Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial (original) (raw)
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BMC cancer, 2016
There still is no evidence which neoadjuvant therapy regimen for stage II-III rectal cancer is superior. The aim of this study was to compare results achieved after long-course chemoradiotherapy (CRT) with short-term radiotherapy (RT) followed by delayed surgery. A randomized trial was carried out between 2007-2013. One hundred fifty patients diagnosed with stage II-III rectal cancer were randomized into one of two neoadjuvant treatment arms: conventional chemoradiotherapy (CRT) and short-term radiotherapy (RT) followed by surgery after 6-8 weeks. Primary endpoints of this trial were downstaging and pathological complete response rate. Secondary endpoints were local recurrence rate and overall survival. The pathological complete response was found in 3 (4.4%) cases after RT and 8 (11.1%) after CRT (P = 0.112). Downstaging (stage 0 and I) was observed in 21 (30.9%) cases in RT group vs. 27 (37.5%) cases in CRT group (P = 0.409). Median follow-up time was 39.7 (range 4.9-79.7) months....
Preoperative Short-Course Radiotherapy and Surgery versus Surgery Alone for Patients with Rectal Cancer: A Propensity Score-Matched Analysis at 18-Year Follow-Up, 2021
A significant problem for long-term rectal cancer survivors may be the late toxicity of radiotherapy. It creates the possible risk of developing second primary malignancy and a theoretical decrease in overall survival. This study aimed to assess the influence of short-course preoperative radiotherapy in patients with locally advanced rectal cancer on overall survival, local recurrence rate, and second malignancy at 18-year follow-up. The rectal cancer trial was conducted in a single tertiary center between February 1992 and June 2006. A total of 389 patients with locally advanced rectal cancer (cT2-cT4, cN0/+, cM0) were included in the study. Preoperative radiotherapy was conducted in 148 patients and 241 patients underwent surgery alone. The propensity-matched group consisted of 105 patients operated on after radiotherapy and 105 controls. The number of local recurrences was 7 (6.7%) in the preoperative radiotherapy group and 22 (21%) in the surgery alone group (p = 0.016). The 18-year survival analysis showed no survival benefit in the preoperative radiotherapy group (38% versus 48%, p = 0.107) but improved recurrence-free survival (81% versus 58%, p = 0.001). The preoperative short-course radiotherapy significantly decreases the risk of local recurrence in locally advanced rectal cancer and may improve recurrence-free survival without an increased risk of second primary malignancy.
Outcomes following a limited approach to radiotherapy in rectal cancer
British Journal of Surgery, 2011
Background: Variation in the use of neoadjuvant and adjuvant radiotherapy for rectal cancer suggests an opportunity to avoid it in all but patients at highest risk of local recurrence. Methods: Between 1 July 1999 and 1 February 2006, patients with primary rectal cancer were treated by a single surgeon operating at McMaster University, Hamilton, Ontario, Canada. Digital rectal examination and pelvic computed tomography were used to determine whether the mesorectal margin was threatened by tumour and thus whether preoperative radiotherapy would be needed. The study outcome was local tumour recurrence.
Preoperative Radiotherapy for Resectable Rectal Cancer
JAMA, 2000
Context 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. Objective 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. Data Sources 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. Study Selection 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 Extraction 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. Data Synthesis 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; PϽ.001), and local recurrence rate (OR, 0.49; 95% CI, 0.38-0.62; PϽ.001). No reduction was observed in the occurrence of distant metastases (OR, 0.93; 95% CI, 0.73-1.18; P = .54). Conclusions 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.
A trial of preoperative radiotherapy in the management of operable rectal cancer
British Journal of Surgery, 1982
In a multicentre study, 824 patients with operable rectal cancer were randomized to receive surgery alone, surgery plus a single fraction of 500 rad (5 Gy) and surgery plus 2000 rad (20 Gy) in 10 equal daily, i.e. multiple, fractions. The ratio of abdominoperineal excision to anterior restorative operations was 3:1. There was no evidence of an increased morbidity or mortality following irradiation. The multiple fraction 2000 rad group had tumours which were significantly smaller than those of the other groups. There was also a reduction in the Dukes' C cases in the multiple fraction group. Neither the tumour size nor the lymph node status was altered in the single fraction group.
Annals of Surgical Oncology, 2009
Background. This study sought to evaluate the long-term outcome and complications, and occurrence of second malignancy after preoperative chemoradiotherapy (pCRT) for rectal cancer. Methods. One hundred twenty-three consecutive patients (78 men, 45 women) with locally advanced mid-low rectal cancer underwent pCRT between 1994 and 2002. Patients were followed up by one surgeon with a standard protocol, and data were prospectively recorded in a dedicated database. No patient was lost to follow-up. Complications were defined as late if they occurred [6 months after surgery. Overall and disease-free survival were calculated by the Kaplan-Meier method. Results. Of 123 patients, 111 underwent an R0 procedure. The rate of pathologic complete response was 16% (n = 20 patients). At a median follow-up of 95 (range, 56-160) months, 50 late complications occurred in 41 patients, 21 of whom required surgery. In seven cases, the complications were clearly CRT related and were significantly associated with the total dose of radiation delivered (P \ .05). The estimated 5-and 10-year overall survival was 76% and 67%, respectively. The estimated 5-and 10-year disease-free survival was 83% and 82%, respectively. In 18 of 19 patients who experienced Ó
Radiotherapy and Oncology, 2011
Purpose: To assess efficacy and tolerance of intra-operative radiation therapy (IORT) in patients suffering from locally advanced rectal cancer, treated with preoperative radiotherapy followed by surgical resection. Methods and materials: In this French, multicenter, comparative, phase III study, 142 patients with locally advanced rectal cancer (T3 or T4 or N+, and M0), treated with a 4-week preoperative radiotherapy (40 grays) were randomly assigned to either surgical resection alone (Control group: n = 69) or combined to 18-gray intra-operative radiation therapy (IORT group: n = 73) between 1993 and 2001. Results: The 5-year cumulative incidence of local control was 91.8% with IORT and 92.8% with surgery alone (p = 0.6018); the mean duration without local relapse (Kaplan-Meier method) was 107 versus 126 months, respectively. No statistically significant difference was demonstrated for overall survival (p = 0.2578) disease-free survival (p = 0.7808) and probability of metastatic relapse (p = 0.6037) with 5-year cumulative incidences of 69.8% versus 74.8%, 63.7% versus 63.1%, and 26.1% versus 30.2%, respectively. 48 patients of the IORT group and 53 patients of the control group were alive with a median follow-up of 60.1 and 61.2 months, respectively. Post-operative complications were observed in the IORT group in 21 patients (29.6%) and in the control group in 13 patients (19.1%) (p = 0.15), with an acceptable tolerance profile. Conclusions: Although this randomized study did not demonstrate any significant improvement in local control and disease-free survival in rectal cancer patients treated with preoperative radiation therapy receiving IORT or not, it confirmed the technical feasibility and the necessity for evaluating IORT for rectal carcinoma in further clinical studies.