Abstract
PurposeTo investigate cosmetic degradation and toxicity for an APBI prescription delivered in five fractions over one week compared to WBI. MethodsThe trial is a multicentre, single-arm, phase II, prospective cohort study. Eligible women 50 years of age or older with ER-positive, HER2-negative, invasive ductal carcinoma or ductal carcinoma in situ after breast conserving surgery received 27 Gy in five daily fractions of APBI. The primary endpoint was non-inferiority of two-year cosmesis using the RAPID trial's WBI arm as the control arm. A global, consensus cosmetic score using the EORTC rating scale of excellent, good, fair, or poor for each patient at baseline and two-years was generated by a panel of five radiation oncologists using photographs of treated and untreated breasts. ResultsFrom 2016 to 2019, 298 eligible women were enrolled. By the two-year follow-up, 76 patients were lost or withdrew, and three had died, resulting in 219 patients available for complete, two-year photographic cosmetic evaluation. The median (interquartile range) follow-up for all participants was 4·7 years (3·8 – 5·5 years). No patient had a fair or poor cosmetic score at the two-year evaluation. Cosmesis was better or unchanged for 97% of patients, worse for 3% (excellent to good), and no cosmetic failures. The confidence intervals are 0·88 (0·86-0·90) and 1·00 (0·99-1·00) for the RAPID and ACCEL trials, respectively. ConclusionCosmetic degradation of five daily treatments of the ACCEL trial's APBI intervention is noninferior to the WBI arm of the RAPID trial.
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