Identifying Factors Predicting Margin Status After Mastectomy.

INTRODUCTION: A positive margin after mastectomy increases the risk of breast cancer recurrence and the morbidity associated with re-excision or chest wall irradiation. This study aimed to identify factors that may predict margin status after mastectomy. METHODS: Women with Tis-T3 breast cancers who underwent mastectomy from 2014 to 2020 were retrospectively analyzed. Comparisons of clinicopathologic data were made between patients with negative margins (> 1 mm) and close (≤ 1 mm) or positive margins. RESULTS: Of 938 women who underwent mastectomy, negative margins were reported for 794 (85%) women, while 144 (15%) women experienced close (97/144, 10%) or positive (47/144, 5%) margins. Re-excision of margins was performed in 37 (26%) of those patients, and 9 (24%) had residual cancer after re-excision. On multivariate analysis, increasing age (odds ratio [OR] 0.97, 95% confidence interval [CI] 0.96-0.99, p = 0.002), increased body mass index (BMI; OR 0.97, 95% CI 0.93-1.00, p = 0.049), and neoadjuvant chemotherapy (NAC; OR 0.44, 95% CI 0.25-0.79, p = 0.006) decreased the risk of close or positive margins. Tumors located in the lower inner quadrant (OR 3.83, 95% CI 1.90-7.72, p < 0.001), multifocal tumors (OR 1.78, 95% CI 1.19-2.66, p = 0.005), immediate reconstruction (OR 1.63, 95% CI 1.03-2.58, p = 0.039), and a preoperative tumor to breast volume ratio > 4.14 (OR 2.66, 95% CI 1.43-4.94, p = 0.002) significantly increased the risk of close or positive margins. CONCLUSIONS: Age, BMI, tumor location, multifocality, NAC, immediate reconstruction, and tumor to breast volume ratio independently predicted margin status after mastectomy. These data should be considered when counseling women considering mastectomy.

A Phase II Trial of Once Weekly Hypofractionated Breast Irradiation for Early Stage Breast Cancer.

PURPOSE: To report an interim analysis of a phase II trial of once weekly, hypofractionated breast irradiation (WH-WBI) following breast conserving surgery (BCS). METHODS: Patients had stage 0-II breast cancer treated with breast BCS with negative margins. WH-WBI was 28.5 or 30Gy delivered to the whole breast using tangential beams with no elective coverage of lymph nodes. The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Secondary endpoints were distant disease-free survival (DDFS), recurrence free survival (RFS), overall survival (OS), adverse events and cosmesis. RESULTS: From 2011 to 2015, 158 patients received WH-WBI. Median follow up was 4.4 years (range 0.2-8.1). Stage distribution was DCIS 22%; invasive pN0 68%; invasive pN1 10%. 80 patients received 30 Gy and 78 received 28.5 Gy with median follow up times of 5.6 and 3.7 years, respectively. There were 5 IBTR events, all in the 30 Gy group. The 5- and 7- year risks of IBRT for all patients were 2.2% (95% CI 0.6-5.8) and 6.0% (95% CI 1.1-17.2), respectively. The 7-year rates of DDFS, RFS, and OS were 96.3%, 91.5% and 89.8%, respectively. Improvement in IBTR-free time was seen in DCIS, lobular histology, low grade tumors, Her2 negative tumors and 28.5 Gy dose (all p < 0.0001). CONCLUSIONS: Disease-specific outcomes after WH-WBI are favorable and parallel those seen with conventional radiation techniques for stage 0-II breast cancer.

Effect of the Ductal Carcinoma In Situ Margin Consensus Guideline Implementation on Re-Excision Rates, Satisfaction, and Cost.

INTRODUCTION: The 2016 consensus guideline on margins for breast-conserving surgery (BCS) with whole-breast irradiation (WBI) for ductal carcinoma in situ (DCIS) recommended 2 mm margins to decrease local recurrence rates. We examined re-excision rates, cost, and patient satisfaction before and after guideline implementation. METHODS: From an Institutional Review Board-approved database, patients with DCIS who underwent BCS with over 1 year of follow-up at one academic institution and one community cancer center were evaluated. Two groups were compared based on when they received treatment, i.e. before (pre-consensus [PRE]) and after November 2016 (post consensus [POST]), with respect to outcome and cost parameters. RESULTS: After consensus guideline implementation, re-excision rate (32.1% vs. 20.0%) and mastectomy conversion (8.3% vs. 2.3%) significantly increased, although total resection volume, operative cost per patient, and satisfaction with breast scores did not differ. Not all patients with <2 mm margins were re-excised, although the re-excision rate among this subset significantly increased (62.4% vs. 31.3%). On multivariable analysis controlling for age, estrogen receptor status, WBI use, and margin status, surgery after consensus guideline publication was independently associated with a higher re-excision rate (odds ratio [OR] 1.97, 95% confidence interval [CI] 1.08-3.59, p = 0.03) and a higher rate of conversion to mastectomy (OR 6.84, 95% CI 1.67-28.00, p = 0.007). CONCLUSIONS: Implementation of the 2016 margin consensus guideline for DCIS resulted in an increase in re-excisions and mastectomy conversions at two institutions. Research is needed for operative tools and strategies to decrease DCIS re-excision rates.

Evaluating the effect of neoadjuvant chemotherapy on surgical outcomes after breast conserving surgery.

BACKGROUND: Neoadjuvant chemotherapy (NAC) increases breast-conserving surgery (BCS) rates with comparable locoregional control and survival outcomes to adjuvant therapy. More women are receiving NAC and achieving pathologic complete responses (pCR). This study sought to evaluate the effect of NAC on surgical outcomes after the adoption of a "no-ink-on-tumor" margin policy in patients undergoing primary BCS (PBSC). METHODS: An IRB approved database was queried for women undergoing BCS for invasive breast cancer after March 2014. We compared patients who underwent NAC followed by BCS versus PBCS. Demographic, tumor, treatment, and outcome variables were compared using both univariate and multivariable analysis. RESULTS: A total of 162 patients were evaluated. NAC patients had significantly lower re-excision rates (0% NAC vs. 9% PBCS, p = .03), margin positivity (0% NAC vs. 5% PBCS, p = .01), and greater patient satisfaction with breast cosmesis (97 NAC vs. 77 PBCS, p = .01). On multivariable analysis, NAC was not an independent predictor of lower final resection volume, total complications, or greater satisfaction with breasts when controlling for age and T category at diagnosis. CONCLUSION: NAC followed by BCS may offer less margin positivity, lower re-excision rates, and greater patient satisfaction when compared to a contemporary PBCS cohort in the "no-ink-on-tumor" era.

Identifying Factors Predicting Prolonged Opioid Use After Mastectomy.

BACKGROUND: Women who undergo mastectomy for breast cancer may be prone to prolonged opioid use (POU). However, risk factors for long-term opioid use after mastectomy remain unclear. This study seeks to identify risk factors for POU after mastectomy. PATIENTS AND METHODS: A single-institution database was queried for women who underwent mastectomy for breast cancer between January 2016 and December 2017. Patients were stratified based on opioid use < 90 or ≥ 90 days after mastectomy or completion of their reconstruction. Clinicopathologic and operative parameters as well as preoperative and postoperative opioid usage were compared. RESULTS: Patients with opioid use ≥ 90 days after last procedure (POU) had a history of preoperative opioid use (29.3% vs 8.2%, p = 0.002), were more likely to have concomitant psychiatric illness (70% vs 35.6%, p < 0.001), and had received adjuvant chemotherapy (43.1% vs 24.7%, p = 0.03). Patients with POU also had greater daily opioid doses prescribed upon discharge (59.6 mg vs 44.6 mg, p < 0.001). On multivariable analysis, preoperative opioid use (OR 3.61, 95% CI 1.16-11.22, p = 0.03), daily oral morphine equivalents prescribed at discharge (OME-D) (OR 1.02, 95% CI 1.01-1.05, p = 0.003), and psychiatric illness (OR 4.48, 95% CI 1.85-10.89, p < 0.001) were independently associated with POU. Among opioid-naïve patients, 37% were found to have POU. Among these patients, OME at discharge (OR 1.02, 95% CI 1.003-1.04, p = 0.02) and psychiatric illness (OR 3.23, 95% CI 1.25-8.31, p = 0.02) independently predicted POU. CONCLUSIONS: Preoperative opioid use, psychiatric illness, and daily OME at discharge independently predict POU after mastectomy.

Identifying factors impacting the efficacy of postmastectomy radiotherapy in patients with early-stage breast cancer and one to two positive lymph nodes.

INTRODUCTION: In women with T1-2 breast cancer and one to two positive axillary lymph nodes (LN) at low risk for recurrence, postmastectomy radiation therapy (PMRT) may provide insufficient benefit to justify its toxicity. This study evaluated the interaction of factors associated with overall survival (OS) after PMRT in these patients. METHODS: The National Cancer Database was queried for women with T1-2 breast cancer undergoing mastectomy with one to two positive LN identified on lymphadenectomy. Patients were grouped according to number of positive LN and then stratified by PMRT use. Differences in OS were evaluated. RESULTS: Multivariable modeling demonstrated an interaction effect of age on the efficacy of PMRT. In patients more than or equal to 60 years old, PMRT was associated with improved survival when adjusting for age and tumor grade in patients with 1 to 2 positive LN (risk ratio = 0.62, 95% confidence interval = 0.40-0.93, P = .018). In patients less than 60 years old, tumor size and grade, but not PMRT, were associated with improved OS. CONCLUSION: For women with T1-2 breast cancer and one to two positive LN, PMRT's association with OS is influenced by age, tumor grade, and number of positive LN. PMRT appears to be associated with improvements in OS in older patients, but not younger patients, regardless of tumor size or nodal status.

Identifying factors influencing delays in breast cancer treatment in Kentucky following the 2014 Medicaid expansion.

BACKGROUND AND OBJECTIVES: A previous analysis of breast cancer care after the 2014 Medicaid expansion in Kentucky demonstrated delays in treatment despite a 12% increase in insurance coverage. This study sought to identify factors associated with treatment delays to better focus efforts for improved breast cancer care. METHODS: The Kentucky Cancer Registry was queried for adult women diagnosed with invasive breast cancer between 2010 and 2016 who underwent up-front surgery. Demographic, tumor, and treatment characteristics were assessed to identify factors independently associated with treatment delays. RESULTS: Among 6225 patients, treatment after Medicaid expansion (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.874-2.535, P < .001), urban residence (OR = 1.362, 95% CI = 1.163-1.594, P < .001), treatment at an academic center (OR = 1.988, 95% CI = 1.610-2.455, P < .001), and breast reconstruction (OR = 3.748, 95% CI = 2.780-5.053, P < .001) were associated with delay from diagnosis to surgery. Delay in postoperative chemotherapy was associated with older age (OR = 1.155,95% CI = 1.002-1.332, P = .0469), low education level (OR = 1.324, 95% CI = 1.164-1.506, P < .001), hormone receptor positivity (OR = 1.375, 95% CI = 1.187-1.593, P < .001), and mastectomy (OR = 1.312, 95% CI = 1.138-1.513, P < .001). Delay in postoperative radiation was associated with younger age (OR = 1.376, 95% CI = 1.370-1.382, P < .001), urban residence (OR = 1.741, 95% CI = 1.732-1.751, P < .001), treatment after Medicaid expansion (OR = 2.007, 95% CI = 1.994-2.021, P < .001), early stage disease (OR = 5.661, 95% CI = 5.640-5.682, P < .001), and mastectomy (OR = 1.884, 95% CI = 1.870-1.898, P < .001). CONCLUSIONS: Patient, tumor, and socioeconomic factors influence the timing of breast cancer treatment. Improving timeliness of treatment will likely require improvements in outreach, education, and healthcare infrastructure.

A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis.

BACKGROUND: Breast cancer-related lymphedema (BCRL) represents a major source of morbidity among breast cancer survivors. Increasing data support early detection of subclinical BCRL followed by early intervention. A randomized controlled trial is being conducted comparing lymphedema progression rates using volume measurements calculated from the circumference using a tape measure (TM) or bioimpedance spectroscopy (BIS). METHODS: Patients were enrolled and randomized to either TM or BIS surveillance. Patients requiring early intervention were prescribed a compression sleeve and gauntlet for 4 weeks and then re-evaluated. The primary endpoint of the trial was the rate of progression to clinical lymphedema requiring complex decongestive physiotherapy (CDP), with progression defined as a TM volume change in the at-risk arm ≥ 10% above the presurgical baseline. This prespecified interim analysis was performed when at least 500 trial participants had ≥ 12 months of follow-up. RESULTS: A total of 508 patients were included in this analysis, with 109 (21.9%) patients triggering prethreshold interventions. Compared with TM, BIS had a lower rate of trigger (15.8% vs. 28.5%, p < 0.001) and longer times to trigger (9.5 vs. 2.8 months, p = 0.002). Twelve triggering patients progressed to CDP (10 in the TM group [14.7%] and 2 in the BIS group [4.9%]), representing a 67% relative reduction and a 9.8% absolute reduction (p = 0.130). CONCLUSIONS: Interim results demonstrated that post-treatment surveillance with BIS reduced the absolute rates of progression of BCRL requiring CDP by approximately 10%, a clinically meaningful improvement. These results support the concept of post-treatment surveillance with BIS to detect subclinical BCRL and initiate early intervention.

Calculation of breast volumes from mammogram: Comparison of four separate equations relative to mastectomy specimen volumes.

BACKGROUND AND OBJECTIVES: Accurately assessing breast volume (BV) relative to the volume of breast tissue to be removed could help objectively determine the optimal surgical candidates for breast conserving surgery. The objective of this study was to determine the optimal mammography-based method of BV estimation. METHODS: Mammography data was obtained for patients who underwent mastectomy for breast cancer from 2005 to 2015. This data was used to calculate BV using four previously published equations. Results were compared to mastectomy specimen volumes calculated from specimen weights and breast density. Five practitioners then independently assessed reproducibility and ease of use. RESULTS: Complete mammographic measurements were available for 65 breasts from 45 patients. Median age was 58 years (range 19-82). Mammographic breast density scores were available for 62 breasts. Of the 65 mastectomies performed, 16 (36%) were simple mastectomies. The equation BV = 1/3πRcc Rmlo Hmlo most closely approximated actual breast specimen volumes (R = 0.89, P < 0.0001). Internal correlation of calculated BV was excellent among all practitioners (lowest Pearson R = 0.963). CONCLUSIONS: Breast volumes can be reliably estimated utilizing measurements from a preoperative mammogram. This low-cost method of volumetric analysis can be employed to guide surgical decision making in treatment of patients with invasive breast cancer.

Breast abscess after intravenous methamphetamine injection into the breast.

Intravenous drug use is a problem plaguing our society. We present a case of a young female who injected methamphetamine into her mammary vein, resulting in the formation of a breast abscess. This case demonstrates a rare but dangerous complication of intravenous drug use and a possible differential diagnosis in a patient presenting with a breast abscess.

Cost-effectiveness Analysis of Contralateral Prophylactic Mastectomy Compared to Unilateral Mastectomy with Routine Surveillance for Unilateral, Sporadic Breast Cancer.

BACKGROUND: Contralateral prophylactic mastectomy (CPM) rates in younger women with unilateral breast cancer have more than doubled. Studies of cost and quality of life of the procedure remain inconclusive. METHODS: A cost-effectiveness analysis using a decision-tree model in TreeAge Pro 2015 was used to compare long-term costs and quality of life following unilateral mastectomy (UM) with routine surveillance versus CPM for sporadic breast cancer in women aged 45 years. A 10-year risk period for contralateral breast cancer (CBC), reconstruction, wound complications, cost of routine surveillance, and treatment for CBC were used to estimate accrued costs. In addition, a societal perspective was used to estimate quality-adjusted life years (QALYs) following either treatment for a period of 30 years. Medical costs were obtained from the 2014 Medicare physician fee schedule and event probabilities were taken from recent literature. RESULTS: The mean cost of UM with surveillance was $14,141 and CPM was $20,319. Treatment with CPM resulted in $6178 more in costs but equivalent QALYs (17.93) compared with UM over 30 years of follow-up. Even with worst-case scenario and varying assumptions, CPM is dominated by UM in terms of cost and quality. CONCLUSIONS: From this refined model, UM with routine surveillance costs less and provides an equivalent quality of life. Patients undergoing CPM may eliminate the anxiety of routine surveillance, but they face the burden of higher lifetime medical costs.

A Randomized Prospective Comparison of Patient-Assessed Satisfaction and Clinical Outcomes with Radioactive Seed Localization versus Wire Localization.

Radioactive seed localization (RSL) has emerged as an alternative to wire localization (WL) in patients with nonpalpable breast cancer. Few studies have prospectively evaluated patient satisfaction and outcomes with RSL. We report the results of a randomized trial comparing RSL to WL in our community hospital. We prospectively enrolled 135 patients with nonpalpable breast cancer between 2011 and 2014. Patients were randomized to RSL or WL. Patients rated the pain and the convenience of the localization on a 5-point Likert scale. Characteristics and outcomes were compared between groups. Of 135 patients enrolled, 10 were excluded (benign pathology, palpable cancer, mastectomy, and previous ipsilateral cancer) resulting in 125 patients. Seventy patients (56%) were randomized to RSL and 55 (44%) to WL. Fewer patients in the RSL group reported moderate to severe pain during the localization procedure compared to the WL group (12% versus 26%, respectively, p = 0.058). The overall convenience of the procedure was rated as very good to excellent in 85% of RSL patients compared to 44% of WL patients (p < 0.0001). There was no difference between the volume of the main specimen (p = 0.67), volume of the first surgery (p = 0.67), or rate of positive margins (p = 0.53) between groups. RSL resulted in less severe pain and higher convenience compared to WL, with comparable excision volume and positive margin rates. High patient satisfaction with RSL provides another incentive for surgeons to strongly consider RSL as an alternative to WL.

A comparison of complication rates in early-stage breast cancer patients treated with brachytherapy versus whole-breast irradiation.

BACKGROUND: The adoption of breast brachytherapy into clinical practice for early-stage breast cancer has increased over the last several years. Studies evaluating complication rates following treatment with brachytherapy have shown conflicting results. We compared local toxicity in patients treated with brachytherapy with those treated with whole-breast irradiation (WBI). METHODS: We identified 417 early-stage breast cancer patients treated with breast-conserving surgery and radiation between 2004 and 2010, and compared 271 women treated with intracavitary brachytherapy with 146 women treated with WBI. Long-term complications were assessed using Kaplan-Meier curves with the log-rank test. RESULTS: Median follow-up was 4.6 years, and the 5-year incidence of infectious skin complications (9.7 vs. 11.0 %, p = 0.84), abscess (1.1 vs. 0 %, p = 0.15), telangiectasia (8.0 vs. 5.3 %, p = 0.35), and breast pain (14.2 vs. 9.4 %, p = 0.2) was similar between the brachytherapy and WBI cohorts. The brachytherapy cohort had a higher 5-year rate of seroma (46.5 vs. 18.5 %, p < 0.001), and fat necrosis (39.5 vs. 24.4 %, p < 0.001). Brachytherapy patients trended towards more frequent biopsies as a result of fat necrosis to rule out a recurrence (11.2 vs. 6.7 %, p = 0.13). CONCLUSIONS: Patients treated with intracavitary brachytherapy had more local toxicity, particularly seroma and fat necrosis. Patients should be counseled on the possible increased rate of long-term complications associated with brachytherapy treatment.

Factors Predicting Overnight Admission after Same-Day Mastectomy Protocol and Associated Financial Implications.

BACKGROUND: Same-day mastectomy (SDM) protocols have been shown to be safe, and their use increased up to 4-fold compared with prepandemic rates. We sought to identify factors that predict overnight patient admission and evaluate the associated cost of care. STUDY DESIGN: Patients undergoing mastectomy from March 2020 to April 2022 were analyzed. Patient demographics, tumor characteristics, operative details, perioperative factors, 30-day complication, fixed and variable cost, and contribution margin were compared between those who underwent SDM vs those who required overnight admission after mastectomy (OAM). RESULTS: Of a total of 183 patients with planned SDM, 104 (57%) had SDM and 79 (43%) had OAM. Both groups had similar demographic, tumor, and operative characteristics. Patients who required OAM were more likely to be preoperative opioid users (p = 0.002), have higher American Society of Anesthesiology class (p = 0.028), and more likely to have procedure start time (PST) after 12:00 pm (49% vs 33%, p = 0.033). The rates of 30-day unplanned postoperative events were similar between SDM and OAM. Preoperative opioid user (odds ratio [OR] 3.62, 95% CI 1.56 to 8.40), postanesthesia care unit length of stay greater than 1 hour (OR 1.17, 95% CI 1.01 to 1.37), and PST after 12:00 pm (OR 2.56, 95% CI 1.19 to 5.51) were independent predictors of OAM on multivariate analysis. Both fixed ($5,545 vs $4,909, p = 0.03) and variable costs ($6,426 vs $4,909, p = 0.03) were higher for OAM compared with SDM. Contribution margin was not significantly different between the 2 groups (-$431 SDM vs -$734 OAM, p = 0.46). CONCLUSIONS: Preoperative opioid use, American Society of Anesthesiology class, longer postanesthesia care unit length of stay, and PST after noon predict a higher likelihood of admission after planned SDM. OAM translated to higher cost but not to decreased profit for the hospital.

Impact of routine expert breast pathology consultation and factors predicting discordant diagnosis.

BACKGROUND: This study aimed to evaluate the impact of expert breast pathology consultation on operative management and predictive factors of discordant diagnosis. METHODS: A retrospective review of patients referred with breast biopsies and subsequent expert pathology consultation from 2014 to 2019. Discordance in diagnosis and documented changes in therapy were recorded. Univariate and multivariable analyses were performed. RESULTS: Ninety-one (91/263, 35%) patients had discordant findings after expert pathology consultation. No benign or in situ diagnoses were upgraded to invasive cancer. Tumor subtype changed in 10% while change in invasive cancer grade was most common (45%). Clinical management was altered in 3/263 (1%) with one change in surgical plan. Benign lesions without atypia (7.5% vs. 1.1%, p = 0.03) and excisional biopsies (8.7% vs. 2.2%, p = 0.04) were more often associated with non-discordant pathology. No independent predictors of discordance were observed. CONCLUSIONS: Discordant diagnoses after expert pathology consultation are common despite few changes in operative management. Excisional biopsy and benign lesions without atypia may be associated with less pathologic discordance after expert review.

Final Analysis of a Phase 2 Trial of Once Weekly Hypofractionated Whole Breast Irradiation for Early-Stage Breast Cancer.

PURPOSE: We hypothesize that 5-fraction once weekly hypofractionated (WH) whole breast irradiation (WBI) would be safe and effective after breast-conserving surgery for medically underserved patients with breast cancer. We report the protocol-specified primary endpoint of in-breast tumor recurrence (IBTR) at 5 years. METHODS AND MATERIALS: After provided informed consent, patients were treated with WH-WBI after breast-conserving surgery were followed prospectively on an institutional review board-approved protocol. Women included in this study had stage 0-II breast cancer treated with negative surgical margins and met prespecified criteria for being underserved. WH-WBI was 28.5 or 30 Gy delivered to the whole breast with no elective coverage of lymph nodes. The primary endpoint was IBTR at 5 years. Secondary endpoints were distant disease-free survival, recurrence-free survival, overall survival, adverse events, and cosmesis. RESULTS: One hundred fifty-eight patients received WH-WBI on protocol from 2010 to 2015. Median follow-up was 5.5 years (range, 0.2-10.0 years). Stage distribution was 22% ductal carcinoma in situ, 68% invasive pN0, and 10% invasive pN1. Twenty-eight percent of patients had grade 3 tumors, 10% were estrogen receptor negative, and 24% required adjuvant chemotherapy. There were 6 IBTR events. The 5-, 7-, and 10-year risks of IBTR for all patients were 2.7% (95% confidence interval [CI], 0.89-6.34), 4.7% (95% CI, 1.4-11.0) and 7.2% (95% CI, 2.4-15.8), respectively. The 5-, 7-, and 10-year rates of distant disease-free survival were 96.4%, 96.4%, and 86.4%; the recurrence-free survival rates were 95.8%, 93.6%, and 80.7%; and the overall survival rates were 96.7%, 88.6%, and 76.7%, respectively. Improvement in IBTR-free time was seen in ductal carcinoma in situ, lobular histology, low-grade tumors, T1 stage, Her2-negative tumors, and receipt of a radiation boost to the lumpectomy bed. CONCLUSIONS: Postoperative WH-WBI has favorable disease-specific outcomes that are comparable to those seen with conventional and moderately hypofractionated radiation techniques. WH-WBI could improve access to care for underserved patients with stage 0-II breast cancer.

Patient-Reported Outcomes and Cosmesis After Once-Weekly Hypofractionated Breast Irradiation in Medically Underserved Patients.

PURPOSE: To evaluate patient-reported outcomes (PROs) and cosmesis from a phase 2 trial of once-weekly hypofractionated breast irradiation (WH-WBI) after breast-conserving surgery (BCS). METHODS AND MATERIALS: Patients had stage 0-II breast cancer treated with BCS and negative margins. WH-WBI was 28.5 to 30 Gy in 5 weekly fractions of 5.7 to 6 Gy delivered with or without a boost. PROs were collected for 3 years after treatment using the Breast Cancer Treatment Outcome Scale (BCTOS) and European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). Physicians rated cosmetic outcome with the Global Cosmesis Score. Longitudinal growth models were used to assess changes in BCTOS across time, and baseline values and changes between time points were correlated with patient and treatment factors. RESULTS: From 2011 to 2015, 158 women received WH-WBI, and 148 were eligible for analysis after a median follow-up of 39.3 months. Adverse changes (P < .001) in global BCTOS score and breast pain and arm function subscores were observed 6 months after radiation therapy, followed by improvement to near-baseline values at years 1 and 3. Adverse changes in BCTOS cosmetic subscore were also detected at 6 months (P < .001), with no significant improvement at 1 (P = .385) and 3 (P = .644) years. No effect was detected for longitudinal changes in BCTOS scoring for age, body mass index, diabetes, smoking, breast volume, tumor size, seroma volume, dosimetric factors, dose, boost, or systemic therapy. Physician-rated cosmesis at 3 years was excellent/good in 89% and fair/poor in 11%. CONCLUSIONS: WH-WBI was associated with transient worsening in arm function and breast pain but persistent adverse changes in cosmetic PROs that were typically mild or moderate in severity. Physician-rated cosmetic outcomes were acceptable.

L-Dex, arm volume, and symptom trajectories 24 months after breast cancer surgery.

PURPOSE: Study objectives were to examine: (a) biomarker trajectories (change from presurgical baseline values of Lymphedema index (L-Dex) units and arm volume difference) and symptom cluster scores 24 months after breast cancer surgery and (b) associations of these objective biomarkers and symptom cluster scores. Patient/treatment characteristics influencing trajectories were also evaluated. METHODS: A secondary analysis of data from the published interim analysis of a randomized parent study was undertaken using trajectory analysis. Five hundred and eight participants included in the prior analysis with 24 months of postsurgical follow-up were initially measured with bioelectric impedance spectroscopy (BIS) and tape measure (TM) and completed self-report measures. Patients were reassessed postsurgery for continuing eligibility and then randomized to either BIS or TM groups and measured along with self-report data at regular and optional* visits 3, 6,12,15*,18, 21*, and 24-months. RESULTS: Three subclinical trajectories were identified for each biomarker (decreasing, stable, increasing) and symptom cluster scores (stable, slight increase/decrease, increasing). Subclinical lymphedema was identified throughout the 24-month period by each biomarker. An L-Dex increase at 15 months in the BIS group was noted. The self-report sets demonstrated contingency coefficients of 0.20 (LSIDS-A soft tissue, P = .031) and 0.19 (FACTB+4, P = .044) with the L-Dex unit change trajectories. CONCLUSIONS: These data support the need for long-term (24 months) prospective surveillance with frequent assessments (every 3 months) at least 15 months after surgery. Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.