Data presented at the 2024 American Society for Radiation Oncology (ASTRO) Annual Meeting indicates that moderate hypofractionated radiotherapy demonstrates similar health-related quality of life outcomes compared to conventional fractionation in patients with intermediate-risk prostate cancer. The findings, from a randomized clinical trial, support the use of hypofractionation as a standard treatment option.
Study Design and Methods
The study randomized 1,206 intermediate-risk prostate cancer patients to either conventional fractionation (78 Gy in 39 fractions over 8 weeks) or moderate hypofractionation (60 Gy in 20 fractions over 4 weeks). Patient-reported outcomes were evaluated at baseline, 24 months, and 48 months using the EPIC questionnaire and the SF-12. The minimally important difference (MID) was defined as a deterioration in health-related quality of life scores at each time point, compared to baseline, by ≥0.5 standard deviations. Statistical significance was set at p<0.01.
Key Findings
Overall, the study found no statistically significant or clinically meaningful differences in urinary, sexual, or hormonal domains between the two treatment arms. While there was a similar 10-point decrease in the mean sexual domains score in both groups, bowel summary scores were superior in the conventional fractionation arm at 48 months (p=0.01). The urinary function and incontinence subdomains scores showed a decline of approximately 5 points. The hormone subdomains remained stable, with a transient significant difference favoring conventional fractionation at 24 months, which was not sustained at 48 months.
Impact on Clinical Practice
According to Dr. Noelia Sanmamed, Radiation Oncologist at Hospital Clinico San Carlos, Madrid, Spain, the results align with clinician-reported toxicity data. The study's findings, combined with efficacy, toxicity, and patient convenience data, support the use of moderate hypofractionation as a standard of care for organ-confined prostate cancer. The proportion of patients reporting MID in bowel function at 48 months was significantly higher in the conventionally fractionated arm.
Additional Considerations
While overall satisfaction scores slightly favored the conventional fractionation treatment arm, the comprehensive assessment of patient-reported outcomes suggests that moderate hypofractionation does not compromise quality of life and offers a shorter treatment duration, potentially improving patient convenience.
