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Effect of interval between preoperative radiotherapy and surgery on clinical outcome and radiation proctitis in rectal cancer from FOWARC trial.

ABSTRACT: OBJECTIVE:The aim of this study was to evaluate the effect of the interval between CRT and surgery on radiation proctitis, the pathologic response, and postoperative morbidity. METHODS:This was a cohort study from a phase III, randomized controlled trial (FOWARC study, NCT01211210). Data were retrieved from the leading center of the trial. Patients were divided into the short-interval (?7 weeks) group and the long-interval (>7 weeks) group. The rate of radiation proctitis, pathologic complete regression (pCR) and morbidities were calculated for each group. Multivariate analysis was used to verify the impact of interval on radiation proctitis. RESULTS:Surgery was performed in 60 patients after an interval of ?7 weeks and in 97 patients after an interval of >7 weeks. The two groups according to interval were comparable in terms of baseline demographic and clinicotherapeutic characteristics. Radiation proctitis was identified by imaging in 9 (15.0%) patients in short-interval group and in 31 (32.0%) patients in long-interval group (P = .018). Multivariate analysis confirmed the correlation between long interval and radiation proctitis (P = .018). The long interval was significantly associated with longer median operation time compared to the short interval (P = .022). The rates of pCR and postoperative complications were not different between two groups. CONCLUSIONS:A longer interval after CRT may be associated with higher rate of radiation proctitis and longer operation time. Moreover it did not increase the rate of pCR.

SUBMITTER: Cheng YK

PROVIDER: S-EPMC6997091 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Effect of interval between preoperative radiotherapy and surgery on clinical outcome and radiation proctitis in rectal cancer from FOWARC trial.

Cheng Yi-Kan YK Qin Qi-Yuan QY Huang Xiao-Yan XY Lan Ping P Wang Lei L Gao Xiang X Ma Teng-Hui TH

Cancer medicine 20191212 3

<h4>Objective</h4>The aim of this study was to evaluate the effect of the interval between CRT and surgery on radiation proctitis, the pathologic response, and postoperative morbidity.<h4>Methods</h4>This was a cohort study from a phase III, randomized controlled trial (FOWARC study, NCT01211210). Data were retrieved from the leading center of the trial. Patients were divided into the short-interval (≤7 weeks) group and the long-interval (>7 weeks) group. The rate of radiation proctitis, patholo ...[more]

PMID: 31828956

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Project description:BackgroundThis aim of this study was to evaluate the effects of time interval between the completion of radiotherapy and robotic-assisted surgery on the outcomes among patients with rectal cancer undergoing preoperative concurrent chemoradiotherapy (CCRT).MethodsIn total, 116 patients with stage I-III rectal cancer who underwent preoperative CCRT and robotic-assisted surgery between September 2013 and February 2019 were enrolled. Patients were categorized into two groups based on the time interval: group A (10-12 weeks) and group B (≥ 12 weeks).ResultsAmong the 116 enrolled patients, 98 (84.5%) had middle and lower rectal cancers. Two (1.7%) patients underwent abdominoperineal resection with a sphincter preservation rate of 98.3%. Thirty-seven (31.9%) patients had a pathologic complete response (pCR). The circumferential resection margin and distal resection margin were positive in 2 (1.7%) and 1 (0.9%) patients, respectively. Therefore, the R0 resection rate was 97.4%. A total of 24 (22.4%) patients experienced postoperative relapse and 12 (10.3%) patients died; these were slightly more common in group B than in group A (28.8% vs 15.8% and 15.3% vs 5.3%, respectively; both P > 0.05); however, this difference was nonsignificant. Three-year disease-free survival (DFS) and overall survival (OS) were 75% and 89%, respectively, among all patients. Non-significant trend of favorable 3-year DFS, 3-year OS, 3-year locoregional control rate and 3-year distant metastasis control rate were observed in group A compared with group B (all P > 0.05).ConclusionRobotic-assisted surgery after a longer interval is safe and feasible for patients with rectal cancer undergoing preoperative CCRT. The present study's results suggested that the time interval of 10-12 weeks can be considered because comparable clinical and perioperative outcomes and preferable oncological outcomes were observed for interval of this length. However, future prospective randomized clinical trials are required to verify the present finding.

Project description:BACKGROUND:Preoperative capecitabine-based chemoradiotherapy (CRT) is feasible for the treatment of resectable locally advanced rectal cancer (LARC). To try to improve efficacy, we conducted a phase II study in which the epidermal growth factor receptor-targeting monoclonal antibody cetuximab was added to capecitabine-based CRT. The results for long-term survival and for an analysis investigating the relationship between survival and patient and disease characteristics, including tumour KRAS mutation status, and surgery type, are presented. PATIENTS AND METHODS.: Patients with resectable LARC received capecitabine (1250 mg/m(2) twice daily, orally) for 2 weeks followed by cetuximab alone (400 mg/m(2) for 1 week) and then with CRT (250 mg/m(2)/week) comprising capecitabine (825 mg/m(2) twice daily) and radiotherapy to the small pelvis (45 Gy in 25 1.8-Gy fractions), five days a week for five weeks. Surgery was conducted six weeks following CRT, with post-operative chemotherapy with capecitabine (1250 mg/m(2) twice daily for 14 days every 21 days) three weeks later. RESULTS:Forty-seven patients were enrolled and 37 underwent treatment. Twenty-eight of the patients (75.7%) had T3N+ disease. Thirty-six patients were evaluable for efficacy. The median follow-up time was 39.0 months (range 5.0--87.0). The three-year local control, disease-free survival, relapse-free survival and overall survival rates were 96.9% (95% CI 90.0--100), 72.2% (57.5--86.9), 74.3% (95% CI 59.8--88.8) and 68.1% (95% CI 36.7--99.4), respectively. There was no significant association between survival and gender, age, tumour location in the rectum, type of surgery, pathological T or N status, tumour regression grade or tumour KRAS mutation status, although sample sizes were small. CONCLUSIONS:Preoperative cetuximab plus capecitabine-based CRT was feasible in patients with resectable LARC and was associated with an impressive three-year local control rate. The use of tumour KRAS mutation status as a biomarker for the efficacy of cetuximab-based regimens in this setting requires further investigation.

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Effect of interval between preoperative radiotherapy and surgery on clinical outcome and radiation proctitis in rectal cancer from FOWARC trial.

Publications

Effect of interval between preoperative radiotherapy and surgery on clinical outcome and radiation proctitis in rectal cancer from FOWARC trial.

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