Zhao Shen, Su Liyu, Chen Yigui, Li Xiaofeng, Lin Peicheng, Chen Wujin, Fang Wenzheng, Zhu Jinfeng, Li Hui, Ren Liping, Liu Jie, Hong Yanni, Lin Shaowei, Fan Nanfeng, Lin Rongbo
Department of Gastrointestinal Medical Oncology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.
Fujian Key Laboratory of Translational Cancer Medicine, Fuzhou, China.
Front Oncol. 2022 Sep 7;12:850242. doi: 10.3389/fonc.2022.850242. eCollection 2022.
We conducted a phase 2 trial to compare the safety and efficacy of intravenous paclitaxel or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 in untreated advanced gastric cancer.
Participants with untreated advanced gastric cancer were randomly assigned (1:1:1) to: intravenous paclitaxel 135 mg/m or intraperitoneal paclitaxel 80 mg/m plus mFOLFOX6 omitting bolus fluorouracil; or mFOLFOX6 (oxaliplatin 85 mg/m, leucovorin 400 mg/m, fluorouracil 400 mg/m bolus, fluorouracil 2,400 mg/m 46-h continuous infusion). Treatment was every 14 days for up to 9 cycles followed by S-1 maintenance. The primary outcome was progression-free survival.
Of 90 enrolled participants, 30 in the intravenous paclitaxel group, 29 in the intraperitoneal paclitaxel group, and 30 in the mFOLFOX6 group were included in the analyses. The median progression-free survival was 6.52, 5.83, and 4.55 months, respectively, for the intravenous paclitaxel group, intraperitoneal paclitaxel group, and mFOLFOX6 group. The hazard ratios were 0.56 (95% CI: 0.33-0.94; = 0.026) and 0.56 (95% CI: 0.33-0.96; = 0.037), respectively, for the intravenous paclitaxel group and the intraperitoneal paclitaxel group vs. the mFOLFOX6 group. The most common grade 3/4 adverse events for the intravenous paclitaxel group, intraperitoneal paclitaxel group, and mFOLFOX6 group, respectively, were neutropenia (30.0%, 34.5%, 33.3%), diarrhea (13.3%, 20.7%, 13.3%), and leukopenia (10.0%, 13.8%, 10.0%). No treatment-related death occurred.
The findings of this phase 2 trial suggest that adding intravenous paclitaxel or intraperitoneal paclitaxel to mFOLFOX6 for untreated advanced gastric cancer improved progression-free survival with manageable adverse events.
我们开展了一项2期试验，比较静脉注射紫杉醇或腹腔注射紫杉醇联合mFOLFOX6与mFOLFOX6用于未经治疗的晚期胃癌的安全性和疗效。
将未经治疗的晚期胃癌患者随机分配（1:1:1）至以下组：静脉注射紫杉醇135mg/m²或腹腔注射紫杉醇80mg/m²联合省略推注氟尿嘧啶的mFOLFOX6；或mFOLFOX6（奥沙利铂85mg/m²、亚叶酸钙400mg/m²、氟尿嘧啶400mg/m²推注、氟尿嘧啶2400mg/m²持续输注46小时）。每14天进行一次治疗，最多9个周期，随后进行S-1维持治疗。主要结局为无进展生存期。
90名入组参与者中，分析纳入了静脉注射紫杉醇组的30名、腹腔注射紫杉醇组的29名和mFOLFOX6组的30名。静脉注射紫杉醇组、腹腔注射紫杉醇组和mFOLFOX6组的中位无进展生存期分别为6.52个月、5.83个月和4.55个月。静脉注射紫杉醇组和腹腔注射紫杉醇组相对于mFOLFOX6组的风险比分别为0.56（95%CI：0.33 - 0.94；P = 0.026）和0.56（95%CI：0.33 - 0.96；P = 0.037）。静脉注射紫杉醇组、腹腔注射紫杉醇组和mFOLFOX6组最常见的3/4级不良事件分别为中性粒细胞减少（30.0%、34.5%、33.3%）、腹泻（13.3%、20.7%、13.3%）和白细胞减少（10.0%、13.8%、10.0%）。未发生与治疗相关的死亡。
这项2期试验的结果表明，对于未经治疗的晚期胃癌，在mFOLFOX6基础上加用静脉注射紫杉醇或腹腔注射紫杉醇可改善无进展生存期，且不良事件可控。
