Ichikawa Ryoko, Torii Yutaka, Oe Shuko, Kawamura Kyoko, Kato Rina, Hasegawa Kiyoshi, Udagawa Yasuhiro
Department of Obstetrics and Gynecology, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
Arch Gynecol Obstet. 2014 Nov;290(5):979-84. doi: 10.1007/s00404-014-3268-7. Epub 2014 May 6.
This study was conducted to retrospectively compare the efficacy and safety of irinotecan (CPT-11) and pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant or -refractory recurrent epithelial ovarian and primary peritoneal carcinoma.
Nineteen patients who received CPT-11 and eleven patients who received PLD were enrolled. CPT-11 was intravenously administered at a starting dose of 60-100 mg/m(2) on day 1, 8, and 15 every 28 days, and PLD was administered at a starting dose of 40-50 mg/m(2) on day 1 every 28 days. Primary outcomes were overall response rate (complete response [CR] + partial response [PR]), disease control rate (CR + PR + stable disease), and progression-free survival (PFS) in each group. Clinical response was evaluated every two or three cycles using the Response Evaluation Criteria in Solid Tumors criteria; CA125 analysis was not performed.
The overall response rate was 21.1 % (PR, four cases) and 0 % (p = 0.10) in the CPT-11 and PLD groups, respectively, and the disease control rate was 73.7 and 45.5 % (p = 0.12), respectively. Median PFS was 25.3 (range 5.4-69.9) weeks and 12.7 (range 4.0-43.1) weeks in the CPT-11 and PLD groups, respectively; however, this difference was not statistically significant (p = 0.064). Major adverse events in the CPT-11 group were neutropenia, nausea, and diarrhea, whereas those in the PLD group included thrombocytopenia, anemia, stomatitis, and hand-foot syndrome.
This retrospective study demonstrated comparable efficacy outcomes for CPT-11 and PLD. The overall response rate, disease control rate, and median PFS were more favorable in the CPT-11 group compared to the PLD group, although the difference was not significant. The adverse event profiles were different between groups. These results suggest that CPT-11 might be a feasible choice as single-agent salvage chemotherapy for platinum-resistant or -refractory recurrent epithelial ovarian and primary peritoneal carcinoma beside established regimen like PLD.
本研究旨在回顾性比较伊立替康（CPT - 11）与聚乙二醇脂质体阿霉素（PLD）治疗铂耐药或难治性复发性上皮性卵巢癌及原发性腹膜癌患者的疗效和安全性。
纳入19例接受CPT - 11治疗的患者和11例接受PLD治疗的患者。CPT - 11每28天在第1、8和15天静脉给药，起始剂量为60 - 100mg/m²，PLD每28天在第1天给药，起始剂量为40 - 50mg/m²。主要观察指标为每组的总缓解率（完全缓解[CR] + 部分缓解[PR]）、疾病控制率（CR + PR + 疾病稳定）和无进展生存期（PFS）。每两或三个周期使用实体瘤疗效评价标准评估临床缓解情况；未进行CA125分析。
CPT - 11组和PLD组的总缓解率分别为21.1%（PR，4例）和0%（p = 0.10），疾病控制率分别为73.7%和45.5%（p = 0.12）。CPT - 11组和PLD组的中位PFS分别为25.3周（范围5.4 - 69.9周）和12.7周（范围4.0 - 43.1周）；然而，这种差异无统计学意义（p = 0.064）。CPT - 11组的主要不良事件为中性粒细胞减少、恶心和腹泻，而PLD组的不良事件包括血小板减少、贫血、口腔炎和手足综合征。
这项回顾性研究表明CPT - 11和PLD的疗效相当。与PLD组相比，CPT - 11组的总缓解率、疾病控制率和中位PFS更优，尽管差异不显著。两组的不良事件谱不同。这些结果表明，除了像PLD这样的既定方案外，CPT - 11可能是铂耐药或难治性复发性上皮性卵巢癌及原发性腹膜癌单药挽救化疗的可行选择。
