Efficacy and safety of melphalan, arsenic trioxide and ascorbic acid combination therapy in patients with relapsed or refractory multiple myeloma: a prospective, multicentre, phase II, single-arm study
Efficacy and safety of melphalan, arsenic trioxide and ascorbic acid combination therapy in patients with relapsed or refractory multiple myeloma: a prospective, multicentre, phase II, single-arm study
复制标题
DOI：
10.1111/j.1365-2141.2006.06280.x
复制
发表时间：
2006-10-01
影响因子：
6.5
通讯作者：
Swift, Regina A.
中科院分区：
文献类型：
--
作者：
Berenson, James R.;Boccia, Ralph;Swift, Regina A.
我们评估了美法仑、三氧化二砷（ATO）和抗坏血酸（AA）（MAC）联合治疗两种以上既往治疗方案失败的多发性骨髓瘤（MM）患者的安全性和有效性。患者接受美法仑（0.1 mg/kg p.o.），ATO（0.25 mg/kg i.v.）和AA（1 g i.v）在第1周的第1-4天给药，ATO和AA在第2-5周每周两次给药，第1周期的第6周不给药;在第2-6周期，除ATO和AA在第1周每周两次给药外，方案保持不变。65例患者中有31例（48%）出现客观缓解，包括2例完全缓解、15例部分缓解和14例轻微缓解。中位无进展生存期和总生存期分别为7个月和19个月。22例患者在基线时血清肌酐水平（SCr）升高，18/22例（82%）在治疗期间SCr水平降低。特殊的3/4级血液学（3%）或心脏不良事件很少发生。常见的3/4级非血液学不良事件包括发热/寒战（15%）、疼痛（8%）和疲乏（6%）。这种无类固醇治疗方案在重度预治疗组中有效且耐受性良好。这些结果表明，MAC方案是复发性或难治性MM患者的一种新的治疗选择。
We assessed the safety and efficacy of melphalan, arsenic trioxide (ATO) and ascorbic acid (AA) (MAC) combination therapy for patients with multiple myeloma (MM) who failed more than two different prior regimens. Patients received melphalan (0.1 mg/kg p.o.), ATO (0.25 mg/kg i.v.) and AA (1 g i.v) on days 1-4 of week 1, ATO and AA twice weekly during weeks 2-5 and no treatment during week 6 of cycle 1; during cycles 2-6, the schedule remained the same except ATO and AA were given twice weekly in week 1. Objective responses occurred in 31 of 65 (48%) patients, including two complete, 15 partial and 14 minor responses. Median progression-free survival and overall survival were 7 and 19 months respectively. Twenty-two patients had elevated serum creatinine levels (SCr) at baseline, and 18 of 22 (82%) showed decreased SCr levels during treatment. Specific grade 3/4 haematological (3%) or cardiac adverse events occurred infrequently. Frequent grade 3/4 non-haematological adverse events included fever/chills (15%), pain (8%) and fatigue (6%). This steroid-free regimen was effective and well tolerated in this heavily pretreated group. These results indicate that the MAC regimen is a new therapeutic option for patients with relapsed or refractory MM.