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Ann Surg. 2017 May;265(5):882-888. doi: 10.1097/SLA.0000000000001987.

Acute Adverse Events and Postoperative Complications in a Randomized Trial of Preoperative Short-course Radiotherapy Versus Long-course Chemoradiotherapy for T3 Adenocarcinoma of the Rectum: Trans-Tasman Radiation Oncology Group Trial (TROG 01.04).

Author information

1
*Surgical Outcome Research Centre (SOuRCe, The Institute of Academic Surgery at Royal Prince Alfred Hospital, University of Sydney, Sydney, New South Wales, Australia †Peter MacCallum Cancer Centre, Centre for Biostatistics and Clinical Trials, Melbourne, Victoria, Australia ‡Department of Surgical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia §Princess Alexandra Hospital, The University of Queensland, Woolloongabba, Queensland, Australia ¶Department of Oncology, Calvary Mater Hospital, Newcastle, New South Wales, Australia ||Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia **Department of Oncology, St. Vincent's Hospital, Melbourne, Victoria, Australia ††Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia ‡‡Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.

Abstract

OBJECTIVE:

To compare acute adverse events (AE) and postoperative complication rates in a randomized trial of short-course (SC) versus long-course (LC) preoperative radiotherapy.

BACKGROUND:

Evidence demonstrates that adding neoadjuvant radiotherapy to surgery offers better local control in the management of rectal cancer. With both SC and LC therapy there is a potential for acute treatment-related toxicity and increased patient morbidity.

METHODS:

Eligible patients had clinical-stage T3 rectal adenocarcinoma within 12 cm of the anal verge with no evidence of metastasis. SC consisted of pelvic radiotherapy 5 × 5 Gy in 1 week, early surgery and 6 courses of adjuvant chemotherapy. LC was 50.4 Gy administered in 28 fractions during 5.5 weeks, with infusion 5-fluorouracil, surgery in 4 to 6 weeks, and 4 courses of chemotherapy.

RESULTS:

All SC patients and 93% of LC patients received preoperative planned radiotherapy. There was no 30-day operative mortality. A statistically significant higher percentage of at least 1 AE occurred in the LC group (SC, 72.3%; LC, 99.4%; P < 0.001). There were significant differences in favor of SC for grade 3 AE: radiation dermatitis (0% vs 5.6%, P = 0.003), proctitis (0% vs 3.7% P = 0.016), nausea (0% vs 3.1%, P = 0.029), fatigue (0% vs 3.7%, P = 0.016) and grade 3/4 diarrhea rates (1.3% vs 14.2% P < 0.001). No statistically significant differences in surgical complication rates were seen (SC 53.2 vs 50.4% LC, p = 0.68), although permanent stoma (38.0% vs 29.8%, P = 0.13) and anastomotic breakdown (7.1% vs 3.5%, P = 0.26) rates favored LC with perineal wound complications (38.3% vs 50.0%, P = 0.26) in favor of SC.

CONCLUSIONS:

LC had significantly higher AEs compared with SC with no statistically significant differences in postoperative complications. There were clinical trends in permanent stoma rates and anastomotic leaks in favor of LC but with an increased perineal wound breakdown rate.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00145769.

PMID:
27631775
DOI:
10.1097/SLA.0000000000001987
[Indexed for MEDLINE]

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