Zinzani P L, Martelli M, Storti S, Musso M, Cantonetti M, Leone G, Cajozzo A, Papa G, Iannitto E, Perrotti A
Istituto di Ematologia, L. e A. Seràgnoli, Università di Bologna, Italy.
Leuk Lymphoma. 1995 Oct;19(3-4):329-35. doi: 10.3109/10428199509107906.
Until now, literature data support the fact that the CHOP regimen represents the standard first line treatment for patients with advanced intermediate-grade non-Hodgkin's lymphoma. Recently, idarubicin has been introduced in clinical trials because of its favourable preclinical profile: it is more active than daunorubicin and doxorubicin against a number of experimental tumour systems and is significantly less cardiotoxic in animal models. From March 1991 to June 1993, 115 previously untreated patients with stage II to IV intermediate-grade non-Hodgkin's lymphoma, according to the Kiel classification, were enrolled in a phase III comparative trial. The objectives of the study were to compare the efficacy and safety of using idarubicin instead of doxorubicin in the polychemotherapeutic regimen CHOP (cyclophosphamide, doxorubicin, vincristine, and dexamethasone). Of the 115 patients registered for the trial, 103 were evaluable: 52 received CH (doxorubicin)OP and 51 received CI(Idarubicin)OP. Known prognostic factors were equally distributed among the two groups. There were no significant differences between the 2 groups in the rates of partial and complete response. The overall response rate was 87%, with complete response in 62%: 63% in the CHOP group, and 59% in the CIOP group. At 30 months (median 20 months), 86% of all CR patients were alive without disease in the CHOP group and 85% in the CIOP group. Patients treated with CHOP experienced severe alopecia more frequently (P = .004). Only three patients in the CIOP group showed cardiac adverse events (1 moderate and 2 mild), while in the CHOP group 4 mild, 2 moderate and 1 severe were recorded. LVEF monitoring was carried out in 31 patients of the CHOP group and in 27 of the CIOP group. A median drop of 8.3% of the LVEF was observed in patients treated with CHOP regimen as compared to 4.8% in patients with CIOP regimen (P = .0001). In this trial, the "idarubicin arm" (CIOP regimen) was found to have an equivalent therapeutic efficacy and, slightly, reduced clinical toxicity in comparison to the standard doxorubicin-containing CHOP regimen in patients with intermediate-grade non-Hodgkin's lymphoma.
到目前为止，文献数据支持这样一个事实，即CHOP方案是晚期中级别非霍奇金淋巴瘤患者的标准一线治疗方案。最近，伊达比星因其良好的临床前特性被引入临床试验：在多个实验性肿瘤系统中，它比柔红霉素和阿霉素更具活性，并且在动物模型中心脏毒性明显更低。从1991年3月到1993年6月，115例根据基尔分类法诊断为II至IV期的中级别非霍奇金淋巴瘤且既往未接受过治疗的患者被纳入一项III期对照试验。该研究的目的是比较在多药化疗方案CHOP（环磷酰胺、阿霉素、长春新碱和地塞米松）中使用伊达比星替代阿霉素的疗效和安全性。在登记参加试验的115例患者中，103例可评估：52例接受CH（阿霉素）OP方案，51例接受CI（伊达比星）OP方案。已知的预后因素在两组中分布均匀。两组之间在部分缓解率和完全缓解率方面没有显著差异。总体缓解率为87%，完全缓解率为62%：CHOP组为63%，CIOP组为59%。在30个月（中位时间20个月）时，CHOP组所有完全缓解患者中有86%无病存活，CIOP组为85%。接受CHOP方案治疗的患者更频繁地出现严重脱发（P = 0.004）。CIOP组只有3例患者出现心脏不良事件（1例中度和2例轻度），而CHOP组记录到4例轻度、2例中度和1例重度。对CHOP组的31例患者和CIOP组的27例患者进行了左心室射血分数（LVEF）监测。与接受CIOP方案的患者相比，接受CHOP方案治疗的患者LVEF中位数下降了8.3%，而接受CIOP方案的患者为4.8%（P = 0.0001）。在这项试验中，与标准的含阿霉素CHOP方案相比，“伊达比星组”（CIOP方案）在中级别非霍奇金淋巴瘤患者中具有相当的治疗效果，且临床毒性略有降低。
