title: Palliative Short-Course Radiation Therapy in Rectal Cancer: A Phase 2 Study.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.affiliation: Department of Radiotherapy, Fondazione di Ricerca e Cura "Giovanni Paolo II," Campobasso, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Picardi
authors.affiliation: Department of Radiotherapy, Fondazione di Ricerca e Cura "Giovanni Paolo II," Campobasso, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Deodato
authors.affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Guido
authors.affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Giaccherini
authors.affiliation: Department of Radiotherapy, Fondazione di Ricerca e Cura "Giovanni Paolo II," Campobasso, Italy. Electronic address: gmacchia@rm.unicatt.it.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Macchia
authors.affiliation: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Frazzoni
authors.affiliation: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Farioli
authors.affiliation: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Dajana
authors.initials: D
authors.lastname: Cuicchi
authors.affiliation: Department of Radiotherapy, Fondazione di Ricerca e Cura "Giovanni Paolo II," Campobasso, Italy.
authors.forename: Savino
authors.initials: S
authors.lastname: Cilla
authors.affiliation: Radiation Oncology Department, Policlinico Universitario Campus Bio-Medico, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cellini
authors.affiliation: Department of Radiation Oncology, United Hospital Limited, Dhaka, Bangladesh.
authors.forename: A F M Kamal
authors.initials: AF
authors.lastname: Uddin
authors.affiliation: Department of Radiotherapy, Policlinico Universitario "A. Gemelli," Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Maria Antonietta
authors.initials: MA
authors.lastname: Gambacorta
authors.affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna, Italy.
authors.forename: Milly
authors.initials: M
authors.lastname: Buwenge
authors.affiliation: Medical Oncology Unit, Azienda Ospedaliera Universitaria, Policlinico S. Orsola-Malpighi, Bologna, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Ardizzoni
authors.affiliation: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Gilberto
authors.initials: G
authors.lastname: Poggioli
authors.affiliation: Department of Radiotherapy, Policlinico Universitario "A. Gemelli," Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.affiliation: Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Fuccio
authors.affiliation: Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna, Bologna, Italy.
authors.forename: Alessio G
authors.initials: AG
authors.lastname: Morganti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003125:Colostomy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology; D012004:Rectal Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D015996:Survival Rate