Department of Leukemia, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, 77030, USA.
Blood. 2011 Nov 10;118(19):5126-9. doi: 10.1182/blood-2011-04-348656. Epub 2011 Aug 19.
Ofatumumab, the human CD20 monoclonal antibody that binds a distinct epitope from rituximab, has demonstrated clinical benefit as monotherapy for patients with chronic lymphocytic leukemia refractory to fludarabine and alemtuzumab (FA-ref) and patients refractory to fludarabine with bulky (> 5 cm) lymph nodes (BF-ref). To potentially gain insight into outcomes in patients previously treated with or refractory to rituximab, we performed an ad hoc retrospective analysis in the final 96 FA-ref and 111 BF-ref patients. There were 117 patients previously treated with rituximab (98 rituximab-refractory); 89 patients were rituximab-naive. For rituximab-treated, rituximab-refractory, and rituximab-naive patients, overall response rate was 43%, 44%, and 53%; median progression-free survival was 5.3, 5.5, and 5.6 months; and median overall survival was 15.5, 15.5, and 20.2 months. There were no significant differences in ofatumumab-related infusion reactions, or hematologic or infectious adverse events between subgroups. In summary, ofatumumab monotherapy was effective and well tolerated in patients with fludarabine-refractory chronic lymphocytic leukemia, including in patients with previous rituximab exposure. This trial was registered at www.clinicaltrials.gov as #NCT00349349.
奥法妥珠单抗是一种人源化抗 CD20 单克隆抗体，与利妥昔单抗结合的表位不同，在氟达拉滨和阿仑单抗（FA-难治）耐药的慢性淋巴细胞白血病患者和氟达拉滨耐药且有大块（> 5cm）淋巴结（BF-难治）的患者中作为单药治疗已显示出临床获益。为了深入了解先前接受过利妥昔单抗治疗或耐药的患者的结果，我们对最后 96 例 FA-难治和 111 例 BF-难治患者进行了一项特别的回顾性分析。有 117 例患者先前接受过利妥昔单抗治疗（98 例利妥昔单抗耐药）；89 例患者为利妥昔单抗初治患者。对于接受过利妥昔单抗治疗、利妥昔单抗耐药和利妥昔单抗初治的患者，总缓解率分别为 43%、44%和 53%；中位无进展生存期分别为 5.3、5.5 和 5.6 个月；中位总生存期分别为 15.5、15.5 和 20.2 个月。各组之间奥法妥珠单抗相关输注反应、血液学或感染性不良事件无显著差异。总之，奥法妥珠单抗单药治疗在氟达拉滨难治性慢性淋巴细胞白血病患者中是有效且耐受良好的，包括先前接受过利妥昔单抗治疗的患者。该试验在 www.clinicaltrials.gov 上注册，编号为 #NCT00349349。
