As reported in The Lancet Oncology by Fransson et al, analysis of patient-reported quality of life in the Scandinavian phase III HYPO-RT-PC trial showed no significant differences at up to 6 years of follow-up between patients receiving ultrahypofractionated radiotherapy vs conventionally fractionated radiotherapy for localized prostate cancer.
The previously reported primary analysis of the trial showed that ultrahypofractionated radiotherapy was noninferior to conventional fractionation in 5-year failure-free survival, and associated with a similar rate of late toxicity, but a higher rate of acute toxicity.
“Although acute toxicity was higher for ultrahypofractionation than conventional fractionation, this long-term patient-reported quality of life analysis shows that ultrahypofractionation was as well tolerated as conventional fractionation up to 6 years after completion of treatment. These findings support the use of ultrahypofractionation radiotherapy for intermediate-to-high-risk prostate cancer.”— Fransson et al
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Study Details
In the open-label trial, 1,180 patients from sites in Sweden and Denmark were randomly assigned between July 2005 and November 2015 to receive ultrahypofractionation (n = 589) or conventional fractionation (n = 591). Quality of life was evaluated by the Prostate Cancer Symptom Scale (PCSS) and EORTC QOL Questionnaire (EORTC QLQ-C30), with scheduled assessments at baseline; end of radiotherapy; 3, 6, 12, and 24 months after radiotherapy; every other year thereafter up to 10 years; and at 15 years. The current analysis presents data through 6 years after radiotherapy.
Key Findings
Median follow-up was 48 months (interquartile range = 25–72 months). Among 1,165 patients from the per-protocol population included in analysis, 455 (78%) of 583 in the ultrahypofractionation group and 479 (82%) of 582 in the conventional fractionation group completed the quality-of-life questionnaires. Questionnaires were completed by 146 (66%) of 220 and 158 (71%) of 223 patients at 6 years.
At the end of radiotherapy, significantly more ultrahypofractionation patients had clinically relevant deterioration in 7 of 10 bowel symptoms/problems, consisting of stool frequency (P < .0001), rush to toilet (P = .0013), flatulence (P = .0013), bowel cramp (P < .0001), mucus in stool (P = .0014), blood in stool (P < .0001), and limitation in daily activity (P = .0014).
At the end of radiotherapy, there were no significant differences between groups in proportions of patients with clinically relevant acute urinary symptoms/problems (total = 14 items) or sexual functioning.
At all other assessments, no clinically relevant differences between groups were observed for bowel or urinary symptoms/problems or sexual functioning.
At 6 years, there were no significant differences between the ultrahypofractionation patients vs the conventional fractionation patients in overall urinary bother (28% vs 33%, mean difference = 5.1%, P = .38), overall bowel bother (28% vs 33%, mean difference = 5.7%, P = .33), overall sexual bother (50% vs 60%, mean difference = 9.1%, P = .15), or clinically relevant deterioration in global health/quality of life (37% vs 42%; mean difference = 5.0%, P = .41).
The investigators concluded, “Although acute toxicity was higher for ultrahypofractionation than conventional fractionation, this long-term patient-reported quality of life analysis shows that ultrahypofractionation was as well tolerated as conventional fractionation up to 6 years after completion of treatment. These findings support the use of ultrahypofractionation radiotherapy for intermediate-to-high-risk prostate cancer.”
Per Fransson, PhD, of the Department of Nursing, Umeå University, Sweden, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by the Nordic Cancer Union, Swedish Cancer Society, and Swedish Research Council. For full disclosures of the study authors, visit thelancet.com.
