L-l 61 Can carboplatin-etoposide substitute for cisplatin- etoposide in the treatment of all patients with small cell lung cancer? E. Samantas, D. Skarlos, N. Milonakis, G. Klouvas, N. Pavlidis, G. Fountzilas, C. Bamias, P. Kosmidis. HeCOG Data Office, Athens, GR From 1987 until 1991, a total of 147 patients with SCLC were randomly treated with the combination of etoposide and cisplatin (EP) or etoposrde and carboplatin (EC) and chest irradiation. Details of thts study have been prevrously published (Ann Oncol 5: 601607, 1994). The purpose of this study is to compare the ‘durability’ of responses and the long-term survival rates achieved by the 2 regimens. Nineteen patients (10 EP, 9 EC) survived for more than 2 years and were eligible for the present analysis. Patients were simtlarly stratified according to the stage of the disease, PS, sodium and alkaline phosphatase. Results: (EP vs EC): a) Response rate: CR 80% (95% Cl: 44%-97%) vs 67% (95% Cl: 30%-93%) PR 10% (95% Cl: c&45%) vs 33% (95% Cl: 7%-70%) b) Ov. Surv (months): Median: 46 (28-Sl+) vs 48 (28-lOO+) c) TTP (months): Median: 44 (4-Sl+) vs 24 (3-lOO+) d) DFS (months): Not reached yet vs 48.43 (27.67-98.98+). There were no statistically significant differences in median TTP, median DFS and median OS between the two groups. As of November 1996, after a median follow-up of 88 months (range 27-100) 7 pts are still alive, 5 in the EP and 2 in the EC Group. Conclusion: Carboplatin appears to be equally active with cisplatin regarding the ‘durability’ of responses and the probability of long-term survival in SCLC patients. cl 62 Phase II study of paclitaxel (Taxol@) and cisplatin (CDDP) in advanced oleural malignant mesothelioma (MM) ’ Ft. Caliandro’, C. Boutin *, M. Perol 3, I, Monnet4, G. Dabouiss, J.C. Guerin3, T. Le Chevalier’, P. Ruffie’. ‘Institut Gustave Roussy, Wejuif; ‘H6pital de /a Conception Marseille; 3 H6pifal de /a Croix Rousse, Lyon; 4 Centre Hospitalier lntercommunal de Cn ?il; 5 Centre Hospitalier Universitaire de Nantes, France MM is a rare chemoresistant tumor and chemotherapy (CT) remains con- troversial in its management, CDDP and Taxol have shown low antitumor activity in clinical trials, but are synergistic in e .,Jerimental MM models. A french multicenter phase II study was initiated with the recommended doses from lung cancer studies: paclitaxel 200 mg/m* I.V. over 3 hours Dl, CDDP 100 mg/ms I.V. Dl, q 3 weeks with a maximum of 6 cycles. Responses were evaluated every 6 weeks. Between 11195 and 05/96, 18 untreated patients (pts) were included. Patients characteristics were: male/female 15/3, median age: 58 (35-70), WHO PS 51, I.M.I.G. stages: lb = 2, II = 5, III = 9, IV = 2, histologic subtype: epithelial: 15, biphasic = I, desmoplasttc = 2. Results: 17 pts were evaluable for the response and toxtcity analysis. Pts received a median of 3 cycles (l-6). Toxicity (WHO grade/pts): grade 3-4 nausea/vomiting: = 5, grade 3-4 neutropenia = 5, grade 3 anemia = 1, grade 1-2 neurotoxicity = 4, grade 2 renal toxicity = I. No toxrc deaths. 1 objective partial response was observed (6%) with 11 stabrlisations and 5 disease progressions. The median survival (MS) was 18 months from dragnostic. Median actuarial suwival from the beginning of CT hasn’t yet been reached to date. Conclusion: Taxol-CDDP is an ineffective treatment in MM, and these results don’t confirm in vivo promising data. MM persists to be a chemore- sistant tumor and other therapeutic approaches will be constdered. 0 63 Navelbine (NVB), and fractionated doses of cisplatin (CDDP) - 20 mo/m*/5 davs - in the management of advanded non-small cellslung cancer: An-overview of 3 phase II trials J. Rodrigues’, M. Pawlicki*, D. Firat3, J. Altino’, K. Krawczyk’, Baristas, F. Le Bras4, J.P. Burillon4, F.M. Delgado4. ‘ELAN do Brazil, Erazi!. ‘Oncology Centre, Krakow and lnstifute for Tuberculosis & Lung Disease, Warsaw, Poland, 3Ankara University Turkey, Turkey 4 lnsfitut de Recherche Pierre Fabre, France NVB has already shown an increased survival rate in randomised trials. The combination of NVB and CDDP have showed statistically superior survival compared with standard therapy (JCO 1994, ASCO 1996). Based on these data, 3 phase II studies were conducted in order to assess a new schedule of this combination: NVB 25 mg/ma (1 trial 30 mglm’) on day 1 & 5 and CDDP 20 mg/m2 daily over 5 days (day 1 to 5) every 21 days, for a maximum of 6 cycles, to make out patients administration easier. 127 (pts) were included between July 1994 and February 1996: median age 60 (34-75). 112 (88%) males; PS 0: 16%, PS 1: 55%, PS 2: 27%; 56% squamous cell carcinoma, 36% adenocarcinoma and 8% large cell carcinoma; 12% inoperable stage IIIA. 36% stage IIIB and 49% stage IV and 3% unknown (metastatic). 471 courses (median 4 range I-8) were administered. At least one episode of WHO grade (G) 34 neutropenta was observed in 12% of pts. The incidence infection episodes was very low (1.4% of courses: G3-4). Significant (G 3) nausea/vomiting was seen only in 18% of pts corresponding to 5.4% of cycles. Only 4% of pts developed WHO grade 3 constipation and grade 3-4 peripheral neuropathy was observed in 9% of patients (2.4% G 4). 12% of patients developed grade 3 alopecia. Other side effects were uncommon. The overall response rates observed in Brazilian, Polish and Turkish studies are 46%, 47% (N 30 mg/m2) and 29% respectively; median time to progression: 7.4 months and medtan survival IS: 9.2 months These results confirm that Navelbine + CDDP combination has constant and reproducible major antitumour activity in NSCLC. This new schedule of NVB + CDDP seems well suited for the use in the out patient treatment of non-small cell lung cancer. u.. 64 A phase II study of docetaxel (Taxotere@) alternating wrth crsplatin with full doses of both drugs for advanced NSCLC K. Mattson ’ , J. Vansteenkistes, A. Saarinen 3, M. Bargetzi 4, G. Fillet’, E. Teixeira5, U. Gatzemeier6, F. Soulas7, K. Soussan-Lazard’, J. Berille 7, N. Bougon ‘, A. Jekunen ‘. ’ He/sin/d University Central Hospital, Fin/and, *, Belgium, 3, Fin/and, 4, Switzerland, 5, Portugal, 6, Germany 7RhBne-Poulenc Rorer Research Group, Antony France Forty-four chemotherapy-naive patients with metastatic or unresectable localised NSCLC have been treated wrth docetaxel (100 mg/m*, 1 h-r in- fusion) in cycles 1, 3 and 5 and with cisplatin (120 mg/ms or 100 mg/ms, [cycle 6 only], 3-hr Infusion) in cycles 2, 4 and 6. Each cycle lasts 3 weeks. 5-day Prednisolon pre-medication is given with each docetaxel infusion and preventive antiemetic treatment with each cisplatin infusion. 32 pts had metastatic disease and 12 pts locally advanced disease. There were 34 men and 10 women. Median PS was 80% (Karnofsky), 45% of tumours were squamous cell carcinoma, 32% adenocarcinoma and 18% large cell carcinoma. 7 pts (16%) had prior radiotherapy and 4 pts (9%) prior surgery. The mean number of cycles given was 5 (range I-9). Among the 44 patients evaluable for toxicity, there was no toxic death; 27 pts (63%) expe- rienced grade 4 neutropenra and 6 pts (13.6%) febrile neutropenia. 38 pts are evaluable for response: response rate 33% (30% intent-to-treat); the median duration of response was 10 months, the median time to progres- sion was 4 months and the median survival was 8.8 months. This method of combrnrng docetaxel and cisplatin allows the full dose of both drugs to be administered. The combination has significant activity in NSCLC. However, we await the l-year survival figures before making final conclusion on the optimal way of combining cisplatin and docetaxel in NSCLC. El 65 Weekly paclitaxel - Marked activity, diminished toxicity and platelet stimulating effect W. Akerley, H. Choy, H. Safran, W. Sikov, V. Rege, S. Sambandam, J. Josephs, E. Wittels. Brown University Oncology Group (BUOG), Prowdence, RI, USA In a previous phase I study of Paclitaxel (P) using a weekly schedule, we demonstrated diminished toxicity and determined the maximum-tolerated dose to be P 175 mglm2iwk (P ASCO 15: 1122, 96). This represented a 2-fold increase rn dose intensity and provided the background for this phase II study of P for patients with chemotherapy-naive, advanced NSCLC. P 175 mg/m2 was administered over 3 hours for weeks l-6 of an 8 week cycle with doses modification for ANC <I500 or neuropathy zgrade 2. Stable and responding patients continued therapy until progression. Data is presented on the first 25 patients, The median age is 65 (38-78) with 18 males and 7 females, PS = 0.1 in 23, prior RTX in 14 and stage IV in