Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: An intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group
Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: An intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group
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DOI：
10.1200/jco.2001.19.4.1001
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发表时间：
2001-02-15
影响因子：
45.3
通讯作者：
Sickel, J
中科院分区：
文献类型：
--
作者：
Markman, M;Bundy, BN;Sickel, J
目的：比较小体积残余卵巢癌静脉注射（IV）顺铂和紫杉醇或静脉注射卡铂然后静脉注射紫杉醇和腹腔注射顺铂实验方案治疗后的无进展生存期和总生存期。 患者和方法：患者被随机分配接受 24 小时内静脉注射紫杉醇 135 mg/m(2) 随后每 3 周静脉注射 75 mg/m(2)，持续六个疗程，或每 28 天静脉注射卡铂（曲线 9 下面积），持续两个疗程，然后在 24 小时内静脉注射紫杉醇 135 mg/m(2)，随后每 3 周腹膜内 (IP) 顺铂 100 mg/m(2)，持续六个疗程。 结果：在进入该研究的 523 名患者中 试验中，462 例被确定为可评估，治疗之间的预后因素得到了很好的平衡。实验组中性粒细胞减少症、血小板减少症以及胃肠道和代谢毒性更大。结果，18% 的患者接受了少于或等于两个疗程的 IP 治疗。随机分配至实验治疗组的患者的无进展生存期较高（中位时间为 28 个月与 22 个月；相对风险为 0.78；对数秩 P = 0.01，单尾）。与该方案相关的总生存期略有改善（中位数为 63 个月 vs 52 个月；相对风险为 0.81；P = 0.05，单尾）。 结论：与静脉注射顺铂和静脉注射顺铂的标准方案相比，包括中等高剂量静脉注射卡铂、随后腹腔注射紫杉醇和静脉注射顺铂的实验方案可显着改善无进展生存期。 紫杉醇。由于总体生存率的改善具有统计学意义，并且毒性较大，因此不建议常规使用该实验组。然而，这些结果为小体积卵巢癌的进一步临床研究提供了方向。
Purpose: To compare the progression-free and overall survival in small-volume residual ovarian cancer after treatment with intravenous (IV) cisplatin and paclitaxel or an experimental regimen of IV carboplatin followed by IV paclitaxel and intraperitoneal cisplatin.Patients and Methods: Patients were randomized to receive either IV paclitaxel 135 mg/m(2) over 24 hours followed by IV cisplatin 75 mg/m(2) every 3 weeks for six courses or IV carboplatin (area under curve 9) every 28 days for two courses, then IV paclitaxel 135 mg/m(2) over 24 hours followed by intraperitoneal (IP) cisplatin 100 mg/m(2) every 3 weeks for six courses.Results: Of the 523 patients who entered this trial, 462 were determined to be assessable, with prognostic factors well balanced between the treatments. Neutropenia, thrombocytopenia, and gastrointestinal and metabolic toxicities were greater in the experimental arm. As a result, 18% of the patients received less than or equal to two courses of IP therapy. Progression-free survival was superior for patients randomized to the experimental treatment arm (median, 28 v 22 months; relative risk, 0.78; log-rank P = .01, one-tail). There was a borderline improvement in overall survival associated with this regimen (median, 63 v 52 months; relative risk, 0.81; P = .05, one-tail).Conclusion: An experimental regimen including moderately high-dose IV carboplatin followed by IP paclitaxel and IV cisplatin yielded a significant improvement in progression-free survival when compared with a standard regimen of IV cisplatin and paclitaxel. Because the improvement in overall survival was of borderline statistical significance and toxicity was greater, the experimental arm is mot recommended for routine use. However, the results provide direction for further clinical investigation in small-volume ovarian cancer.