medwireNews: Hypofractionated radiotherapy (RT) is similar to conventional radiotherapy when it comes to health-related quality of life (QoL) in men with low-risk prostate cancer, according to the RTOG 0415 phase III randomized controlled trial.
“[This] study adds further evidence supporting [hypofractionated RT] as a new standard of care, and it counters arguments that reduced treatment duration is offset by clinically meaningful increased AEs [adverse events] and decreased QOL,” write Deborah Bruner (Emory University, Atlanta, Georgia, USA) and co-researchers in JAMA Oncology.
A total of 478 men who were treated with conventional (73.8 Gy in 41 fractions over 8.2 weeks) and 484 treated with hypofractionated RT (70 Gy in 28 fractions over 5.6 weeks) reported similar changes from baseline in the vast majority of QoL outcomes at 6, 12, 24, and 60 months. These included bowel, urinary, sexual, and hormonal domains as measured using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire, anxiety and depression on the 25-item Hopkins Symptom Checklist, and global QoL using the EuroQol-5 Dimensions questionnaire.
The single exception was the bowel domain of EPIC, in which men treated with hypofractionated RT showed a significantly larger decline at 12 months than those given conventional RT, with mean scores of –7.5 and –3.7 respectively. However, this difference was not clinically significant (effect size 0.29 vs 0.50 for clinical significance), with the researchers noting that “the single time point [at which] the bowel score was statistically significantly worse in the [hypofractionated RT] arm was of small consequence as perceived by the patient.”
This noninferiority of hypofractionated RT in terms of QoL came despite a slightly higher rate of late grade 2 gastrointestinal AEs, at 18.3% compared with 11.4% with conventional treatment. However, grade 3 or higher gastrointestinal and any-grade genitourinary adverse events were similar between the two groups.
Bruner and colleagues note that long duration of therapy is often cited by men as a major disadvantage of RT. Therefore, they say: “Therapy that has no more AEs for a course of 5.6 weeks compared with 8.2 weeks would have obvious implications for patient decision making and resource savings.”
The researchers conclude: “In conjunction with the results of the efficacy analysis of RTOG 0415, which demonstrated that moderate [hypofractionated RT] is not inferior to [conventional RT] in terms of therapeutic efficacy, the current data add to the soundness of a conclusion that there is also no between-arm clinically meaningful differences in AEs nor quality of life, the last lingering concern of [hypofractionated radiotherapy].”
By Catherine Booth
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