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      Preoperative Concurrent Chemoradiotherapy for Locally Advanced Rectal Cancer: Treatment Outcomes and Analysis of Prognostic Factors

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          Abstract

          Purpose

          This study was designed to investigate the long-term oncologic outcomes for locally advanced rectal cancer patients after treatment with preoperative concurrent chemoradiotherapy followed by total mesorectal excision, and to identify prognostic factors that affect survival and pathologic response.

          Materials and Methods

          From June 1996 to June 2009, 135 patients with locally advanced rectal cancer were treated with preoperative concurrent chemoradiotherapy followed by total mesorectal excision at Kyung Hee University Hospital. Patient data was retrospectively collected and analyzed in order to determine the treatment outcomes and identify prognostic factors for survival.

          Results

          The median follow-up time was 50 months (range, 4.5 to 157.8 months). After preoperative chemoradiotherapy, sphincter preservation surgery was accomplished in 67.4% of whole patients. A complete pathologic response was achieved in 16% of patients. The estimated 5- and 8-year overall survival, loco-regional recurrence-free survival, and distant metastasis-free survival rate for all patients was 82.7% and 75.7%, 76.8% and 71.9%, 67.9% and 63.3%, respectively. The estimated 5- and 8-year overall survival, loco-regional recurrence-free survival, and distant metastasis-free survival rate for pathologic complete responders was 100% and 100%, 100% and 88.9%, 95.5% and 95.5%, respectively. In the multivariate analysis, pathologic complete response was significantly associated with overall survival. The predictive factor for pathologic complete response was pretreatment clinical stage.

          Conclusion

          Preoperative chemoradiotherapy for locally advanced rectal cancer resulted in a high rate of overall survival, sphincter preservation, down-staging, and pathologic complete response. The patients achieving pathologic complete response had very favorable outcomes. Pathologic complete response was a significant prognostic factor for overall survival and the significant predictive factor for a pathologic complete response was pretreatment clinical stage.

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          Most cited references19

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          Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R-03.

          Although chemoradiotherapy plus resection is considered standard treatment for operable rectal carcinoma, the optimal time to administer this therapy is not clear. The NSABP R-03 (National Surgical Adjuvant Breast and Bowel Project R-03) trial compared neoadjuvant versus adjuvant chemoradiotherapy in the treatment of locally advanced rectal carcinoma. Patients with clinical T3 or T4 or node-positive rectal cancer were randomly assigned to preoperative or postoperative chemoradiotherapy. Chemotherapy consisted of fluorouracil and leucovorin with 45 Gy in 25 fractions with a 5.40-Gy boost within the original margins of treatment. In the preoperative group, surgery was performed within 8 weeks after completion of radiotherapy. In the postoperative group, chemotherapy began after recovery from surgery but no later than 4 weeks after surgery. The primary end points were disease-free survival (DFS) and overall survival (OS). From August 1993 to June 1999, 267 patients were randomly assigned to NSABP R-03. The intended sample size was 900 patients. Excluding 11 ineligible and two eligible patients without follow-up data, the analysis used data on 123 patients randomly assigned to preoperative and 131 to postoperative chemoradiotherapy. Surviving patients were observed for a median of 8.4 years. The 5-year DFS for preoperative patients was 64.7% v 53.4% for postoperative patients (P = .011). The 5-year OS for preoperative patients was 74.5% v 65.6% for postoperative patients (P = .065). A complete pathologic response was achieved in 15% of preoperative patients. No preoperative patient with a complete pathologic response has had a recurrence. Preoperative chemoradiotherapy, compared with postoperative chemoradiotherapy, significantly improved DFS and showed a trend toward improved OS.
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            Predictive factors of pathologic complete response after neoadjuvant chemoradiation for rectal cancer.

            This study evaluates factors associated with a pathologic complete response (pCR) after neoadjuvant chemoradiation for rectal cancer. Approximately 20% of rectal cancer patients undergoing neoadjuvant chemoradiation achieve pCR, which has been associated with decreased local recurrence and improved recurrence-free survival. Means of predicting pCR remain incompletely defined. A total of 306 consecutive patients with stage II or stage III rectal cancer who underwent neoadjuvant chemoradiation then surgery between 1997 and 2007 were identified from a single-institution. Sixty-four patients with concurrent inflammatory bowel disease, hereditary colorectal cancer, other malignancy, urgent surgery, incomplete chemoradiation, or insufficient data were excluded. All patients received neoadjuvant 5-FU-based chemotherapy and external beam radiation. Histologic response was categorized as pCR or not-pCR, which defined the 2 study cohorts. Variables were analyzed by univariate and multivariate analysis with pCR as the dependent variable. Fisher exact test, chi2, Wilcoxon rank-sum, and logistic regression were used for analysis. P < 0.05 was considered statistically significant. Of the total patients, 242 were studied, including 58 (24%) that achieved pCR. The 2 groups were statistically similar in terms of age, gender, body mass index, tumor differentiation, radiation dose, and pretreatment stage. On multivariate analysis, an interval ≥ 8 weeks between treatment completion and surgical resection was significantly associated with a higher rate of pCR, which correlated with decreased local recurrence and improved overall survival. Despite traditional beliefs that certain patient and tumor factors influence pCR, an extended interval between completion of neoadjuvant therapy and surgery was the single most important determinant in achieving a pCR.
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              Preoperative radiotherapy for resectable rectal cancer: A meta-analysis.

              The benefit of adjuvant radiotherapy for resectable rectal cancer has been extensively studied, but data on survival are still equivocal despite a reduction in the rate of local recurrence. To assess the effectiveness of preoperative radiotherapy followed by surgery in the reduction of overall and cancer-related mortality and in the prevention of local recurrence and distant metastases. Computerized bibliographic searches of MEDLINE and CANCERLIT (1970 to December 1999), including non-English sources, were supplemented with hand searches of reference lists. The medical subject headings used were rectal cancer, radiotherapy, surgery, RCT, randomized, and clinical trial. Studies were included if they were randomized controlled trials (RCTs) comparing preoperative radiotherapy plus surgery with surgery alone and if they included patients with resectable histologically proven rectal adenocarcinoma, without metastatic disease. Fourteen RCTs were analyzed. Data on population, intervention, and outcomes were extracted from each RCT according to the intention-to-treat method by 3 independent observers and combined using the DerSimonian and Laird method. Radiotherapy plus surgery compared with surgery alone significantly reduced the 5-year overall mortality rate (odds ratio [OR] 0.84; 95% confidence interval [CI], 0.72-0.98; P =.03), cancer-related mortality rate (OR, 0.71; 95% CI, 0.61-0.82; P<.001), and local recurrence rate (OR, 0.49; 95% CI, 0.38-0.62; P<.001). No reduction was observed in the occurrence of distant metastases (OR, 0.93; 95% CI, 0.73-1.18; P =.54). In patients with resectable rectal cancer, preoperative radiotherapy significantly improved overall and cancer-specific survival compared with surgery alone. The magnitude of the benefit is relatively small and criteria are needed to identify patients most likely to benefit from adjuvant radiotherapy. JAMA. 2000;284:1008-1015
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                Author and article information

                Journal
                Cancer Res Treat
                Cancer Res Treat
                CRT
                Cancer Research and Treatment : Official Journal of Korean Cancer Association
                Korean Cancer Association
                1598-2998
                2005-9256
                June 2012
                30 June 2012
                : 44
                : 2
                : 104-112
                Affiliations
                [1 ]Department of Radiation Oncology, Kyung Hee University School of Medicine, Seoul, Korea.
                [2 ]Department of Diagnostic Radiology, Kyung Hee University School of Medicine, Seoul, Korea.
                [3 ]Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
                Author notes
                Correspondence: Seong Eon Hong, MD. Department of Radiation Oncology, Kyung Hee University Medical Center, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 130-701, Korea. Tel: 82-2-958-8661, Fax: 82-2-958-9469, anjdixn@ 123456naver.com
                Article
                10.4143/crt.2012.44.2.104
                3394859
                22802748
                aa33d518-f81b-4e5b-86a2-7fe1bf960b6f
                Copyright © 2012 by the Korean Cancer Association

                This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 26 January 2012
                : 19 March 2012
                Categories
                Original Article

                Oncology & Radiotherapy
                preoperative care,rectal neoplasms,chemoradiotherapy,pathologic complete response

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