High-dose therapy intensification compared with continued standard chemotherapy in multiple myeloma patients responding to the initial chemotherapy:: long-term results from a prospective randomized trial from the Spanish cooperative group PETHEMA
High-dose therapy intensification compared with continued standard chemotherapy in multiple myeloma patients responding to the initial chemotherapy:: long-term results from a prospective randomized trial from the Spanish cooperative group PETHEMA
复制标题
DOI：
10.1182/blood-2005-03-1301
复制
发表时间：
2005-12-01
期刊：
影响因子：
20.3
通讯作者：
San Miguel, J
中科院分区：
文献类型：
--
作者：
Bladé, J;Rosiñol, L;San Miguel, J
本随机试验的目的是在对初始治疗有反应的多发性骨髓瘤（MM）患者中比较高剂量治疗（HDT）与持续常规化疗。从1994年5月至1999年10月，216例患者（122例男性/94例女性; 11期或III期;东部肿瘤协作组[ECOG]评分小于3）入组研究。初始化疗包括4个周期的长春新碱、BCNU、美法仑、环磷酰胺、泼尼松/长春新碱、BCNU、阿霉素、地塞米松（VBMCP/VBAD）交替化疗。有反应的患者被随机分配接受另外8个周期的VBMCP/VBAD，用美法仑200 mg/m2强化，或美法仑140 mg/m2加12戈伊分次全身照射（TBI）。164例患者被随机分配，83例继续化疗，81例HDT。HDT组的完全缓解（CR）率显著高于HDT组（30% vs 11%; P = 0.002）。然而，HDT和常规治疗的无进展生存期（PFS）无显著差异（中位数，42 vs 33个月; P =无显著性[NS]），两组的总生存期（OS）相似（中位数，61 vs 66个月）。最后，两组复发后的生存期相同（15.9 vs 16.4个月）。总之，这些结果表明，当对初始化疗有反应的骨髓瘤患者进行HDT强化治疗时，CR率显著增加，但对PFS或OS无显著影响。
The aim of the present randomized trial was to compare high-dose therapy (HDT) with continued conventional chemotherapy in patients with multiple myeloma (MM) who responded to the initial treatment. From May 1994 to October 1999, 216 patients (122 men/94 women; stage 11 or III; Eastern Cooperative Oncology Group [ECOG] score less than 3) entered the study. Initial chemotherapy consisted of 4 cycles of alternating vincristine, BCNU, melphalan, cyclophosphamide, prednisone/vincristine, BCNU, Adriamycin, dexamethasone (VBMCP/VBAD). Responding patients were randomly assigned to receive 8 additional cycles of VBMCP/VBAD, intensification with melphalan 200 mg/m(2), or melphalan 140 mg/m(2) plus 12 Gy fractionated total body irradiation (TBI). One-hundred sixty-four patients were randomly assigned, 83 to continued chemotherapy and 81 to HDT. The complete remission (CR) rate was significantly higher with HDT (30% vs 11%; P = .002). However, progression-free survival (PFS) was not significantly different between HDT and conventional therapy (median, 42 vs 33 months; P = not significant [NS]), and overall survival (OS) was similar in both groups (median, 61 vs 66 months). Finally, survival after relapse was identical in the 2 arms (15.9 vs 16.4 months). In conclusion, these results show that HDT intensification, when given to myeloma patients who have responded to the initial chemotherapy, significantly increases the CR rate but has no significant impact on PFS or OS.