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一线化疗联合或不联合贝伐珠单抗治疗晚期卵巢癌、输卵管癌和原发性腹膜癌的疗效比较(东北妇科癌症研究组:TGCU-RS001 研究)。

Comparison of treatment outcomes between first-line chemotherapy with or without bevacizumab for advanced ovarian, fallopian tube, and primary peritoneal cancer (Tohoku gynecologic cancer unit: TGCU-RS001 study).

机构信息

Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, 2-1-1, Idaidori, Yahaba, Iwate, 028-3695, Japan.

Department of Obstetrics and Gynecology, Hirosaki University School of Medicine, Hirosaki, Japan.

出版信息

Int J Clin Oncol. 2022 Dec;27(12):1874-1880. doi: 10.1007/s10147-022-02246-1. Epub 2022 Oct 10.

Abstract

BACKGROUND

Outcomes with and without bevacizumab as first-line chemotherapy in Japanese-only ovarian cancer patients have not been reported. In this study, we report a retrospective study conducted at the Tohoku Gynecologic Cancer Unit.

PATIENTS AND METHODS

The study included 453 patients with stage III/IV ovarian, fallopian tube, and primary peritoneal cancer who received first-line platinum-based chemotherapy. The patients were divided into two groups: bevacizumab (168 patients) and without bevacizumab (285 patients). The primary endpoint was the rate of platinum-resistant recurrence and the secondary endpoints were the antitumor response, progression-free survival, overall survival, and adverse events.

RESULTS

The objective response rates for patients with measurable diseases treated with and without bevacizumab were 84.5% and 73.0%, respectively (P = 0.0066). Platinum-resistant recurrence in the groups treated with and without bevacizumab was noted in 31 (18.4%) and 111 (38.6%) patients, respectively (P < 0.0001). The median progression-free survival for the bevacizumab and without bevacizumab groups was 23 and 15 months, respectively (P = 0.0002), and the median overall survival was not reached and 49 months, respectively (P = 0.0005). Hypertension of grade 3 or higher was observed in 21 patients (12.5%) in the bevacizumab group (P < 0.001), and proteinuria was observed in 18 patients (10.7%) and 1 patient (0.3%) in the bevacizumab and without bevacizumab groups, respectively (P < 0.001). Intestinal perforation was observed in only one patient (0.6%) in the bevacizumab group.

CONCLUSION

Combination and maintenance with bevacizumab in primary chemotherapy for advanced ovarian, fallopian tube, and primary peritoneal cancer was effective in reducing platinum-resistant recurrence rates and prolonging progression-free and overall survival.

摘要

背景

在仅为日本人群的卵巢癌患者中,贝伐珠单抗作为一线化疗的疗效和预后尚未见报道。本研究报告了东北妇科癌症组开展的一项回顾性研究。

患者和方法

本研究纳入了 453 例接受一线铂类化疗的 III/IV 期卵巢癌、输卵管癌和原发性腹膜癌患者。患者被分为贝伐珠单抗组(168 例)和非贝伐珠单抗组(285 例)。主要终点是铂耐药复发率,次要终点是抗肿瘤反应、无进展生存期、总生存期和不良事件。

结果

贝伐珠单抗组和非贝伐珠单抗组中可测量疾病患者的客观缓解率分别为 84.5%和 73.0%(P=0.0066)。贝伐珠单抗组和非贝伐珠单抗组中铂耐药复发的患者分别为 31 例(18.4%)和 111 例(38.6%)(P<0.0001)。贝伐珠单抗组和非贝伐珠单抗组的中位无进展生存期分别为 23 个月和 15 个月(P=0.0002),中位总生存期分别为未达到和 49 个月(P=0.0005)。贝伐珠单抗组中 21 例(12.5%)患者出现 3 级或以上高血压,而贝伐珠单抗组和非贝伐珠单抗组中分别有 18 例(10.7%)和 1 例(0.3%)患者出现蛋白尿(P<0.001)。贝伐珠单抗组仅 1 例(0.6%)患者发生肠穿孔。

结论

在晚期卵巢癌、输卵管癌和原发性腹膜癌的一线化疗中联合和维持使用贝伐珠单抗,可有效降低铂耐药复发率,并延长无进展生存期和总生存期。

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