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Title: 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%,more » 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.« less

Authors:
;  [1]; ;  [2];  [1]; ; ;  [3];  [1];  [4];  [5];  [6];  [2];  [7];  [3];  [6];
  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)
Publication Date:
OSTI Identifier:
22648734
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 95; Journal Issue: 4; Other Information: Copyright (c) 2016 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CHEMOTHERAPY; GY RANGE 10-100; NEOPLASMS; PATIENTS; RADIOTHERAPY; RECTUM; TOXICITY

Citation Formats

Picardi, Vincenzo, Deodato, Francesco, Guido, Alessandra, Giaccherini, Lucia, Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it, Frazzoni, Leonardo, Farioli, Andrea, Cuicchi, Dajana, Cilla, Savino, Cellini, Francesco, Uddin, A.F.M. Kamal, Gambacorta, Maria Antonietta, Buwenge, Milly, Ardizzoni, Andrea, Poggioli, Gilberto, Valentini, Vincenzo, and and others. Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study. United States: N. p., 2016. Web. doi:10.1016/J.IJROBP.2016.03.010.
Picardi, Vincenzo, Deodato, Francesco, Guido, Alessandra, Giaccherini, Lucia, Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it, Frazzoni, Leonardo, Farioli, Andrea, Cuicchi, Dajana, Cilla, Savino, Cellini, Francesco, Uddin, A.F.M. Kamal, Gambacorta, Maria Antonietta, Buwenge, Milly, Ardizzoni, Andrea, Poggioli, Gilberto, Valentini, Vincenzo, & and others. Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study. United States. doi:10.1016/J.IJROBP.2016.03.010.
Picardi, Vincenzo, Deodato, Francesco, Guido, Alessandra, Giaccherini, Lucia, Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it, Frazzoni, Leonardo, Farioli, Andrea, Cuicchi, Dajana, Cilla, Savino, Cellini, Francesco, Uddin, A.F.M. Kamal, Gambacorta, Maria Antonietta, Buwenge, Milly, Ardizzoni, Andrea, Poggioli, Gilberto, Valentini, Vincenzo, and and others. Fri . "Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study". United States. doi:10.1016/J.IJROBP.2016.03.010.
@article{osti_22648734,
title = {Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study},
author = {Picardi, Vincenzo and Deodato, Francesco and Guido, Alessandra and Giaccherini, Lucia and Macchia, Gabriella, E-mail: gmacchia@rm.unicatt.it and Frazzoni, Leonardo and Farioli, Andrea and Cuicchi, Dajana and Cilla, Savino and Cellini, Francesco and Uddin, A.F.M. Kamal and Gambacorta, Maria Antonietta and Buwenge, Milly and Ardizzoni, Andrea and Poggioli, Gilberto and Valentini, Vincenzo and and others},
abstractNote = {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.},
doi = {10.1016/J.IJROBP.2016.03.010},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 4,
volume = 95,
place = {United States},
year = {Fri Jul 15 00:00:00 EDT 2016},
month = {Fri Jul 15 00:00:00 EDT 2016}
}