QUATTRO-II randomized trial: CAPOXIRI+bevacizumab vs. FOLFOXIRI+bevacizumab as first-line treatment in patients with mCRC.

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL Med Pub Date : 2024-09-13 Epub Date: 2024-06-19 DOI:10.1016/j.medj.2024.05.012

Hideaki Bando, Daisuke Kotani, Hironaga Satake, Tetsuya Hamaguchi, Manabu Shiozawa, Masahito Kotaka, Toshiki Masuishi, Hisateru Yasui, Yoshinori Kagawa, Yoshito Komatsu, Eiji Oki, Yoshiyuki Yamamoto, Hisato Kawakami, Toshihiro Misumi, Hiroya Taniguchi, Kentaro Yamazaki, Kei Muro, Takayuki Yoshino, Takeshi Kato, Akihito Tsuji

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Abstract

Background: The QUATTRO-II trial examined the efficacy and safety of capecitabine+oxaliplatin+irinotecan (CAPOXIRI)+bevacizumab (BEV) vs. 5-fluorouracil+folinic acid+oxaliplatin+irinotecan (FOLFOXIRI)+BEV in metastatic colorectal cancer (mCRC).

Methods: In this phase II study (ClinicalTrials.gov: NCT04097444; jRCTs041190072), patients were randomized (1:1) to FOLFOXIRI+BEV or CAPOXIRI+BEV. The induction treatment in the FOLFOXIRI+BEV/CAPOXIRI+BEV arms was continued for 8/6 cycles (maximum 12/8 cycles if feasible), and the maintenance treatment was 5-fluorouracil/leucovorin+BEV or capecitabine+BEV at the investigators' discretion. The primary endpoint was progression-free survival (PFS), with the two arms deemed equivalent if the hazard ratio (HR) of the point estimate was 0.80 < HR < 1.25. Secondary endpoints were overall response rate (ORR), overall survival (OS), incidence of adverse events (AEs), and patient-reported outcomes.

Findings: Overall, 51 and 52 patients were randomized to FOLFOXIRI+BEV and CAPOXIRI+BEV, respectively. The study met its primary endpoint; PFS at median follow-up of 23.7 months was 10.6 months (95% confidence interval [CI], 7.7-13.3) in the FOLFOXIRI+BEV arm vs. 10.9 months (95% CI, 9.3-14.3) in the CAPOXIRI+BEV arm (HR 1.114 [0.80 < HR < 1.25], p = 0.654). In the FOLFOXIRI+BEV vs. CAPOXIRI+BEV arms, the 2-year OS rate (95% CI) was 65.5% (49.5%-77.6%) vs. 74.3% (59.8%-84.2%), and the ORR (95% CI) was 76.5% (62.5%-87.2%) vs. 84.6% (71.9%-93.1%). Major (grade ≥3) AEs in the FOLFOXIRI+BEV vs. CAPOXIRI+BEV arms were neutropenia (68.6% vs. 40.4%), febrile neutropenia (9.8% vs. 11.5%), diarrhea (7.8% vs. 17.3%), and appetite loss (7.8% vs. 17.3%).

Conclusion: CAPOXIRI+BEV was well tolerated with reduced hematological toxicity and efficacy comparable to those of FOLFOXIRI+BEV, providing a potentially convenient first-line treatment alternative to FOLFOXIRI+BEV in patients with mCRC.

Funding: Chugai Pharmaceutical Co., Ltd.

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QUATTRO-II 随机试验：CAPOXIRI+bevacizumab vs. FOLFOXIRI+bevacizumab 作为 mCRC 患者的一线治疗。

研究背景QUATTRO-II试验考察了卡培他滨+奥沙利铂+伊立替康（CAPOXIRI）+贝伐单抗（BEV）与5-氟尿嘧啶+叶酸+奥沙利铂+伊立替康（FOLFOXIRI）+BEV在转移性结直肠癌（mCRC）中的疗效和安全性：在这项II期研究（ClinicalTrials.gov: NCT04097444; jRCTs041190072）中，患者被随机（1:1）分配到FOLFOXIRI+BEV或CAPOXIRI+BEV。FOLFOXIRI+BEV/CAPOXIRI+BEV组的诱导治疗持续8/6个周期（如可行，最多12/8个周期），维持治疗由研究者决定采用5-氟尿嘧啶/亮紫杉醇+BEV或卡培他滨+BEV。主要终点是无进展生存期（PFS），如果点估计的危险比（HR）为0.80，则认为两组结果相当：共有 51 和 52 名患者分别随机接受了 FOLFOXIRI+BEV 和 CAPOXIRI+BEV。研究达到了主要终点；中位随访 23.7 个月时，FOLFOXIRI+BEV 组的 PFS 为 10.6 个月（95% 置信区间 [CI]，7.7-13.3），CAPOXIRI+BEV 组为 10.9 个月（95% 置信区间 [CI]，9.3-14.3）（HR 1.114 [0.80 结论：CAPOXIRI+BEV 组的 PFS 为 10.6 个月（95% 置信区间 [CI]，7.7-13.3），FOLFOXIRI+BEV 组为 10.9 个月（95% 置信区间 [CI]，9.3-14.3）：CAPOXIRI+BEV耐受性良好，血液学毒性降低，疗效与FOLFOXIRI+BEV相当，为mCRC患者提供了替代FOLFOXIRI+BEV的一线治疗方案：中外制药有限公司

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来源期刊

Med MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

17.70

自引率

0.60%

发文量

102

期刊介绍： Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.