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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.
Yoshino, T, Kotaka, M, Shinozaki, K, Touyama, T, Manaka, D, Matsui, T, Ishigure, K, Hasegawa, J, Inoue, K, Munemoto, Y, et al
Cancer chemotherapy and pharmacology. 2019;(6):1269-1277
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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.
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[Five-Year Recurrence-Free Survival after mFOLFOX6 Administration, Right Hemicolectomy, and Lymphadenectomy for Portal Venous Tumor Thromboembolism].
Nishimura, Y, Nishizawa, Y, Ishikawa, H, Mori, Y, Takano, M, Takenoya, T, Asayama, M, Kawashima, Y, Sakamoto, H, Tanaka, Y
Gan to kagaku ryoho. Cancer & chemotherapy. 2015;(12):1653-5
Abstract
A 71-year-old woman was admitted for fever and appetite loss. She was diagnosed with ascending colon cancer, with portal vein tumor thromboembolism extending to the portosplenic junction. This was deemed unresectable despite the absence of distant metastasis. She underwent 16 courses of mFOLFOX6 therapy, and because the effect of chemotherapy was PR, right hemicolectomy with high ligation of the ileocolic vessels and the right branch of the middle colic vessels was performed. The tumor stage was yp-T3N1bM0, StageⅢB with a few remaining cancer cells in the portal venous system. Staging after chemotherapy effect was Grade 1a. Postoperatively, 13 courses of mFOLFOX6 were administered. A repeat CT scan showed lymph node recurrence along the SMV, which was subsequently resected again. After the second operation, 9 courses of the DeGramont regimen was administered and discontinued. Five years after the last operation, the patient remains well and without any recurrences. Colonic carcinoma with portal venous tumor thromboembolism has been reported in 9 cases, including ours. Among these, 8 cases involved the ascending colon. Seven of the affected patients were female while 3 were poorly differentiated adenocarcinoma. None of the other patients, except for our case, reported a 5 year patient survival rate without recurrence.