Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Republic of Korea.
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
Gynecol Oncol. 2019 Jan;152(1):61-67. doi: 10.1016/j.ygyno.2018.10.031. Epub 2018 Nov 6.
To evaluate the effectiveness of bevacizumab with single-agent chemotherapy for platinum-resistant ovarian cancer in a real-world setting.
We enrolled recurrent platinum-resistant ovarian cancer patients from 27 institutions. All had received bevacizumab with single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin (PLD), topotecan) between 2015 and 2017 for second- or third-line chemotherapy in routine clinical practice. The primary endpoint was progression-free survival (PFS) and safety. Secondary endpoints included the objective response rate (ORR), PFS2, overall survival, duration of chemotherapy, and reasons for discontinuing chemotherapy.
Of 391 patients, 259 (66.2%) received bevacizumab with PLD, 94 (24.0%) with topotecan, and 38 (9.7%) with weekly paclitaxel. The median PFS was 6.1 months with all forms of bevacizumab-containing therapy. Although the cohort with weekly paclitaxel had a better PFS than the PLD cohort (P = 0.028), this finding was not found in patients with a previous platinum-free interval of less than three months. The median duration of therapy was five cycles (range, one to 20 cycles), and 29 patients (7.4%) discontinued treatment because of adverse events from bevacizumab-containing regimens. The PLD cohort had fewer grade ≥ 3 adverse events than the other regimens (PLD, 35.8%; weekly paclitaxel, 52.6%; topotecan, 51.1%; P = 0.012), especially events of hematologic toxicities.
In Korean ovarian cancer patients, the safety and effectiveness of chemotherapy with bevacizumab in a real-world setting was consistent with the results from a randomized controlled study. The effectiveness and toxicity profiles varied among the chemotherapy regimens, and this finding should be considered in practice.
NCT03367182.
评估贝伐珠单抗联合单药化疗治疗铂耐药卵巢癌的真实世界疗效。
我们纳入了 27 家机构的铂耐药复发性卵巢癌患者。所有患者均在 2015 年至 2017 年接受了贝伐珠单抗联合单药化疗(每周紫杉醇、聚乙二醇脂质体多柔比星(PLD)、拓扑替康)治疗,作为二线或三线化疗,应用于常规临床实践。主要终点为无进展生存期(PFS)和安全性。次要终点包括客观缓解率(ORR)、PFS2、总生存期、化疗持续时间和停止化疗的原因。
在 391 例患者中,259 例(66.2%)接受了贝伐珠单抗联合 PLD、94 例(24.0%)接受了贝伐珠单抗联合拓扑替康、38 例(9.7%)接受了贝伐珠单抗联合每周紫杉醇。所有含贝伐珠单抗治疗方案的中位 PFS 均为 6.1 个月。尽管每周紫杉醇组的 PFS 优于 PLD 组(P=0.028),但在无铂间期小于 3 个月的患者中并未发现这一结果。中位治疗持续时间为 5 个周期(范围 1 至 20 个周期),29 例患者(7.4%)因含贝伐珠单抗方案的不良反应而停止治疗。PLD 组的 3 级及以上不良事件发生率低于其他方案(PLD 组 35.8%、每周紫杉醇组 52.6%、拓扑替康组 51.1%,P=0.012),尤其是血液学毒性事件。
在韩国卵巢癌患者中,真实世界中贝伐珠单抗联合化疗的安全性和有效性与随机对照研究结果一致。化疗方案的有效性和毒性谱存在差异,在实践中应考虑这一点。
NCT03367182。