Schulman P, McCarroll K, Cooper M R, Norton L, Barcos M, Gottlieb A J
Department of Medicine, North Shore University Hospital, Manhasset, NY 11030.
Med Pediatr Oncol. 1990;18(6):482-6. doi: 10.1002/mpo.2950180609.
To further evaluate possible non-cross-resistant regimens in Hodgkin's disease, a phase II trial utilizing antimetabolites and etoposide was initiated by the Cancer and Leukemia Group B (CALGB). Etoposide was included because of its known efficacy in relapsed Hodgkin's disease and to evaluate for synergy with an alkylating agent and vincristine. Cytosine arabinoside and methotrexate were included to evaluate their effectiveness in rapidly growing resistant disease. Forty-two patients with previously treated Hodgkin's disease were entered, of which 37 are evaluable for response and toxicity. All patients had at least 2 prior regimens of chemotherapy and 59% had additional radiation therapy. Complete and partial response was observed in 61%; there were 32% complete responders. Duration of complete response was a median of 8 months (range 2-28+ months). Duration of partial response was 7 months (range 1-17 months). Three patients remain in complete remission at 19, 19, and 28 months. Major toxicity was hematologic with severe or life-threatening toxicity in 54%. There was one patient with a fatal infection. Non-hematologic toxicity, save for nausea and vomiting, was mild and uncommon. There were two fatal and one severe pulmonary toxicities reported in patients who had previous exposure to bleomycin and mediastinal radiation. Three had interstitial pneumonitis and one pulmonary emboli. The interstitial pneumonitis was thought to be drug related. Survival of the entire group is estimated at 61% at 12 months. We conclude that MOPLACE is an effective regimen with an appreciable complete response rate in this heavily pretreated group of patients. Hematologic and pulmonary toxicities are severe and may necessitate dose modifications. The use of etoposide containing combinations requires further study as primary therapy in untreated patients.
为了进一步评估霍奇金淋巴瘤可能的非交叉耐药治疗方案,癌症与白血病B组(CALGB)开展了一项使用抗代谢药物和依托泊苷的II期试验。纳入依托泊苷是因为其在复发霍奇金淋巴瘤中已知的疗效,以及评估其与烷化剂和长春新碱的协同作用。纳入阿糖胞苷和甲氨蝶呤是为了评估它们在快速生长的耐药疾病中的有效性。42例既往接受过治疗的霍奇金淋巴瘤患者入组,其中37例可评估疗效和毒性。所有患者至少接受过2种先前的化疗方案,59%还接受过放疗。观察到完全缓解和部分缓解的比例为61%;完全缓解者占32%。完全缓解的持续时间中位数为8个月(范围2 - 28 +个月)。部分缓解的持续时间为7个月(范围1 - 17个月)。3例患者分别在19、19和28个月时仍处于完全缓解状态。主要毒性为血液学毒性,54%的患者出现严重或危及生命的毒性。有1例患者死于感染。除恶心和呕吐外,非血液学毒性轻微且不常见。在先前接受过博来霉素和纵隔放疗的患者中,报告了2例致命和1例严重的肺部毒性。3例发生间质性肺炎,1例发生肺栓塞。间质性肺炎被认为与药物有关。整个组的12个月生存率估计为61%。我们得出结论,MOPLACE方案在这群经过大量预处理的患者中是一种有效的方案,完全缓解率可观。血液学和肺部毒性严重,可能需要调整剂量。含依托泊苷的联合方案作为未治疗患者的一线治疗需要进一步研究。