Randomized Trial of Short-Course Radiotherapy Versus Long-Course Chemoradiation Comparing Rates of Local Recurrence in Patients With T3 Rectal Cancer: Trans-Tasman Radiation Oncology Group Trial 01.04
Top Cited Papers
- 1 November 2012
- journal article
- research article
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 30 (31), 3827-3833
- https://doi.org/10.1200/jco.2012.42.9597
Abstract
Purpose: To compare the local recurrence (LR) rate between short-course (SC) and long-course (LC) neoadjuvant radiotherapy for rectal cancer. Patients and Methods: Eligible patients had ultrasound- or magnetic resonance imaging–staged T3N0-2M0 rectal adenocarcinoma within 12 cm from anal verge. SC consisted of pelvic radiotherapy 5 × 5 Gy in 1 week, early surgery, and six courses of adjuvant chemotherapy. LC was 50.4 Gy, 1.8 Gy/fraction, in 5.5 weeks, with continuous infusional fluorouracil 225 mg/m2 per day, surgery in 4 to 6 weeks, and four courses of chemotherapy. Results: Three hundred twenty-six patients were randomly assigned; 163 patients to SC and 163 to LC. Median potential follow-up time was 5.9 years (range, 3.0 to 7.8 years). Three-year LR rates (cumulative incidence) were 7.5% for SC and 4.4% for LC (difference, 3.1%; 95% CI, −2.1 to 8.3; P = .24). For distal tumors (< 5 cm), six of 48 SC patients and one of 31 LC patients experienced local recurrence (P = .21). Five-year distant recurrence rates were 27% for SC and 30% for LC (log-rank P = 0.92; hazard ratio [HR] for LC:SC, 1.04; 95% CI, 0.69 to 1.56). Overall survival rates at 5 years were 74% for SC and 70% for LC (log-rank P = 0.62; HR, 1.12; 95% CI, 0.76 to 1.67). Late toxicity rates were not substantially different (Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer G3-4: SC, 5.8%; LC, 8.2%; P = .53). Conclusion: Three-year LR rates between SC and LC were not statistically significantly different; the CI for the difference is consistent with either no clinically important difference or differences in favor of LC. LC may be more effective in reducing LR for distal tumors. No differences in rates of distant recurrence, relapse-free survival, overall survival, or late toxicity were detected.Keywords
This publication has 17 references indexed in Scilit:
- Primary Tumor Response to Preoperative Chemoradiation With or Without Oxaliplatin in Locally Advanced Rectal Cancer: Pathologic Results of the STAR-01 Randomized Phase III TrialJournal of Clinical Oncology, 2011
- Comparison of Two Neoadjuvant Chemoradiotherapy Regimens for Locally Advanced Rectal Cancer: Results of the Phase III Trial ACCORD 12/0405-Prodige 2Journal of Clinical Oncology, 2010
- Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trialThe Lancet, 2009
- Swedish Rectal Cancer Trial: Long Lasting Benefits From Radiotherapy on Survival and Local Recurrence RateJournal of Clinical Oncology, 2005
- Preoperative versus Postoperative Chemoradiotherapy for Rectal CancerThe New England Journal of Medicine, 2004
- Adjuvant radiotherapy for rectal cancer: a systematic overview of 8507 patients from 22 randomised trialsThe Lancet, 2001
- Preoperative Radiotherapy Combined with Total Mesorectal Excision for Resectable Rectal CancerThe New England Journal of Medicine, 2001
- Preoperative Radiotherapy for Resectable Rectal CancerJAMA, 2000
- Improved Survival with Preoperative Radiotherapy in Resectable Rectal CancerThe New England Journal of Medicine, 1997
- Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European organization for research and treatment of cancer (EORTC)International Journal of Radiation Oncology*Biology*Physics, 1995