Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, 757 Ichibancho, Asahimachi-dori, Chuo Ward, Niigata, Niigata, Japan.
Division of Obstetrics and Gynecology, Faculty of Medicine, Tohoku Medical and Pharmaceutical University, 4-4-1 Komatsushima, Aobaku, Sendai, Miyagi, Japan.
Int J Clin Oncol. 2021 Nov;26(11):2123-2129. doi: 10.1007/s10147-021-01996-8. Epub 2021 Jul 26.
Despite being widely used, to date (June 2021), the regimen of bevacizumab 10 mg/kg every 2 weeks (Q2W) combined with chemotherapy is not approved in Japan for patients with platinum-resistant recurrent ovarian cancer. In this retrospective analysis, we evaluated the usage patterns of bevacizumab administered for platinum-resistant recurrent ovarian cancer.
We obtained clinical data from 155 Japanese medical facilities between November 2013 and December 2018 via a survey. Items included the number of cases of platinum-resistant recurrent ovarian cancer treated with bevacizumab according to dosage. For regimens including bevacizumab 10 mg/kg Q2W, additional information was requested relating to concomitantly administered agents, and the efficacy and safety of the regimen.
Of 1739 bevacizumab-containing regimens reported in 1633 patients with recurrent ovarian cancer, 264 used 10 mg/kg Q2W. The overall response rate (ORR) with this regimen was 26.1%. Response rates varied according to regimen and were particularly favorable when bevacizumab 10 mg/kg Q2W was administered with paclitaxel (ORR, 53.0%) versus liposomal doxorubicin (15.0%; P < 0.0001) and irinotecan (7.7%; P < 0.028). The most frequent Grade ≥ 3 adverse events associated with bevacizumab 10 mg/kg Q2W were neutropenia (11.7%) and hypertension (11.7%). The most frequent bevacizumab-associated Grade ≥ 3 adverse events with bevacizumab plus paclitaxel versus bevacizumab plus liposomal doxorubicin were hypertension (9.0% versus 13.9%) and proteinuria (3.0% versus 8.4%).
Bevacizumab 10 mg/kg Q2W appears efficacious for patients with recurrent ovarian cancer, with a manageable toxicity profile. Approval of this regimen is clinically desirable for Japanese patients with ovarian cancer.
尽管贝伐珠单抗 10mg/kg 每 2 周(Q2W)联合化疗方案被广泛应用,但截至 2021 年 6 月,该方案尚未在日本被批准用于铂耐药复发性卵巢癌患者。在这项回顾性分析中,我们评估了贝伐珠单抗治疗铂耐药复发性卵巢癌的应用模式。
我们通过调查从 2013 年 11 月至 2018 年 12 月期间的 155 家日本医疗机构获得了临床数据。项目包括根据剂量治疗铂耐药复发性卵巢癌的贝伐珠单抗病例数。对于包含贝伐珠单抗 10mg/kg Q2W 的方案,我们还要求提供同时使用的药物信息,以及该方案的疗效和安全性。
在 1633 例复发性卵巢癌患者的 1739 个贝伐珠单抗方案中,有 264 个方案使用了 10mg/kg Q2W。该方案的总缓解率(ORR)为 26.1%。方案的缓解率存在差异,当贝伐珠单抗 10mg/kg Q2W 联合紫杉醇(ORR,53.0%)与脂质体多柔比星(15.0%;P<0.0001)和伊立替康(7.7%;P<0.028)联合使用时,疗效更为显著。与贝伐珠单抗 10mg/kg Q2W 相关的最常见的 3 级及以上不良事件是中性粒细胞减少症(11.7%)和高血压(11.7%)。与贝伐珠单抗 10mg/kg Q2W 联合紫杉醇相比,与贝伐珠单抗 10mg/kg Q2W 联合脂质体多柔比星相关的最常见的 3 级及以上贝伐珠单抗相关不良事件是高血压(9.0%与 13.9%)和蛋白尿(3.0%与 8.4%)。
贝伐珠单抗 10mg/kg Q2W 对复发性卵巢癌患者有效,具有可管理的毒性特征。对于日本卵巢癌患者,该方案的临床批准是合乎需要的。