Zhao Shen, Fan Nanfeng, Li Hui, Liu Jie, Huang Feng, Chen Yigui, Zhou Min, Yu Jiaqing, Lin Rongbo
Department of Gastrointestinal Medical Oncology, Fujian Cancer Hospital, Fuzhou, Fujian, China.
Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
Ann Transl Med. 2020 Oct;8(19):1233. doi: 10.21037/atm-20-5841.
Apatinib combined with chemotherapy might be effective and safe for the management of advanced gastric cancer, but the available data are limited. To investigate the efficacy and safety of apatinib in combination with paclitaxel (PTX) alone or POF (PTX, oxaliplatin, and 5-fluorouracil) in patients with taxane-resistant advanced gastric cancer.
Patients with taxane-resistant advanced gastric cancer were enrolled in the single-center, open-labeled, single-arm, exploratory study (ClinicalTrials.gov #NCT02697838). Apatinib was administered at 850 mg po in combination with weekly PTX or the POF regimen. The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), the time to tumor progression (TTP), and safety.
Twenty participants were recruited from 08/2016 to 01/2018. The duration of the study treatment was 2.07 (0.03-16.2) months. The median follow-up was 24.8 (0.3-26.0) months. The reasons for termination of treatment were disease progression (n=6), adverse events (AEs) (n=5), and patients' will (n=9). The ORR was 11.1% (95% CI: 1.4-34.7%) and the DCR was 77.8% (95% CI: 52.4-93.6%). The median PFS was 3.5 (95% CI: 1.9-5.1) months, the median OS was 4.7 (95% CI: 2.0-7.3) months, and the median TTP was 4.2 (95% CI: 0.562-7.838) months. All 20 (100%) patients had AEs, 17 (85%) had apatinib treatment-emergent AEs (TEAEs), and 18 (90%) had chemotherapy TEAEs. The main grade 3-4 TEAEs were neutropenia, leukopenia, hypertension, and anemia.
This preliminary study suggests that apatinib combined with PTX or POF might be effective and tolerable in patients with chemotherapy-refractory gastric cancer. Studies are necessary to confirm the results.
ClinicalTrials.gov #NCT02697838.
阿帕替尼联合化疗可能对晚期胃癌的治疗有效且安全，但现有数据有限。本研究旨在探讨阿帕替尼联合紫杉醇（PTX）单药或POF（紫杉醇、奥沙利铂和5-氟尿嘧啶）方案治疗对紫杉烷耐药的晚期胃癌患者的疗效和安全性。
对紫杉烷耐药的晚期胃癌患者进行单中心、开放标签、单臂探索性研究（ClinicalTrials.gov #NCT02697838）。阿帕替尼口服850 mg，联合每周一次的PTX或POF方案。主要终点为客观缓解率（ORR）。次要终点包括疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）、肿瘤进展时间（TTP）和安全性。
2016年8月至2018年1月共招募了20名参与者。研究治疗持续时间为2.07（0.03 - 16.2）个月。中位随访时间为24.8（0.3 - 26.0）个月。治疗终止原因包括疾病进展（n = 6）、不良事件（AE）（n = 5）和患者意愿（n = 9）。ORR为11.1%（95%CI：1.4 - 34.7%），DCR为77.8%（95%CI：52.4 - 93.6%）。中位PFS为3.5（95%CI：1.9 - 5.1）个月，中位OS为4.7（95%CI：2.0 - 7.3）个月，中位TTP为4.2（95%CI：0.562 - 7.838）个月。所有20名（100%）患者均出现AE，17名（85%）出现阿帕替尼治疗期间出现的不良事件（TEAE），18名（90%）出现化疗TEAE。主要的3 - 4级TEAE为中性粒细胞减少、白细胞减少、高血压和贫血。
这项初步研究表明，阿帕替尼联合PTX或POF方案可能对化疗难治性胃癌患者有效且耐受性良好。需要进一步研究以证实该结果。
ClinicalTrials.gov #NCT02697838。
