S216 Abstracts Not Presented/Chemotherapy: NSCLC 1

0 5 Paclitaxel treatment in patients with advanced non-small cell lung cancer

Ferah Ece’, Nuray Erdalz, Nilgun Fatma Hatabays. ’ SSK Sureyyapasa Chest and Cardiovascular Diseaes Hospital, Istanbul, Turkey; ’ SSK Sureyyapasa Chest and Cardiovascular Diseases Hospital Istanbul, Turkey

Twenty one patients with Stage IIIB/IV NSCLC who had disease recurrence or failure with previous chemotherapy regimens were included in this study. The median age was 54 years (range 41-66 years); 9 patients had Eastern Cooperative Oncology Group performance status of 0 and 12 had PS of 1. Twelve patients (57.14%) had stage IIIB disease and 9 (42.86%) stage IV. Patients who had received platinum based chemotherapy and/or radiotherapy previously, were treated with paclitaxel 80 mg/m* as a 1 h infusion on days 1,8,15 every 28 day. A total of 276 treatments were administered to the pa- tients. One patient experienced grade 3 and 1 grade 4 hematologic toxicity. We observed grade l-2 sensory neuropathy in 7 patients (33%), alopecia in 11 pa- tients (52%) and arthralgia-myalgia in 3 patients (14%). The overall response rate: 14 PR (66.67%) (%95 Cl: 43.03-85.41), 7 SD (33.33%) (%95 Cl: 14.59- 56.97). Median overall survival was 13 months (95% Cl, 7.60-18.40). Median time to progression was 4 months. As a conclusion low-dose, weekly paclitaxel regimen had clinical activity with low toxicity in patients with advanced NSCLC who had disease progression.

q 6 Combination chemotherapy with vinorelbine, ifosfamide and cisplatin in advanced non-small-cell lung cancer

Jin-Hvounq Kang’ , Do Ho Moon’ , Myung Ah Lee’, In Sook Woo’, Young Sun Hong2, Kyung Shick Lee’, Keon Hyon Jo3, Su-Mi Chung4. ‘Division of Medical Oncology, Kangnam St Mary’s Hospital, The Catholic University of Korea, Seou/, Korea; *Division of Medical Oncology St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea; s Department of Thoracic Surger)! Kangnam St Mary’s Hospital, The Catholic University of Korea, Seoul, Korea; 4 Department of Radiation Oncology, Kangnam St Mary’s Hospital, The Catholic University of Korea, Seoul, Korea

Purpose: We conducted this study to assess the anti-tumor efficacy and toxici- ties of combined treatment with vinorelbine, ifosfamide and cisplatin in patients with advanced non-small cell lung cancer (NSCLC).

Methods: Between Sep. 1999 and Jul. 2002, 27 patients who were diag- nosed as NSCLC at Kangnam St. Mary’s Hospital, were enrolled in the study. The combination chemotherapy of vinorelbine (25mg/ms on day 1, 8) ifos- famide (1,50Omg/m’ on days 1, 2 with mesna), and cisplatin (30mg/m* on day 1, 2, 3) was administered and repeated every 3 weeks. Tumor response was evaluated every 2 cycles and toxicities were assessed every cycle according to WHO criteria.

Results: There were 16 males and 11 females, and median age of patients were 56 years(range 37-69). One patient was stage IIIA, 9 lllb and 17 IV. Performance status (ECOG) of 20 patients were 0 or 1, and 7 were 2. Eigh- teen patients were adenocarcinoma, 8 squamous cell carcinoma and 1 large cell carcinoma. Fifteen patients were chemotherapy naive and the others were the patients who were previously treated with chemotherapy. Nine partial re- sponses were observed with 1 complete response and overall response rate was 39%. During a total of 108 cycles, grade 3-4 neutropenia occurred in 53%, grade 3-4 thrombocytopenia in 17%, grade 3-4 anemia in 8%, and grade 3 nau- sea/vomiting in 8%. No significant change in nadir WBC of each cycle was seen during NIP chemotherapy. However, in spite of pack RBC and platelet transfu- sion, nadir of hemoglobin and platelet gradually decreased from the 1st to 6th cycles of chemotherapy. The mean duration of overall survival was 31 weeks (range 6-l 18).

Conclusion: These results suggest that combination chemotherapy with vi- norelbine, ifosfamide, and cisplatin are effective and tolerable in the patients with advanced NSCLC. Because poor anti-tumor efficacy and severe toxici- ties were observed in the prior chemotherapy subgroup, clinical development of combination chemotherapy including novel anti-cancer drugs is warranted.

0 7 A Phase II Study on Combination of Carboplatin with Docetaxel in Advanced Non-small Cell Lung Cancer

Hideharu Kimura, Kazuo Kasahara, Tomoyuki Araya, Takashi Sone, Toshiyuki Kita, Kazuhiko Shibata, Hiromoto Shintani, Masaki Fujimura, Shinji Nakao. Kanazawa Lung Cancer Chemotherapy Group, Kanazawa-city, Japan

Efficacy and tolerability of a single agent carboplatin or docetaxel as well as their combination have been well documented in advanced NSCLC. Our pre- vious phase I study revealed that the recommended dose for the combination therapy was using tAUC 5.5 of C and 60mg/m* of D in Japanese NSCLC pa- tients (Jpn J C/in Oncol2002; 32(12) 512-516). Purpose: To evaluate the ef- ficacy and safety profile of the combination therapy with C and D as a front

line treatment in advanced NSCLC patients (pts). Eligibility: Stage $VB or $W, chemo-naive with measurable diseases, 575 yrs, PS O-2, adequate organ func- tions and written informed consent.

Treatment schedule: Pts were treated with C (tAUC 5.5) and D (60mg/m”) on dayl, every 3 weeks.

Results: 39 pts (27 male/l2 female) were evaluable for responses and tox- icities. Median age was 66 (range 39-75). PS 0, 1, 2: 24, 12, 3. Stage $V,$W: 17, 22. Histological diagnoses were squamous cell carcinoma in 10, adenocar- cinema in 25, and large cell carcinoma in 4. The median treatment course was 3 (range, l-6). One pt (2.6%) achieved CR, 13 (33.3%) PR, 17 (38.5%) SD, and 8 (17.9%) PD. The median survival time was 372 days. The l-year survival rate was 53.8%. The progression free survival was 155 days. A total of 117 courses in all patients were evaluable for toxicity. Among all treated courses assessed, grade 3 and 4 toxicities included leukocytopenia in 33.3% of courses, neutrope- nia 56.4%, anemia 8.5%, thrombocytopenia 1.7%. No courses in any patients were associated with grade 3 or 4 of nonhematological toxicities.

Conclusion: Combination chemotherapy with C and D is safe and effective in pts with advanced NSCLC.

0 8 Gemcitabine-cisplatin as first-line treatment of non-small cell lung cancer (NSCLC): The Hungarian experience

Gabor Kovacs’ , Gyula Ostoros’ , Erzsebet Gergely-Farmost , Pal Magyars, Klara Szondy’, Janos Strausz3, EnikB Ferenczi3. ‘National Koranyi Pulmonology Institute, Budapest, Hungary; 2 Semmelweis University Pulmonology C/inic, Budapest, Hungary; 3 Pulmonology Institute, T&iikbB/int, Hungary

Introduction: This Hungarian clinical trial investigated the efficacy and safety of the gemcitabine-cisplatin combination as first-line treatment of NSCLC.

Objectives: Primary endpoint: response rate (RR). Secondary: median sur- vival (MS), time to progression (TTP), and toxicity.

Methods: Between May 1999 and June 2001, 120 chemotherapy-naive pa- tients with NSCLC received gemcitabine 1250 mglms IV on days 1 and 8, and cisplatin 70 mg/m* IV on day 1, every 3 weeks.

Results: 120 patients enrolled; all were evaluable. Patient characteristics: median age 53.1 years (range, 29-72) M/F 65%/35%, and WHO PS O/l: 32 (27%)/88 (73%). Staging: llla (23%) lllb (37%), IV (40%). Histology: adenocar- cinema 64 (53.3%) patients; squamous-cell 48 (40.0%); mixed-cell 3 (2.5%); macrocellular 1 (0.8%) NSCLC, but not identified 4 (3.3%). Patients received a minimum of 2 cycles of chemotherapy, a total of 452 cycles, and a median of 3.44 cycles. Overall RR was 40.0%, with a CR in 2.5% of patients and PR in 37.5%. Minor response was seen in 13.3%, and SD in 25.0% of patients (22% progressed). (Responders during the first and second cycles maintained responses in the third and fourth cycles.) Overall MS was 54.9 weeks (Kaplan- Meier estimator); 62.1 weeks for responders; 59.1 for SD+MR; and 34.4 for PD. Overall TTP was 28.1 weeks; 34.1 weeks for responders; and 29.8 for SD+MR. Safety profile included the following grade 3/4 hematologic toxicity: neutrope- nia 20 cycles (4.4%) anemia 15 (3.3%) thrombocytopenia 10 (2.2%) febrile neutopenia 4 (0.9%). Nonhematologic toxicity: grade 3/4 vomiting 215 cycles (47.6%) alopecia 17 (3.8%), allergic reaction 4 (0.9%).

Conclusion: The gemcitabine-cisplatin combination is an active and well tol- erated regimen as first-line treatment of NSCLC. Moreover, a special reimburse- ment system (of the National Health Insurance Fund) may allow this combina- tion to be available for large groups of eligible patients.

0 9 Docetaxel in pre-treated advanced non-small cell lung cancer Katrin Wiesenberqer, Gudrun Pohl, Lilian Doweik, Reza Malayeri, Gerhard Krajnik, Wilma Minar, Robert Pirker. Division of Onco/ogy, Department of Internal Medicine I, University of Vienna, Vienna, Austria

We evaluated both efficacy and toxicity of docetaxel in pre-treated patients with advanced non-small cell lung cancer. Thirty-eight patients received 75 mg/ms docetaxel every three weeks. The characteristics of the patients were: 24% female, 76% male; age median 58 years, range 41-82; 20% ECOG 0, 77% ECOG I, 3% ECOG 2; 13% stage 1118, 87% stage IV; 83% adenocarcinoma, 10% squamous cell carcinoma, 7% large cell carcinoma; 24 (63%) patients had been pre-treated with one chemotherapy protocol and 14 (37%) with two or more chemotherapy protocols. Patients received l-6 (median 4) cycles of chemotherapy. Thirty-three patients were evaluable for both response and tox- icity. Four (12%) patients achieved a partial response, 17 (52%) patients had stable disease and 12 (36%) patients had progressive disease. Symptom relief was obtained in 47% of the symptomatic patients. Median time to disease pro- gression was 4 months. The median overall survival time was 9,7 months and the 1 -year survival rate was 38%. WHO grade 3 toxicity included neutropenia in 10 (26%) patients, anemia in 1 (2,6%) patient, neurotoxicity in 1 (2,6%) patient and diarrhea in 4 (10,5%) patients. WHO grade 4 toxicity included neutropenia in 1 (2,6%) patient. One patient (2,6%) had a mild allergic reaction. None of