Hypofractionated radiotherapy (HRT) offers quality-of-life outcomes similar to conventional radiation therapy for men with low-risk prostate cancer, according to recently published results of a phase 3 randomized study. HRT offers a less expensive and more convenient treatment option for some patients, and in light of the new findings about quality of life, should be considered a practice standard for these patients, the researchers argued. Oncology nurses and nurse navigators should describe these findings when educating patients about treatment options.
Hypofractionated radiotherapy is noninferior to conventional radiotherapy (CRT) for quality-of-life outcomes among men with low-risk prostate tumors, according to an analysis of data from the phase 3 randomized NRG Oncology RTOG 0415 clinical trial, conducted in the United States, Canada, and Switzerland (ClinicalTrials.gov identifier: NCT00331773).1
“This study provides evidence to affirm that HRT is a practice standard for men with low-risk prostate cancer,” the researchers wrote. “Treatment with HRT is noninferior to CRT in men with low-risk prostate cancer in terms of disease-free survival and, as shown in the present study, in prostate cancer-specific (bowel, bladder, sexual) and general quality of life, as well as in anxiety and depression.”
Previous research has shown that among men with prostate cancer, subjective study outcomes such as sexual function, anxiety, depression, diarrhea, and bloating were “more reflective of the patient experience” than Common Terminology Criteria Adverse Events (CTCAEs) outcomes, the researchers noted.1
RTOG 0415 was a noninferiority radiotherapy trial. Of 1092 men initially enrolled in the trial, 542 were randomly assigned to receive conventional radiotherapy and 550 were assigned to receive HRT. At a median follow-up of 5.8 years, 5-year disease-free survival was 85.3% for conventional radiotherapy (73.8 Gy in 41 fractions over 8 weeks) and 86.3% for HRT (70 Gy in 28 fractions over 5.6 weeks).1
But before practice standards can be revised, “it is important to demonstrate that not only is tumor control and disease-free survival noninferior, but also that quality of life is not diminished by a shorter fractionation schedule with a higher dose per treatment session,” the researchers noted.1
Physician-reported grade 2 and 3 gastrointestinal and genitourinary CTCAEs were previously reported to have been modestly elevated among men in the HRT arm of the RTOG 0415 trial, compared with those receiving conventional radiotherapy (relative risk, 1.59; 95% CI, 1.22-2.06; P =.002).1
The newly reported analysis examined RTOG 0415 data for the 962 men (mean age, 66.6 years) who had consented to participate in the quality of life component of the study: 478 from the conventional radiotherapy arm and 484 from the HRT arm.
Quality of life was assessed at baseline and 6, 12, 24, and 60 months, using 3 questionnaires: the Expanded Prostate Index Composite questionnaire for bowel, urinary, sexual, and hormonal outcomes; the Hopkins Symptom Checklist for anxiety and depression outcomes; and the EuroQol-5 Dimension questionnaire for global quality of life.
At baseline, the authors found no statistically significant differences between study groups for patient characteristics or quality of life scores.
“There were no differences in change score between arms with respect to any of the Expanded Prostate Index Composite questionnaire domain scores,” the researchers reported.1
And, no differences were observed between study arms for the Hopkins Symptom Checklist and EuroQol–5 Dimension questionnaire scores.
The researchers observed no difference in patient-reported urinary symptom scores between those who underwent HRT and those who underwent conventional radiotherapy. “There were also no differences in patient-reported bowel symptom scores between arms at 6, 24, or 60 months,” they reported.1