Randomized, placebo-controlled study of oregovomab for consolidation of clinical remission in patients with advanced ovarian cancer
Randomized, placebo-controlled study of oregovomab for consolidation of clinical remission in patients with advanced ovarian cancer
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DOI：
10.1200/jco.2004.09.016
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发表时间：
2004-09-01
影响因子：
45.3
通讯作者：
Nicodemus, CF
中科院分区：
文献类型：
--
作者：
Berek, JS;Taylor, PT;Nicodemus, CF
PurposeTo assess oregovomab as consolidation treatment of advanced ovarian cancer and refine the immunodeficiency strategy for subsequent study.Patients and MethodsPatients with stage III/IV ovarian cancer who had a complete clinical response to primary treatment were randomly assigned to oregovomab or placebo administered at weeks 0，4，and 8，and every 12 weeks up to 2 years or until recurrence.主要终点是复发时间（TTR）。结果145例患者接受了奥戈伏单抗（n = 73）或安慰剂（n = 72）治疗。对于总体人群，治疗组间的中位TTR无差异，oregovomab组为13.3个月，安慰剂组为10.3个月（P = 0.71）。在大多数积极治疗的患者中诱导了免疫应答。这与TTR延长有关。治疗未对生活质量产生不良影响。奥戈伏单抗组和安慰剂组报告的不良事件频率相似，表明安全性特征良好。长期生存随访正在进行中。复发数据的考克斯分析确定了重要因素：体能状态、第三周期前的CA-125和基线CA-125。进一步的评估确定了一个具有良好预后指标的亚群，被指定为成功的一线治疗（SFLT）人群。对于SFLT人群，与安慰剂组的10.8个月相比，奥戈伏单抗组的TTR为24.0个月（未校正的风险比为0.543 [95%CI，0.287至1.025]），这是一个产生假设的观察结果。已经启动了一组确证性III期研究，以确定SFLT人群是否从oregovomab治疗中获益。(C)2004年，美国临床肿瘤学会。
PurposeTo assess oregovomab as consolidation treatment of advanced ovarian cancer and refine the immunotherapeutic strategy for subsequent study.Patients and MethodsPatients with stage III/IV ovarian cancer who had a complete clinical response to primary treatment were randomly assigned to oregovomab or placebo administered at weeks 0, 4, and 8, and every 12 weeks up to 2 years or until recurrence. The primary end-point was time to relapse (TTR).ResultsOne hundred forty-five patients were treated with oregovomab (n = 73) or placebo (n = 72). For the population overall, median TTR was not different between treatments at 13.3 months for oregovomab and 10.3 months for placebo (P = .71). Immune responses were induced in most actively treated patients. This was associated with prolonged TTR. Quality of life was not adversely impacted by treatment. Adverse events were reported with similar frequency in oregovomab and placebo groups, indicating a benign safety profile. A long-term survival follow-up is ongoing. Cox analysis of relapse data identified significant factors: performance status, CA-125 before third cycle, and baseline CA-125. Further evaluation identified a subpopulation with favorable prognostic indicators designated as the successful front-line therapy (SFLT) population. For the SFLT population, TTR was 24.0 months in the oregovomab group compared with 10.8 months for placebo (unadjusted hazard ratio of 0.543 [95% CI, 0.287 to 1.025]), a hypothesis-generating observation.ConclusionConsolidation therapy with oregovomab did not significantly improve TTR overall. A set of confirmatory phase III studies has been initiated to determine whether the SFLT population derives benefit from oregovomab treatment. (C) 2004 by American Society of Clinical Oncology.