Randomized phase IIB evaluation of weekly paclitaxel versus weekly paclitaxel with oncolytic reovirus (Reolysin®) in recurrent ovarian, tubal, or peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study.
Randomized phase IIB evaluation of weekly paclitaxel versus weekly paclitaxel with oncolytic reovirus (Reolysin®) in recurrent ovarian, tubal, or peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study.
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在复发性卵巢，输卵管或腹膜癌中，每周紫杉醇与每周紫杉醇的随机IIB评估：NRG肿瘤学/妇科肿瘤学组研究。
DOI：
10.1016/j.ygyno.2017.07.135
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发表时间：
2017-09
影响因子：
4.7
通讯作者：
Aghajanian C
中科院分区：
文献类型：
--
作者：
Cohn DE;Sill MW;Walker JL;O'Malley D;Nagel CI;Rutledge TL;Bradley W;Richardson DL;Moxley KM;Aghajanian C
旨在评估在治疗患有复发性或持续性卵巢癌、输卵管癌或原发性腹膜癌的女性时，在每周一次的紫杉醇中添加溶瘤呼肠孤病毒 (Reolysin®) 是否可以延长无进展生存期 (PFS)。患有复发性或持续性上皮性卵巢癌、输卵管癌或腹膜癌、可测量或可检测到的疾病以及三种或更少既往治疗方案的患者被随机分配至紫杉醇组（每 4 周第 1、8 和 15 天静脉注射 80 mg/m2）或紫杉醇联合治疗（第 1、8 和 15 天静脉注射 80 mg/m2）加呼肠孤病毒组 3×1010 TCID50/天，第 1-5 天静脉注射，每 4 周一次，直至疾病进展或毒性。主要终点是 PFS。该研究设计为在 10% 显着性水平上采用 80% 的单边替代方案，检测到危险减少了 37.5%。该研究招募了 108 名患者，其中 100 名可进行毒性评估。紫杉醇的中位 PFS 为 4.3 个月，紫杉醇加呼肠孤病毒的中位 PFS 为 4.4 个月（风险比，1.11；90% 两侧 CI，0.78 至 1.59；一侧 P = 0.687）。在仅接受紫杉醇治疗的 45 名患有可测量疾病的患者中，对紫杉醇有反应的比例（总体反应率）为 20%，而在接受联合治疗的 46 名患者中，该比例为 17.4%。渐进相对响应概率为 0.87（90% CI，0.42 至 1.79）。联合治疗方案中严重中性粒细胞减少症（≥ 4 级，12% 与 0%）和严重呼吸系统不良事件（≥ 3 级，25% 与 2%）的严重不良事件比紫杉醇组更常见。没有死亡被认为与治疗有关。在治疗患有复发性或持续性卵巢癌、输卵管癌或腹膜癌的女性时，在每周一次的紫杉醇中添加呼肠孤病毒并不能充分降低进展或死亡的风险，值得进一步研究。
To assess whether the addition of oncolytic reovirus (Reolysin®) to weekly paclitaxel prolonged progression-free survival (PFS) in the treatment of women with recurrent or persistent ovarian, tubal or primary peritoneal cancer. Patients with recurrent or persistent epithelial ovarian, tubal, or peritoneal carcinoma, measurable or detectable disease, and three or fewer prior regimens were randomly assigned to paclitaxel (80 mg/m2 intravenously days 1, 8, and 15 every 4 weeks) or the combination of paclitaxel (80 mg/m2 intravenously days 1, 8, and 15) plus reovirus 3×1010 TCID50/day intravenously on days 1-5, both every 4 weeks until disease progression or toxicity. The primary end point was PFS. The study was designed with 80% power for a one-sided alternative at a 10% level of significance to detect a reduction in the hazard by 37.5%. The study accrued 108 patients, 100 of whom were evaluable for toxicity. Median PFS was 4.3 months for paclitaxel and 4.4 months for paclitaxel plus reovirus (hazard ratio, 1.11; 90% two-sided CI, 0.78 to 1.59; one-sided P = 0.687). The proportion responding (overall response rate) to paclitaxel was 20% among 45 patients with measurable disease receiving paclitaxel alone, and 17.4% among the 46 patients treated with the combination. The asymptotic relative probability of responding was 0.87 (90% CI, 0.42 to 1.79). Severe adverse events were more common in the combination regimen than in paclitaxel arm for severe neutropenia (grade ≥ 4, 12% versus 0%), and severe respiratory adverse events (grade ≥ 3, 25% versus 2%). No deaths were considered treatment related. The addition of reovirus to weekly paclitaxel in the treatment of women with recurrent or persistent ovarian, tubal or peritoneal cancer did not sufficiently reduce the hazard of progression or death to warrant further investigation.
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影响因子：
--
作者：
Gupta-Saraf P;Miller CL
通讯作者：
Miller CL
影响因子：
3.8
作者：
Heinemann L;Simpson GR;Boxall A;Kottke T;Relph KL;Vile R;Melcher A;Prestwich R;Harrington KJ;Morgan R;Pandha HS
通讯作者：
Pandha HS
影响因子：
4.7
作者：
Gemignani, ML;Schlaerth, AC;Boyd, J
通讯作者：
Boyd, J
影响因子：
11.5
作者：
Comins, Charles;Spicer, James;Pandha, Hardev S.
通讯作者：
Pandha, Hardev S.
影响因子：
50.3
作者：
Pàez-Ribes M;Allen E;Hudock J;Takeda T;Okuyama H;Viñals F;Inoue M;Bergers G;Hanahan D;Casanovas O
通讯作者：
Casanovas O