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Knowledge of axillary nodal status is highly important for correct staging and treatment planning in patients with breast cancer. Axillary US is a recognized highly specific and cost-effective tool for assessing nodal status and guiding appropriate treatment. Axillary US imaging with US-guided biopsy is routinely performed throughout the world. However, because of recent developments in the surgical management of the axilla in patients with newly diagnosed breast cancer (American College of Surgeons Oncology Group [ACOSOG] Z0011 trial) and in patients with breast cancer receiving neoadjuvant systemic therapy (ACOSOG Z1071, SENTinel NeoAdjuvant [SENTINA] and Sentinel Node biopsy aFter NeoAdjuvant Chemotherapy [SN FNAC] trials), some have questioned the utility of axillary US for nodal staging. Here, we review the evidence to date supporting the additional value of axillary US for patients with breast cancer. Nodal US in patients with newly diagnosed breast cancer is useful for staging; in a significant proportion of patients, nodal US identifies additional axillary level II or level III nodal disease, which allows for appropriate treatment of disease. Furthermore, ongoing clinical trials may show that axillary surgery can be omitted in patients with negative findings on axillary US. In patients with lymph node-positive disease undergoing neoadjuvant systemic therapy, nodal US can guide the approach to axillary surgery. A more personalized patient approach, taking into the account tumor biology, among other factors, may help to mitigate the controversy surrounding the role of axillary US in breast cancer patients. [ABSTRACT FROM AUTHOR]

The article presents a three-year analysis of treatment efficacy, cosmetic results and toxicities for patients enrolled on the American Society of Breast Surgeons MammoSite Breast Brachytherapy Registry Trial. It notes that accelerated partial breast irradiation (APBI) is explored as an alternative option to deliver adjuvant radiation therapy (RT) after lumpectomy in breast cancer patients treated with breast conserving therapy (BCT). It concludes that treatment efficacy, cosmesis and toxicity after treatment with APBI using MammoSite device are good.

Black women with breast cancer have significantly poorer survival rates, a more advanced stage distribution, and are diagnosed at younger ages compared to white patients in the United States. We evaluated tumor response and survival with respect to race and age after induction chemotherapy. The study population consisted of 303 patients (229 white, 74 black) registered in two prospective trials of induction chemotherapy for locally advanced breast cancer [stage II (T >= 4 cm), stage III (noninflammatory), and stage IV (supraclavicular lymph node involvement only)] between 1989 and 1996. Chemotherapy regimens utilized 5-fluorouracil, cyclophosphamide, and doxorubicin (FAC). Response was defined as complete (CR, no clinical/radiographic detectable disease), partial (PR, >=50% reduction in disease), minor (MR, <50% reduction), no change (NC), or progressive disease (PD). Median follow-up was 58 months; survival was calculated using the Kaplan–Meier method. There was no significant difference in age at presentation (54% of black patients compared to 58% of white patients <50 years of age). The black patients had significantly more advanced stages of disease at diagnosis (50% of black patients compared to 30% of white patients with stage IIIB disease; p = 0.03). For both age groups together, tumor response, 5-year overall survival (OS), and 5-year disease-free survival (DFS) rates were similar between the black and white patients. A trend was noted that the younger black patients were more likely to have a clinical CR or PR; this did not translate into a survival advantage. Despite the more advanced stage distribution for black women with breast cancer, induction chemotherapy yields high response rates (especially for younger black patients) and survival rates equivalent to white patients. [ABSTRACT FROM AUTHOR]

Background: Emergency department (ED) overuse is a large contributor to healthcare spending in the USA. We examined the rate of and risk factors for ED visits following outpatient breast cancer surgery., Patients and Methods: Using linked data from the Surveillance, Epidemiology, and End Results (SEER) program and Medicare, we identified women who underwent curative breast cancer surgery between 2003 and 2015. Our outcome of interest was ED visits within 30 days of surgery. Multivariate regression was used to evaluate the odds of ED visit while controlling for clinical and socioeconomic variables. Secondary analyses assessed admission from the ED as well as costs., Results: Of the 78,060 included patients, 5.1% returned to the ED, of which only 29.8% required hospital admission. Rate of ED visits increased with patient age. A higher percentage of Black patients returned to the ED compared with white patients (7.0% versus 5.0%, p < 0.001). Patients with higher income were less likely to visit the ED compared with those with lower income (OR 0.76, p < 0.001). Predictors of ED visits included: being unmarried (OR 1.18, p < 0.001), having stage 2 (OR 1.20, p < 0.001) or stage 3 cancer (OR 1.38, p < 0.001), and those with Charlson comorbidity score of 1 (OR 1.39, p < 0.001) or ≥ 2 (OR 2.29, p < 0.001)., Conclusion: While a substantial number of patients return to the ED following outpatient breast surgery, most do not require hospital admission, which indicates that a large proportion of these visits could have been avoided. We identified several clinical and socioeconomic predictors of postoperative ED visits, which will aid in the development of patient risk profiling tools., (© 2022. Society of Surgical Oncology.)

Introduction: The early COVID-19 pandemic rapidly transformed healthcare and medical education. We sought to evaluate the professional and personal impact of the pandemic on 2019-2020 Breast Surgical Oncology (BSO) fellows in Society of Surgical Oncology approved programs to capture the experience and direct future changes., Methods: From July 15, 2020 to August 4, 2020 a survey was administered to the American Society of Breast Surgeons' fellow members. The survey assessed the impact of the pandemic on clinical experience, education/research opportunities, personal health/well-being, and future career. Responses were collected and aggregated to quantify the collective experience of respondents., Results: Twenty-eight of fifty-seven (54%) eligible fellows responded. Twenty-one (75%) indicated the clinical experience changed. Twenty-seven (96%) reported less time spent caring for ambulatory breast patients and sixteen (57%) reported the same/more time spent in the operating room. Fourteen (50%) stated their future job was impacted and eight (29%) delayed general surgery board examinations. Stress was increased in 26 (93%). Personal health was unaffected in 20 (71%), and 3 (10%) quarantined for COVID-19 exposure/infection., Conclusion: The COVID-19 pandemic altered the clinical experience of BSO fellows; however, the operative experience was generally unaffected. The creation of frameworks and support mechanisms to mitigate potential challenges for fellows and fellowship programs in the ongoing pandemic and other times of national crisis should be considered., (© 2021 Wiley Periodicals LLC.)

Purpose: To our knowledge, NRG/RTOG 9804 is the only randomized trial to assess the impact of whole breast irradiation (radiation therapy [RT]) versus observation (OBS) in women with good-risk ductal carcinoma in situ (DCIS), following lumpectomy. Long-term results focusing on ipsilateral breast recurrence (IBR), the primary outcome, are presented here., Patients and Methods: Eligible patients underwent lumpectomy for DCIS that was mammogram detected, size ≤ 2.5 cm, final margins ≥ 3 mm, and low or intermediate nuclear grade. Consented patients were randomly assigned to RT or OBS. Tamoxifen use was optional. Cumulative incidence was used to estimate IBR, log-rank test and Gray's test to compare treatments, and Fine-Gray regression for hazard ratios (HRs)., Results: A total of six hundred thirty-six women were randomly assigned from 1999 to 2006. Median age was 58 years and mean pathologic DCIS size was 0.60 cm. Intention to use tamoxifen was balanced between arms (69%); however, actual receipt of tamoxifen varied, 58% RT versus 66% OBS ( P = .05). At 13.9 years' median follow-up, the 15-year cumulative incidence of IBR was 7.1% (95% CI, 4.0 to 11.5) with RT versus 15.1% (95% CI, 10.8 to 20.2) OBS ( P = .0007; HR = 0.36; 95% CI, 0.20 to 0.66); and for invasive LR was 5.4% (95% CI, 2.7 to 9.5) RT versus 9.5% (95% CI, 6.0 to 13.9) OBS ( P = .027; HR = 0.44; 95% CI, 0.21 to 0.91). On multivariable analysis, only RT (HR = 0.34; 95% CI, 0.19 to 0.64; P = .0007) and tamoxifen use (HR = 0.45; 95% CI, 0.25 to 0.78; P = .0047) were associated with reduced IBR., Conclusion: RT significantly reduced all and invasive IBR for good-risk DCIS with durable results at 15 years. These results are not an absolute indication for RT but rather should inform shared patient-physician treatment decisions about ipsilateral breast risk reduction in the long term following lumpectomy., Competing Interests: Beryl McCormickStock and Other Ownership Interests: Varian Medical Systems Henry M. KuererLeadership: American Society of Breast Surgeons, ASCOHonoraria: Genomic HealthConsulting or Advisory Role: Targeted Medical Education Inc, Genomic Health InternationalSpeakers' Bureau: PERPatents, Royalties, Other Intellectual Property: NEJM Group, McGraw-Hill Publishing Eileen RakovitchHonoraria: AstraZenecaResearch Funding: Genomic Health International Barbara L. SmithPatents, Royalties, Other Intellectual Property: Royalty as textbook editor Judith O. HopkinsConsulting or Advisory Role: AIM Specialty Health Lori J. PierceStock and Other Ownership Interests: PFS GenomicsPatents, Royalties, Other Intellectual Property: UpToDate, PFS GenomicsUncompensated Relationships: Bristol Myers Squibb, Exact SciencesOpen Payments Link: https://openpaymentsdata.cms.gov/physician/1250431/summary Kenneth N. M. SumidaEmployment: Hawaii Oncology Inc Danny VespriniHonoraria: MerckConsulting or Advisory Role: AstraZeneca Canada Julia R. WhiteResearch Funding: Intraop MedicalNo other potential conflicts of interest were reported.

Importance: Most lymphedema studies include a heterogeneous population and focus on patients treated with adjuvant chemotherapy., Objective: To examine factors associated with lymphedema after neoadjuvant chemotherapy (NAC) and axillary lymph node dissection in women with node-positive breast cancer., Design, Setting, and Participants: This cohort study included data from 701 women 18 years or older with cT0-T4N1-2M0 breast cancer with documented axillary nodal metastasis at diagnosis who were enrolled in the American College of Surgeons Oncology Group Z1071 (Alliance for Clinical Trials in Oncology) trial, which took place from January 1, 2009, to December 31, 2012. Data analysis was performed from January 11, 2018, to November 9, 2018., Interventions: All participants received NAC, breast operation, and axillary lymph node dissection. Participants underwent prospective arm measurements and symptom assessment after NAC completion and at 6-month intervals to 36 months postoperatively., Main Outcomes and Measures: Factors associated with lymphedema were defined as self-reported arm heaviness or swelling (lymphedema symptoms) or an arm volume increase of 10% or more (V10) or 20% or more (V20)., Results: A total of 486 patients (mean [SD] age, 50.1 [10.8] years) were included in this study. Median follow-up for the 3 measures was 2.2 to 3.0 years. Cumulative lymphedema incidence at 3 years was 37.8% (95% CI, 33.1%-43.2%) for lymphedema symptoms, 58.4% (95% CI, 53.2%-64.1%) for V10, and 36.9% (95% CI, 31.9%-42.6%) for V20. Increasing body mass index (hazard ratio [HR], 1.04; 95% CI, 1.01-1.06) and NAC for 144 days or longer (HR, 1.48; 95% CI, 1.01-2.17) were associated with lymphedema symptoms. The V20 incidence was higher among patients who received NAC for 144 days or longer (HR, 1.79; 95% CI, 1.19-2.68). The V10 incidence was highest in patients with 30 nodes or more removed (HR, 1.70; 95% CI, 1.15-2.52) and increased with number of positive nodes (HR, 1.03; 95% CI, 1.00-1.06). On multivariable analysis, obesity was significantly associated with lymphedema symptoms (HR, 1.03; 95% CI, 1.01-1.06), and NAC length was significantly associated with V20 (HR, 1.74; 95% CI, 1.15-2.62)., Conclusions and Relevance: In this study, longer NAC duration and obesity were associated with increased lymphedema incidence, suggesting that patients in these groups may benefit from enhanced prospective lymphedema surveillance.

Importance: No comprehensive data are available regarding the frequency of breast biopsies performed during follow-up of treatment for invasive breast cancer., Objective: To determine how often patients treated for breast cancer require breast biopsies during follow-up., Design, Setting, and Participants: This nationwide population-based cohort study included 41 510 patients 64 years or younger in a commercial insurance database and 80 369 patients 66 years or older in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Patients were diagnosed with incident invasive breast cancer (stages I-III) from January 1, 2000, through December 31, 2011. Diagnosis and procedural codes were used to identify biopsy rates during follow-up. Data were analyzed from March 3 through October 3, 2017., Main Outcomes and Measures: Cumulative incidence and adjusted risk of breast biopsy and subsequent breast cancer treatment were calculated using the Kaplan-Meier method and Cox proportional hazards regression. All statistical tests were 2 sided., Results: Among the 121 879 patients in the study population, 5- and 10-year overall incidences of breast biopsy were 14.7% and 23.4%, respectively, in the commercial insurance cohort and 11.8% and 14.9%, respectively, in the SEER-Medicare cohort. The 5-year estimated incidence of breast biopsy was higher among women treated with brachytherapy (24.0% in the commercial insurance and 25.0% in the SEER-Medicare cohorts) than among those treated with whole-breast irradiation (16.7% in the commercial insurance and 15.1% in the SEER-Medicare cohorts) and persisted after multivariate adjustment in the commercial insurance (hazard ratio [HR], 1.53; 95% CI, 1.38-1.70; P < .001) and SEER-Medicare (HR, 1.76; 95% CI, 1.63-1.91; P < .001) cohorts. Adjuvant chemotherapy use (HR, 1.31; 95% CI, 1.25-1.37; P < .001) and patient age (>85 vs 66-69 years; HR, 0.40; 95% CI, 0.36-0.44; P < .001) in the SEER-Medicare cohort and endocrine therapy in the commercial insurance (HR, 0.88; 95% CI, 0.82-0.93; P < .001) and SEER-Medicare (HR, 0.91; 95% CI, 0.85-0.97; P = .002) cohorts were independently associated with biopsy. After unilateral mastectomy, the estimated 5-year contralateral breast biopsy rates were 10.4% and 7.7% in the commercial insurance and SEER-Medicare cohorts, respectively. Of the patients with breast biopsy, 1239 of 4158 patients (29.8%) in the commercial insurance cohort and 2258 of 9747 patients (23.2%) in the SEER-Medicare cohort underwent subsequent cancer treatment., Conclusions and Relevance: These data on the need for breast biopsies during follow-up and subsequent treatments from a large cohort of women with commercial insurance and Medicare can be used in the context of therapy-planning discussions and survivorship expectations for patients with breast cancer.

Purpose: Value in healthcare-i.e., patient-centered outcomes achieved per healthcare dollar spent-can define quality and unify performance improvement goals with health outcomes of importance to patients across the entire cycle of care. We describe the process through which value-based measures for breast cancer patients and dynamic capture of these metrics via our new electronic health record (EHR) were developed at our institution., Methods: Contemporary breast cancer literature on treatment options, expected outcomes, and potential complications was extensively reviewed. Patient perspective was obtained via focus groups. Multidisciplinary physician teams met to inform a 3-phase process of (1) concept development, (2) measure specification, and (3) implementation via EHR integration., Results: Outcomes were divided into 3 tiers that reflect the entire cycle of care: (1) health status achieved, (2) process of recovery, and (3) sustainability of health. Within these tiers, 22 patient-centered outcomes were defined with inclusion/exclusion criteria and specifications for reporting. Patient data sources will include the Epic Systems EHR and validated patient-reported outcome questionnaires administered via our institution's patient portal., Conclusions: As healthcare costs continue to rise in the United States and around the world, a value-based approach with explicit, transparently reported patient outcomes will not only create opportunities for performance improvement but will also enable benchmarking across providers, healthcare systems, and even countries. Similar value-based breast cancer care frameworks are also being pursued internationally.

Background: Although many plastic surgeons perform autologous fat grafting (lipofilling) for breast reconstruction after oncologic surgery, it has not been established whether postoncologic lipofilling increases the risk of breast cancer recurrence. The authors assessed the risk of locoregional and systemic recurrence in patients who underwent lipofilling for breast reconstruction., Methods: The authors identified all patients who underwent segmental or total mastectomy for breast cancer (719 breasts) (i.e., cases) or breast cancer risk reduction or benign disease (305 cancer-free breasts) followed by breast reconstruction with lipofilling as an adjunct or primary procedure between June of 1981 and February of 2014. They also then identified matched patients with breast cancer treated with segmental or total mastectomy followed by reconstruction without lipofilling (670 breasts) (i.e., controls). The probability of locoregional recurrence was estimated by the Kaplan-Meier method., Results: Mean follow-up times after mastectomy were 60 months for cases, 44 months for controls, and 73 months for cancer-free breasts. Locoregional recurrence was observed in 1.3 percent of cases (nine of 719 breasts) and 2.4 percent of controls (16 of 670 breasts). Breast cancer did not develop in any cancer-free breast. The cumulative 5-year locoregional recurrence rates were 1.6 percent and 4.1 percent for cases and controls, respectively. Systemic recurrence occurred in 2.4 percent of cases and 3.6 percent of controls (p = 0.514). There was no primary breast cancer in healthy breasts reconstructed with lipofilling., Conclusions: The study results showed no increase in locoregional recurrence, systemic recurrence, or second breast cancer. These findings support the oncologic safety of lipofilling in breast reconstruction., Clinical Question/level of Evidence: Risk, II.

Purpose: The American Society of Breast Surgeons enrolled women in a registry trial to prospectively study patients treated with the MammoSite Radiation Therapy System breast brachytherapy device. The present report examined the outcomes in women aged >70 years enrolled in the trial., Methods and Materials: A total of 1,449 primary early stage breast cancers were treated in 1,440 women. Of these, 537 occurred in women >70 years old. Fisher's exact test was performed to correlate age (≤ 70 vs. >70 years) with toxicity and with cosmesis. The association of age with local recurrence (LR) failure times was investigated by fitting a parametric model., Results: Older women were less likely to develop telangiectasias than younger women (7.9% vs. 12.4%, p = 0.0083). The incidence of other toxicities was similar. Cosmesis was good or excellent in 92% of the women >70 years old. No significant difference was found in LR as a function of age. The 5-year actuarial LR rate with invasive disease for the older vs. younger population was 2.79% and 2.92%, respectively (p = 0.5780). In women >70 years with hormone-sensitive tumors ≤ 2 cm who received hormonal therapy (n = 195), the 5-year actuarial rate of LR, overall survival, disease-free survival, and cause-specific survival was 2.06%, 89.3%, 87%, and 97.5%, respectively. These outcomes were similar in women who did not receive hormonal therapy. Women with small, estrogen receptor-negative disease had worse LR, overall survival, and disease-free survival compared with receptor-positive patients., Conclusions: Accelerated partial breast irradiation with the MammoSite radiation therapy system resulted in low toxicity and produced similar cosmesis and local control at 5 years in women >70 years compared with younger women. This treatment should be considered as an alternative to omitting adjuvant radiotherapy for older women with small-volume, early-stage breast cancer., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose: American Joint Committee on Cancer (AJCC) staging is used to determine breast cancer prognosis, yet patient survival within each stage shows wide variation. We hypothesized that differences in biology influence this variation and that addition of biologic markers to AJCC staging improves determination of prognosis., Patients and Methods: We identified a cohort of 3,728 patients who underwent surgery as the first intervention between 1997 and 2006. A Cox proportional hazards model, with backward stepwise exclusion of factors and stratification on pathologic stage (PS), was used to test the significance of adding grade (G), lymphovascular invasion (L), estrogen receptor (ER) status (E), progesterone receptor (PR) status, combined ER and PR status (EP), or combined ER, PR, and human epidermal growth factor receptor 2 status (M). We assigned values of 0 to 2 to these disease-specific survival (DSS) -associated factors and assessed six different staging systems: PS, PS + G, PS + G L, PS + G E, PS + G EP, and PS + G M. We compared 5-year DSS rates, Akaike's information criterion (AIC), and Harrell's concordance index (C-index) between systems. Surveillance, Epidemiology, and End Results data were used as the external validation cohort (n = 26,711)., Results: Median follow-up was 6.5 years, and 5-year DSS rate was 97.4%. The PS + G E status staging system was most precise, with a low AIC (1,931.9) and the highest C-index (0.80). PS + G E status was confirmed to stratify outcomes in internal bootstrapping samples and the external validation cohort., Conclusion: Our results validate an improved breast cancer staging system that incorporates grade and ER status. We recommend that biologic markers be incorporated into revised versions of the AJCC staging system.

Background: Young age is an independent risk factor for local-regional recurrence after mastectomy in patients with T1/T2 tumors with zero or one to three positive lymph nodes. The authors evaluated the current incidence and management of local-regional recurrence after immediate breast reconstruction in patients with T1/T2 tumors and zero to three positive lymph nodes who did not receive postmastectomy radiotherapy., Methods: Clinical and pathologic factors were identified for 495 patients with T1/T2 tumors and zero to three positive lymph nodes who were treated with mastectomy and immediate breast reconstruction between 1997 and 2002 and did not receive primary systemic chemotherapy or postmastectomy radiation therapy., Results: Autologous tissue-based reconstruction was performed in 70 percent of patients, and 30 percent had tissue expander placement. At a median follow-up of 7.5 years, local-regional recurrence had occurred in 16 patients (3.2 percent). Independent predictors of local-regional recurrence were age 40 years or less, estrogen receptor-negative tumors, and T2 (versus T1) tumors (p < 0.05). Multimodality therapy was utilized for all 16 patients with local-regional recurrence. Nine patients (56.3 percent) who had an isolated local-regional recurrence had a 100 percent local control rate and were treated with curative intent. The 10-year overall survival rate for patients with an isolated local-regional recurrence (87.5 percent) was not significantly different from that for patients without a local-regional recurrence (90.3 percent; p = 0.234)., Conclusions: Routine use of postmastectomy radiation therapy in this heterogeneous patient population should be discouraged to allow more patients to undergo immediate breast reconstruction and ease the burden on plastic surgeons who have had to confront the problems of reconstruction in the face of perioperative radiation in an ever-increasing number of patients.

Background: We present a 4-year update on the efficacy, cosmetic results, and complications of MammoSite breast brachytherapy in patients enrolled in the American Society of Breast Surgeons registry trial., Methods: A total of 1,449 breasts in 1,440 patients with early stage breast cancer undergoing breast-conserving therapy were treated with adjuvant, accelerated partial breast irradiation (APBI) (34 Gy in 3.4-Gy fractions) delivered with the MammoSite device. The median follow-up period for the entire group was 36.1 months., Results: The 3-year actuarial rate of ipsilateral breast tumor recurrence was 2.15%. The 3-year actuarial rate of axillary recurrence was .36%. Complication rates were as follows: infection, 9.5%; seroma, 26.8% (symptomatic seroma, 12.7%); and fat necrosis, 2.0%. The percentages of breasts with good or excellent cosmetic results were as follows: 12 months, 95%; 24 months, 94%; 36 months, 94%; and 48 months, 91%., Conclusions: Locoregional control, complications, and cosmetic outcomes from MammoSite APBI at the 4-year update are acceptable and similar to results seen with other forms of APBI.

Purpose: The National Surgical Adjuvant Breast and Bowel Project B-24 trial, published in June 1999, demonstrated that tamoxifen after breast-conserving surgery (BCS) and radiotherapy for ductal carcinoma in situ (DCIS) reduced the absolute occurrence of ipsilateral and contralateral breast cancer. We assessed the impact of B-24 on practice patterns at selected National Comprehensive Cancer Network (NCCN) centers., Patients and Methods: Tamoxifen use after surgery was examined among 1,622 patients presenting for treatment of unilateral DCIS between July 1997 and December 2003 at eight NCCN centers. Associations of clinicopathologic and treatment factors with tamoxifen use were assessed in univariate and multivariable logistic regression analyses., Results: Overall, 41% of patients (665 of 1,622) received tamoxifen. The proportion increased from 24% before July 1, 1999, to 46% on or after July 1, 1999. Factors significantly associated with receipt of tamoxifen included diagnosis on or after July 1, 1999 (odds ratio [OR], 3.85; P < .0001), BCS in patients younger than 70 years (OR, 3.21; P = .0073), no history of cerebrovascular or peripheral vascular disease (OR, 3.13; P = .0071), receipt of radiotherapy (OR, 1.82; P = .0009), and previous hysterectomy (OR, 1.34; P = .0459). Tamoxifen use varied significantly by center, from 34% to 74% after BCS and 17% to 53% after mastectomy (P < .0001)., Conclusion: Tamoxifen use after surgery for DCIS at NCCN centers increased after presentation of the B-24 results. Rates varied substantially by institution, suggesting that physicians differ in how they weigh the modest reduction in breast cancer risk with tamoxifen against its potential adverse effects in this population.

Background: Incidence and mortality rates for cancers vary by ethnic background and patient age. Accrual of diverse patient populations to cancer clinical trials is essential in order to ensure that findings related to new management strategies can be generalized. The goal of this study was to evaluate accrual patterns for patients participating in the American College of Surgeons Oncology Group (ACOSOG) cancer protocols. Ethnic diversity among clinical trial investigators may also influence accrual patterns, so the ethnic background of the ACOSOG membership was also evaluated., Study Design: Demographics for the patients registered on ACOSOG breast, thoracic, and colorectal clinical trials were evaluated and compared with data on the general population and the cancer population in the United States. Accrual patterns for patients from other reported cancer clinical trials were also presented, and the self-reported ethnic distribution of the ACOSOG membership was analyzed., Results: Distribution of African Americans, Hispanic Americans, and Asian Americans to the ACOSOG breast and colorectal clinical trials was relatively proportionate to the cancer population. African Americans were underrepresented in the thoracic clinical trials, and this disparity was partially offset by data on the proportion of African Americans with stage-eligible lung cancer. Accrual rates for patients age 65 years and older were better than those reported by most other clinical trialists., Conclusions: Elderly patients are successfully recruited into surgical clinical trials, and this will provide important data for future analyses regarding cancer outcomes in this growing population of cancer patients. Aggressive outreach to minority-ethnicity cancer patients for accrual into clinical trials should continue.

Purpose: The impact of postmastectomy radiation therapy (PMRT) on overall survival (OS) for patients with Stage II breast cancer with 1-3 positive lymph nodes is controversial. We sought to compare the outcome of salvage treatment for patients with chest wall recurrence (CWR) according to initial disease stage to shed light on the potential benefit of PMRT in specific subgroups of patients., Methods: We retrospectively reviewed information concerning 96 patients with CWR who were not previously treated with PMRT. The patients were divided according to their initial extent of disease: T1-T2N0 (Group 1), T1-T2 with 1-3 positive lymph nodes (Group 2), and T3-T4 or > or =4 positive lymph nodes (Group 3). The OS and distant metastasis-free survival (DMFS) from the time of CWR were compared using the method of Kaplan and Meier, and a Cox regression model was used for a multivariate analysis., Results: Group 1 had an improved OS and DMFS compared with Group 2 and Group 3 (p < 0.001), but there were no differences in OS or DMFS between Group 2 and Group 3 (p = 0.250 and p = 0.492, respectively). The respective 5-year rates for the three groups were as follows: OS 79.9% vs. 41.9% vs. 29.1%; DMFS 75.2% vs. 33.6% vs. 25.9%., Conclusions: Breast cancer patients with T1-T2N0 breast cancer who develop a CWR have a significantly better outcome than those with lymph node-positive disease. Patients with T1-T2 tumors and one to three positive lymph nodes have a similar outcome after CWR as those with larger tumors or more than four positive lymph nodes. These data should be considered when weighing the risks and benefits of PMRT for patients with Stage II breast cancer with one to three positive lymph nodes.

The efficacy of prophylactic thyroidectomy in patients with positive RET mutational analysis, familial thyroid cancer, or both has been reported. As cost has become critical to medical decision-making, this study was designed to evaluate currently existing coverage policies for prophylactic thyroidectomy. A confidential detailed cross-sectional nationwide survey of 481 medical directors from the American Association of Health Plans, Medicare, and Medicaid was conducted. Of the 150 respondents, 65% (n = 97) had 100,000 or more enrolled members, and 35% (n = 53) had fewer than 100,000 enrolled members. Only 9% of private plans have specific policies for coverage of prophylactic thyroidectomy for patients with a strong family history of thyroid cancer, 19% provided no coverage, and 72% had no policy. Only 9% of private plans have specific policies for patients with a known thyroid cancer genetic mutation, 12% provided no coverage, and 79% had no policy. Governmental carriers were less likely to provide coverage for prophylactic surgery: 4% for a strong family history and 6% for a genetic mutation. Altogether, 52% of government carriers provided no coverage for patients with a strong family history, and 50% provided no coverage in patients with a known genetic mutation; 44% of governmental carriers had no policy for either clinical scenario. Limited health insurance coverage for prophylactic thyroidectomy is offered in both private and governmental plans, with variations in coverage. As genetic testing becomes more widespread and with the potential identification of a gene predisposing to familial nonmedullary thyroid cancer, more uniform policies should be established to enable appropriate high risk candidates broader, equal coverage and access to these procedures.