Tura S, Mandelli F, Mazza P, Pileri S, Gherlinzoni F, Bocchia M, Zinzani P L, Fiacchini M, Martelli M, Papa G
Istituto di Ematologia L. e A. Seràgnoli, Università di Bologna, Italy.
Leukemia. 1991;5 Suppl 1:74-8.
From September 1988 two hundred-sixty-seven (267) untreated patients (pts) with stage II to IV high grade non Hodgkin's lymphoma (NHL) have been enrolled in a multicenter, randomized, still ongoing study, comparing two third-generation combination chemotherapy regimens, MACOP-B versus F-MACHOP. At the present time, 177 pts have completed the treatment program and are evaluable, with a median follow-up of 13 months. Clinical, histologic and laboratory characteristics are equally distributed in both groups. Among the 92 pts treated with MACOP-B, 58 (63%) achieved a complete remission (CR), 17 complete responders have relapsed (29%), and 21 have died (23%), including 3 treatment-related deaths. Among the 85 pts who received F-MACHOP, 65 (76%) achieved a CR, 9 complete responders have relapsed (14%), and 11 pts have died (13%), including 3 treatment related deaths. 30 months-projected survival is 64% for MACOP-B treated pts compared to 84% for F-MACHOP treated pts; 30 months-projected relapse- free survival is 80% and 84%, respectively. F-MACHOP seems to be superior in immunoblastic lymphoma (overall survival, OS, 82% vs. 54%) and in Burkitt-type lymphoblastic lymphoma (OS 100% vs, 42%). The degree of hematological and non-hematological toxicity was similar in both regimens. More reliable conclusions will be drawn after a longer follow-up.
自1988年9月起,267例未经治疗的II至IV期高级别非霍奇金淋巴瘤(NHL)患者被纳入一项多中心、随机且仍在进行的研究,比较两种第三代联合化疗方案,即MACOP-B方案与F-MACHOP方案。目前,177例患者已完成治疗方案且可进行评估,中位随访时间为13个月。两组患者的临床、组织学和实验室特征分布均衡。在接受MACOP-B方案治疗的92例患者中,58例(63%)实现完全缓解(CR),17例完全缓解者复发(29%),21例死亡(23%),其中包括3例与治疗相关的死亡。在接受F-MACHOP方案治疗的85例患者中,65例(76%)实现CR,9例完全缓解者复发(14%),11例患者死亡(13%),其中包括3例与治疗相关的死亡。MACOP-B方案治疗患者的30个月预计生存率为64%,而F-MACHOP方案治疗患者为84%;30个月预计无复发生存率分别为80%和84%。F-MACHOP方案在免疫母细胞淋巴瘤(总生存期,OS,82%对54%)和伯基特型淋巴细胞淋巴瘤(OS 100%对42%)方面似乎更具优势。两种方案的血液学和非血液学毒性程度相似。更长时间的随访后将得出更可靠的结论。