340

90

341

LONG TERM SURVIVAL AFTER CHElblOTHFBAPY IN PATIENTS WITH ADVANCED UMfESRcTABwE NON SMALL CELL LUNG CANCER (T’BCLQ : A REPORT BY THE EUROPEAN LUNG CANCER WORKlNG PARTY. J.P. Sculier, M. Paesmans, P. Libert, G. Bureau J. Thiriaux, 0. Van Cutsem, P. Mommen, J. Klastemky. Institut Jules Bordet, Btuxelles, Belgium.

Prognosis of patients with unresectable NSCLC is poor. Since 1980, the European Lung Cancer Working Party has conducted several &_l_ ____1_._11__ .._>_.._ _l.-_rl-.. -_I-___ ^_J .._t__ _I_ti_._- lrnus e”amaoug “LLn”us cuem0ulelzFy ~giruens an” uslug pniunum derivatives as central agents. By September 1991, 1052 patients have been included into these trials : 927 (88 %) were evaluable for the present analysis, among which 65 (7 %) were long term survivors (LTS), defined as patients surviving for at least 2 years after the start of chemotherapy. The overall survival of these LTS is at present the following : &xgA(years) 2i3 3;” 465 5p 627 7-T tt$

dead : Ii&d: 2 :: :: :. ii;

Prognostic factors analysis was performed by uni-and multivariate methods, considering age, sex, loss of body weight, histological type, prior therapy, Karnofsky PS, disease extent, type of lesions, metastatic sites, and various biological parameters. Limited disease, normal leucocytosis, normal granulocytosis and absence of liver metastases were found to be significant factors associated with better long-term survival at univariate analysis. By multivariate analysis, only disease extent appeamd to be a significant prognostic factor. The impact on long-term survival of response to chemotherapy was evaluated in the 721 patients who survived at least 12 weeks. Objective response (OR) rates were respectively 58 % in survivors 22 years and 32 % in those surviving < 2 years. In a logistic regression model, OR and limited disease appeared to be the two most significant parameters for predicting LTS. All of the > 5 year LTS were treated subsequently by chest irradiation and/or sugery, failing to demonstrate NSCLC cure by chemotherapy alone.

ANALYSIS OF SURVIVAL DATA IN 1052 PATIENTS g ANi&V~‘NRESECTARLE NON SMALL

: APPLH2ATION OF A REcuRSIvE PAR?lTmraN G AND AMALGAMATION ALGORITHM (RECPAM). M. Paesmans, J.P. Sculier, P. Libert, G. Bureau, 0. Van Cutsem, J. Thhiaux, P. Mommen and J. Klastersky for the Emopean Lung Cancer Working Party. Institut Jules Bordet, Bruxelles, Belgium.

August 1991, 1052 eligible patients with advanced unresectable non small cell hmg carcinoma (NSCLC) were registered in one of seven consecutive clinical trials testing a chemotherapy regimen based on cisplatin or carboplatin. We collected, prospectively, 23 pretreatment variables includii sex (male : 945, female : 107 patients), loss of weight (< 5 % : 663, B 5 46 : 302 patients), Karnofw performance status (5 70 : 440, 2 80 : 612 patients), disease extent (limited : 383, metastatic : 669 patients!, age, histology, prior therapy, type of lesions, metastatrc sites and various biological variables which were dichotomized according to normal laboratory ranges. The impact of these pretreatment variables on survival was analyxed retrolectively. At the time of analysis, we reached a medii follow-up of 270 weeks with less than 10% of censored data. We applied to these censored data a RECPAM algorithm in order to identify a classification of the patients into subgroups homogemtous for survival. The splitthrg variables were : disease extent, performance status and white blood cell count, neutrophil count, weight loss and sex, resulting, after amalgamation, in the obtention of four groups of patients with, respectively, estimated median survival times of 60, 38, 24 and 18 weeks. These results were in accordance with those obtained when fitting the data with a forward stepwise Cox regression model. The classification needs now to be validated in another series of patients.

342

AN ESTIMATE OF THE COST-EFFECTIVENESS OF COMBINED MODALITY THERAPY FOR STAGE IIIb NSCLC IN CANADA. W.K. Evans, B.P. Will, M.C. Wolfson, J.F. Gentleman, J-M Be&slot. Ottawa Regional Cancer Centre and Statistics Canada, Ottaws, Canada.

Rising health care costs are forcing a critical evaluation of the coot and cost-effectiveness of new treatmsnt stratepies. Statistics Canada has developed a microsimulation model of lung cancer (MMLC) which can he used to estimate the impact of new therapies such as combined modal&y tmatrnsnt (CMT) ti staga W NSCLC. The MMLC incorpaatea information on +8ttc&., staging and treatment by stage and cell type

_ . . based on &&sonm lxac&e panems. Fttutisned Suthd reSUhS by S&&S

and co-St data from previous costing shdies, hospital per diem costs and fee schedules are inch&d in the model. costing is in 1988 Canadian dollars.

Based on a survey of &radian radiation oncolo8ista (n48), 80% of patients with stage II& NSCLC are treated with radiotherapy (XRT) (35 Gy in 10 tractions) (20% no @eatme@ The cost of standard therapy was detemdnedandincludedintheMMLC. ResultsofCMTforstageWare encaunging (Dillman et al. NlHM 323: 940, 1990). The cost of 2 cycles of vinblastim and cisplatin, in&din8 hospitahition, and XRT (60 Gy in 3O~s)wascostedand~etatalinclementalcosttothecanadian health cam systsm and the cosr-eft+ctiveness of therapy relative to standard therapyweredeterm&d Thetirstyearcostsofueatingthe1605casesof Stage IEb NSCLC in Canada in 1988 (12.8% of NSUC) were as follows: no treatment, 848oo/csse; standard XRT, 87229lcase; CMT S13,886!ease. Theimemntalcmtpercaseishigh(S6,657)asisthetotalcasttothe health care system ($6.6 million). However, the &mated Me years gained withC~wouldbe2,274yesFJandtraaslstetoacostpesLifeyearBained of only $2,898. CMT appears to be highly cost-effective in the context of Cam&an health care.

343

Rowland. SH June. CL Lonrinxi. JI-I Washburn. EG Shaw for the North Central Cancer Treatnent’Group, and Rochester, MN 55905 Urbana, IL

M is a progestational agent that has been shown to be effective in manaaement of cancer related anorexia and cachexia. We hypothe&ed that early use of M in combination with chemotherapy would have a positive influence on survival and quality of life (QOL). 237 pts with extensive stage SCLC were treated with P (30 mg/m2/d) and E (100 mg/m2/d) daily X3 every 28d for 4 cycles. M (800 mg PO q.d.) or placebo was started on day 3-5 of the ftrst cycle of chemotherapy and continued indeEnitely unless they experienced undue toxicity. Patients with CR outside of the chest after 4 cycles of PE received thoracic radiotherapy (5040 &y/28 Fx). We used a modified visual analog scale (VAS) and FLIC questionnaire to assess QOL. Treatment groups were well balanced for prognostic factors. Overall tumor response rates and survival favored the placebo arm.

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Pts taking M had less anorexia (p=.O2), nausea (p=.O3) and vomiting (p=.O3), but they had more deep vein thromboses (12~~2) p=.Ol and grade 5 infections (1 lvs4) p=.ll. QGL from the VAS was superior for the placebo arm (p=.O2).

Gur study indicates that early use of M is associated with an inferior response to PE chemotherapy and may be associated with inferior survival. Pts on M had an increased incidence of deep venous thrombosis and possible increase in fatal treatment-related infections.