Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.
Bottom Line: Treatment allocation was not masked.Comparison of 74 Gy in 37 fractions, 60 Gy in 20 fractions, and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 (66%), 266 (65%), and 282 (65%) men; very small bother in 92 (22%), 91 (22%), and 93 (21%) men; small bother in 26 (6%), 28 (7%), and 38 (9%) men; moderate bother in 19 (5%), 23 (6%), and 21 (5%) men, and severe bother in four (<1%), three (<1%) and three (<1%) men respectively (74 Gy vs 60 Gy, ptrend=0.64, 74 Gy vs 57 Gy, ptrend=0·59).We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months.
Affiliation: The Institute of Cancer Research, London, UK.Show MeSH
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Mentions: We modelled the odds of any specific change from baseline or pre-radiotherapy to 24 months using ordinal logistic regression after checking the validity of the proportional odds assumption.15 Odds ratios less than one favour the relevant experimental group. For the ordinal logistic regression models, the dependent variable is the post-radiotherapy score minus the baseline or pre-radiotherapy score, taking values of −4, −3, −2, −1, 0, 1, 2, 3, or 4, where negative numbers represent an improvement in QoL and positive numbers represent worsening QoL. We used ANCOVA modelling to assess change from baseline for continuous variables such as domain scores, adjusting for baseline or pre-radiotherapy score as indicated above. We assessed the normality assumption of the ANCOVA model visually via histograms and we did not deem formal tests to be necessary. Patients were excluded from the fixed timepoint analyses if their QoL assessments were dated outside prespecified acceptable time intervals, as outlined in figure 1.