Rybak M E, Anderson J, Kaplan R, Budman D R, Vinciguerra V, Gottlieb A J
Department of Medicine, University of Massachusetts Medical Center, Worcester.
Med Pediatr Oncol. 1993;21(6):441-5. doi: 10.1002/mpo.2950210610.
A phase-II study was conducted by the Cancer and Leukemia Group B (CALGB) in patients with refractory and relapsed non-Hodgkin's lymphoma (NHL) to assess the activity of the combination of etoposide and cisplatin. Sixty-five patients were entered on study, and 51 patients were evaluated 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, repeated every 21 days. All patients had failed 1-3 prior chemotherapeutic 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% Cl: 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. Severe neutropenia occurred in 20 patients (39%), severe anemia in 8 patients (16%), and severe thrombocytopenia in 18 patients (35%). One patient died of infection. Severe neurotoxicity (1) and hemorrhage (3) were also seen. The etoposide, cisplatin combination is active in NHL; however, in this dose and schedule their combined activity is only minimally better than published reports of etoposide alone. Further studies of related combinations are under evaluation by the CALGB.
癌症与白血病B组（CALGB）开展了一项II期研究，以评估依托泊苷和顺铂联合用药对难治性及复发性非霍奇金淋巴瘤（NHL）患者的疗效。65例患者参与了该研究，本报告纳入了其中51例患者的评估结果。治疗方案为依托泊苷80mg/m²，静脉注射，每日1次，共5天；顺铂20mg/m²，静脉注射，每日1次，共5天，每21天重复一次。所有患者此前接受1 - 3种化疗方案均告失败，有可测量病灶，且体能状态评分为0 - 2。在51例可评估患者中，有4例完全缓解（8%），12例部分缓解（23%），总缓解率为31%（95%置信区间：19%，46%）。此外，15例患者（29%）病情有所改善，6例患者（12%）病情稳定。51例符合条件患者的无进展生存期在3个月时为40%，6个月时为23%，1年时为15%。该方案观察到显著毒性。20例患者（39%）出现严重中性粒细胞减少，8例患者（16%）出现严重贫血，18例患者（35%）出现严重血小板减少。1例患者死于感染。还观察到严重神经毒性（1例）和出血（3例）。依托泊苷和顺铂联合用药对NHL有活性；然而，在此剂量和给药方案下，其联合活性仅略优于单独使用依托泊苷的已发表报告。CALGB正在对相关联合用药进行进一步研究评估。
