Patient reported outcomes in NRG Oncology RTOG 0938, evaluating two ultrahypofractionated regimens for prostate cancer

Publication date: Available online 18 June 2018
Source:International Journal of Radiation Oncology*Biology*Physics
Author(s): Himanshu R. Lukka, Stephanie L. Pugh, 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, Wayne H. Pinover, David C. Beyer, John O. Amanie, Howard M. Sandler, Lisa A. Kachnic
BackgroundThere is considerable interest in very short (ultrahypofractionated) radiotherapy regimens to treat prostate cancer based on potential radiobiological advantages, patient convenience and resource allocation benefits.ObjectiveTo 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.Design, Setting, and ParticipantsXXXX is a non-blinded randomized phase II study of NCCN low risk prostate cancer where each arm is compared to a historical control.Intervention(s)Patients were randomized to five fractions (7.25Gy in two weeks), or twelve fractions (4.3Gy in 2.5 weeks).Outcome Measurements and Statistical AnalysisThe co-primary endpoints were the proportion of patients with a change in EPIC bowel score at one year (baseline to one-year) >five points and in EPIC urinary score >two points tested with a one-sample binomial test.Resultsand Limitations: 127 patients were enrolled to five fractions (121 analyzed) and 128 to twelve fractions (125 analyzed). Median follow-up for all patients at the time of analysis was 3.8 years. The one year frequency for >five point change in bowel score for five and twelve fractions were 29.8%(p<0.001) and 28.4%(p<0.001) respectively. The one year frequency for >two point change in urinary score for five and twelve fractions were 45.7%(p<0.001) and 42.2%(p<0.001) respectively. For five and twelve fractions 32.9% of patients had a drop in 1 year EPIC sexual score ≥ 11 points (p=0.34) while 30.9% of patients had a drop in 1 year EPIC sexual score ≥11 points (p=0.20) in the twelve fraction arm respectively. DFS at two years is 93.3% (95% CI: 88.8, 97.8) and 88.3% (95% CI: 82.5, 94.0) in the five and twelve fraction arms, respectively. 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 five and twelve fractions regimens are well tolerated. These ultrahypofractionated approaches need to be compared to current standard radiotherapy regimens

Teaser

The urinary and rectal quality of life outcomes reported by prostate cancer patients undergoing 5 & 12 prostate radiotherapy treatments are comparable to current standard 38-44 radiotherapy treatments. These shorter radiotherapy treatments need to be compared to the current standard radiotherapy treatments in a larger study.


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