Tribalto M, Amadori S, Cantonetti M, Franchi A, Papa G, Pileri A, Boccadoro M, Dammacco F, Vacca A, Centurioni R
Leuk Res. 1985;9(8):1043-9. doi: 10.1016/0145-2126(85)90075-x.
The results of an Italian multicentric trial for treatment of symptomatic Multiple Myeloma (MM) are reported. One hundred and thirty-three previously untreated patients were singled out at random for three different chemotherapy schedules: Melphalan plus Prednisone (M.P.) X 6 monthly cycles; Vincristine plus Melphalan plus Cyclophosphamide plus Prednisone (VMCP) X 6 monthly cycles; Peptichemio, Cyclophosphamide, BCNU. Drugs in this latter schedule were administered sequentially, for a period of six months. Criteria for response, progression and relapse were those of the Southwestern Oncology Group. Fifteen patients in MP chemotherapy (35%) and 20 patients in VCMP chemotherapy (46%) achieved an objective response (decrease of at least 50% in the synthesis index of Monoclonal Component (M.C.], while only 3 out of the other 21 patients assigned to the third schedule responded to treatment. No significant differences were noted in the survival curves in either of the three treatment groups. The 38 responding patients did not receive maintenance therapy; no significant difference was found in remission duration between patients in MP and VCMP arms, with a median duration of 16 months for the whole group. No statistical difference was observed between survival and remission curves of patients with a 'response' (M. spike reduction greater than 75%) and those with 'improvement' (M. spike reduction between 75 and 50%). The authors conclude that the inclusion of Vintristine in a combination chemotherapy does not produce clear survival benefits; a longer induction period (12 cycles) could allow a better differentiation between MP and VMCP regimens.
本文报告了一项意大利多中心治疗有症状多发性骨髓瘤(MM)的试验结果。133例既往未接受过治疗的患者被随机分为三种不同的化疗方案:美法仑加泼尼松(M.P.),每月6个周期;长春新碱加美法仑加环磷酰胺加泼尼松(VMCP),每月6个周期;癌抑散、环磷酰胺、卡氮芥。后一种方案中的药物按顺序给药,为期6个月。疗效、进展和复发的标准采用西南肿瘤协作组的标准。接受MP化疗的15例患者(35%)和接受VCMP化疗的20例患者(46%)达到客观缓解(单克隆成分合成指数至少降低50%),而分配到第三种方案的其他21例患者中只有3例对治疗有反应。三个治疗组的生存曲线均未发现显著差异。38例有反应的患者未接受维持治疗;MP组和VCMP组患者的缓解持续时间无显著差异,全组中位持续时间为16个月。“反应”(M峰降低大于75%)和“改善”(M峰降低在75%至50%之间)的患者的生存曲线和缓解曲线之间未观察到统计学差异。作者得出结论,在联合化疗中加入长春新碱不会产生明显的生存益处;延长诱导期(12个周期)可能会使MP方案和VMCP方案之间的差异更明显。