奥沙利铂联合氟嘧啶/贝伐单抗作为老年不可切除转移性结直肠癌的初始疗法：一项多中心、随机、开放标签 III 期试验（JCOG1018）。

IF 42.1 1区医学 Q1 ONCOLOGY Journal of Clinical Oncology Pub Date : 2024-08-26 DOI:10.1200/JCO.23.02722

Atsuo Takashima, Tetsuya Hamaguchi, Junki Mizusawa, Fumio Nagashima, Masahiko Ando, Hitoshi Ojima, Tadamichi Denda, Jun Watanabe, Katsunori Shinozaki, Hideo Baba, Masako Asayama, Seiji Hasegawa, Toshiki Masuishi, Ken Nakata, Shunsuke Tsukamoto, Hiroshi Katayama, Kenichi Nakamura, Haruhiko Fukuda, Yukihide Kanemitsu, Yasuhiro Shimada

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引用次数: 0

摘要

目的：氟嘧啶（FP）和奥沙利铂（OX）加贝伐单抗（BEV）的双联化疗是治疗不可切除转移性结直肠癌（MCRC）的标准方案。然而，在FP+BEV（FP+BEV）中加入OX对老年患者的疗效仍不明确，而老年患者是FP+BEV的标准人群。我们的目的是确认在 FP + BEV 的基础上添加 OX 对这一人群的优越性：这项开放标签、随机的 III 期试验在日本 42 家医疗机构进行。年龄在 70-74 岁、东部合作肿瘤学组表现状态（ECOG-PS）为 2 和 75 岁及以上、ECOG-PS 为 0-2 的不可切除 MCRC 患者被随机分配（1:1）到 FP + BEV 组或添加 OX（FP + BEV + OX）组。入组前声明使用氟尿嘧啶加左亚叶酸钙或卡培他滨。主要终点是无进展生存期（PFS）。该研究已在日本临床试验注册中心注册（标识符：jRCTs031180145）：2012年9月至2019年3月，251名患者被随机分配到FP+BEV组（125人）和FP+BEV+OX组（126人）。两组患者的中位年龄分别为 80 岁和 79 岁。FP + BEV 组的中位 PFS 为 9.4 个月（95% CI，8.3 至 10.3），FP + BEV + OX 组为 10.0 个月（9.0 至 11.2）（危险比 [HR]，0.84 [90.5% CI，0.67 至 1.04]；单侧 P = .086）。FP+BEV治疗组的中位总生存期为21.3个月（18.7至24.3个月），FP+BEV+OX治疗组的中位总生存期为19.7个月（15.5至25.5个月）（HR，1.05 [0.81至1.37]）。FP+BEV+OX治疗组发生≥3级不良事件的比例更高（52%对69%）。FP+BEV组有1例治疗相关死亡，FP+BEV+OX组有3例：结论：在MCRC老年患者的一线治疗中，在FP + BEV的基础上加用OX并无益处。建议在这一人群中使用 FP + BEV。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Oxaliplatin Added to Fluoropyrimidine/Bevacizumab as Initial Therapy for Unresectable Metastatic Colorectal Cancer in Older Patients: A Multicenter, Randomized, Open-Label Phase III Trial (JCOG1018).

Purpose: Doublet chemotherapy with fluoropyrimidine (FP) and oxaliplatin (OX) plus bevacizumab (BEV) is a standard regimen for unresectable metastatic colorectal cancer (MCRC). However, the efficacy of adding OX to FP plus BEV (FP + BEV) remains unclear for older patients, a population for whom FP + BEV is standard. We aimed to confirm the superiority of adding OX to FP + BEV for this population.

Methods: This open-label, randomized, phase III trial was conducted at 42 institutions in Japan. Patients with unresectable MCRC age 70-74 years with Eastern Cooperative Oncology Group performance status (ECOG-PS) 2 and those 75 years and older with ECOG-PS 0-2 were randomly assigned (1:1) to an FP + BEV arm or an OX addition (FP + BEV + OX) arm. Fluorouracil plus levofolinate calcium or capecitabine was declared before enrollment. The primary end point was progression-free survival (PFS). The study was registered in the Japan Registry of Clinical Trials (identifier: jRCTs031180145).

Results: Between September 2012 and March 2019, 251 patients were randomly assigned to the FP + BEV arm (n = 125) and the FP + BEV + OX arm (n = 126). The median age was 80 and 79 years in the respective arm. The median PFS was 9.4 months (95% CI, 8.3 to 10.3) in the FP + BEV arm and 10.0 months (9.0 to 11.2) in the FP + BEV + OX arm (hazard ratio [HR], 0.84 [90.5% CI, 0.67 to 1.04]; one-sided P = .086). The median overall survival was 21.3 months (18.7 to 24.3) in the FP + BEV arm and 19.7 months (15.5 to 25.5) in the FP + BEV + OX arm (HR, 1.05 [0.81 to 1.37]). The proportion of any grade ≥3 adverse events was higher in the FP + BEV + OX arm (52% v 69%). There was one treatment-related death in the FP + BEV arm and three in the FP + BEV + OX arm.

Conclusion: No benefit of adding OX to FP + BEV as first-line treatment was demonstrated in older patients with MCRC. FP + BEV is recommended for this population.

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来源期刊

Journal of Clinical Oncology 医学-肿瘤学

CiteScore

41.20

自引率

2.20%

发文量

8215

审稿时长

2 months

期刊介绍： The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.