Keldsen N, Bjerrum O W, Dahl I M, Drivsholm A, Ellegaard J, Gadeberg O, Gimsing P, Grønvold T, Hansen M M, Hippe E
Department of Internal Medicine and Haematology, KAS Gentofte, Denmark.
Eur J Haematol. 1993 Aug;51(2):80-5. doi: 10.1111/j.1600-0609.1993.tb01597.x.
One-hundred-and-fifty-one patients with previously untreated multiple myeloma were allocated to treatment with either NOP regimen (mitoxantrone 16 mg/m2 and vincristine 2 mg day 1 and prednisolone 250 mg day 1-4 and 17-20) or M+P regimen (melphalan 0.25 mg/kg and prednisolone 100-200 mg/day day 1-4). Both regimens were repeated every 4 weeks and were scheduled for 1 year. Seventy-seven patients were treated with NOP and 74 patients with M+P. No major clinical differences were recorded between the groups before treatment. Sixty percent of the patients responded (CR+PR) to NOP versus 64% to M+P (NS). The time to progression was 16 months (95% C.L. 14-51) in the NOP group versus 21 months (95% C.L. 15-27) in the M+P group (NS). The median survival was 14 months (7-21) in the NOP group and 31 months (21-43) in the M+P group (p = 0.02). NOP was significantly more toxic than M+P. Seven patients treated with NOP died due to infection and neutropenia and 1 patient died of cardiac toxicity, in contrast to 1 death due to infection and neutropenia in the M+P group. Gastrointestinal toxicity was acceptable in both groups. In conclusion, NOP was inferior to M+P as primary treatment of multiple myeloma.
151例既往未接受过治疗的多发性骨髓瘤患者被分配接受NOP方案（米托蒽醌16mg/m²、长春新碱2mg第1天、泼尼松龙250mg第1 - 4天和17 - 20天）或M + P方案（美法仑0.25mg/kg、泼尼松龙100 - 200mg/天第1 - 4天）治疗。两种方案均每4周重复一次，疗程为1年。77例患者接受NOP治疗，74例患者接受M + P治疗。治疗前两组间未记录到重大临床差异。NOP方案的患者缓解率（CR + PR）为60%，而M + P方案为64%（无统计学差异）。NOP组的疾病进展时间为16个月（95%可信区间14 - 51），M + P组为21个月（95%可信区间15 - 27）（无统计学差异）。NOP组的中位生存期为14个月（7 - 21），M + P组为31个月（21 - 43）（p = 0.02）。NOP的毒性明显高于M + P。接受NOP治疗的7例患者死于感染和中性粒细胞减少，1例死于心脏毒性，相比之下，M + P组有1例死于感染和中性粒细胞减少。两组的胃肠道毒性均可接受。总之，作为多发性骨髓瘤的一线治疗，NOP方案劣于M + P方案。
