Burton C, Smith P, Vaughan-Hudson G, Qian W, Hoskin P, Cunningham D, Hancock B, Linch D
Lymphoma Trials Office, University College London and CRUK Clinical Trials Centre, London, UK.
Br J Haematol. 2005 Aug;130(4):536-41. doi: 10.1111/j.1365-2141.2005.05640.x.
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) has been the standard chemotherapy regimen used for diffuse large cell lymphomas for over 30 years. Idarubicin is a 4-demethoxy-anthracycline analogue of daunorubicin that has proven activity in non-Hodgkin lymphoma, and has been reported to cause less cardiotoxicity. We therefore initiated a randomised trial of standard dose CHOP versus CIOP (cyclophosphamide, idarubicin, vincristine and prednisolone), in which doxorubicin 50 mg/m2 was substituted by idarubicin 10 mg/m2, a dose thought to have equivalent anti-lymphoma activity. This trial was closed prematurely after 211 patients had completed therapy when a lower complete remission (CR) rate was noted in the CIOP arm. The formal results with long-term follow up are now reported. Overall response rate was 84% in the CHOP arm and 78% in the CIOP arm, CR rates were 70% and 52% respectively in all patients (P=0.013) and 73% and 52% respectively for the eligible patients (P=0.0084). At a median of 8 years follow-up, 4-year progression-free survival for all patients was 56% in the CHOP arm and 40% in the CIOP arm (P=0.0096). Overall survival for all patients was 65% in the CHOP arm and 56% in the CIOP arm (P=0.14). Results for eligible patients were comparable. CIOP containing idarubicin at a dose of 10 mg/m2 is clearly inferior to standard CHOP.
CHOP（环磷酰胺、阿霉素、长春新碱和泼尼松龙）30多年来一直是用于弥漫性大细胞淋巴瘤的标准化疗方案。伊达比星是柔红霉素的4-去甲氧基蒽环类类似物，已证实其在非霍奇金淋巴瘤中具有活性，并且据报道其心脏毒性较小。因此，我们开展了一项标准剂量CHOP与CIOP（环磷酰胺、伊达比星、长春新碱和泼尼松龙）的随机试验，其中用10mg/m²的伊达比星替代50mg/m²的阿霉素，该剂量被认为具有等效的抗淋巴瘤活性。在211例患者完成治疗后，该试验提前结束，当时发现CIOP组的完全缓解（CR）率较低。现将长期随访的正式结果报告如下。CHOP组的总缓解率为84%，CIOP组为78%；所有患者的CR率分别为70%和52%（P=0.013），符合条件的患者分别为73%和52%（P=0.0084）。在中位8年的随访中，所有患者的4年无进展生存率在CHOP组为56%，在CIOP组为40%（P=0.0096）。所有患者的总生存率在CHOP组为65%，在CIOP组为56%（P=0.14）。符合条件患者的结果相似。含10mg/m²伊达比星的CIOP明显劣于标准CHOP。
