Long-Term Patient-Reported Arm Symptoms in Breast Cancer Survivors.

BACKGROUND: Understanding long-term arm symptoms in breast cancer survivors is critical given excellent survival in the modern era. METHODS: This cross-sectional study included patients treated for stage 0-III breast cancer at our institution from 2002 to 2012. Patient-reported arm symptoms were collected from the EORTC QLQ-BR23 questionnaire. We used linear regression to evaluate adjusted associations between locoregional treatments and the continuous Arm Symptom (AS) score (0-100; higher score reflects more symptoms). RESULTS: A total of 1126 patients expressed interest in participating and 882 (78.3%) completed the questionnaire. Mean time since surgery was 10.5 years. There was a broad distribution of locoregional treatments, including axillary lymph node dissection (ALND) in 37.1% of patients, mastectomy with reconstruction in 36.5% of patients, and post-mastectomy radiation in 38.2% of patients. Overall, 64.3% (95% confidence interval [CI] 61.1-67.4%) of patients reported no arm symptoms, 17.0% (95% CI 14.7-19.6%) had one mild symptom, 9.4% (95% CI 7.7-11.5%) had two or more mild symptoms, and 9.3% (95% CI 7.6-11.4%) reported one or more severe symptoms. Adjusted AS scores were significantly higher with ALND versus sentinel node biopsy (ß 3.5, p = 0.01), and with autologous reconstruction versus all other breast/reconstructive surgery types (ß 4.5-5.5, all p < 0.05). There was a significant interaction between axillary and breast/reconstructive surgery, with the greatest effect of ALND in those with mastectomy with implant (ß 9.7) or autologous (ß 5.7) reconstruction. CONCLUSIONS: One in three patients reported arm symptoms at a mean of 10 years from treatment for breast cancer, although rates of severe symptoms were low (<10%). Attention is warranted to the arm morbidity related to both axillary and breast surgery during treatment counseling and survivorship.

Early postoperative psychological distress as a mediator of subsequent persistent postsurgical pain outcomes among younger breast cancer patients.

PURPOSE: Younger age is a risk factor for worse pain outcomes following breast cancer surgery, yet little is known about how younger women's psychological state may contribute to their pain experience. Using prospectively collected longitudinal data from a surgical cohort, we examined whether early postoperative psychological distress at 2 weeks mediated the association between younger age and subsequent worse pain-related functioning 3 months after surgery. METHODS: Patients (N = 159) were recruited before breast cancer surgery into this longitudinal cohort study. Age at time of surgery, psychological distress (anxiety, depression, and sleep disturbance) assessed 2 weeks postoperatively, and impact of surgical pain on cognitive/emotional functioning and physical functioning assessed 3 months postoperatively were used for analysis. RESULTS: Younger age was associated with greater depression, anxiety, and sleep disturbance 2 weeks postoperatively. Younger age was also associated with greater ratings of pain impacting cognitive/emotional functioning and physical functioning 3 months postoperatively. The association between younger age and worse cognitive/emotional impact of pain was mediated by greater anxiety and sleep disturbance. Similarly, the association between younger age and worse physical impact of pain was mediated by greater sleep disturbance. CONCLUSION: The degree of anxiety and sleep disturbance that occur early after breast surgery may contribute to greater chronic pain-related functional disability among younger patients. Anxiety and sleep disturbance are modifiable with behavioral interventions, making them potential perioperative targets to improve long-term outcomes in young breast cancer survivors.

Time-Driven Activity-Based Costing in Breast Cancer Care Delivery.

BACKGROUND: Accurate measurement of healthcare costs is required to assess and improve the value of oncology care. OBJECTIVES: We aimed to determine the cost of breast cancer care provision across collaborating health care organizations. METHODS: We used time-driven activity-based costing (TDABC) to calculate the complete cost of breast cancer care-initial treatment planning, chemotherapy, radiation therapy, surgical resection and reconstruction, and ancillary services (e.g., psychosocial oncology, physical therapy)-across multiple hospital sites. Data were collected between December 2019 and February 2020. TDABC steps involved (1) developing process maps for care delivery pathways; (2) determine capacity cost rates for staff, medical equipment, and hospital space; (3) measure the time required for each process step, both manually through clinic observation and using data from the Real-Time Location System (RTLS); and (4) calculate the total cost of care delivery. RESULTS: Surgical care costs ranged from $1431 for a lumpectomy to $12,129 for a mastectomy with prepectoral implant reconstruction. Radiation therapy was costed at $1224 for initial simulation and patient education, and $200 for each additional treatment. Base costs for chemotherapy delivery were $382 per visit, with additional costs driven by chemotherapy agent(s) administered. Personnel expenses were the greatest contributor to the cost of surgical care, except in mastectomy with implant reconstruction, where device costs equated to up to 60% of the cost of surgery. CONCLUSION: The cost of complete breast cancer care depended on (1) treatment protocols; (2) patient choice of reconstruction; and (3) the need for ancillary services (e.g., physical therapy). Understanding the actual costs and cost drivers of breast cancer care delivery may better inform resource utilization to lower the cost and improve the quality of care.

Management and outcomes of men diagnosed with primary breast cancer.

BACKGROUND: Fewer than 1% of all breast cancers occur in men. As a result, a distinct lack of data exists regarding the management and outcomes in this cohort. METHODS: Any male patient with pathologically confirmed breast cancer diagnosed between August 2000 and October 2017 at either Massachusetts General Hospital or Brigham and Women's Hospital/Dana-Farber Cancer Institute and their affiliate satellite locations were included. Primary chart review was used to assess clinical and pathologic characteristics. Patient and treatment variables were reported via descriptive statistics. Local-regional failure (LRF), overall survival (OS), breast cancer-specific survival (BCSS), and disease-free survival (DFS) were estimated using the Kaplan-Meier method. RESULTS: 100 patients were included in this study. Median follow-up was 112 months (range 1-220 months). Approximately 1/3 of patients experienced at least a 3-month delay to presentation. 83 patients ultimately underwent mastectomy as definitive surgical treatment. 46 patients received adjuvant radiation therapy, and 37 patients received chemotherapy. Of 82 hormone receptor-positive patients with invasive cancer, 94% (n = 77) received endocrine therapy. Of the fifty-eight patients who underwent genetic testing, 15 (26%) tested positive. The 5-year OS, BCSS, DFS, and LRF rates were 91.5%, 96.2%, 86%, and 4.8%, respectively. Delay to presentation was not associated with worse survival. CONCLUSIONS: Male breast cancer remains a rare diagnosis. Despite this, the majority of patients in this study received standard of care therapy and experienced excellent oncologic outcomes. Penetration for genetic testing improved over time.

Arm Morbidity After Local Therapy for Young Breast Cancer Patients.

BACKGROUND: The impact of patient demographics and local therapy choice on arm morbidity in young breast cancer patients is understudied despite its importance given the long survivorship period. This study assessed patient-reported arm morbidity in the Young Women's Breast Cancer Study (YWS), a prospective cohort study. METHODS: From 2006 to 2016, 1302 women with breast cancer diagnosed at the age of 40 years or younger enrolled in the YWS. The participants regularly complete surveys. The response rates are higher than 86%. Using the Breast Cancer Prevention Trial Checklist, this study examined the prevalence of patient-reported postoperative arm swelling and decreased range of motion (ROM) 1 year after diagnosis, stratified by local therapy strategy, in patients who had surgery for stages 1 to 3 disease. Logistic regression analysis was used to identify risk factors for arm morbidity. RESULTS: Among 888 eligible participants (median age, 37 years), 14% reported arm swelling and 34% reported decreased ROM at 1 year. Arm swelling was reported by 23.6% of the patients who had axillary lymph node dissection (ALND) and 24.6% of the patients who received ALND and post-mastectomy radiation therapy (PMRT). In the multivariable analysis, the patients who reported being financially uncomfortable or who had ALND were at higher risk of arm swelling at 1 year. Being overweight, receiving ALND after sentinel lymph node biopsy, and receiving PMRT were associated with decreased ROM at 1 year. CONCLUSION: High rates of self-reported arm morbidity in young breast cancer survivors were reported, particularly in patients receiving ALND and PMRT. Attention to the risks and benefits of differing local therapy strategies for ALND and PMRT patients is warranted.

Patient-reported outcomes in the Translational Breast Cancer Research Consortium.

Members of the Translational Breast Cancer Research Consortium conducted an expert-driven literature review to identify a list of domains and to evaluate potential measures of these domains for inclusion in a list of preferred measures. Measures were included if they were easily available, free of charge, and had acceptable psychometrics based on published peer-reviewed analyses. A total of 22 domains and 52 measures were identified during the selection process. Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient-reported outcomes in relevant patients.

Incorporating Patient-Reported Outcome Measures into Breast Surgical Oncology: Advancing Toward Value-Based Care.

Value in health care is defined as the health outcome achieved per unit of cost. For health care systems, improving value means achieving better outcomes at lower costs. Improving outcomes, including patient-reported outcomes (PROs), as well as more established metrics such as mortality and complication rates, ensures high-quality care. This is particularly true in breast cancer surgery, where survival and recurrence rates are comparable across different surgical approaches. Outcomes reflecting survivorship quality may therefore better inform decision making regarding surgical approaches. PROs can be assessed using validated instruments known as patient-reported outcome measures (PROMs). They are obtained directly from patients reflecting their health-related quality of life (HRQOL). Ongoing initiatives strive to define PROMs that accurately reflect HRQOL and demonstrate value, with the goal of establishing benchmarks for quality of care. Clinicians caring for patients with breast cancer are well positioned to be involved in defining meaningful measures of value-based breast cancer care. This article reviews value-based breast cancer care in the context of locoregional therapy, with attention paid to the work done by the International Consortium of Health Outcome Measures in which a "standard set" of value-based patient-centered outcomes for breast cancer for international use is defined. In addition, an overview is provided of relevant PROMs and previously reported scores. Recommendations and future challenges for implementation of routine collection of PROs are also discussed. IMPLICATIONS FOR PRACTICE: Opportunity exists to act as early adopters of the routine collection of longitudinal patient-reported outcome data for breast cancer, allowing transition of current care to value-based cancer care.

The Jacki Jacket after mastectomy with reconstruction: a randomized pilot study.

BACKGROUND: Breast cancer patients undergoing mastectomy with reconstruction (TM + R) often experience post-operative discomfort from surgical drains. Despite a variety of garment options for use in the post-operative period, high-quality data assessing the impact of specific garments on post-operative pain are lacking. We report the results of a prospective randomized trial assessing the impact of the Jacki Jacket (JJ), a long-sleeve jacket with inner drain receptacle pockets, on post-discharge pain and quality of life (QOL) after TM + R. METHODS: Breast cancer patients undergoing TM + R at a single institution were randomized post-operatively to receive a JJ or usual care (UC). Participant-reported demographics, pain intensity, and QOL were collected on post-operative day 1 (T1). Following discharge, participants completed a daily pain and medication dairy (T2); on day of drain(s) removal (T3), participants again completed pain and QOL questionnaires. Linear models were used to evaluate associations between JJ use, post-operative pain, and QOL. RESULTS: From 3/8/17 to 12/20/17, 139 women were randomized. All participants completed T1 measures, 102 returned the T2 diary, and 118 (84.9%) completed T3 questionnaires. There was no significant difference in pain scores between JJ and UC arms at any timepoint. Adjusting for surgery type, age, marital status, depression, and obesity, participants randomized to JJ reported significantly better body image scores (estimate = 12.94, p = 0.009). There were no adverse events. CONCLUSIONS: Although JJ garment use did not impact post-operative pain intensity scores, the significant impact of JJ use on body image supports consideration for inclusion of such garments in post-operative care for patients undergoing TM + R. CLINICAL TRIAL REGISTRATION INFORMATION: Registered with ClinicalTrials.gov, NCT number NCT02976103, November 18, 2016.

Patterns of breast reconstruction in patients diagnosed with inflammatory breast cancer: The Dana-Farber Cancer Institute's Inflammatory Breast Cancer Program experience.

Inflammatory breast cancer (IBC) exhibits dermal lymphatic involvement at presentation, and thus, the standard surgical approach is a nonskin-sparing modified radical mastectomy (MRM) without breast reconstruction (BR). In this study, we evaluated immediate and delayed BR receipt and its outcomes in IBC. Using an IRB-approved database, we retrospectively evaluated stage III IBC patients who received trimodality therapy (preoperative systemic therapy, followed by MRM and postmastectomy chest wall/regional nodal radiation). Patients with an insufficient response to preoperative systemic therapy and/or who required preoperative radiotherapy were excluded. BR receipt, timing, and morbidity were evaluated. Among 240 stage III IBC patients diagnosed between 1997 and 2016, 40 (17%) underwent BR. Thirteen (33%) had immediate, and 27 (67%) had delayed BR. Four patients had complications (1 [8%] immediate BR and 3 [11%] delayed BR); only 1 BR (delayed) was unsuccessful. From the MRM date, the median time to recurrence was 35 months (<1-212) and median overall survival was 87 months (<1-212). In this cohort of stage III IBC patients, only 11% pursued delayed BR following trimodality therapy, possibly attributable to the observed high recurrence rates hindering BR. Further studies addressing BR outcomes in IBC are needed for better counseling patients regarding their reconstructive options.

Standardized activities for lay patient navigators in breast cancer care: Recommendations from a citywide implementation study.

BACKGROUND: There is a need for guidelines on patient navigation activities to promote both the quality of patient navigation and the standards of reimbursement for these services because a lack of reimbursement is a major barrier to the implementation, maintenance, and sustainability of these programs. METHODS: A broad community-based participatory research process was used to identify the needs of patients for navigation. A panel of stakeholders of clinical providers was convened to identify specific activities for navigators to address the needs of patients and providers with the explicit goal of reducing delays in the initiation of cancer treatment and improving adherence to the care plan. RESULTS: Specific activities were identified that could be generalized to all patient navigation programs for care during active cancer management to address the needs of vulnerable communities. CONCLUSIONS: Oncology programs that seek to implement lay patient navigation may benefit from the adoption of these activities for quality monitoring. Such activities are necessary as we consider reimbursement strategies for navigators without clinical training or licensure.

Patterns of axillary evaluation in older patients with breast cancer and associations with adjuvant therapy receipt.

PURPOSE: Although axillary lymph node status has traditionally been a key factor in informing adjuvant breast cancer therapy recommendations, this information may be less relevant as our focus shifts more towards tumor biology, particularly in older patients where comorbidity influences treatment decisions and nodal staging and/or surgery may not improve outcomes. We examined patterns of axillary surgery and associations between axillary surgery and receipt of adjuvant treatment in older breast cancer patients. METHODS: Women aged ≥ 65 years with clinically node-negative, stage I-II breast cancer treated between 2012 and 2013 were identified using the National Cancer Data Base. Using multivariable logistic regression, we examined associations between axillary surgery and age, adjusting for patient, clinical, and facility factors. We also examined receipt of adjuvant treatment by nodal surgery. RESULTS: Among 68,205 women, 40.1% were aged 65-70, 24.5% were 71-75, 17.4% were 76-80, and 18.0% were > 80. Overall, 91.2% had axillary surgery (67.8% sentinel lymph node biopsy, 11.7% axillary lymph node dissection, 11.7% unspecified/unknown axillary surgery); 88.0% of those aged ≥ 70 with lower risk, hormone receptor-positive tumors underwent axillary surgery. In adjusted analyses, compared to patients aged 65-70, increasing age was associated with lower odds of any axillary surgery (ages 71-75: OR 0.64, 95% CI 0.57-0.71; ages 76-80: OR 0.33, 95% CI 0.30-0.37; age > 80: OR 0.08, 95% CI 0.07-0.08). Axillary surgery was associated with higher odds of receipt of radiation after breast conservation and receipt of chemotherapy in human epidermal growth factor 2-positive disease. CONCLUSIONS: In a large nationwide dataset, the vast majority of older women with clinically node-negative breast cancer underwent axillary staging despite uncertainty about its impact on survival, particularly for those with lower-risk disease. Further study on how to tailor node assessment in older patients is warranted.

Implementation of a Venous Thromboembolism Prophylaxis Protocol Using the Caprini Risk Assessment Model in Patients Undergoing Mastectomy.

BACKGROUND: Guidelines for venous thromboembolism (VTE) prophylaxis are not well-established for breast surgery patients. An individualized VTE prophylaxis protocol using the Caprini score was adopted at our institution for patients undergoing mastectomy ± implant-based reconstruction. In this study, we report our experience during the first year of implementation. METHODS: In August 2016, we adopted a VTE prophylaxis protocol for patients undergoing mastectomy ± implant-based reconstruction. We used the Caprini score, a validated risk assessment tool for VTE, to determine each patient's perioperative prophylaxis regimen. Detailed chart review was performed to record patient and treatment details, the Caprini score, pharmacologic VTE prophylaxis administration, and 30-day incidence of VTE and bleeding complications. We performed univariate analysis to identify factors associated with protocol compliance. RESULTS: Overall, 522 patients met the inclusion criteria. Median age was 51 years, 486 (93.1%) patients had malignancy, 234 (44.8%) underwent bilateral mastectomy, and 350 (67.0%) underwent reconstruction. Caprini scores ranged from 2 to 11, with 431 (82.6%) patients having a score from 5 to 7. Overall protocol compliance was 60.5%, and was associated with bilateral mastectomy (p = 0.02), reconstruction (p = 0.03), and longer procedures (p < 0.001). The rate of VTE was 0.2% (95% confidence interval [CI] 0.03-1.1%), rate of reoperation for hematoma was 2.7% (95% CI 1.6-4.5%), and rate of blood transfusion was 0.4% (95% CI 0.1-1.4%). CONCLUSIONS: The implementation of an individualized VTE prophylaxis protocol for patients undergoing mastectomy ± implant-based reconstruction is safe and feasible. Despite a high-risk cohort, the incidence of VTE was very low and bleeding complications were consistent with reported rates for breast surgery. Continued evaluation of this strategy is warranted.

The Impact of Residual Disease After Preoperative Systemic Therapy on Clinical Outcomes in Patients with Inflammatory Breast Cancer.

BACKGROUND: Inflammatory breast cancer (IBC) is a rare and aggressive disease treated with multimodality therapy: preoperative systemic therapy (PST) followed by modified radical mastectomy (MRM), chest wall and regional nodal radiotherapy, and adjuvant biologic therapy and/or endocrine therapy when appropriate. In non-IBC, the degree of pathologic response to PST has been shown to correlate with time to recurrence (TTR) and overall survival (OS). We sought to determine if pathologic response correlates with oncologic outcomes of IBC patients. METHODS: Following review of IBC patients' records (1997-2014), we identified 258 stage III IBC patients; 181 received PST followed by MRM and radiotherapy and were subsequently analyzed. Pathologic complete response (pCR) to PST, hormone receptor and human epidermal growth factor receptor 2 (HER2) status, grade, and histology were evaluated as predictors of TTR and OS by Cox model. RESULTS: Overall, 95/181 (52%) patients experienced recurrence; 93/95 (98%) were distant metastases (median TTR 3.2 years). Seventy-three patients (40%) died (median OS 6.9 years). pCR was associated with improved TTR (hazard ratio [HR] 0.20, 95% confidence interval [CI] 0.09-0.46, p < 0.01, univariate; HR 0.17, 95% CI 0.07-0.41, p < 0.0001, multivariate) and improved OS (HR 0.26, 95% CI 0.11-0.65, p < 0.01, univariate). In patients with pCR, grade III (HR 1.91, 95% CI 1.16-3.13, p = 0.01), and triple-negative phenotype (HR 3.54, 95% CI 1.79-6.98, p = 0.0003) were associated with shorter TTR, while residual ductal carcinoma in situ was not (HR 0.85, 95% CI 0.53-1.35, p = 0.48, multivariate). CONCLUSIONS: In stage III IBC, pCR was associated with prognosis, further influenced by grade, hormone receptor, and HER2 status. Investigating mechanisms that contribute to better response to PST could help improve oncologic outcomes in IBC.

Immediate breast reconstruction following mastectomy in pregnant women with breast cancer.

BACKGROUND: Surgical management of breast cancer in pregnancy (BCP) requires balancing benefits of therapy with potential risks to the developing fetus. Minimal data describe outcomes after mastectomy with immediate breast reconstruction (IR) in pregnant patients. METHODS: Retrospective review was performed of patients who underwent IR after mastectomy within a BCP cohort. Parameters included intra- and post-operative complications, short-term maternal/fetal outcomes, surgery duration, and delayed reconstruction in non-IR cohort. RESULTS: Of 82 patients with BCP, 29 (35%) had mastectomy during pregnancy: 10 (34%) had IR, 19(66%) did not. All IR utilized tissue expander (TE) placement. Mean gestational age (GA) at IR was 16.2 weeks. Mean surgery duration was 198 min with IR versus 157 min without IR. Those with IR delivered at, or close to, term infants of normal birthweight. No fetal or major obstetrical complications were seen. Post-mastectomy radiation (PMRT) was provided after pregnancy in 2 (20%) patients in the IR cohort and 12 (63%) in the non-IR cohort. All patients in the IR cohort successfully transitioned to permanent implant. CONCLUSIONS: This report represents one of the largest series describing IR during BCP. IR after mastectomy increased surgery duration, but was not associated with adverse obstetrical or fetal outcomes. IR with TE may preserve reconstructive options when PMRT is indicated. J. Surg. Oncol. 2016;114:140-143. © 2016 Wiley Periodicals, Inc.

Arm morbidity and financial difficulty in breast cancer survivors.

PURPOSE: Long-term upper extremity symptoms after breast cancer treatment may impact patient-reported financial difficulty. In this cross-sectional investigation, we hypothesized that severity of arm symptoms would be associated with greater financial difficulty. METHODS: Stage 0-III breast cancer patients treated at our institution from 2002 to 2012 were recruited for a 2018 survey study appraising disease-specific patient-centered outcomes using EORTC-QLQ-BR23 and EORTC-QLQ-C30 questionnaires. The association between Arm Symptom (AS) score and Financial Impact (FI) score was assessed, adjusting for clinically relevant variables. RESULTS: Of 1126 interested participants, 882 (78%) responded to surveys. Three hundred fourteen (36%) with incomplete responses were excluded. Median time from surgery was 9 years; 181 (32%) and 117 (21%) had mastectomy with or without reconstruction, 126 (22%) received postmastectomy radiation (PMRT), and 221 (39%) underwent axillary lymph node dissection. 76 (13%) reported some degree of financial difficulty; 10 (2%) the highest degree of difficulty. Of 217 (38%) patients experiencing arm symptoms, 60 (28%) had severe symptoms. Seven (70%) of those with highest degree of financial difficulty had severe arm symptoms. Younger age at surgery (p = .029), mastectomy with reconstruction (p = 0.003), Hispanic ethnicity (p < 0.001), PMRT (p = 0.027), recurrence (p < 0.001), and higher AS score (p < 0.001) were associated with greater financial difficulty. On multivariable analysis, AS score, younger age, Hispanic ethnicity, and recurrence remained associated with financial difficulty. CONCLUSION: In this study, younger age, Hispanic ethnicity, and arm morbidity were associated with increased risk for financial difficulty. Clarifying how treatment-related adverse events such as arm morbidity increase financial hardship may guide interventions to mitigate this burden.

Shared decision making in breast cancer: national practice patterns of surgeons.

BACKGROUND: The purpose of this study was to assess national practices of surgeons who treat breast cancer in order to identify opportunities to improve patient education. METHODS: In June 2012, the membership of the American Society of Breast Surgeons (ASBrS) (n = 2,818) was surveyed via email questionnaire to evaluate their current practice of shared decision making and informed consent for breast cancer patients. RESULTS: A total of 737 members (26 %) responded, including 384 breast surgeons and 306 general surgeons, 13 midlevel providers, and 25 other specialists. It was found that 90 % of surgeons spent more than 30 min meeting with a new cancer patient, and of these, 30 % spent more than an hour. Surgeons who spent more than 1 h face-to-face with a new cancer patient reported higher levels of overall patient knowledge compared with those who spent less (mean = 3.80 vs. 3.64 of 5; p = 0.001). Also, 89 % of respondents reported using educational tools, of whom more than 90 % used written tools. In addition, 65 % of members stated an interest in a free online educational tool if available and indicated a preference for a flexible tool that could be used by the patient alone or with a nurse. CONCLUSIONS: While practice patterns may vary, our results reveal that one-third of surgeons spend at least 1 h in consultation with a new breast cancer patient. More time spent translated to a higher perceived patient understanding of their disease and treatment options. Although the majority of surgeons currently use written materials, there was clear support for a free online educational tool.

Implications of constructed biologic subtype and its relationship to locoregional recurrence following mastectomy.

INTRODUCTION: We examined the prognostic value of biologic subtype on locoregional recurrence (LRR) after mastectomy in a cohort of low risk women who did not receive adjuvant radiation therapy. METHODS: A total of 819 patients with invasive breast cancer underwent mastectomy from January 2000 through December 2005. No patient received preoperative chemotherapy. Estrogen receptor (ER) receptor, progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) status were used to construct the following 4 subtypes: i) ER+ or PR+ and HER2- (HR+/HER2-), ii) ER+ or PR+ and HER2+ (HR+/HER2+), iii) ER- and PR- and HER2+ (HR-/HER2+)and iv) ER- and PR- and HER2- (HR-/HER2-). LRR-free survival was estimated by the Kaplan-Meier method. Cox proportional hazard models were used to evaluate the association between time-to-event outcomes and patient prognostic factors. RESULTS: At a median follow-up of 58 months, five-year cumulative incidence of LRR for the entire cohort was 2.5%. Subtype specific LRR rates were 1% for HR+/HER2-, 6.5% in HR+/HER2+, 2% for HR-/HER2+ and 10.9% for HR-/HER2- (P < 0.01). In HER-2+ patients (irrespective of ER/PR status), trastuzumab therapy was not associated with LRR-free survival. On multivariate analysis, one to three positive lymph nodes (HR 4.75 (confidence interval (CI) 1.75 to 12.88, P < 0.01), ≥ 4 positive lymph nodes (HR23.4 (CI 4.64 to 117.94, P < 0.01), HR+/HER2+ (HR 4.26 (CI 1.05 to 17.33), P = 0.04), and HR-/HER2- phenotype (HR 13.87 (CI 4.96 to 38.80), P < 0.01) were associated with shorter LRR-free survival whereas age > 50 at diagnosis (HR 0.31 (CI 0.12 to 0.80), P = 0.02) was associated with improved LRR-free survival. Among the HR-/HER2- subtypes, five-year LRR incidence was 23.4% in patients with positive lymph nodes compared to 7.8% for lymph node negative patients (P = 0.01), although this association did not reach significance when the analysis was limited to HR-/HER2- women with only one to three positive lymph nodes (15.6% versus 7.8%, P = 0.11). CONCLUSIONS: Constructed subtype is a prognostic factor for LRR after mastectomy among low risk women not receiving adjuvant radiation therapy, although rates of LRR remain low across subtypes. Patients with node positive, HR-/HER2- type tumors were more likely to experience LRR following mastectomy alone. Prospective studies to further investigate the potential benefit of adjuvant radiation therapy in these women are warranted.

Implant-based Breast Reconstruction after Mastectomy for Breast Cancer: A Systematic Review and Meta-analysis.

Women undergoing implant-based reconstruction (IBR) after mastectomy for breast cancer have numerous options, including timing of IBR relative to radiation and chemotherapy, implant materials, anatomic planes, and use of human acellular dermal matrices. We conducted a systematic review to evaluate these options. Methods: We searched Medline, Embase, Cochrane CENTRAL, CINAHL, and ClinicalTrials.gov for studies, from inception to March 23, 2021, without language restriction. We assessed risk of bias and strength of evidence (SoE) using standard methods. Results: We screened 15,936 citations. Thirty-six mostly high or moderate risk of bias studies (48,419 patients) met criteria. Timing of IBR before or after radiation may result in comparable physical, psychosocial, and sexual well-being, and satisfaction with breasts (all low SoE), and probably comparable risks of implant failure/loss or explantation (moderate SoE). No studies addressed timing relative to chemotherapy. Silicone and saline implants may result in clinically comparable satisfaction with breasts (low SoE). Whether the implant is in the prepectoral or total submuscular plane may not impact risk of infections (low SoE). Acellular dermal matrix use probably increases the risk of implant failure/loss or need for explant surgery (moderate SoE) and may increase the risk of infections (low SoE). Risks of seroma and unplanned repeat surgeries for revision are probably comparable (moderate SoE), and risk of necrosis may be comparable with or without human acellular dermal matrices (low SoE). Conclusions: Evidence regarding IBR options is mostly of low SoE. New high-quality research is needed, especially for timing, implant materials, and anatomic planes of implant placement.

Autologous Reconstruction after Mastectomy for Breast Cancer.

Background: Women undergoing autologous reconstruction (AR) after mastectomy for breast cancer and their surgeons must make decisions regarding timing of the AR and choose among various flap types. We conducted a systematic review to evaluate the comparative benefits and harms of (1) timing of AR relative to chemotherapy and radiation therapy, and (2) various flap types for AR. Methods: We searched Medline, Embase, Cochrane CENTRAL, CINAHL, and ClinicalTrials.gov for studies, from inception to March 23, 2021, without language restriction. We assessed risk of bias of individual studies and strength of evidence (SoE) of our findings using standard methods. Results: We screened 15,936 citations. Twelve mostly high risk of bias studies, including three randomized controlled trials and nine nonrandomized comparative studies met criteria (total N = 31,833 patients). No studies addressed timing of AR relative to chemotherapy or radiation therapy. Six flap types were compared, but conclusions were feasible for only the comparison between transverse rectus abdominus myocutaneous (TRAM) and deep inferior epigastric perforator (DIEP) flaps. The choice of either flap may result in comparable patient satisfaction with breasts and comparable risk of necrosis (low SoE for both outcomes), but TRAM flaps probably pose a greater risk of harm to the area of flap harvest (abdominal bulge/hernia and need for surgical repair) (moderate SoE). Conclusions: Evidence regarding details for AR is mostly of low SoE. New high-quality research among diverse populations of women is needed for the issue of timing of AR and for comparisons among flap types.