of 1 /1
139 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 Fund. 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

Phase II trial of mitomycin, vindesine and cisplatin in the treatment of stage III non-small cell lung cancer (NSCLC)

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Page 1: Phase II trial of mitomycin, vindesine and cisplatin in the treatment of stage III non-small cell lung cancer (NSCLC)

139

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

Fund.

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