Five-year patient reported outcomes in NRG Oncology RTOG 0938, evaluating two ultrahypofractionated regimens for prostate cancer

Autor: Himanshu R, Lukka, Snehal, Deshmukh, Deborah W, Bruner, Jean-Paul, Bahary, Colleen A F, Lawton, Jason A, Efstathiou, Rajat J, Kudchadker, Lee E, Ponsky, Samantha A, Seaward, Ian S, Dayes, Darindra D, Gopaul, Jeff M, Michalski, Guila, Delouya, Irving D, Kaplan, Eric M, Horwitz, Mack, Roach, Felix Y, Feng, Stephanie L, Pugh, Howard M, Sandler, Lisa A, Kachnic
Rok vydání: 2022
Zdroj: International journal of radiation oncology, biology, physics.
ISSN: 1879-355X
Popis: There 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.xxxx 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 (7.25Gy in 2 week and a day - twice a week) or 12 fractions (4.3Gy in 2.5 weeks- five times a week). Secondary objectives assessed patient-reported toxicity at 5 years using the Expanded Prostate cancer Index Composite (EPIC). Chi-square tests were used to assess the proportion of patients with a deterioration from baseline of5 points for bowel,2 points for urinary, and11 points for sexual score, RESULTS: The study enrolled 127 patients to 5 fractions (121 eligible) and 128 patients to 12 fractions (125 eligible). Median follow-up for all patients at the time of analysis was 5.38 years. The 5-year frequency for5 point change in bowel score were 38.4% (P=0.27) and 23.4% (= 0.98) for 5 and 12 fractions, respectively. The 5-year frequencies for2 point change in urinary score were 46.6% (P=0.15) and 36.4% (P=0.70) for 5 and 12 fractions, respectively. For 5 fractions, 49.3% (P=0.007) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points; for 12 fractions, 54% (P0.001) of patients had a drop in 5-year EPIC-50 sexual score of ≥11 points. Disease-free survival at 5 years is 89.6% (95% confidence interval:84.0-95.2) in the 5-fraction arm and 92.3% (95% confidence interval: 87.4- 97.1) in the 12-fraction arm. There was no late grade 4 or 5 treatment-related urinary or bowel toxicity.This study confirms that, based on long-term changes in bowel and urinary domains and toxicity, the 5- and 12-fraction regimens are well tolerated. These ultrahypofractionated approaches need to be compared with current standard radiation therapy regimens.
Databáze: OpenAIRE