Impact of ultrahypofractionated adjuvant regional nodal radiotherapy on patient-reported quality of life: the HYPORT adjuvant trial (NCT03788213).

Abstract

The HYPORT Adjuvant trial is comparing a one-week (26 Gy) course of adjuvant breast radiotherapy (RT) to a three-week (40 Gy) course. We report the interaction of regional nodal irradiation (RNI) and the dose fractionation regimen on the quality of life (QoL). Self-reported QoL was assessed using the EORTC-QLQ-C30 and FACT-B questionnaires at baseline, at the end of RT, and at 6, 12, and 18 months post-RT. Linear mixed models (LMM) were used to compare mean scale scores across time points in patients who received or did not receive RNI. Marginal means, along with confidence intervals, were calculated. A total of 2173 patients were evaluable, of whom 1508 (69.4%) received RNI. At 18 months 690 and 686 patients completed the EORTC-QLQ-C30 and FACTB questionnaires respectively. The coefficient for the interaction term between the randomisation arm and RNI for the C30 global QoL scale (GQoL) was -0.36 (95% CI: -3.1 to 2.4, p = 0.8). Marginal means for GQoL at 18 months for the patients receiving RNI in the control and experimental arms were 71.75 (69.65-73.84) and 71.80 (95% CI: 69.78-73.83) (p = 0.969), respectively. Other functional and symptom scales were also not different between the two arms. 23/303 (7.6%) patients receiving RNI in the control arm and 19/330 (5.7%) in the experimental arm reported significant arm swelling and tenderness at 18 months. RNI delivered using ultra-hypofractionated radiotherapy did not result in a worse quality of life than moderately hypofractionated radiotherapy in the trial.