Gopal Ajay K, Chen Robert, Smith Scott E, Ansell Stephen M, Rosenblatt Joseph D, Savage Kerry J, Connors Joseph M, Engert Andreas, Larsen Emily K, Chi Xuedong, Sievers Eric L, Younes Anas
University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA;
City of Hope National Medical Center, Duarte, CA;
Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.
We present response and survival outcomes of a pivotal phase 2 trial of the antibody-drug conjugate brentuximab vedotin in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant (N = 102) after a median observation period of approximately 3 years. Median overall survival and progression-free survival were estimated at 40.5 months and 9.3 months, respectively. Improved outcomes were observed in patients who achieved a complete remission (CR) on brentuximab vedotin, with estimated 3-year overall survival and progression-free survival rates of 73% (95% confidence interval [CI]: 57%, 88%) and 58% (95% CI: 41%, 76%), respectively, in this group (medians not reached). Of the 34 patients who obtained CR, 16 (47%) remain progression-free after a median of 53.3 months (range, 29.0 to 56.2 months) of observation; 12 patients remain progression-free without a consolidative allogeneic stem cell transplant. Younger age, good performance status, and lower disease burden at baseline were characteristic of patients who achieved a CR and were favorable prognostic factors for overall survival. These results suggest that a significant proportion of patients who respond to brentuximab vedotin can achieve prolonged disease control. The trial was registered at www.clinicaltrials.gov as #NCT00848926.
我们报告了抗体药物偶联物本妥昔单抗治疗自体干细胞移植后复发/难治性霍奇金淋巴瘤患者(N = 102)的关键2期试验的缓解和生存结果,中位观察期约为3年。中位总生存期和无进展生存期分别估计为40.5个月和9.3个月。在本妥昔单抗治疗后达到完全缓解(CR)的患者中观察到了更好的结果,该组患者的估计3年总生存率和无进展生存率分别为73%(95%置信区间[CI]:57%,88%)和58%(95%CI:41%,76%)(中位值未达到)。在34例获得CR的患者中,16例(47%)在中位53.3个月(范围29.0至56.2个月)的观察期后仍无进展;12例患者在未进行巩固性异基因干细胞移植的情况下仍无进展。年龄较小、体能状态良好和基线疾病负担较低是达到CR的患者的特征,也是总生存期的有利预后因素。这些结果表明相当一部分对本妥昔单抗有反应的患者可以实现长期疾病控制。该试验在www.clinicaltrials.gov上注册为#NCT00848926。