Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study.

Abstract

PURPOSE:

The management of patients with symptomatic rectal cancer not amenable to curative treatment may be challenging. The aim of this phase 2 study was to evaluate the efficacy of short-course radiation therapy in patients with obstructing rectal cancer.

METHODS AND MATERIALS:

Patients who were not candidates for surgical resection because of synchronous metastases, age, and/or comorbidities were considered eligible. The sample size was calculated based on the 2-stage design of Simon. Short-course radiation therapy was delivered with an isocentric 4-field box technique (total, 25 Gy; 5 fractions in 5 days). Chemotherapy was suspended during radiation treatment. Clinical outcome measures were symptomatic response rate, toxicity, colostomy-free survival, and overall survival.

RESULTS:

From October 2003 to November 2012, 18 patients (median age, 77.5 years) were enrolled. The median follow-up was 11.5 months (range, 3-36 months). Four weeks after treatment, a complete response (ie, complete symptom resolution) was observed in 38.9% of patients and a partial response in 50.0% cases, whereas 11.1% had no response. The rates of reduction or resolution of pain and bleeding were 87.5% and 100%, respectively. The 1-, 2-, and 3-year colostomy-free survival rates were 100%, 71.4%, and 47.6%, respectively (median, 30 months). The 1-, 2-, and 3-year cumulative overall survival rates were 85.2%, 53%, and 39.8%, respectively (median, 25 months). No patients stopped treatment because of gastrointestinal or genitourinary toxicities: 38.9% of patients had grade 1 to 2 toxicity, and 16.7% had grade 3 toxicity. Only 1 patient had hematologic grade 2 toxicity, and 2 patients had grade 2 skin toxicity.

CONCLUSIONS:

Short-course radiation therapy may represent a safe and effective alternative treatment option in patients with obstructing rectal cancer not eligible for curative treatment, allowing colostomy to be avoided in a substantial proportion of patients.

• Authors: Vincenzo Picardi, Francesco Deodato, Alessandra Guido, Lucia Giaccherini, Gabriella Macchia, Leonardo Frazzoni, Andrea Farioli, Dajana Cuicchi, Savino Cilla, Francesco Cellini, A F M Kamal Uddin, Maria Antonietta Gambacorta, Milly Buwenge, Andrea Ardizzoni, Gilberto Poggioli, Vincenzo Valentini, Lorenzo Fuccio, Alessio G Morganti
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 95 Issue 4 Pg. 1184-90 (07 15 2016) ISSN: 1879-355X [Electronic] United States
• PMID: 27215449 (Publication Type: Clinical Trial, Phase II, Journal Article)
• Copyright: Copyright © 2016 Elsevier Inc. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Colostomy
• Female
• Humans
• Male
• Middle Aged
• Palliative Care
• Prospective Studies
• Radiation Injuries (etiology)
• Rectal Neoplasms (mortality, radiotherapy)
• Survival Rate