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    Original Investigation
    Gastroenterology and Hepatology
    July 20, 2020

    Effect of Reduced-Dose Capecitabine Plus Cetuximab as Maintenance Therapy for RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Clinical Trial

    Author Affiliations
    • 1Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
    • 2Department of Medical Oncology of Zhengzhou University Affiliated Cancer Hospital, Henan Cancer Hospital, Zhengzhou, Henan, China
    • 3Gastroenterology and Urology Department, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China
    • 4Department of Medical Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
    • 5Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
    JAMA Netw Open. 2020;3(7):e2011036. doi:10.1001/jamanetworkopen.2020.11036
    Key Points español 中文 (chinese)

    Question  Does the combination of capecitabine and cetuximab as maintenance therapy achieve expected progression-free survival and overall survival among patients with RAS wild-type metastatic colorectal cancer?

    Findings  Forty-seven patients with RAS wild-type metastatic colorectal cancer were recruited in this phase 2 clinical trial. The median maintenance progression-free survival was 7.2 months, and the median overall survival was 27.4 months.

    Meaning  The combination of capecitabine and cetuximab as maintenance therapy achieved good outcomes and may be an alternative choice for patients with RAS wild-type metastatic colorectal cancer.

    Abstract

    Importance  Fluorouracil-based chemotherapy combined with anti–epidermal growth factor receptor/vascular endothelial growth factor therapy is the standard first-line treatment for metastatic colorectal cancer followed by low-intensity maintenance therapy to balance the clinical efficacy and adverse effects (AEs). However, there have been concerns about the AEs of capecitabine plus cetuximab as a maintenance therapy in patients with RAS wild-type metastatic colorectal cancer.

    Objective  To evaluate the biological activity and safety of capecitabine plus cetuximab as a novel maintenance therapy for RAS wild-type metastatic colorectal cancer.

    Design, Setting, and Participants  This phase 2 prospective clinical trial was conducted from April 29, 2016, to April 29, 2019, at 5 centers in China. Patients diagnosed as having RAS wild-type metastatic colorectal cancer were recruited to receive fluorouracil-based cytotoxic agents combined with cetuximab followed by capecitabine plus cetuximab for maintenance therapy. Forty-seven patients with histologically confirmed metastatic colorectal cancer and genetic test results showing a wild-type RAS were enrolled in maintenance therapy.

    Interventions  Induction therapy for patients with RAS wild-type metastatic colorectal cancer was 8 to 12 cycles of fluorouracil-based chemotherapy combined with cetuximab. After stable disease status or better was achieved, reduced-dose capecitabine plus cetuximab was administered for maintenance therapy.

    Main Outcomes and Measures  The primary end point was progression-free survival during maintenance therapy. The secondary end points were total progression-free survival, overall survival, quality of life, safety, and toxic effects of treatment.

    Results  Forty-seven patients were enrolled in maintenance therapy, with a median age of 52 years (range, 25-81 years) and 32 (68%) of them being men. The median maintenance progression-free survival was 7.2 (95% CI, 5.8-8.6) months. The median progression-free survival was 12.7 (95% CI, 11.8-15.4) months. The median overall survival was 27.4 (95% CI, 21.4-35.5) months. Grade 3 to 4 AEs during induction therapy included neutropenia (4 patients [9%]), diarrhea (4 patients [9%]), nausea or vomiting (3 patients [6%]), rash acneiform (10 patients [21%]), and hand-foot syndrome (8 patients [17%]). Grade 3 to 4 AEs during maintenance therapy included diarrhea (2 patients [4%]), rash acneiform (8 patients [17%]), and hand-foot syndrome (5 patients [11%]).

    Conclusions and Relevance  Reduced-dose capecitabine plus cetuximab after initial chemotherapy is a novel maintenance therapy for patients with RAS wild-type metastatic colorectal cancer that achieved good outcomes and tolerable nonserious AEs.

    Trial Registration  ClinicalTrials.gov Identifier: NCT02717923

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