Cornwell G G, Pajak T F, Kochwa S, McIntyre O R, Glowienka L P, Brunner K, Rafla S, Silver R T, Cooper M R, Henderson E, Kyle R A, Haurani F I, Cuttner J
Cancer. 1982 Nov 1;50(9):1669-75. doi: 10.1002/1097-0142(19821101)50:9<1669::aid-cncr2820500902>3.0.co;2-n.
A total of 361 evaluable patients with previously untreated multiple myeloma were randomized to receive oral melphalan (0.15 mg/kg/day for seven days, followed by 0.05 mg/kg/day after recovery from the nadir of the leukocytes), BCNU (150 mg/m2 intravenously every six weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-weeks) or CCNU (100 mg/m2 orally every six weeks). All patients received a tapering six-week course of prednisone starting at 0.8 mg/kg for the first two weeks. At week 22, one-half of the patients were randomized to receive vincristine (1 mg/m2) and prednisone (0.6 mg/kg for seven days) every two months in addition to previous therapy. The melphalan treated patients showed a significantly higher overall objective response frequency (59%), according to Myeloma Task Force criteria, when compared to those treated with BCNU (40%) or CCNU (42%). The survivals for all patients were not statistically different for the three treatment programs. However, the good-risk patients treated with melphalan had significantly longer survival (P = 0.02) than the equivalent patients who received BCNU or CCNU. The addition of vincristine and prednisone at week 2 did not significantly increase the percentage of subsequent objective responses or prolong the subsequent survival of any treatment group. It is concluded that oral melphalan is superior to BCNU and CCNU in producing objective responses and in prolonging survival in good risk patients.
共有361例既往未接受过治疗的多发性骨髓瘤可评估患者被随机分组，分别接受口服美法仑（0.15mg/kg/天，共7天，白细胞计数从最低点恢复后改为0.05mg/kg/天）、卡氮芥（150mg/m²，每6周静脉注射一次）或洛莫司汀（100mg/m²，每6周口服一次）治疗。所有患者均接受为期6周的泼尼松逐渐减量疗程，开始时前两周为0.8mg/kg。在第22周时，一半患者被随机分组，除先前治疗外，每两个月接受一次长春新碱（1mg/m²）和泼尼松（0.6mg/kg，共7天）治疗。根据骨髓瘤工作组标准，与接受卡氮芥（40%）或洛莫司汀（42%）治疗的患者相比，接受美法仑治疗的患者总体客观缓解频率显著更高（59%）。三个治疗方案的所有患者生存率无统计学差异。然而，接受美法仑治疗的低危患者的生存期显著长于接受卡氮芥或洛莫司汀治疗的同等患者（P=0.02）。在第22周添加长春新碱和泼尼松并未显著增加后续客观缓解的百分比，也未延长任何治疗组的后续生存期。得出的结论是，口服美法仑在产生客观缓解和延长低危患者生存期方面优于卡氮芥和洛莫司汀。
