1
274 Mucositis (grade II in six patients, grade III-IV in seven patients) was the dose-li- miting toxicity, especially in Group 2. These responses to cisplatin bolus and 5-FU infusion in patients with non-small cell lung cancer were not greater than those achieved with other cisplatin-containing regimens. However, this combination does have activity and might be effectively com- bined with radiation therapy as has been done for carcinomas of other sites. Phase II Study of Vindesine in Patients with Non-Small Cell Lung Cancer. Fujita, J., Saijo, N., Eguchi, K. et al. Department of Internal Medicine, National Cancer Center, Chuo-ku, Tokyo 104, Japan. Jpn. J. Cancer Res., Gann 76: 902-905, 1985. A phase II of vindesine (VDS) was car- ried out in 21 patients with non-small cell lung cancer (NSCLC). There were 13 and 8 patients with and without prior chemotherapy, respectively. VDS wa~ administered at a week- ly iv dose of 3 mg/m-. Partial response was observed in two of 15 adenocarcinomas and one of 2 adenosquamous cell carcinomas, and the overall response rate was 14.3% (3/21). Myelosuppression, especially leuko- penia, was the most common dose-limiting side effect. Neurotoxicity was also a common side effect but the degree was mild. I~ was concluded that VDS at a dose of 3 mg/m- every week seems to be active against NSCLC. Phase II Study of the Three-Drug Combination of Mitomycin C, CCNU, and Methotrexate (MC~ in Advanced Non-Small Cell Lung Cancer. Eagan, R.T., Frytak, S., Richardson, R.L. et al. Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, U.S.A. Am. J. Clin. Oncol., Cancer Clin. Trials 9: 67-70, 1986. Ninety-two patients with advanced non- small cell lung cancer, 51 without prior chemotherapy exposure, were treated with the combination of mitomycin C, lomustine (CCNU), and methotrexate (MCM). Overall, the regression rate was 33%, the median regres- sion duration 4.9 months, and the median survival 4.9 months. Patients with ECOG performance shores (PSs) of 0-i had a sta- tistically significant higher regression rate than did patients with ECOG PSs of 2-3 (43% versus 15%; p = 0.005) as did patients without prior chemotherapy (41% versus 22%; p = 0.005). Cell type and prior chemothera- py exposure did not affect regression dura- tion, time to progression, nor survival. Sub- jective toxicity was quite acceptable. Cu- mulative myelosuppression was the most signi- ficant objective toxicity. MCM is a relati- vely effective combination chemotherapy re- gimen, even in patients with prior chemo- therapy exposure (predominantly doxorubicin and cisplatin-based chemotherapy). Vinblastine Plus Cisplatin in Advanced Non- Small Cell Lung Cancer: Lack of Advantage for Vinblastine Infusion Schedule. Huberman, M., Lokich, J., Greene, R. et al. Section of Medical Oncology, New England Deaconess Hospital, Boston, MA 02215, U.S.A. Cancer Treat. Rep. 70: 287-289, 1986. We have evaluated 31 patients with ad- vanced non-small cell lung cancer treated by short-term 5-day vinblastine infusion combined with bolus cisplatin. Nine of 31 patients (29%) had partial and complete re- sponses. Although five of nine (55%) of the responders were alive at > or = 1 year, three of the 31 patients experienced drug-related mortality. Out experience, as well as a re- view of previously reported trials in the literature, suggests that the infusion sche- dule of vinblastine offers no advantage over the bolus schedule. A Randomized Trial of the Four Most Active Regimens for Metastatic Non-Small-Cell Lung Cancer. Ruckdeschel, J.C., Finkelstein, D.M., Ettin- ger, D.S. et al. Albany Medical College, Division of Oncology, Albany, NY 12208, U.S.A.J. Clin. Oncol. 4: 14-22, 1986. Between October 1981 and June 1983, the Eastern Cooperative Oncology Group (ECOG) conducted a prospectively randomized trial (EST 1581) of the four most active chemo- therpay regimens for metastatic non-small- cell lung cancer (NSCLC). Four hundred eighty-~ix good performance status patients (PS 0 or i; 81%) were randomized to receive cyclophosphamide, doxorubicin, methotrexate, and procarbazine (CAMP); mitomycin, vinbla- stine, and cisplatin (MVP); etoposide and cisplatin (VP-P); or vindesine and cispla- tin (VDA-P). All regimens were administered in the doses and schedules originally repor- ted. Complete response (CR) plus partial response (PR) rates for the four regimens were CAMP, 17%; MVP, 31%; VP-P, 20%; and VDA-P, 25%. The response rate for MVP was significantly higher in patients with squa- mous and adenocarcinoma histologies, but there was not impact on median survival (overall, 24.5 weeks). The duration of re- sponse did not differ by treatment as previ- ously suggested for VDA-P. There were 15 CRs (CAMP, one; MVP, six; VP-P, two; VDA-P, six), and 12 patients have survived more than 2 years. Toxicity Was significant with 20 treatment-related deaths. CAMP was signi- ficantly less toxic than the other regimens (P < .001). VDA-P demonstrated significantly more life-threatening (seven) and lethal (three) episodes of nephrotoxicity (P < .001) -~espite an aggressive hydration program that in itself caused significant morbidity. Ana- lysis of the toxicity data showed, however, that most of the severe toxicity occurred in the 19% of patients who were initially PS2,

Phase II study of the three-drug combination of mitomycin C, CCNU, and methotrexate (MCM) in advanced non-small cell lung cancer

Embed Size (px)

Citation preview

274

Mucositis (grade II in six patients, grade

III-IV in seven patients) was the dose-li- miting toxicity, especially in Group 2. These responses to cisplatin bolus and 5-FU infusion in patients with non-small cell lung cancer were not greater than those achieved with other cisplatin-containing regimens. However, this combination does have activity and might be effectively com- bined with radiation therapy as has been done for carcinomas of other sites.

Phase II Study of Vindesine in Patients with Non-Small Cell Lung Cancer. Fujita, J., Saijo, N., Eguchi, K. et al. Department of Internal Medicine, National Cancer Center, Chuo-ku, Tokyo 104, Japan. Jpn. J. Cancer Res., Gann 76: 902-905, 1985.

A phase II of vindesine (VDS) was car- ried out in 21 patients with non-small cell lung cancer (NSCLC). There were 13 and 8 patients with and without prior chemotherapy, respectively. VDS wa~ administered at a week- ly iv dose of 3 mg/m-. Partial response was observed in two of 15 adenocarcinomas and one of 2 adenosquamous cell carcinomas, and the overall response rate was 14.3% (3/21). Myelosuppression, especially leuko- penia, was the most common dose-limiting side effect. Neurotoxicity was also a common side effect but the degree was mild. I~ was concluded that VDS at a dose of 3 mg/m- every week seems to be active against NSCLC.

Phase II Study of the Three-Drug Combination of Mitomycin C, CCNU, and Methotrexate (MC~ in Advanced Non-Small Cell Lung Cancer. Eagan, R.T., Frytak, S., Richardson, R.L. et al. Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, U.S.A. Am. J. Clin. Oncol., Cancer Clin. Trials 9: 67-70, 1986.

Ninety-two patients with advanced non- small cell lung cancer, 51 without prior chemotherapy exposure, were treated with the combination of mitomycin C, lomustine (CCNU), and methotrexate (MCM). Overall, the regression rate was 33%, the median regres- sion duration 4.9 months, and the median survival 4.9 months. Patients with ECOG performance shores (PSs) of 0-i had a sta- tistically significant higher regression rate than did patients with ECOG PSs of 2-3 (43% versus 15%; p = 0.005) as did patients without prior chemotherapy (41% versus 22%; p = 0.005). Cell type and prior chemothera- py exposure did not affect regression dura- tion, time to progression, nor survival. Sub- jective toxicity was quite acceptable. Cu- mulative myelosuppression was the most signi- ficant objective toxicity. MCM is a relati- vely effective combination chemotherapy re- gimen, even in patients with prior chemo- therapy exposure (predominantly doxorubicin

and cisplatin-based chemotherapy).

Vinblastine Plus Cisplatin in Advanced Non- Small Cell Lung Cancer: Lack of Advantage for Vinblastine Infusion Schedule. Huberman, M., Lokich, J., Greene, R. et al. Section of Medical Oncology, New England Deaconess Hospital, Boston, MA 02215, U.S.A. Cancer Treat. Rep. 70: 287-289, 1986.

We have evaluated 31 patients with ad- vanced non-small cell lung cancer treated by short-term 5-day vinblastine infusion combined with bolus cisplatin. Nine of 31 patients (29%) had partial and complete re- sponses. Although five of nine (55%) of the responders were alive at > or = 1 year, three of the 31 patients experienced drug-related mortality. Out experience, as well as a re- view of previously reported trials in the literature, suggests that the infusion sche- dule of vinblastine offers no advantage over the bolus schedule.

A Randomized T r i a l of the Four Most Act ive Regimens fo r M e t a s t a t i c Non-Small-Cell Lung Cancer. Ruckdeschel, J.C., Finkelstein, D.M., Ettin- ger, D.S. et al. Albany Medical College, Division of Oncology, Albany, NY 12208, U.S.A.J. Clin. Oncol. 4: 14-22, 1986.

Between October 1981 and June 1983, the Eastern Cooperative Oncology Group (ECOG) conducted a prospectively randomized trial (EST 1581) of the four most active chemo- therpay regimens for metastatic non-small- cell lung cancer (NSCLC). Four hundred eighty-~ix good performance status patients (PS 0 or i; 81%) were randomized to receive cyclophosphamide, doxorubicin, methotrexate, and procarbazine (CAMP); mitomycin, vinbla- stine, and cisplatin (MVP); etoposide and cisplatin (VP-P); or vindesine and cispla- tin (VDA-P). All regimens were administered in the doses and schedules originally repor- ted. Complete response (CR) plus partial response (PR) rates for the four regimens were CAMP, 17%; MVP, 31%; VP-P, 20%; and VDA-P, 25%. The response rate for MVP was significantly higher in patients with squa- mous and adenocarcinoma histologies, but there was not impact on median survival (overall, 24.5 weeks). The duration of re- sponse did not differ by treatment as previ- ously suggested for VDA-P. There were 15 CRs (CAMP, one; MVP, six; VP-P, two; VDA-P, six), and 12 patients have survived more than 2 years. Toxicity Was significant with 20 treatment-related deaths. CAMP was signi- ficantly less toxic than the other regimens (P < .001). VDA-P demonstrated significantly more life-threatening (seven) and lethal (three) episodes of nephrotoxicity (P < .001)

-~espite an aggressive hydration program that in itself caused significant morbidity. Ana- lysis of the toxicity data showed, however, that most of the severe toxicity occurred in

the 19% of patients who were initially PS2,