Back to Search Results

JOIN trial: treatment outcome and recovery status of peripheral sensory neuropathy during a 3-year follow-up in patients receiving modified FOLFOX6 as adjuvant treatment for stage II/III colon cancer.

Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan. tyoshino@east.ncc.go.jp. Gastrointestinal Cancer Center, Sano Hospital, Kobe, 655-0031, Japan. Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, 734-8530, Japan. Department of Surgery, Nakagami Hospital, Okinawa, 904-2195, Japan. Department of Surgery, Gastrointestinal Center, Kyoto Katsura Hospital, Kyoto, 615-8256, Japan. Department of Gastroenterological Surgery, Aichi Cancer Center Aichi Hospital, Aichi, 444-0011, Japan. Department of Surgery, Konan Kosei Hospital, Konan, Aichi, 483-8704, Japan. Department of Surgery, Osaka Rosai Hospital, Osaka, 591-8025, Japan. Surgery Nagasaki Harbor Medical Center City Hospital, Nagasaki, 850-8555, Japan. Department of Surgery, Fukui-ken Saiseikai Hospital, Fukui, 918-8503, Japan. Department of Surgery, Hakodate Goryoukaku Hospital, Hokkaido, 040-8611, Japan. Department of Gastrointestinal Surgery, Sasebo City General Hospital, Nagasaki, 857-8511, Japan. Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Kawagoe, 350-8550, Japan. Cancer Center, Kurume University Hospital, Fukuoka, 830-0011, Japan. Department of Biostatistics, School of Public Health, Graduate School of Medicine, and Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, 113-8655, Japan. Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, 277-8577, Japan. Tokai Central Hospital, Kakamigahara, 504-8601, Japan. Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, 136-0071, Japan. Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, 277-8577, Japan.

Cancer chemotherapy and pharmacology. 2019;(6):1269-1277
Full text from:

Other resources

Abstract

PURPOSE Adjuvant FOLFOX therapy is an established standard-of-care for resected colon cancer. Peripheral sensory neuropathy (PSN) is regarded as the major toxicity issue related to FOLFOX therapy. There have been a few reports on the recovery status from PSN thereafter. JOIN trial investigated the tolerability and efficacy of adjuvant modified FOLFOX6 (mFOLFOX6) in Japanese patients with stage II/III colon cancer. METHODS Twelve cycles of mFOLFOX6 were given to patients with stage II/III curatively resected colon cancer. Treatment outcomes, including disease-free survival (DFS), relapse-free survival (RFS), overall survival (OS), and recovery status of PSN during 3-year follow-up, were investigated. RESULTS Of the 882 patients enrolled from 2010 to 2012, 864 were eligible for the efficacy analyses. Three-year DFS, RFS, and OS were favorable in 92.1, 92.8, and 97.4% of stage II patients; 76.4, 77.9, and 93.8% of stage IIIA/B; and 61.6, 62.7, and 85.9% of stage IIIC, respectively. The cumulative incidence of PSN during treatment was 47.8% in grade 1 (G1), 30.3% in G2, and 5.8% in G3. For those with G3 PSN during treatment, there was gradual recovery in 1.1% of patients at 12 months after enrollment, 0.5% at 24 months, and 0.2% at 36 months. However, G1 or G2 residual PSN after 3 years was observed in 21.0% (18.7%, G1; 2.3%, G2). CONCLUSIONS Adjuvant mFOLFOX6 therapy was effective and well tolerated in patients with stage II/III colon cancer. Most patients recovered from G3 PSN related to oxaliplatin, but approximately 20% of patients had G1 or G2 PSN at 3-year follow-up.

Methodological quality

Publication Type : Clinical Trial

Metadata