente
Bookman MA et al. Topotecan in squamous cell carcinoma ofthe cervix: A Phase II study of the Gynecologic Oncology Group.Gynecol Oncol 2000;77:446-449
Abu-Rustum NR et al. Topotecan for recurrent cervical cancerafter platinum-based therapy. Int J Gynecol Cancer 2000;10:285-288
Muderspach LI et al. A Phase II study of topotecan in patientswith squamous cell carcinoma of the cervix: a gynecologiconcology group study. Gynecol Oncol 2001;81:213-215
Neuroblastoma resistente alla terapia di prima linea
Simon T et al. Topotecan, cyclophosphamide and etoposide(TCE) in the treatment of high-risk neuroblastoma. Results of aphase-II trial. J Cancer Res Clin Oncol 2007;133:653-661
Sarcoma di Ewing resistente alla terapia di primalinea e Rabdomiosarcoma resistente alla terapia diprima linea
Budd GT et al. Phase II trial of topotecan by continuous infusionin patients with advanced soft tissue sarcomas, a SWOG study.Southwest Oncology Group. Invest New Drugs 2002;20:129-132
Hunold A et al. Topotecan and cyclophosphamide in patientswith refractory or relapsed Ewing tumors. Pediatr Blood Cancer2006;47:795-800
Leucemia acuta
Cortes J et al. Cyclophosphamide, ara-C and topotecan (CAT) forpatients with refractory or relapsed acute leukemia. Leukemiaand Lymphoma 2000;36:479-484
Sindromi mielodisplastiche
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
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(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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Kantarjian H et al. Long-term follow-up results of thecombination of topotecan and cytarabine and other intensivechemotherapy regimens in myelodysplastic syndrome. Cancer2006;106:1099-1109
Beran M et al. Topotecan, a topoisomerase I inhibitor, is active inthe treatment of myelodysplastic syndrome and chronicmyelomonocytic leukemia. Blood 1996;88:2473-2479
Rosenthal CJ and Thapper A. Sequential therapy with amifostine,topotecan, and etoposide induced repeated responses in patientswith myelodysplastic syndrome. Leuk Res 1999;23:S77
VINBLASTINA -Linfoma di Hodgkin (stadio III eIV)
-Linfoma linfocitico
-Linfoma istiocitico
-Micosi fungoide
-Carcinoma del testicolo
-Sarcoma di Kaposi
-Coriocarcinoma
-Carcinoma della mammella
-Morbo di Letterer-Siwe (IstiocitosiX)
-Carcinomi della vescica
-Carcinoma a cellule renali
-Linfoma di Hodgkin in stadio I e II
Linfoma di Hodgkin in stadio I e II
Press OW et al. Phase III randomized intergroup trial of subtotallymphoid irradiation versus doxorubicin, vinblastine, and subtotallymphoid irradiation for stage IA to IIA Hodgkin's disease. J ClinOncol 2001;19:4238-4244
Engert A et al. Two cycles of doxorubicin, bleomycin,vinblastine, and dacarbazine plus extended-field radiotherapy issuperior to radiotherapy alone in early favorable Hodgkin'slymphoma: final results of the GHSG HD7 trial. J Clin Oncol2007;25:3495-3502
VINCRISTINA -Leucemie acute
-Linfomi maligni
-Osteosarcoma
-Sarcoma di Ewing
-Mieloma multiplo
-Leucemia linfatica cronica
-Leucemia mieloide cronica in fase blastica
-Carcinoma del polmone a piccole cellule
Osteosarcoma
Gasparini M et al. Continuous cisplatin infusion in combinationwith vincristine and high-dose methotrexate for advancedosteogenic sarcoma. Am J Clin Oncol 1987;10:152-155
Sarcoma di Ewing
Bernstein ML et al. Intensive therapy with growth factor supportfor patients with Ewing tumor metastatic at diagnosis: PediatricOncology Group/Children's Cancer Group Phase II Study 9457-areport from the Children's Oncology Group. J Clin Oncol
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
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(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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-Carcinoma della cervice uterina 2006;24:152-159
Milano GM et al. High histologic and overall response to doseintensification of ifosfamide, carboplatin and etoposide withcyclophosphamide, doxorubicin and vincristine in patients withhigh-risk Ewing sarcoma family tumors: the Bambino GesùChildren's Hospital experience. Cancer 2006;106:1838-1845
Navid F et al. Concomitant administration of vincristine,doxorubicin, cyclophosphamide, ifosfamide and etoposide forhigh-risk sarcomas: the St. Jude Children's Research Hospitalexperience. Cancer 2006;106:1846-1856
Mieloma multiplo
Zervas K et al. Primary treatment of multiple myeloma withthalidomide, vincristine, liposomal doxorubicin anddexamethasone (T-VAD doxil); a phase II multicenter study. AnnOncol 2004; 15:134-138
Zervas K et al. Comparison of vincristine, carmustine,melphalan, cyclophosphamide, prednisone (VBMCP) andinterferon-alpha with melphalan and prednisone (MP) andinterferon-alpha (IFN-alpha) in patients with good-prognosismultiple myeloma: a prospective randomized study. Eur JHaematol 2001;66:18-23
Leucemia linfatica cronica
Vilpo JA et al. Selective toxicity of vincristine against chroniclymphocytic leukemia cells in vitro. Eur J Haematol2000;65:370-378
CLL Trialists' Collaborative Group . Chemotherapeutic options inchronic lymphocytic leukemia: a meta-analysis of the randomizedtrials. J Natl Cancer Inst 1999;91:861-868
Raphael B et al. Comparison of chlorambucil and prednisoneversus cyclophosphamide, vincristine and prednisone as initialtreatment for chronic lymphocytic leukemia: long-term follow-upof an Eastern Cooperative Oncology Group randomized clinicaltrial. J Clin Oncol 1991;9:770-776
Leucemia mieloide cronica in fase blastica
Rea D et al. High-dose imatinib mesylate combined withvincristine and dexamethasone (DIV regimen) as inductiontherapy in patients with resistant Philadelphia-positive acute
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
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lymphoblastic leukemia and lymphoid blast crisis of chronicmyeloid leukemia. Leukemia 2006;20:400-403
Goto H et al. Lymphoid blast crisis during interferon-alphatherapy in a patient with chronic myelogenous leukemia inmyeloid blast crisis. Int J Hematol 2000;72:474-476
Carcinoma del polmone a piccole cellule
Thatcher N et al. Ifosfamide, carboplatin and etoposide withmidcycle vincristine versus standard chemotherapy in patientswith small-cell lung cancer and good performance status: clinicaland quality-of-life results of the British Medical ResearchCouncil multicenter randomized LU21 trial. J Clin Oncol2005;23:8371-8379
Sundstrøm S et al. Second-line chemotherapy in recurrent smallcell lung cancer. Results from a crossover schedule after primarytreatment with cisplatin and etoposide (EP-regimen) orcyclophosphamide, epirubicin and vincristin (CEV-regimen).Lung Cancer 2005;48:251-261
White SC et al. Randomized phase II study of cyclophosphamide,doxorubicin, and vincristine compared with single-agentcarboplatin in patients with poor prognosis small cell lungcarcinoma. Cancer 2001;92:601-608
Carcinoma della cervice uterina
Eddy GL et al. Treatment of ("bulky") stage IB cervical cancerwith or without neoadjuvant vincristine and cisplatin prior toradical hysterectomy and pelvic/para-aortic lymphadenectomy: aphase III trial of the gynecologic oncology group. Gynecol Oncol2007;106:362-369
Choi CH et al. Phase II study of neoadjuvant chemotherapy withmitomycin-c, vincristine and cisplatin (MVC) in patients withstages IB2-IIB cervical carcinoma. Gynecol Oncol 2007;104:64-69
NOME COMPOSTO SINTESI DELLE INDICAZIONIGIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONISULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZESCIENTIFICHE (grassetto)
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VINORELBINA -Carcinoma polmonare non apiccole cellule
-Carcinoma della mammellametastatico
-Carcinoma della mammella metastatico HER2positivo in associazione a trastuzumab, dopoterapia con taxani
-Carcinoma del distretto cervico-facciale
-Carcinoma della prostata ormono-resistente
-Linfoma di Hodgkin e non Hodgkin, da sola o inassociazione
-Carcinoma renale metastatico dopofallimento di immunoterapia
-Carcinoma della cervice uterina
Carcinoma renale metastatico dopo fallimento diimmunoterapia
Muggia FM et al. Evaluation of vinorelbine in persistent or recurrentsquamous cell carcinoma of the cervix: a Gynecologic OncologyGroup study. Gynecol Oncol 2004;92:639-643
Schmidinger M et al. Vinorelbine and interferon-alpha2c as second-line therapy in metastatic renal cell carcinoma. Anticancer Drugs2000;11:175-179
Carcinoma della cervice uterina
Lacava JA et al. Vinorelbine as neoadjuvant chemotherapy inadvanced cervical carcinoma. J Clin Oncol 1997;15:604-609
Morris M et al. Phase II study of vinorelbine in advanced andrecurrent squamous cell carcinoma of the cervix. J Clin Oncol1998;16:1094-1098