Combination chemotherapy for non-small cell lung cancer with cisplatin (CDDP) and vindesine (VDS) or...

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113 signed. 13 evaluable patients have now been treated. Efficacy has been maintained with 1/13 CR and 5/13 PR for a total RR of 46%. Median survival has not been reached. Leukopenia/thrombocytopenia and neurotox- icity continue to be seen. However, nephro- toxicity continue to be seen. However, ne- phrotoxicity has only been seen in (1/13 (8%) and a possible decrease in severity of anemia has been noted. Additional modifications of dose and schedule may maintain this excellent rate of activity while further reducing toxi- city. A Randomized Study of Cisplatin (C) Versus Cisplatin (C) Plus Vindesine (V) in Non- Small C~II Carcinomalof the L1,n~ r~qc1 c~ Tsur~ta , M., Furus~ , K., Arai ~ R., Ko- dama2, N., Yamatom~-, M., Negoro-, S., Ta- kada , M., Fukuoka-, M..I. Department of Med. Natl. Kinki-chuo Hospital for Chest Disease, Sakai, Japan. 2. Department of Med., Osaka Prefectural Habikino Hospital, Osaka, Japan. From Sept. 1983 to June 1984, 84 patients (pts) with NSCLC were entered into a ran- domized, controlled study comparing the two induction regimens of C (80 mg/m intra- venously on day 1 ann 29) versus C (80 mg/ intravenously on day 1 and 29) and V ~3 mg/m intravenously on day 1,8,15, 29, 36 and 43). 80 pts were evaluable; 6 of 41 pts (14.6%) responded to the regimen C, 14 of 39 pts (35.9%) responded to the regimen C+V. Median duration of remission was 17 weeks for regimen C and 20 weeks for regi- men C+V. The major toxicities for both induction regimens were vomiting and anorexia. Espe- cially, alopecia, peripheral neuropathy and stomatitis were frequently observed in the pts treated with regimen C+V. Leukope- nia (< 4000) occurred in 20% of pts on regimen C and 85% of pts on regimen C+V. Anemia occurred in 30% of pts on regimen C and 78% of pts on regimen V+C. But, the- re was no toxic death. It was concluded that CDDP plus vinde- sine combination was clearly an active in- duction regimen in NSCLC. Combination Chemotherapy For Non-Small Cell Lung Cancer With Cisplatin (CDDP) and Vin- desine (VDS) or CDDP and ACNU. Shimabukuro, Z., Shibuya, M., Yano, T., Niitani, H. Department of Clinical Patho- logy, Nippon Medical School, Tokyo, Japan. Yoshimura, A., Hasegawa, K., Tsuboi, E. Tsuboi Memorial Cancer Institute, Fukushima, Japan. A randomized phase II trial of CDDP in combination with VDS or ACNU was plan- ned to compare the tumor effect by both regimens and to examine the suppressive effect of ACNU on brain metastasis in 37 patients with non-small cell lung cancer (adenocarcinoma 20 patients, squamous cell carcinoma 15 patients, large cell carcinoma 2 patients). The therapeutic regimen of CDD~ and VDS consi- sted of CDDP at a dose of 80 ~g/m i.v. on day 2 and VDS at a dose of 3 mg/m i.v. on day i, 8 and 15, repeated every 5 weeks. Patients treated with CD~P and ACNU received CDDP at a dose of 80 mg/m i.v. on day 1 and ACNU at a dose of i00 mg/m 2 i.v. on day 3 every 5 weeks. In the CDDP and VDS arm, we observed two partial response (squamous cell carcinomas) among 15 evaluable patients, for an overall re- sponse rate of 13.3%. One complete and partial response (squamous cell carcinomas) was obtained among 20 evaluable patients, for an overall re- sponse rate of 10% in the CDDP and ACNU ~rm. Although leukopenia less than 2000/mm were obtained in 60% of cases with CDDP and VDS, in 40% of cases with CDDP and ACNU respectively, and thrombocytopenia less than 5 x I0 /mm were observed in 50% of cases with CDDP and ACNU, no toxic death was experienced. As an interim result, no differences were obtained both in response rate and toxic effects between two regimens. Suppressive effect of ACNU on brain metastasis is obscure for lack of sa- tisfactory observation periods at present. Results of Combination Therapy of Carboquone, Cisplatin and OK-432 to Primary Non-Small Cell Lung Cancer. Nakarai, I., Shinoda, A. National Sanatorium Ohmuta Hospital, Fukuoka, Japan. Three drugs combination therapy has been per- formed to obtain the response of not less than 50% to un-operable non-small cell lung cancer. Patients: Histology Clinical Stage Squamous Cell Ca. 14 cases Grade 1 1 case Adenocarcinoma 12 cases - 2 0 Large Cell Ca. 3 cases - 3 9 cases Unknown 1 case - 4 20 cases Drugs: One course is composed of OK-432 (OK, lyophi- lized powder of Su-strain of streptococcus pyo- genes) (I KE/body I.M. day 1 - day 6), carboquone (CQ, etgylene-imine-quinone, alkylating agents) (7 mg/m 9i.v. day 7 and 9) and cisplatin (C) (70 mg/m- i.v. day 8). Another course was taken after 5-6 weeks. Results: Evaluable cases 30 cases Complete remission 0 Partial remission 16 cases Response rate 53% Side effects: Hematologic toxicity; Nadir has been shown at the second week after CQ administration on white blood cell count and platelet count, but tendency of recovery has been observed after 2 or 3 days.

Transcript of Combination chemotherapy for non-small cell lung cancer with cisplatin (CDDP) and vindesine (VDS) or...

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signed. 13 evaluable patients have now been treated. Efficacy has been maintained

with 1/13 CR and 5/13 PR for a total RR of 46%. Median survival has not been reached. Leukopenia/thrombocytopenia and neurotox- icity continue to be seen. However, nephro- toxicity continue to be seen. However, ne- phrotoxicity has only been seen in (1/13 (8%) and a possible decrease in severity of anemia has been noted.

Additional modifications of dose and schedule may maintain this excellent rate of activity while further reducing toxi- city.

A Randomized Study of Cisplatin (C) Versus Cisplatin (C) Plus Vindesine (V) in Non- Small C~II Carcinomalof the L1,n~ r~qc1 c~ Tsur~ta , M., Furus~ , K., Arai ~ R., Ko- dama2, N., Yamatom~-, M., Negoro-, S., Ta- kada , M., Fukuoka-, M..I. Department of Med. Natl. Kinki-chuo Hospital for Chest Disease, Sakai, Japan. 2. Department of Med., Osaka Prefectural Habikino Hospital, Osaka, Japan.

From Sept. 1983 to June 1984, 84 patients (pts) with NSCLC were entered into a ran- domized, controlled study comparing the two induction regimens of C (80 mg/m intra- venously on day 1 ann 29) versus C (80 mg/

intravenously on day 1 and 29) and V ~3 mg/m intravenously on day 1,8,15, 29, 36 and 43).

80 pts were evaluable; 6 of 41 pts (14.6%) responded to the regimen C, 14 of 39 pts (35.9%) responded to the regimen C+V. Median duration of remission was 17 weeks for regimen C and 20 weeks for regi- men C+V.

The major toxicities for both induction regimens were vomiting and anorexia. Espe- cially, alopecia, peripheral neuropathy and stomatitis were frequently observed in the pts treated with regimen C+V. Leukope- nia (< 4000) occurred in 20% of pts on regimen C and 85% of pts on regimen C+V. Anemia occurred in 30% of pts on regimen C and 78% of pts on regimen V+C. But, the- re was no toxic death.

It was concluded that CDDP plus vinde- sine combination was clearly an active in- duction regimen in NSCLC.

Combination Chemotherapy For Non-Small Cell Lung Cancer With Cisplatin (CDDP) and Vin- desine (VDS) or CDDP and ACNU. Shimabukuro, Z., Shibuya, M., Yano, T., Niitani, H. Department of Clinical Patho- logy, Nippon Medical School, Tokyo, Japan. Yoshimura, A., Hasegawa, K., Tsuboi, E. Tsuboi Memorial Cancer Institute, Fukushima, Japan.

A randomized phase II trial of CDDP in combination with VDS or ACNU was plan- ned to compare the tumor effect by both

regimens and to examine the suppressive effect

of ACNU on brain metastasis in 37 patients with non-small cell lung cancer (adenocarcinoma 20 patients, squamous cell carcinoma 15 patients, large cell carcinoma 2 patients).

The therapeutic regimen of CDD~ and VDS consi- sted of CDDP at a dose of 80 ~g/m i.v. on day 2 and VDS at a dose of 3 mg/m i.v. on day i, 8 and 15, repeated every 5 weeks. Patients treated with CD~P and ACNU received CDDP at a dose of 80 mg/m i.v. on day 1 and ACNU at a dose of i00 mg/m 2 i.v. on day 3 every 5 weeks.

In the CDDP and VDS arm, we observed two partial response (squamous cell carcinomas) among 15 evaluable patients, for an overall re- sponse rate of 13.3%. One complete and partial response (squamous cell carcinomas) was obtained among 20 evaluable patients, for an overall re- sponse rate of 10% in the CDDP and ACNU ~rm.

Although leukopenia less than 2000/mm were obtained in 60% of cases with CDDP and VDS, in 40% of cases with CDDP and ACNU respectively, and thrombocytopenia less than 5 x I0 /mm were observed in 50% of cases with CDDP and ACNU, no toxic death was experienced.

As an interim result, no differences were obtained both in response rate and toxic effects between two regimens. Suppressive effect of ACNU on brain metastasis is obscure for lack of sa- tisfactory observation periods at present.

Results of Combination Therapy of Carboquone, Cisplatin and OK-432 to Primary Non-Small Cell Lung Cancer. Nakarai, I., Shinoda, A. National Sanatorium Ohmuta Hospital, Fukuoka, Japan.

Three drugs combination therapy has been per- formed to obtain the response of not less than 50% to un-operable non-small cell lung cancer. Patients:

Histology Clinical Stage

Squamous Cell Ca. 14 cases Grade 1 1 case Adenocarcinoma 12 cases - 2 0 Large Cell Ca. 3 cases - 3 9 cases Unknown 1 case - 4 20 cases

Drugs: One course is composed of OK-432 (OK, lyophi-

lized powder of Su-strain of streptococcus pyo- genes) (I KE/body I.M. day 1 - day 6), carboquone (CQ, etgylene-imine-quinone, alkylating agents) (7 mg/m 9i.v. day 7 and 9) and cisplatin (C) (70 mg/m- i.v. day 8). Another course was taken after 5-6 weeks. Results: Evaluable cases 30 cases Complete remission 0 Partial remission 16 cases Response rate 53% Side effects:

Hematologic toxicity; Nadir has been shown at the second week after CQ administration on white blood cell count and platelet count, but tendency of recovery has been observed after 2

or 3 days.