Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer
| Autor: | Deborah Watkins Bruner, Jeff M. Michalski, Jason A. Efstathiou, Jean Paul Bahary, Mack Roach, Guila Delouya, Rajat J. Kudchadker, Eric M. Horwitz, Lisa A. Kachnic, Colleen A. Lawton, Stephanie L. Pugh, Howard M. Sandler, Ian S. Dayes, Darindra D. Gopaul, Lee Ponsky, Wayne H. Pinover, Samantha A. Seaward, David C. Beyer, H. Lukka, Irving D. Kaplan, John Amanie |
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| Rok vydání: | 2018 |
| Předmět: |
Oncology
Male Organs at Risk Cancer Research Aging medicine.medical_treatment Phases of clinical research 030218 nuclear medicine & medical imaging law.invention Prostate cancer 0302 clinical medicine Quality of life Randomized controlled trial 7.1 Individual care needs law Cancer Radiation Prostate Cancer Femur Head Middle Aged Other Physical Sciences 030220 oncology & carcinogenesis Radiation Dose Hypofractionation Urologic Diseases medicine.medical_specialty Urinary system Urinary Bladder Clinical Trials and Supportive Activities Clinical Sciences Oncology and Carcinogenesis Article Disease-Free Survival 03 medical and health sciences Urethra Clinical Research Internal medicine medicine Humans Radiology Nuclear Medicine and imaging Patient Reported Outcome Measures Oncology & Carcinogenesis Aged Radiotherapy business.industry Rectum Prostatic Neoplasms medicine.disease Radiation therapy Clinical trial Quality of Life Management of diseases and conditions business Digestive Diseases Penis Follow-Up Studies |
| Zdroj: | International journal of radiation oncology, biology, physics, vol 102, iss 2 |
| Popis: | PurposeThere is considerable interest in very short (ultrahypofractionated) radiation therapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience, and resource allocation benefits. Our objective is to demonstrate that detectable changes in health-related quality of life measured by the bowel and urinary domains of the Expanded Prostate Cancer Index Composite (EPIC-50) were not substantially worse than baseline scores.Methods and materialsNRG Oncology's RTOG 0938 is a nonblinded randomized phase 2 study of National Comprehensive Cancer Network low-risk prostate cancer in which each arm is compared with a historical control. Patients were randomized to 5 fractions (7.25 Gy in 2 weeks) or 12 fractions (4.3 Gy in 2.5 weeks). The co-primary endpoints were the proportion of patients with a change in EPIC-50 bowel score at 1 year (baseline to 1 year) >5 points and in EPIC-50 urinary score >2 points tested with a 1-sample binomial test.ResultsThe study enrolled 127 patients to 5 fractions (121 analyzed) and 128 patients to 12 fractions (125 analyzed). Median follow-up for all patients at the time of analysis was 3.8 years. The 1-year frequency for >5 point change in bowel score were 29.8% (P < .001) and 28.4% (P < .001) for 5 and 12 fractions, respectively. The 1-year frequencies for >2 point change in urinary score were 45.7% (P < .001) and 42.2% (P < .001) for 5 and 12 fractions, respectively. For 5 fractions, 32.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥11 points (P = .34); for 12 fractions, 30.9% of patients had a drop in 1-year EPIC-50 sexual score of ≥ 11 points (P = .20). Disease-free survival at 2 years is 99.2% (95% confidence interval: 97.5-100) in the 5-fraction arm and 97.5% (95% confidence interval: 94.6-100) in the 12-fraction arm. There was no late grade 4 or 5 treatment-related urinary or bowel toxicity.ConclusionsThis study confirms that, based on changes in bowel and urinary domains and toxicity (acute and late), the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens. |
| Databáze: | OpenAIRE |
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