Bladé J, San Miguel J F, Alcalá A, Maldonado J, Sanz M A, García-Conde J, Moro M J, Alonso C, Besalduch J, Zubizarreta A
Hospital Clínic i Provincial, University of Barcelona, Spain.
J Clin Oncol. 1993 Jun;11(6):1165-71. doi: 10.1200/JCO.1993.11.6.1165.
To determine whether combination chemotherapy with alternating cycles of vincristine, cyclophosphamide, melphalan, and prednisone (VCMP) and vincristine, carmustine (BCNU), Adriamycin (doxorubicin; Farmitalia, Carlo-Erba Laboratories, Spain), and prednisone (VBAP) is better than the standard melphalan-prednisone (MP) regimen in multiple myeloma (MM).
From January 1985 to December 1989, 28 institutions of the Spanish Cooperative Group for Hematological Malignancies Treatment, Spanish Society of Hematology (PETHEMA) entered 487 eligible patients with symptomatic MM into the study. Patients were randomized to receive either MP or alternating courses of VCMP and VBAP. Logistic regression and the Cox proportional hazards models were used to assess the association between patients' characteristics and response rate and survival, respectively.
Among 449 patients who were assessable for response, the overall response rate to MP was 51.8% (31.5% objective response plus 20.3% partial response) as compared with 62.7% (45.2% objective response plus 17.5% partial response) to VCMP/VBAP (P = .025). Also, a significantly higher proportion of objective responses was observed with combination chemotherapy (45.2% v 31.5%; P = .004). The factors associated with an unfavorable response rate in the overall series were low platelet count, treatment with MP, high creatinine level and immunoglobulin, (IgG) monoclonal (M)-component. No significant differences were found when survival rates of both groups of patients were compared. However, patients with IgA myeloma treated with VCMP/VBAP survived significantly longer than those who received MP (median, 20.2 v 38.4 months; P < .005).
These results indicate that combination chemotherapy improves response rate in MM. However, this does not result in a significantly different survival rate, except for patients with IgA myeloma, who survive significantly longer with combination chemotherapy.
确定长春新碱、环磷酰胺、美法仑和泼尼松(VCMP)与长春新碱、卡莫司汀(BCNU)、阿霉素(多柔比星;法玛西亚公司,西班牙卡罗 - 埃尔巴实验室)和泼尼松(VBAP)交替周期的联合化疗方案在多发性骨髓瘤(MM)中是否优于标准的美法仑 - 泼尼松(MP)方案。
1985年1月至1989年12月,西班牙血液恶性肿瘤治疗合作组、西班牙血液学会(PETHEMA)的28家机构将487例符合条件的有症状MM患者纳入研究。患者被随机分配接受MP方案或VCMP与VBAP交替疗程。分别使用逻辑回归和Cox比例风险模型评估患者特征与缓解率及生存率之间的关联。
在449例可评估缓解情况的患者中,MP方案的总缓解率为51.8%(完全缓解率31.5%加部分缓解率20.3%),而VCMP/VBAP方案为62.7%(完全缓解率45.2%加部分缓解率17.5%)(P = 0.025)。此外,联合化疗观察到的完全缓解比例显著更高(45.2%对31.5%;P = 0.004)。在整个系列中,与不良缓解率相关的因素为血小板计数低、接受MP治疗、肌酐水平高和免疫球蛋白(IgG)单克隆(M)成分。比较两组患者的生存率时未发现显著差异。然而,接受VCMP/VBAP治疗的IgA骨髓瘤患者的生存期明显长于接受MP治疗的患者(中位数,20.2对38.4个月;P < 0.005)。
这些结果表明联合化疗可提高MM的缓解率。然而,除IgA骨髓瘤患者联合化疗生存期明显更长外,这并未导致生存率有显著差异。