Delain M, Linassier C, Petitdidier C, Goupille P, Luthier F, Combe M, Reisenleiter M, Benboubker L, Lamagnère J P, Colombat P
Department of Hematology/Oncology, Hôpital Bretonneau, Tours, France.
J Clin Oncol. 1994 Dec;12(12):2706-13. doi: 10.1200/JCO.1994.12.12.2706.
This prospective study was undertaken to evaluate the efficacy of combination chemotherapy with alternating cycles of vincristine, doxorubicin, and dexamethasone (VAD) and prednisone, vindesine, carmustine, and cyclophosphamide (PECC) in poor-risk multiple myeloma (MM).
Forty-four patients were previously untreated; 36 had been pretreated with an alkylating agent-containing regimen and had refractory or relapsed MM. All previously untreated patients had a high tumor burden at inclusion (stage III according to the Durie and Salmon classification). Logistic regression and the Cox proportional hazards models were used to assess the association between patient characteristics and response rate and survival, respectively.
The overall response rate was 68% for previously untreated patients, compared with 54% for previously treated patients (P = .16). The median survival time for all patients was 28 months: 53 months in previously untreated patients, and 18 months in previously treated patients. Univariate analysis showed that the predictive factors that had a significant affect on survival in the newly diagnosed patients were age, therapeutic response to VAD-PECC, low pretreatment Karnofsky score, high baseline serum beta 2-microglobulin (beta 2M) level, bone marrow impairment, and renal insufficiency at the start of treatment. When these parameters were used as continuous variables in multivariate analysis, three were found to correlate with survival: serum beta 2M, followed by therapeutic response and Karnofsky score. In the previously treated group, only Karnofsky score entered the Cox model.
These results indicate that combination VAD-PECC chemotherapy is an effective treatment that results in high response rates and long-term survival in advanced MM.
开展这项前瞻性研究以评估长春新碱、阿霉素和地塞米松(VAD)与泼尼松、长春地辛、卡莫司汀和环磷酰胺(PECC)交替周期联合化疗在高危多发性骨髓瘤(MM)中的疗效。
44例患者此前未接受过治疗;36例曾接受含烷化剂方案预处理,患有难治性或复发性MM。所有此前未接受过治疗的患者在纳入时肿瘤负荷较高(根据Durie和Salmon分类为III期)。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。
此前未接受过治疗的患者总缓解率为68%,而此前接受过治疗的患者为54%(P = 0.16)。所有患者的中位生存时间为28个月:此前未接受过治疗的患者为53个月,此前接受过治疗的患者为18个月。单因素分析显示,对新诊断患者生存有显著影响的预测因素为年龄、对VAD - PECC的治疗反应、预处理时较低的卡氏评分、基线血清β2 - 微球蛋白(β2M)水平较高、骨髓损伤以及治疗开始时的肾功能不全。当这些参数在多因素分析中作为连续变量使用时,发现有三个参数与生存相关:血清β2M,其次是治疗反应和卡氏评分。在既往治疗组中,只有卡氏评分进入Cox模型。
这些结果表明,VAD - PECC联合化疗是一种有效的治疗方法,可使晚期MM患者获得高缓解率和长期生存。