Wendtner C-M, Ritgen M, Schweighofer C D, Fingerle-Rowson G, Campe H, Jäger G, Eichhorst B, Busch R, Diem H, Engert A, Stilgenbauer S, Döhner H, Kneba M, Emmerich B, Hallek M
Klinikum Grosshadern, Medical Clinic III, Ludwig-Maximilians-University, Munich, Germany.
Leukemia. 2004 Jun;18(6):1093-101. doi: 10.1038/sj.leu.2403354.
Patients with CLL responding to initial chemotherapy with fludarabine alone (F) or in combination with cyclophosphamide (FC) were randomized for treatment with alemtuzumab (30 mg i.v. TIW, 12 weeks) or observation. Of 21 evaluable patients, 11 were randomized to alemtuzumab before the study was stopped due to severe infections in seven of 11 patients. These infections (one life-threatening pulmonary aspergillosis IV; four CMV reactivations III requiring i.v. ganciclovir; one pulmonary tuberculosis III; one herpes zoster III) were successfully treated and not associated with cumulative dose of alemtuzumab. In the observation arm, one herpes zoster infection II and one sinusitis I were documented. At 6 months after randomization, two patients in the alemtuzumab arm converted to CR, while three patients in the observation arm progressed. After alemtuzumab treatment, five of six patients achieved a molecular remission in peripheral blood while all patients in the observation arm remained MRD-positive (P=0.048). At 21.4 months median follow-up, patients receiving alemtuzumab showed a significant longer progression-free survival (no progression vs mean 24.7 months; P=0.036). In conclusion, a consolidation therapy with alemtuzumab is able to achieve molecular remissions and longer survival in CLL, but a safe treatment regimen needs to be determined.
接受氟达拉滨单药（F）或联合环磷酰胺（FC）初始化疗有反应的慢性淋巴细胞白血病（CLL）患者被随机分为接受阿仑单抗治疗（30mg静脉注射，每周3次，共12周）或观察。在21例可评估患者中，11例被随机分配接受阿仑单抗治疗，但在研究因11例患者中有7例发生严重感染而停止前，该组患者未完成治疗。这些感染（1例危及生命的IV级肺曲霉病；4例需要静脉注射更昔洛韦治疗的III级巨细胞病毒再激活；1例III级肺结核；1例III级带状疱疹）均得到成功治疗，且与阿仑单抗的累积剂量无关。在观察组，记录到1例II级带状疱疹感染和1例I级鼻窦炎。随机分组后6个月，阿仑单抗组有2例患者转为完全缓解（CR），而观察组有3例患者病情进展。阿仑单抗治疗后，6例患者中有5例在外周血中达到分子缓解，而观察组所有患者微小残留病（MRD）仍为阳性（P=0.048）。在中位随访21.4个月时，接受阿仑单抗治疗的患者无进展生存期显著延长（无进展vs平均24.7个月；P=0.036）。总之，阿仑单抗巩固治疗能够使CLL患者达到分子缓解并延长生存期，但需要确定安全的治疗方案。
