Randomized Trial of Postoperative Adjuvant Chemotherapy With or Without Radiotherapy for Carcinoma of the Rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02

Wolmark, Norman; Wieand, H. Samuel; Hyams, David M.; Colangelo, Linda H.; Dimitrov, Nikolay V.; Romond, Edward H.; Wexler, Marvin J.; Prager, David; Cruz, Anatolio B.; Gordon, Philip H.; Petrelli, Nicholas J.; Deutsch, Melvin; Mamounas, Eleftherios P.; Wickerham, D. Lawrence; Fisher, Edwin R.; Rockette, Howard E.; Fisher, Bernard

doi:10.1093/jnci/92.5.388

Cited by 486 publications

(216 citation statements)

References 13 publications

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“…A more recent expert opinion again recommends radiotherapy to be used as an adjunct to surgery preoperatively (short term or long term) or postoperatively (van Cutsem et al, 2002). Local failure was reduced in the postoperative radiotherapy arm of the NSABP protocol R-02 (8 vs 13% at 5 years), although survival was not affected by radiotherapy (Wolmark et al, 2000). In the Swedish Rectal Cancer Trial, the 5-year actuarial local recurrence rate decreased from 27% without to 11% with preoperative short-term radiotherapy of 25 Gy, and survival increased from 48 to 58% at 5 years in the radiotherapyplus-surgery arm (Swedish rectal cancer trial, 1997).…”

Section: Discussionmentioning

confidence: 99%

Preoperative short-term radiation therapy (25 Gy, 2.5 Gy twice daily) for primary resectable rectal cancer (phase II)

et al. 2005

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To evaluate the feasibility, effectiveness, and long-term bowel function of preoperative hyperfractionated accelerated radiotherapy in primary resectable rectal cancer. A total of 184 consecutive patients (median age 65 years, male : female ¼ 2 : 1) with clinical T3Nx rectal adenocarcinoma received preoperative pelvic radiation therapy with single fractions of 2.5 Gy twice daily (interval 6 h between fractions) to a total dose of 25 Gy within 1 week. Surgery was conducted the following week. Postoperative histology revealed UICC stage I in 33%, stage II in 26%, stage III in 34%, and stage IV in 7% of the patients. Median follow-up was 43 months (53 months for surviving patients). The actuarial 4-year-local-recurrence rate was 2.1%, overall recurrence 23%. Disease-specific and disease-free survivals at 4 years (excluding stage IV) were 82 and 69%, respectively. Overall survival for 4 years was 68%. Postoperative mortality was 0.5% (one patient), early anastomotic leakage occurred in 11.4%, and anastomotic stenosis requiring treatment in 6%, of 132 patients with primary anastomosis. Seven of 184 patients (3.8%) died of abdominal complications, all within the first year. Bowel function was satisfactory after more than 5 years. Local control in primarily resectable rectal cancer after 10 Â 2.5 Gy is excellent, warranting further evaluation of this treatment.

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Section: Discussionmentioning

confidence: 99%

Preoperative short-term radiation therapy (25 Gy, 2.5 Gy twice daily) for primary resectable rectal cancer (phase II)

et al. 2005

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“…Twenty-two of the 27 evaluated trials allowing a comparison between irradiated and not irradiated resectable rectal cancer (excluding three small trials with no data and the two most recent trials, (23,31)) have been included in a metaanalysis based upon individual patient data (47) (Overview 1). In addition, a meta-analysis of the preoperative radiotherapy trials based upon published data only (48) has been performed.…”

Section: Search Methods and Selectionmentioning

confidence: 99%

A Systematic Overview of Radiation Therapy Effects in Rectal Cancer

et al. 2003

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“…Although radiotherapy has been considered one of the standard adjuvant treatments in the Western countries, significant survival benefit has not been shown with reproducibility (Wolmark et al, 2000;Colorectal Cancer Collaborative Group, 2001). The ostensible advantage of adjuvant radiotherapy is to decrease local recurrence of rectal cancers.…”

Section: Meta-analysis Of Uft For Rectal Cancer J Sakamoto Et Almentioning

confidence: 99%

An individual patient data meta-analysis of adjuvant therapy with uracil–tegafur (UFT) in patients with curatively resected rectal cancer

et al. 2007

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Uracil -Tegafur (UFT), an oral fluorinated pyrimidine chemotherapeutic agent, has been used for adjuvant chemotherapy in curatively resected colorectal cancer patients. Past trials and meta-analyses indicate that it is somewhat effective in extending survival of patients with rectal cancer. The objective of this study was to perform a reappraisal of randomised clinical trials conducted in this field. We designed an individual patient-based meta-analysis of relevant clinical trials to examine the benefit of UFT for curatively resected rectal cancer in terms of overall survival (OS), disease-free survival (DFS), and local relapse-free survival (LRFS). We analysed individual patient data of five adjuvant therapy randomised clinical trials for rectal cancer, which met the predetermined inclusion criteria. These five trials had a combined total of 2091 patients, UFT as adjuvant chemotherapy compared to surgery-alone, 5-year follow-up, intention-to-treat-based analytic strategy, and similar endpoints (OS and DFS). In a pooled analysis, UFT had significant advantage over surgery-alone in terms of both OS (hazard ratio, 0.82; 95% confidence interval (CI), 0.70 -0.97; P ¼ 0.02) and DFS (hazard ratio, 0.73; 95%CI, 0.63 -0.84; Po0.0001). This individual patient-based meta-analysis demonstrated that oral UFT significantly improves both OS and DFS in patients with curatively resected rectal cancer.

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Randomized Trial of Postoperative Adjuvant Chemotherapy With or Without Radiotherapy for Carcinoma of the Rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02

Abstract: The addition of postoperative radiation therapy to chemotherapy in Dukes' B and C rectal cancer did not alter the subsequent incidence of distant disease, although there was a reduction in locoregional relapse when compared with chemotherapy alone.

Cited by 486 publications

References 13 publications

Preoperative short-term radiation therapy (25 Gy, 2.5 Gy twice daily) for primary resectable rectal cancer (phase II)

Preoperative short-term radiation therapy (25 Gy, 2.5 Gy twice daily) for primary resectable rectal cancer (phase II)

A Systematic Overview of Radiation Therapy Effects in Rectal Cancer

An individual patient data meta-analysis of adjuvant therapy with uracil–tegafur (UFT) in patients with curatively resected rectal cancer

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