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      Japanese Society for Cancer of the Colon and Rectum (JSCCR) Guidelines 2014 for treatment of colorectal cancer

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      , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Japanese Society for Cancer of the Colon and Rectum
      International Journal of Clinical Oncology
      Springer Japan
      Colorectal cancer, Guideline, Surgery, Chemotherapy, Endoscopy, Radiotherapy

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          Abstract

          Colorectal cancer is a major cause of death in Japan, where it accounts for the largest number of deaths from malignant neoplasms among women and the third largest number among men. Many new methods of treatment have been developed during recent decades. The Japanese Society for Cancer of the Colon and Rectum Guidelines 2014 for treatment of colorectal cancer (JSCCR Guidelines 2014) have been prepared as standard treatment strategies for colorectal cancer, to eliminate treatment disparities among institutions, to eliminate unnecessary treatment and insufficient treatment, and to deepen mutual understanding among health-care professionals and patients by making these guidelines available to the general public. These guidelines have been prepared as a result of consensuses reached by the JSCCR Guideline Committee on the basis of careful review of evidence retrieved by literature searches and taking into consideration the medical health insurance system and actual clinical practice in Japan. They can, therefore, be used as a guide for treating colorectal cancer in clinical practice. More specifically, they can be used as a guide to obtaining informed consent from patients and choosing the method of treatment for each patient. As a result of the discussions of the Guideline Committee, controversial issues were selected as clinical questions, and recommendations were made. Each recommendation is accompanied by a classification of the evidence and a classification of recommendation categories, on the basis of consensus reached by Guideline Committee members. Here we present the English version of the JSCCR Guidelines 2014.

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          Most cited references76

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          Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer.

          Panitumumab, a fully human antibody against the epidermal growth factor receptor (EGFR), has activity in a subset of patients with metastatic colorectal cancer (mCRC). Although activating mutations in KRAS, a small G-protein downstream of EGFR, correlate with poor response to anti-EGFR antibodies in mCRC, their role as a selection marker has not been established in randomized trials. KRAS mutations were detected using polymerase chain reaction on DNA from tumor sections collected in a phase III mCRC trial comparing panitumumab monotherapy to best supportive care (BSC). We tested whether the effect of panitumumab on progression-free survival (PFS) differed by KRAS status. KRAS status was ascertained in 427 (92%) of 463 patients (208 panitumumab, 219 BSC). KRAS mutations were found in 43% of patients. The treatment effect on PFS in the wild-type (WT) KRAS group (hazard ratio [HR], 0.45; 95% CI: 0.34 to 0.59) was significantly greater (P < .0001) than in the mutant group (HR, 0.99; 95% CI, 0.73 to 1.36). Median PFS in the WT KRAS group was 12.3 weeks for panitumumab and 7.3 weeks for BSC. Response rates to panitumumab were 17% and 0%, for the WT and mutant groups, respectively. WT KRAS patients had longer overall survival (HR, 0.67; 95% CI, 0.55 to 0.82; treatment arms combined). Consistent with longer exposure, more grade III treatment-related toxicities occurred in the WT KRAS group. No significant differences in toxicity were observed between the WT KRAS group and the overall population. Panitumumab monotherapy efficacy in mCRC is confined to patients with WT KRAS tumors. KRAS status should be considered in selecting patients with mCRC as candidates for panitumumab monotherapy.
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            Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study.

            To evaluate the efficacy and safety of bevacizumab when added to first-line oxaliplatin-based chemotherapy (either capecitabine plus oxaliplatin [XELOX] or fluorouracil/folinic acid plus oxaliplatin [FOLFOX-4]) in patients with metastatic colorectal cancer (MCRC). Patients with MCRC were randomly assigned, in a 2 x 2 factorial design, to XELOX versus FOLFOX-4, and then to bevacizumab versus placebo. The primary end point was progression-free survival (PFS). A total of 1,401 patients were randomly assigned in this 2 x 2 analysis. Median progression-free survival (PFS) was 9.4 months in the bevacizumab group and 8.0 months in the placebo group (hazard ratio [HR], 0.83; 97.5% CI, 0.72 to 0.95; P = .0023). Median overall survival was 21.3 months in the bevacizumab group and 19.9 months in the placebo group (HR, 0.89; 97.5% CI, 0.76 to 1.03; P = .077). Response rates were similar in both arms. Analysis of treatment withdrawals showed that, despite protocol allowance of treatment continuation until disease progression, only 29% and 47% of bevacizumab and placebo recipients, respectively, were treated until progression. The toxicity profile of bevacizumab was consistent with that documented in previous trials. The addition of bevacizumab to oxaliplatin-based chemotherapy significantly improved PFS in this first-line trial in patients with MCRC. Overall survival differences did not reach statistical significance, and response rate was not improved by the addition of bevacizumab. Treatment continuation until disease progression may be necessary in order to optimize the contribution of bevacizumab to therapy.
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              Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study.

              Panitumumab, a fully human anti-epidermal growth factor receptor (EGFR) monoclonal antibody that improves progression-free survival (PFS), is approved as monotherapy for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The Panitumumab Randomized Trial in Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy (PRIME) was designed to evaluate the efficacy and safety of panitumumab plus infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as initial treatment for mCRC. In this multicenter, phase III trial, patients with no prior chemotherapy for mCRC, Eastern Cooperative Oncology Group performance status of 0 to 2, and available tissue for biomarker testing were randomly assigned 1:1 to receive panitumumab-FOLFOX4 versus FOLFOX4. The primary end point was PFS; overall survival (OS) was a secondary end point. Results were prospectively analyzed on an intent-to-treat basis by tumor KRAS status. KRAS results were available for 93% of the 1,183 patients randomly assigned. In the wild-type (WT) KRAS stratum, panitumumab-FOLFOX4 significantly improved PFS compared with FOLFOX4 (median PFS, 9.6 v 8.0 months, respectively; hazard ratio [HR], 0.80; 95% CI, 0.66 to 0.97; P = .02). A nonsignificant increase in OS was also observed for panitumumab-FOLFOX4 versus FOLFOX4 (median OS, 23.9 v 19.7 months, respectively; HR, 0.83; 95% CI, 0.67 to 1.02; P = .072). In the mutant KRAS stratum, PFS was significantly reduced in the panitumumab-FOLFOX4 arm versus the FOLFOX4 arm (HR, 1.29; 95% CI, 1.04 to 1.62; P = .02), and median OS was 15.5 months versus 19.3 months, respectively (HR, 1.24; 95% CI, 0.98 to 1.57; P = .068). Adverse event rates were generally comparable across arms with the exception of toxicities known to be associated with anti-EGFR therapy. This study demonstrated that panitumumab-FOLFOX4 was well tolerated and significantly improved PFS in patients with WT KRAS tumors and underscores the importance of KRAS testing for patients with mCRC.
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                Author and article information

                Contributors
                +81-3-5800-8653 , toshwatanabe@yahoo.co.jp
                Journal
                Int J Clin Oncol
                Int. J. Clin. Oncol
                International Journal of Clinical Oncology
                Springer Japan (Tokyo )
                1341-9625
                1437-7772
                18 March 2015
                18 March 2015
                2015
                : 20
                : 2
                : 207-239
                Affiliations
                [ ]Department of Surgical Oncology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655 Japan
                [ ]Department of Surgery 2, Tokyo Women’s Medical University, Tokyo, Japan
                [ ]Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan
                [ ]Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan
                [ ]Department of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan
                [ ]Division of Molecular and Diagnostic Pathology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan
                [ ]Division of Gastroenterology, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki, Japan
                [ ]Department of Endoscopy, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
                [ ]Department of Digestive Tract and General Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan
                [ ]Department of Surgical Oncology, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan
                [ ]Colorectal Surgery Division, National Cancer Center Hospital, Tokyo, Japan
                [ ]Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
                [ ]Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
                [ ]Pathology Division, Research Center for Innovative Oncology, National Cancer Centre Hospital East, Chiba, Japan
                [ ]Radiation Oncology Department, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
                [ ]Department of Pathology, Kyorin University School of Medicine, Tokyo, Japan
                [ ]Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan
                [ ]Department of Surgery, Kyoto University, Kyoto, Japan
                [ ]Department of Surgery, National Defense Medical College, Saitama, Japan
                [ ]Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan
                [ ]Department of Clinical Oncology, St. Marianna University, Kawasaki, Japan
                [ ]Department of Surgical and Molecular Pathology, Dokkyo Medical University School of Medicine, Tochigi, Japan
                [ ]Department of Health Administration and Policy, Tohoku Pharmaceutical University, Miyagi, Japan
                [ ]Department of Surgery, Cancer Center, Aomori Prefectural Central Hospital, Aomori, Japan
                [ ]Department of Surgery, Japanese Red Cross Kanazawa Hospital, Ishikawa, Japan
                [ ]CEO, Misawa City Hospital, Aomori, Japan
                [ ]Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan
                [ ]Division of GI Endoscopy, Kurume University School of Medicine, Fukuoka, Japan
                [ ]Department of Gastroenterological Surgery, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
                [ ]Department of Hemodialysis and Surgery, Chemotherapy Research Institute, International University of Health and Welfare, Chiba, Japan
                [ ]Library, Toho University Medical Center Sakura Hospital, Chiba, Japan
                [ ]Department of Surgery, Tochigi Cancer Center, Tochigi, Japan
                Article
                801
                10.1007/s10147-015-0801-z
                4653248
                25782566
                fe1496de-e6b3-434f-8c8c-5c9cf235ec3d
                © Japan Society of Clinical Oncology 2015
                History
                : 14 January 2015
                : 4 February 2015
                Categories
                Special Article
                Custom metadata
                © Japan Society of Clinical Oncology 2015

                colorectal cancer,guideline,surgery,chemotherapy,endoscopy,radiotherapy

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