Early toxicity from preoperative radiotherapy with continuous infusion 5-fluorouracil for resectable adenocarcinoma of the rectum: a Phase II trial for the Trans-Tasman Radiation Oncology Group

• Published in: International journal of radiation oncology, biology, physics Vol. 50; no. 4; pp. 883 - 887
• Main Authors: Ngan, Samuel Y.K, Burmeister, Bryan H, Fisher, Richard, Rischin, Danny, Schache, David J, Kneebone, Andrew, MacKay, John R, Joseph, David, Bell, Andrew, Goldstein, David
• Format: Journal Article Conference Proceeding
• Language: English
• Published: New York, NY Elsevier Inc 15.07.2001; Elsevier
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - radiotherapy; Adenocarcinoma - surgery; Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic - adverse effects; Antimetabolites, Antineoplastic - therapeutic use; Biological and medical sciences; Combined Modality Therapy; Confidence Intervals; Diarrhea - etiology; Diseases of the digestive system; Female; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Male; Medical sciences; Middle Aged; Neoplasm Staging; Postoperative Complications; Preoperative radiotherapy; Radiotherapy Dosage; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Rectal cancer; Rectal Neoplasms - drug therapy; Rectal Neoplasms - radiotherapy; Rectal Neoplasms - surgery; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors; Preoperative radiotherapy; Rectal cancer; Antineoplastic agent; Human; Focal lesion; Rectal disease; Toxicity; Treatment efficiency; Fluoropyrimidine derivatives; Stage classification; Malignant tumor; Radiotherapy; Chemotherapy; Phase II trial; Rectum; Digestive diseases; Intestinal disease; Pyrimidine derivatives; Advanced stage; Preoperative; Therapeutic protocol; Fluorouracil
• ISSN: 0360-3016; 1879-355X
• DOI: 10.1016/S0360-3016(01)01536-X

Purpose: To assess the toxicity and the efficacy of preoperative radiotherapy with continuous infusion 5-fluorouracil (5-FU) for locally advanced adenocarcinoma of the rectum. Methods and Materials: Eligible patients had newly diagnosed localized adenocarcinoma of the rectum within 12 cm of the anal verge, Stage T3–4, and were suitable for curative resection. Eighty-two patients were treated with radiotherapy—50.4 Gy in 28 fractions in 5.6 weeks, given concurrently with continuous infusion 5-FU, using either 96-h/week infusion at 300 mg/m 2/day or 7-days/week infusion at 225 mg/m 2/day. Results: The median age was 59 years (range, 27–87), and 67% of patients were male. Pretreatment stages of the rectal cancer were T3, 89% and resectable T4, 11%, with endorectal ultrasound confirmation in 67% of patients. Grade 3 acute toxicity occurred in 5 of 82 patients (6%; 95% confidence interval [CI], 2–14%). Types of surgical resection were anterior resection, 61%; abdominoperineal resection, 35%; and other procedures, 4%. There was no operative mortality. Anastomotic leakage after low anterior resection occurred in 3 of 50 patients (6%; 95% CI, 1–17%). The pathologic complete response rate was 16% (95% CI, 9–26%). Pathologic Stages T2 or less occurred in 51%. Conclusion: Preoperative radiotherapy with continuous infusion 5-FU for locally advanced rectal cancer is a safe regimen, with a significant downstaging effect. It does not seem to lead to a significant increase in serious surgical complications.