贝伐珠单抗联合紫杉醇作为局部晚期或转移性乳腺癌一线或二线化疗的前瞻性观察研究：JBCRG-C05（B-SHARE）研究。
Prospective observational study of bevacizumab combined with paclitaxel as first- or second-line chemotherapy for locally advanced or metastatic breast cancer: the JBCRG-C05 (B-SHARE) study.
机构信息
Department of Breast and Endocrine Surgery, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
Department of Breast Surgery, Tenri Yorozu Hospital, Nara, Japan.
出版信息
Breast Cancer. 2021 Jan;28(1):145-160. doi: 10.1007/s12282-020-01138-4. Epub 2020 Jul 26.
PURPOSE
To investigate the effectiveness and safety of bevacizumab-paclitaxel combination therapy as first- or second-line chemotherapy for HER2-negative locally advanced or metastatic breast cancer in daily clinical practice.
METHODS
In this prospective multicenter observational study, bevacizumab-paclitaxel was administered at the discretion of attending physicians. Cohorts A and B had hormone receptor-positive and triple-negative breast cancer (TNBC), respectively. Primary endpoint was overall survival (OS). Multivariate analyses were conducted to identify prognostic factors.
RESULTS
Between November 2012 and October 2014, 767 patients were enrolled from 155 institutions across Japan. Effectiveness was analyzed in 754 eligible patients (cohort A, 539; cohort B, 215) and safety in 750 treated patients (median observation period, 19.7 months). Median OS (95% CI) was 21.7 (19.8-23.6) months in eligible patients; 25.2 (22.4-27.4) months and 13.2 (11.3-16.6) months in cohorts A and B, respectively; and 24.4 (21.9-27.2) months and 17.6 (15.2-20.0) months in patients receiving first- and second-line therapy, respectively. Factors affecting OS (hazard ratio 95% CI) were TNBC (1.75, 1.44-2.14), second-line therapy (1.35, 1.13-1.63), ECOG performance status ≥ 1 (1.28, 1.04-1.57), taxane-based chemotherapy (0.65, 0.49-0.86), cancer-related symptoms (0.56, 0.46-0.68), and visceral metastasis (0.52, 0.40-0.66). Incidences of grade ≥ 3 AEs hypertension, neutropenia, peripheral neuropathy, proteinuria, and bleeding were 35.7%, 27.2%, 7.2%, 3.7%, and 0.3%, respectively.
CONCLUSIONS
In Japanese clinical practice, combined bevacizumab-paclitaxel was as effective as in previous studies. Factors that independently predicted poor prognosis in the present study are consistent with those identified previously.
TRIAL REGISTRATION
Trial no. UMIN000009086.
目的
在日常临床实践中，研究贝伐珠单抗联合紫杉醇作为曲妥珠单抗阴性局部晚期或转移性乳腺癌一线或二线化疗的有效性和安全性。
方法
在这项前瞻性多中心观察性研究中，贝伐珠单抗联合紫杉醇由主治医生决定使用。队列 A 和 B 分别为激素受体阳性和三阴性乳腺癌（TNBC）。主要终点是总生存期（OS）。采用多变量分析确定预后因素。
结果
2012 年 11 月至 2014 年 10 月，从日本 155 家机构共招募了 767 名患者。对 754 名符合条件的患者（队列 A：539 例；队列 B：215 例）进行疗效分析，对 750 例接受治疗的患者（中位观察期 19.7 个月）进行安全性分析。符合条件患者的中位 OS（95%CI）为 21.7（19.8-23.6）个月；队列 A 和 B 分别为 25.2（22.4-27.4）个月和 13.2（11.3-16.6）个月；一线和二线治疗患者分别为 24.4（21.9-27.2）个月和 17.6（15.2-20.0）个月。影响 OS 的因素（风险比 95%CI）为 TNBC（1.75，1.44-2.14）、二线治疗（1.35，1.13-1.63）、ECOG 表现状态≥1（1.28，1.04-1.57）、紫杉烷类化疗（0.65，0.49-0.86）、癌症相关症状（0.56，0.46-0.68）和内脏转移（0.52，0.40-0.66）。3 级及以上不良事件（AE）的发生率为高血压（35.7%）、中性粒细胞减少症（27.2%）、周围神经病（7.2%）、蛋白尿（3.7%）和出血（0.3%）。
结论
在日本的临床实践中，贝伐珠单抗联合紫杉醇与既往研究一样有效。本研究中独立预测不良预后的因素与既往研究一致。
试验注册
UMIN000009086。
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