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首页> 外文期刊>Gynecologic Oncology: An International Journal >Southwest Oncology Group Trial S9912: intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer.
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Southwest Oncology Group Trial S9912: intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer.

机译：西南肿瘤小组试验S9912：腹膜内顺铂和紫杉醇联合静脉注射紫杉醇和聚乙二醇化脂质体阿霉素作为小剂量残留III期卵巢癌的主要化疗药物。

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OBJECTIVE: While primary cisplatin-based intraperitoneal chemotherapy has been shown to favorably impact survival in small-volume residual advanced ovarian cancer, there is a need to develop strategies that improve the effectiveness of this approach. METHODS: A multi-center phase 2 trial was conducted that added intravenous pegylated liposomal doxorubicin (day 8; 30-40 mg/m(2)) to a regimen of intraperitoneal cisplatin (day 2; 75 mg/m(2)) and intravenous (day 1; 135 mg/m(2)) plus intraperitoneal (day 8; 60 mg/m(2)) paclitaxel. Treatment was initially delivered on an every 3-week schedule, but was modified to an every 4-week program due to excessive toxicity. Patients were to receive 6 cycles of this regimen. RESULTS: Of 68 patients entering this trial, 63 patients were eligible and evaluable, of whom 39 (62%) completed 6 cycles. Overall, 32 (51%) experienced at least 1 grade 4 or worse toxicity (most commonly hematologic) including 5 treatment-related deaths. Median progression-free survival (PFS) was 25 months (2-year PFS: 52%) and median overall survival 51 months, an outcome similar to previous reports of cisplatin-based intraperitoneal chemotherapy in comparable patient populations. Seventeen patients (27% of all eligible patients) were without evidence of disease recurrence >4 years following entry into the trial. CONCLUSION: Both the overall trial outcome, and specifically the excessively severe systemic toxicity of this regimen would prevent its future development in this exact form. The provocative PFS in a subset of individuals should encourage the development of alternative strategies designed to optimize the delivery of regional therapy in ovarian cancer management.
机译：目的：尽管已证明基于顺铂的腹膜内原发性化疗对小剂量残留晚期卵巢癌的生存具有有利影响，但仍需要制定策略来提高这种方法的有效性。方法：进行了一项多中心的2期试验，该试验在腹膜内顺铂（第2天; 75 mg / m（2））方案中添加了静脉内聚乙二醇化脂质体阿霉素（第8天; 30-40 mg / m（2））。静脉（第1天; 135 mg / m（2））加上腹膜内（第8天; 60 mg / m（2））紫杉醇。最初每3周进行一次治疗，但由于毒性过大，改为每4周进行一次治疗。患者将接受该方案的6个周期。结果：进入该试验的68名患者中，有63名患者是合格且可评估的，其中39名（62％）完成了6个周期。总体而言，有32名（51％）经历了至少1级4级或更严重的毒性反应（最常见的是血液学），包括5例与治疗相关的死亡。中位无进展生存期（PFS）为25个月（2年PFS：52％），中位总体生存期为51个月，其结果与以前在可比患者人群中基于顺铂腹腔内化疗的报道相似。进入试验后，有17名患者（占所有合格患者的27％）没有疾病复发> 4年的证据。结论：该方案的整体试验结果，特别是过度严重的全身毒性，都将阻止其以这种确切形式发展。在个体中具有挑衅性的PFS应该鼓励开发替代策略，这些策略旨在优化卵巢癌治疗中的区域治疗。

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