Discussion
breast cancer, chronic pain, edema-related, pain
INVASIVE BREAST CANCER, BREAST CANCER, INVASIVE CANCER, ADVERSE EFFECTS, SECONDARY, CHRONIC PAIN
This is the first report of longitudinal PROs in this emerging field of omission of breast surgery for highly selected patients whose invasive breast cancers have a pCR to NST. The results of this analysis demonstrate an overall positive experience for trial participants, with longitudinal improvements in decisional comfort and overall HRQOL, and minimal lasting adverse effects of therapy. Coupled with the 100% IBTR–free survival rate to date,Although changes in PRO scores overall were significantly associated with time, most were driven by differences over the first 6 to 12 months. These analyses are limited by the fact that only 15 patients (48%) had 36–month PRO data. It remains to be seen whether short-term trends will persist with longer follow-up and greater numbers of patients. We anticipate complete 5-year data for the entire cohort within the next 3 years.Our finding that decisional comfort increased over time is unique. A systematic reviewOur finding that all BCTOS subscores except pain significantly increased over the first 12 months and then returned to near-baseline values by 36 months is in keeping with findings from a trialOur unexpected finding that biopsy during surveillance was associated with lower BCTOS pain subscores is difficult to explain. Biopsy-associated pain may have been less impactful than pain secondary to other interventions, particularly given that chemotherapy and hormone therapy are associated with chronic pain in breast cancer survivors.Prior studies on HRQOL in breast cancer patients have had mixed results, possibly because of differences in PROMs used to measure well-being. For example, a registry studyFew prior studies have examined ARM subscores from the FACT-B+4 questionnaire, and to our knowledge this is the first study of longitudinal changes in arm-specific PROs. Our finding that neither axillary surgery nor axillary radiation was significantly associated with ARM subscores is reassuring. Although breast pCR and axillary pCR are highly correlated,The observed associations between PRO scores and race or ethnicity must be interpreted with caution given the low number of patients in some categories and missing ethnicity data for 2 patients precluding their inclusion in some models. Our observation that Black patients experienced more edema-related asymmetry than White patients is congruent with a prior reportAs this is the first trial we know of to evaluate omission of breast surgery for invasive cancer based on image-guided biopsy after NST, there are few data with which to compare our results. PROs for cryoablation, a minimally invasive procedure, might be similar to PROs for a nonoperative approach. Indeed, in a nonrandomized study