The Ohio State University, James Cancer Hospital, Columbus, OH.
Roswell Park Comprehensive Cancer Center, State University of New York at Buffalo, Buffalo, NY.
J Clin Oncol. 2022 Dec 10;40(35):4119-4128. doi: 10.1200/JCO.22.00146. Epub 2022 Jun 27.
To compare taxane maintenance chemotherapy, paclitaxel (P) and paclitaxel poliglumex (PP), with surveillance (S) in women with ovarian, peritoneal, or fallopian tube (O/PC/FT) cancer who attained clinical complete response after first-line platinum-taxane therapy.
Women diagnosed with O/PC/FT cancer who attained clinical complete response after first-line platinum-taxane-based chemotherapy were randomly allocated 1:1:1 to S or maintenance, P 135 mg/m once every 28 days for 12 cycles, or PP at the same dose and schedule. Overall survival (OS) was the primary efficacy end point.
Between March 2005 and January 2014, 1,157 individuals were enrolled. Grade 2 or worse GI adverse events were more frequent among those treated with taxane (PP: 20%, P: 27% S: 11%). Grade 2 or worse neurologic adverse events occurred more often with taxane treatment (PP: 46%, P: 36% S: 14%). At the fourth scheduled interim analysis, both taxane regimens passed the OS futility boundary and the Data Monitoring Committee approved an early release of results. With a median follow-up of 8.1 years, 653 deaths were reported; none were attributed to the study treatment. Median survival durations were 58.3, 56.8, and 60.0 months for S, P, and PP, respectively. Relative to S, the hazard of death for P was 1.091 (95% CI, 0.911 to 1.31; = .343) and for PP, it was 1.033 (95% CI, 0.862 to 1.24; = .725). The median times to first progression or death (PFS) were 13.4, 18.9, and 16.3 months for S, P, and PP, respectively. Hazard ratio = 0.801; 95% CI, 0.684 to 0.938; = .006 for P and hazard ratio = 0.854; 95% CI, 0.729 to 1.00; = .055 for PP.
Maintenance therapy with P and PP did not improve OS among patients with newly diagnosed O/tubal/peritoneal cancer, but may modestly increase PFS. GI and neurologic toxicities were more frequent in the taxane treatment arms.
比较紫杉烷维持化疗、紫杉醇（P）和聚谷氨酸紫杉醇（PP）与观察（S）在一线铂类紫杉烷治疗后获得临床完全缓解的卵巢、腹膜或输卵管（O/PC/FT）癌女性中的疗效。
诊断为 O/PC/FT 癌症的女性在一线铂类紫杉烷化疗后获得临床完全缓解后，按照 1:1:1 的比例随机分配至 S 或维持治疗，P 组给予 135mg/m 紫杉醇，每 28 天一次，共 12 个周期，或给予相同剂量和方案的 PP。总生存期（OS）是主要疗效终点。
2005 年 3 月至 2014 年 1 月期间，共纳入 1157 名患者。接受紫杉醇治疗的患者更常发生 2 级或更高级别的胃肠道不良事件（PP：20%，P：27%，S：11%）。接受紫杉醇治疗的患者更常发生 2 级或更高级别的神经毒性事件（PP：46%，P：36%，S：14%）。在第四次预定中期分析时，两种紫杉烷方案均通过 OS 无效性边界，数据监测委员会批准提前公布结果。中位随访 8.1 年后，报告了 653 例死亡；无死亡归因于研究治疗。S、P 和 PP 组的中位生存时间分别为 58.3、56.8 和 60.0 个月。与 S 相比，P 的死亡风险比为 1.091（95%CI，0.911 至 1.31；P=0.343），PP 的死亡风险比为 1.033（95%CI，0.862 至 1.24；P=0.725）。S、P 和 PP 组的中位无进展生存期（PFS）分别为 13.4、18.9 和 16.3 个月。风险比=0.801；95%CI，0.684 至 0.938；P=0.006 用于 P，风险比=0.854；95%CI，0.729 至 1.00；P=0.055 用于 PP。
新诊断为卵巢/输卵管/腹膜癌的患者接受紫杉醇和聚谷氨酸紫杉醇维持治疗并未改善 OS，但可能适度延长 PFS。紫杉烷治疗组的胃肠道和神经毒性更为常见。
