Gobbi P G, Broglia C, Bertè R, Petrilli M P, Molica S, Angrilli F, Iannitto E, Ghirardelli M L, Di Renzo N, Cavanna L, Ascari E
Medicina Interna e Oncologia Medica, Università di Pavia, Policlinico S. Matteo, P.le Golgi 2, 27100 Pavia, Italy.
Haematologica. 2000 Jul;85(7):722-8.
To evaluate the feasibility, toxicity and preliminary results of a potentially less toxic variant of the MOPPEBVCAD chemotherapy regimen for advanced Hodgkin's disease: MOPPEBVCyED, in which cyclophosphamide and etoposide replace lomustine and melphalan, respectively, with the remaining components being unaltered.
The study was multicenter, prospective and randomized, and enrolled 67 patients with newly diagnosed stage IIB, III, IV Hodgkin's disease (62 were expected on the grounds of statistical considerations). Radiotherapy was restricted to sites of bulky involvement or to areas that responded incompletely to chemotherapy. Median follow-up was 48 months.
Comparing MOPPEBVCAD vs. MOPPEBVCyED, the results were as follows: complete remissions 35/35 vs. 30/32 (plus one partial remission and one disease progression); relapses 5 vs. 8; deaths 2 (one of myelodysplasia) vs. 2; delivered mean dose intensity (DI): lomustine 0.79+/-0.67 vs. cyclophosphamide 0.82+/-0.32; melphalan 0.80+/-0.13 vs. etoposide 0.86+/-0.18; average DI of the 7 drugs common to both regimens 0.73+/-0.10 vs. 0.83+/-0.11; all 9 drugs 0.75+/-0.13 vs. 0.84+/-0.09 (p=0.002); projected 5-year failure-free survival 0.79 vs 0.62; second cancers, two myelodysplasias vs. one carcinoma of the kidney. Toxicities were not statistically different except for heavier thrombocytopenia being recorded with MOPPEBVCAD.
The higher cumulative and single drug DI recorded with MOPPEBVCyED may reflect better short-term tolerability, but it does not lead to better disease control. Its late toxicity may be expected to be lower in the future but at present it does not seem to be a sufficient reason to substitute MOPPEBVCyED for MOPPEBVCAD.
评估一种针对晚期霍奇金病的毒性可能较低的MOPPEBVCAD化疗方案变体MOPPEBVCyED的可行性、毒性及初步结果。在MOPPEBVCyED方案中,环磷酰胺和依托泊苷分别替代了洛莫司汀和马法兰,其余成分不变。
本研究为多中心、前瞻性且随机的研究,纳入了67例新诊断的IIB期、III期、IV期霍奇金病患者(基于统计学考虑预计为62例)。放疗仅限于肿块较大的部位或对化疗反应不完全的区域。中位随访时间为48个月。
比较MOPPEBVCAD与MOPPEBVCyED,结果如下:完全缓解率分别为35/35和30/32(另加1例部分缓解和1例疾病进展);复发率分别为5例和8例;死亡率均为2例(MOPPEBVCAD组1例为骨髓发育异常,MOPPEBVCyED组1例为骨髓发育异常);给予的平均剂量强度(DI):洛莫司汀0.79±0.67与环磷酰胺0.82±0.32;马法兰0.80±0.13与依托泊苷0.86±0.18;两种方案共有的7种药物的平均DI为0.73±0.10与0.83±0.11;所有9种药物的平均DI为0.75±0.13与0.84±0.09(p = 0.002);预计5年无失败生存率分别为0.79和0.62;第二原发癌,MOPPEBVCAD组为2例骨髓发育异常,MOPPEBVCyED组为1例肾癌。除MOPPEBVCAD记录到更严重血小板减少外,毒性无统计学差异。
MOPPEBVCyED记录到的累积和单药DI较高,可能反映出更好的短期耐受性,但并未带来更好的疾病控制。其晚期毒性未来可能会更低,但目前似乎没有充分理由用MOPPEBVCyED替代MOPPEBVCAD。