Cornwell G G, Pajak T F, Kochwa S, McIntyre O R, Glowienka L P, Brunner K, Rafla S, Coleman M, Cooper M R, Henderson E
Dartmouth Medical School, Hanover, NH 03756.
J Clin Oncol. 1988 Sep;6(9):1481-90. doi: 10.1200/JCO.1988.6.9.1481.
A total of 589 patients with previously untreated multiple myeloma were randomized to receive daily oral melphalan, pulse-dose intravenous (IV) melphalan, carmustine (BCNU), or lomustine (CCNU). All patients received an initial tapering course of prednisone (Pred). During week 22 (day 154), patients were randomized to receive or not to receive additional therapy with vincristine (VCR) (1 mg/m2) and prednisone (0.6 mg/kg/d for seven days) at 8-week intervals. The influence of VCR/Pred was determined in 302 patients who remained on study beyond 22 weeks after initial therapy. VCR/Pred converted a significant percentage of nonresponders to responders in patients treated with melphalan (55% v 19%, P = .002), but not in patients treated with a nitrosourea (48% v 23%, P = .06). Survival beyond week 22 was significantly longer following the addition of VCR/Pred in patients receiving melphalan (median, 35.3 months v 27.0 months; P = .003) but not in patients receiving BCNU or CCNU (median, 28.1 months v 26.2 months; P = .91). These differences were seen both for oral and IV melphalan. A trend for beneficial effect of VCR/Pred was definitely seen in the good-risk patients (P = .03) but only suggestive for poor-risk patients (P = .12). Following adjustment for VCR/Pred effects, there were no differences in the survival of patients receiving any of the four initial treatments.
总共589例先前未经治疗的多发性骨髓瘤患者被随机分为接受每日口服美法仑、脉冲剂量静脉注射美法仑、卡莫司汀（BCNU）或洛莫司汀（CCNU）治疗。所有患者均接受初始递减疗程的泼尼松（Pred）治疗。在第22周（第154天），患者被随机分为每8周接受或不接受长春新碱（VCR）（1 mg/m²）和泼尼松（0.6 mg/kg/d，共7天）的额外治疗。在初始治疗后超过22周仍在研究中的302例患者中确定了VCR/Pred的影响。VCR/Pred使接受美法仑治疗的患者中相当比例的无反应者转变为有反应者（55%对19%，P = 0.002），但在接受亚硝基脲治疗的患者中并非如此（48%对23%，P = 0.06）。在接受美法仑治疗的患者中添加VCR/Pred后，第22周后的生存期显著延长（中位数，35.3个月对27.0个月；P = 0.003），但在接受BCNU或CCNU治疗的患者中并非如此（中位数，28.1个月对26.2个月；P = 0.91）。口服和静脉注射美法仑均观察到这些差异。在低危患者中肯定观察到VCR/Pred有益作用的趋势（P = 0.03），但在高危患者中仅为提示性趋势（P = 0.12）。在对VCR/Pred效应进行调整后，接受四种初始治疗中任何一种的患者的生存期无差异。
