Nakanishi Toru, Aoki Daisuke, Watanabe Yoh, Ando Yuichi, Tomotsugu Naoki, Sato Yuji, Saito Toshiaki
Department of Gynecology, Aichi Cancer Center Hospital, Nagoya
Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo.
Jpn J Clin Oncol. 2015 May;45(5):422-6. doi: 10.1093/jjco/hyv016. Epub 2015 Feb 10.
This single-arm Phase II trial was designed to assess the safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinum-sensitive recurrent ovarian cancer.
Patients with a histological diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who were relapse-free at least 6 months after completion of first-line platinum-based chemotherapy, and who had measurable disease and gave consent to participate in this study received infusions of pegylated liposomal doxorubicin (30 mg/m(2)) at 1 mg/min, followed by carboplatin (AUC 5 mg min/ml) over 30 min every 28 days.
Thirty-three of 35 enrolled patients were eligible for efficacy analysis. One patient (3.0%) achieved a complete response, while 16 (48.5%) achieved a partial response, with an overall objective response rate of 51.5% (95% confidence interval, 34.5-68.6%). Among the 22 patients who had evaluable CA125 levels at entry, responses were observed in 18 patients, with a response rate of 81.8% (95% confidence interval, 65.3-98.3%). The median progression-free survival and overall survival rates for all 35 patients were 10.7 months (95% confidence interval, 8.1-13.2 months) and 38.8 months (95% confidence interval, 31.0-46.7 months), respectively. The most frequent Grade 3-4 toxicities, regardless of cause, were neutropenia (82.9%), thrombocytopenia (51.4%), leukopenia (45.7%) and anemia (17.1%).
The safety and efficacy of pegylated liposomal doxorubicin and carboplatin combination chemotherapy in patients with platinum-sensitive recurrent ovarian cancer were confirmed. Although there were concerns of severe hematological toxicity with this therapy, this potential complication was safely managed through adequate monitoring of bone marrow function.
本单臂II期试验旨在评估聚乙二醇化脂质体阿霉素与卡铂联合化疗对铂敏感复发性卵巢癌患者的安全性和疗效。
组织学诊断为上皮性卵巢癌、输卵管癌或原发性腹膜癌的患者，在完成一线铂类化疗后至少6个月无复发，且有可测量病灶并同意参与本研究，每28天接受一次聚乙二醇化脂质体阿霉素（30mg/m²）以1mg/min的速度静脉输注，随后30分钟内输注卡铂（AUC 5mg·min/ml）。
35例入组患者中有33例符合疗效分析条件。1例患者（3.0%）达到完全缓解，16例（48.5%）达到部分缓解，总客观缓解率为51.5%（95%置信区间，34.5 - 68.6%）。在入组时CA125水平可评估的22例患者中，18例有反应，反应率为81.8%（95%置信区间，65.3 - 98.3%）。35例患者的中位无进展生存期和总生存期分别为10.7个月（95%置信区间，8.1 - 13.2个月）和38.8个月（95%置信区间，31.0 - 46.7个月）。无论原因，最常见的3 - 4级毒性反应为中性粒细胞减少（82.9%）、血小板减少（51.4%）、白细胞减少（45.7%）和贫血（17.1%）。
聚乙二醇化脂质体阿霉素与卡铂联合化疗对铂敏感复发性卵巢癌患者的安全性和疗效得到证实。尽管该疗法存在严重血液学毒性的担忧，但通过对骨髓功能的充分监测，可安全应对这一潜在并发症。
