Background

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.

Methods

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.

Results

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%).

Conclusions

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.

中文翻译：

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含贝伐单抗的化疗每 2 周一次给药对铂类耐药复发性卵巢癌的疗效和安全性

背景

尽管被广泛使用，但迄今为止（2021 年 6 月），贝伐单抗 10 mg/kg 每 2 周（Q2W）联合化疗方案在日本尚未获准用于铂耐药复发性卵巢癌患者。在这项回顾性分析中，我们评估了贝伐单抗治疗铂耐药复发性卵巢癌的使用模式。

方法

我们通过调查获得了 2013 年 11 月至 2018 年 12 月期间日本 155 家医疗机构的临床数据。项目包括根据剂量接受贝伐单抗治疗的铂类耐药复发性卵巢癌病例数。对于包括贝伐单抗 10 mg/kg Q2W 在内的方案，要求提供有关同时给药的药物以及该方案的有效性和安全性的更多信息。

结果

在 1633 例复发性卵巢癌患者中报告的 1739 种含贝伐单抗的方案中，264 例使用 10 mg/kg Q2W。该方案的总体缓解率 (ORR) 为 26.1%。缓解率因方案而异，当贝伐单抗 10 mg/kg Q2W 与紫杉醇 (ORR, 53.0%) 与脂质体阿霉素 (15.0%; P  < 0.0001) 和伊立替康 (7.7%; P  < 0.028) 相比时，缓解率特别有利。与贝伐单抗 10 mg/kg Q2W 相关的最常见的 ≥ 3 级不良事件是中性粒细胞减少症 (11.7%) 和高血压 (11.7%)。贝伐单抗加紫杉醇与贝伐单抗加脂质体多柔比星相比，最常见的贝伐单抗相关 ≥ 3 级不良事件是高血压（9.0% 对 13.9%）和蛋白尿（3.0% 对 8.4%）。

结论

贝伐单抗 10 mg/kg Q2W 似乎对复发性卵巢癌患者有效，且毒性可控。日本卵巢癌患者临床上需要批准该方案。