Division of Gynecologic Oncology, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Desk A81, 9500 Euclid Avenue, Cleveland, OH 44195, United States of America.
Department of Gynecological Oncology, Mercy Hospital for Women, 163 Studley Road, Heidelberg, Victoria 3058, Australia.
Gynecol Oncol. 2020 Aug;158(2):309-315. doi: 10.1016/j.ygyno.2020.04.708. Epub 2020 Jun 1.
To evaluate the efficacy and toxicity of extended duration pegylated liposomal doxorubicin (PLD) in women with recurrent epithelial ovarian carcinoma (rEOC).
Women with rEOC who received >7 cycles of PLD were retrospectively identified. Response was determined by RECIST 1.1. Progression free survival (PFS) and overall survival (OS) were calculated from PLD initiation. Toxicity was assessed by CTCAE v5.0. Kaplan Meier estimates and Cox proportional hazards were used to evaluate differences in time to recurrence or survival.
69 patients with rEOC received a median of 11.0 cycles (range, 7-115) at a median cumulative dose of 400 mg/m (range, 210-4600 mg/m); 29.0% (n = 20) had platinum sensitive and 71.0% (n = 49) had platinum resistant disease. Of the observed grade ¾ toxicities (31.9%; n = 22), dermatologic were most frequent (n = 13; 18.8%). 41 women (59.4%) experienced clinical benefit; complete response in 17.4% (n = 12), partial response in 13.0% (n = 9) and stable disease in 29.0% (n = 20). Median PFS for all patients was 13.0 months (95% CI, 10.7, 15.2); there were no significant differences between platinum sensitive versus resistant disease (15.9 months vs. 12.3 months; HR 1.15, 95% CI, 0.66, 2.00; p = .61). With extended duration PLD, median OS was 40.2 months (95% CI 30.0, 49.0); no significant differences were noted for platinum sensitive versus resistant disease (44.7 months vs. 33.3 months; HR 1.85, 95% CI, 0.91, 3.78; p = .07). Four cases (5.8%) of oral squamous cell carcinoma occurred during treatment.
Among women with both platinum sensitive and resistant rEOC who received >7 cycles of PLD, approximately one-half experienced sustained clinical benefit with acceptable toxicity. PLD may be considered for extended usage and maintenance in initially responding women with rEOC at least stable disease.
评估多疗程聚乙二醇脂质体阿霉素（PLD）在复发性上皮性卵巢癌（rEOC）患者中的疗效和毒性。
回顾性分析接受>7 个周期 PLD 治疗的 rEOC 女性患者。RECIST 1.1 用于确定缓解情况。从 PLD 开始计算无进展生存期（PFS）和总生存期（OS）。采用 CTCAE v5.0 评估毒性。Kaplan-Meier 估计和 Cox 比例风险用于评估复发或生存时间的差异。
69 例 rEOC 患者接受了中位数为 11.0 个周期（范围，7-115）的治疗，累积剂量中位数为 400mg/m（范围，210-4600mg/m）；29.0%（n=20）为铂类敏感，71.0%（n=49）为铂类耐药。观察到的 3 级及以上毒性（31.9%；n=22）中，皮肤毒性最常见（n=13；18.8%）。41 名女性（59.4%）获得了临床获益；完全缓解率为 17.4%（n=12），部分缓解率为 13.0%（n=9），稳定疾病率为 29.0%（n=20）。所有患者的中位 PFS 为 13.0 个月（95%CI，10.7，15.2）；铂类敏感与耐药疾病之间无显著差异（15.9 个月与 12.3 个月；HR 1.15，95%CI，0.66，2.00；p=0.61）。使用延长疗程 PLD，中位 OS 为 40.2 个月（95%CI，30.0，49.0）；铂类敏感与耐药疾病之间无显著差异（44.7 个月与 33.3 个月；HR 1.85，95%CI，0.91，3.78；p=0.07）。在治疗期间，有 4 例（5.8%）发生口腔鳞状细胞癌。
在接受>7 个周期 PLD 治疗的铂类敏感和耐药 rEOC 女性中，约一半患者持续获得临床获益，且毒性可接受。对于至少稳定疾病的初始反应女性 rEOC 患者，PLD 可考虑延长使用和维持治疗。
