Phase II trial of etoposide and cisplatin in patients with refractory and relapsed non-Hodgkin's lymphoma: Cancer and Leukemia Group B study 8351.

Phase II trial of etoposide and cisplatin in patients with refractory and relapsed non-Hodgkin's lymphoma: Cancer and Leukemia Group B study 8351.
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依托泊苷和顺铂治疗难治性和复发性非霍奇金淋巴瘤患者的 II 期试验:癌症和白血病 B 组研究 8351。

DOI:
10.1002/mpo.2950210610
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发表时间:
1993
期刊:
Medical and pediatric oncology
影响因子:
--
通讯作者:
Gottlieb,AJ
Gottlieb,AJ
中科院分区:
--
文献类型:
--
作者:
Rybak,ME;Anderson,J;Kaplan,R;Budman,DR;Vinciguerra,V;Gottlieb,AJ

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癌症和白血病组B(CALGB)在难治性和复发性非霍奇金淋巴瘤(NHL)患者中进行了一项II期研究,以评估依托泊苷和顺铂联合治疗的活性。65例患者入组研究,本报告评价了51例患者。治疗方案为依托泊苷80 mg/m2,静脉滴注,每日5次;顺铂20 mg/m2,静脉滴注,每日5次,每21 d重复。所有患者既往1 - 3个化疗方案失败,有可测量的疾病,体能状态为0 - 2。在51例可评价患者中,有4例完全缓解(8%)和12例部分缓解(23%),总缓解率为31%(95%CI:19%,46%)。此外,15例患者(29%)的疾病有所改善,6例(12%)疾病稳定。51例合格患者的3个月无失败生存率为40%,6个月为23%,1年为15%。该方案观察到显著毒性。20例患者(39%)发生重度中性粒细胞减少,8例患者(16%)发生重度贫血,18例患者(35%)发生重度血小板减少。1例患者死于感染。还观察到严重的神经毒性(1)和出血(3)。依托泊苷,顺铂联合治疗NHL是有效的;然而,在这个剂量和时间表中,它们的联合活性仅比发表的依托泊苷单独治疗的报告好一点点。CALGB正在评估相关组合的进一步研究。© 1993 Wiley利斯公司
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/m2IV daily times 5 and cisplatin 20 mg/m2IV 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. © 1993 Wiley‐Liss, Inc.