PHASE-II TRIAL OF ETOPOSIDE AND CISPLATIN IN PATIENTS WITH REFRACTORYAND RELAPSED NON-HODGKINS-LYMPHOMA - CANCER AND LEUKEMIA GROUP-B STUDY-8351

A phase-II study was conducted by the Cancer and Leukemia Group B (CAL GB) in patients with refractory and relapsed non-Hodgkin's lymphoma (N HL) to assess the activity of the combination of etoposide and cisplat in. Sixty-five patients were entered on study, and 51 patients were ev aluated for this report. The treatment regimen consisted of etoposide, 80 mg/m2 IV daily times 5 and cisplatin 20 mg/m2 IV daily times 5, re peated every 21 days. All patients had failed 1-3 prior chemotherapeut ic regimens, had measurable disease, and had a performance status of 0 -2. In the 51 evaluable patients, there were 4 complete responses (8%) and 12 partial responses (23%), for an overall response rate of 31% ( 95% CI: 19%, 46%). In addition, 15 patients (29%) had some improvement in disease and 6 (12%) had stable disease. Failure-free survival for the 51 eligible patients was 40% at 3 months, 23% at 6 months, and 15% at 1 year. Significant toxicity was observed with this regimen. Sever e neutropenia occurred in 20 patients (39%), severe anemia in 8 patien ts (16%), and severe thrombocytopenia in 18 patients (35%). One patien t died of infection. Severe neurotoxicity (1) and hemorrhage (3) were also seen. The etoposide, cisplatin combination is active in NHL; howe ver, in this dose and schedule their combined activity is only minimal ly better than published reports of etoposide alone. Further studies o f related combinations are under evaluation by the CALGB. (C) 1993 wil ey-Liss, Inc.