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

Journal Article · Fri Jul 15 04:00:00 EDT 2016 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2016.03.010· OSTI ID:22648734

Picardi, Vincenzo; Deodato, Francesco ^[1]; Guido, Alessandra; Giaccherini, Lucia ^[2]; Macchia, Gabriella ^[1]; Frazzoni, Leonardo; Farioli, Andrea; Cuicchi, Dajana ^[3]; Cilla, Savino ^[1]; Cellini, Francesco ^[4]; Uddin, A. F.M. Kamal ^[5]; Gambacorta, Maria Antonietta ^[6]; Buwenge, Milly ^[2]; Ardizzoni, Andrea ^[7]; Poggioli, Gilberto ^[3]; Valentini, Vincenzo ^[6]; others, and

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1. Department of Radiotherapy, Fondazione di Ricerca e Cura “Giovanni Paolo II,” Campobasso (Italy)
2. Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna (Italy)
3. Department of Medical and Surgical Sciences, University of Bologna, Bologna (Italy)
4. Radiation Oncology Department, Policlinico Universitario Campus Bio-Medico, Rome (Italy)
5. Department of Radiation Oncology, United Hospital Limited, Dhaka (Bangladesh)
6. Department of Radiotherapy, Policlinico Universitario “A. Gemelli,” Università Cattolica del Sacro Cuore, Rome (Italy)
7. Medical Oncology Unit, Azienda Ospedaliera Universitaria, Policlinico S. Orsola-Malpighi, Bologna (Italy)

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.

• OSTI ID: 22648734
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 4 Vol. 95; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

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