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years (range 35-70) and in 58 years (range
45-69) in the second series. No pt received previous chemotherapy and/or radiotherapy. After 3 courses of chemotherapy resulted that in group treated with low doses of cisplatin 12 pts reached partial response (PR = 26,7%), whereas in 28 pts was obser- ved stable disease (SD = 62,3%) and in 5 pts progression (P = 11%); the median du- ration of response resulted in 8 weeks (range 7-13) and the MST in 12 months (range 4-22+). In pts treated with high doses of cisplatin were observed i0 partial responses (PR = 30,4%), 16 stable disease (SD = 48,4%) and 7 progression ( p = 21,2%); the median duration of response resulted in i0 weeks (range 3-20+). The comparison between the two chemotherapeutic regimens shows that there are no substantial diffe- rences, except for the response rate which was slightly better in pts treated with high doses of cisplatin.
Cis-Platin~ and Alternating Vinblastine With Bleomycin Both by Continuous Infusi- on in Advanced Squamous Cell Carcinomas. Kocha, W. London Regional Cancer Centre, London, Canada, N6A 4G5.
40 patients with advanced non small cell lung carcinoma (26 squamous cell, 6 adeno- carcinoma, 1 large cell, 4 non small cell not otherwise specifiable), median age of 61 (28 male, 12 female) were treated ~ith a combination of vinblastine 1.6 mg/m-/day by continuous infusion x 4 days, ~is-diammi- ne dichloroplatinum (DDP) 25 mg/m-/day x 4 days alterngting every 4 weeks with bleo- mycin 3 y/m- i.v. (loading dose) followed by 6 u/m /day by continuous infusion x 4 days and DDP 25 mg/m-/day i.v. x 4 days. DDP was administered in 150 ml of 3% saline and preceeded by i.v. hydration. All received dexamethasone and metoclopramide as anti- emetics. The combination was administered either in hospital or with an ambulatory continuous infusion pump. 28 patients were evaluable for response. There were 7 ear- ly deaths: 4 due to disease, 2 due to causes unrelated to either treatment or primary disease and 1 treatment related death. 2 withdrew prior to evaluation and 3 were ineligible. There were 2/28 comple- te responses, 12/28 partial responses, 12/28 with stable disease and 2/28 with progressive disease, for an overall response rate of 50%. 10/16 (62%) with squamous cell and 2/3 with undifferentiated non small cell responded whereas only 2/8 with adenocarcinoma responded. Median duration of response was 8 weeks (6-27) and survi- val (median 20 weeks) was not significant- ly different between responders and non- responders. The regimen was well tolera- ted with only 14 experiencing nausea and
8 vomiting. The response of squamous cell
is better than adenocarcinoma but despite high
objective response rates, durations of response are brief and survival is not affected signifi- cantly. The search for more effective regimens needs to be continued.
Phase II Trial of Mitomycin, Vindesine and Cisplatin in the Treatment of Stage III Non- Small Cell Lung Cancer (NSCLC). Wertheim, M., Gralla, R., Kris, M., O'Connell, J., Fiore, J., Kelsen, D., Burke, M.T., Cibas, I., Heelan, R. Memorial Sloan-Kettering Cancer Center, New York, NY 10021, U.S.A.
91 patients (pts) with stage II~ NSCLC were treated with mitomycin (M) (82mg/m-) day i, 29 and 71; vindesine (V) (3 mg/m ) day 1,8,15,22, 2~ then every 2 weeks and cisplatin (P) (120 mg/ m ) day i, 29 then every 6 weeks. Each of these agents used singly has demonstrated response ra- tes of 15-25%. Previous studies of the combina- tion of M+V or V+P demonstrated a 36% and 37% response rate and 5.8 and 8.6 month response durations respectively. The objectives of this trial were to assess the effect of combining the 3 agents on: (i) response data and (2) toxicity. No pt had any prior chemotherapy. 88 pts (97%) are adequate for response. 55 pts had adenoca, 19 epidermoid ca and 14 large cell ca. 51 pts had PS=80-100, and 37 had PS=60-70. 64 pts (73%) were male and 34 pts (39%) had >5% weight loss prior to treatment. 26 pts were stage III MO and 62 were stage III MI. Major responses were noted in 52/88 or 59% of pts. Median response duration was 7.6 months. Pro- jected median survival is ii months for all pts and 14 months for major responders. Lowest median wbc=1950, platelets=132K; median peak se- rum creatinine=l.5 mg/dl. 15 pts (16%) required admission for fever during nadir wbc counts. There was no treatment related mortality. We conclude that (i) the combination of M+V+P has a high major response rate in pts with NSCLC; (2) combining these agents on this schedule moderately increases myelosuppression and (3) the addition of M on this schedule does not appear to increase response duration. A prospective randomized trial comparing M+V+P with V+P is underway. Supported by CA-05826 and the Tishberg
Combination Chemotherapy of Non-Small Cell Lung Cancer With Mitomycin O~), Vindesine (VDS) and Cisplatin (DDP). Joss, R.A., Ludwig, Ch., Alberto, P., Barrelet, L., Siegenthaler, P., Holdener, E., Bammatter, F., Cavalli, F. for the Swiss Group for Clini- cal Cancer Research (SAKK). SAKK-Operations Of- fice, Seidenweg 63, CH-3012 Bern, Switzerland.
Seventy-nine patients (pts) with NSCLC have been entered in an ongoing phase IIgtrial evalu- ating the qombination of MMC 8 mg/m~gi.v, day i, VDS 3 mg/m = day 1+8, and DDP 60 mg/m- i.v. day 1 with forced diuresis, repeated every 4 weeks. At a preliminary analysis performed in August 1984 37 pts were evaluable for response and
toxicity. The median age of the pts was 55 years