JCO:阿巴伏单抗用于卵巢癌维持治疗无生存获益

2013-04-07 ecoliDH5 丁香园

　　　　　RFS与OS结果　　在2013年3月11日在线出版的《临床肿瘤学杂志》(Journal of Clinical Oncology)上，发表了美国纪念斯隆凯特琳癌症中心Paul Sabbatini博士等人的一项研究结果，该研究针对处于首次临床缓解期的卵巢癌患者，旨在确定阿巴伏单抗维持治疗是否可延长其无复发生存期及整体生存期。　　在该项双盲、安

　　　　　RFS与OS结果

　　在2013年3月11日在线出版的《临床肿瘤学杂志》(Journal of Clinical Oncology)上，发表了美国纪念斯隆凯特琳癌症中心Paul Sabbatini博士等人的一项研究结果，该研究针对处于首次临床缓解期的卵巢癌患者，旨在确定阿巴伏单抗维持治疗是否可延长其无复发生存期及整体生存期。

　　在该项双盲、安慰剂对照、多中心临床III期研究中，研究人员按照2:1比例，对经首次手术及以铂制剂和紫杉类药物化疗后，处于完全临床缓解期的III期至IV期(根据国际妇产科联合会判断标准)卵巢癌患者进行了随机分配。每两周按照1-mL悬液的给药形式进行给药，给药剂量为2 mg的阿巴伏单抗或安慰剂，共给药6周(诱导阶段)，其后每4周给药一次，直至出现复发或给药至最后一例患者完成随机分配后的第21个月为止。研究主要终点为RFS；次要终点为OS及免疫应答。

　　研究结果显示，患者平均年龄为56.3岁；根据东部肿瘤协作组行为状态标准，> 99%的患者评分值≤ 1；81.5%的患者为浆液性乳头状亚型；85.9%为III期；80.9%的患者在第三个周期后，癌抗原125 ≤ 35U/mL。患者平均治疗时间(±标准偏差)为449.7 ± 333.08天。研究人员根据瘤体大小分类(≤ 1 cm, > 1 cm)，得出治疗组RFS风险比(HR)为1.099 (95% CI, 0.919 至 1.315; P = .301)。根据瘤体大小分类(≤ 1 cm, > 1 cm)，得出治疗组OS HR值为1.150 (95% CI, 0.872 至 1.518; P = .322)。报告之中的最常见不良事件为注射部位反应，共有445例(50.2%)患者发生，其次是注射部位红疹及疲劳，分别有227(25.6%)例患者及212(23.9%)例患者发生。最后一次随访发现，抗抗独特型抗体水平中位值为493,000.0 ng/mL，这表明应答强烈。

　　研究人员最后认为，可安全进行每月一次的阿巴伏单抗反复注射给药，且可诱导出可测量到的免疫应答。但处于首次缓解期的卵巢癌患者进行维持治疗给药并不能延长RFS或OS。

Abagovomab As Maintenance Therapy in Patients With Epithelial Ovarian Cancer: A Phase III Trial of the AGO OVAR, COGI, GINECO, and GEICO—The MIMOSA Study

Purpose

To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission.

Patients and Methods

Patients with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum- and taxane-based chemotherapy were randomly assigned at a ratio of 2:1 in a phase III, double-blind, placebo-controlled, multicenter study. Abagovomab 2 mg or placebo was administered as 1-mL suspension once every 2 weeks for 6 weeks (induction phase) and then once every 4 weeks (maintenance phase) until recurrence or up to 21 months after random assignment of the last patient. The primary end point was RFS; secondary end points were OS and immunologic response.

Results

Characteristics of the 888 patients included: mean age, 56.3 years; Eastern Cooperative Oncology Group performance status, ≤ 1 in > 99% of patients; serous papillary subtype, 81.5%; stage III, 85.9%; and cancer antigen 125 ≤ 35U/mL after third cycle, 80.9%. Mean exposure to study treatment (± standard deviation) was 449.7 ± 333.08 days. Hazard ratio (HR) of RFS for the treatment group using tumor size categorization (≤ 1 cm, > 1 cm) was 1.099 (95% CI, 0.919 to 1.315; P = .301). HR of OS using tumor size categorization (≤ 1 cm, > 1 cm) was 1.150 (95% CI, 0.872 to 1.518; P = .322). The most frequently reported type of adverse event was an injection site reaction in 445 patients (50.2%), followed by injection site erythema and fatigue in 227 (25.6%) and 212 patients (23.9%), respectively. By the final visit, median anti–anti-idiotypic antibody level was 493,000.0 ng/mL, indicating a robust response.

Conclusion

Abagovomab administered as repeated monthly injections is safe and induces a measurable immune response. Administration as maintenance therapy for patients with ovarian cancer in first remission does not prolong RFS or OS.

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2014-01-31 lidong40

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2013-09-30 ms8538335253054589

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