Hütter G, Szélenyi H, Schmittel A, Siehl J M, Thiel E, Keilholz U
Department of Medicine III (Hematology, Oncology and Transfusion Medicine), Charité Campus Benjamin Franklin, Berlin, Germany.
Hematol Oncol. 2007 Sep;25(3):132-9. doi: 10.1002/hon.821.
The purpose of this study was to assess the efficacy and safety of pegylated liposomal doxorubicin in combination with cyclophosphamide and dexamethasone (CLAD). In this prospective open-label phase II study, 60 patients with advanced multiple myeloma (MM) received three weekly cycles of CLAD, consisting of cyclophosphamide 200 mg/m2 i.v. d1-4, pegylated liposomal doxorubicin 20 mg/m2 i.v. d1 and dexamethasone 40 mg p.o. d1-4 for a maximum of six cycles in absence of disease progression. Efficacy and toxicity was compared to our immediate historical cohort of 46 patients treated with cyclophosphamide, dexamethasone and conventional doxorubicin (CAD). A total of 239 cycles of CLAD and 209 cycles of CAD, respectively, were given. The objective response rate was 71% (CLAD) and 74% (CAD). Non-cumulative hematological toxicity was predominant in both regimens. It was found that CLAD is an active and well-tolerated treatment regimen for MM. Response rate is comparable to other anthracycline containing regimens like CAD with an advantage in hematological toxicity and lower infectious complications, and a presumed advantage of lower cardiotoxicity.
本研究的目的是评估聚乙二醇化脂质体阿霉素联合环磷酰胺和地塞米松（CLAD）的疗效和安全性。在这项前瞻性开放标签的II期研究中，60例晚期多发性骨髓瘤（MM）患者接受了三个每周一次的CLAD周期治疗，包括静脉注射环磷酰胺200 mg/m²，第1 - 4天；静脉注射聚乙二醇化脂质体阿霉素20 mg/m²，第1天；口服地塞米松40 mg，第1 - 4天，在无疾病进展的情况下最多进行六个周期。将疗效和毒性与我们近期的46例接受环磷酰胺、地塞米松和传统阿霉素（CAD）治疗的历史队列进行比较。分别给予了总共239个CLAD周期和209个CAD周期。客观缓解率分别为71%（CLAD）和74%（CAD）。两种方案中主要是非累积性血液学毒性。结果发现，CLAD是一种治疗MM的有效且耐受性良好的治疗方案。缓解率与其他含蒽环类药物的方案如CAD相当，在血液学毒性和较低的感染并发症方面具有优势，并且推测在心脏毒性方面较低。
