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Purpose: Incorporating patient-reported outcomes (PROs) into survivorship care may improve the comprehensiveness of follow-up. The objective was to engage stakeholders to develop a PRO assessment of survivors’ symptoms and concerns for use during breast cancer follow-up. Methods: We convened patient and oncologist stakeholder advisory groups to develop an initial PRO assessment including survivorship domains of importance, measurement instruments, and clinically significant thresholds, and revise the assessment based on feedback from community focus groups and two rounds of iterative pilot testing with survivors. Results: Stakeholders identified key domains and measurement instruments, including recurrence symptoms, treatment side effects, adherence, mental health, and sexual health. Ninety-four survivors completed the PRO assessment in the initial pilot test (median age 62 years, median 2 years from diagnosis). Most (89/93) reported questions were easy to understand. The level of missingness was low. The most common threshold-level symptoms/concerns were hot flashes (46%), fatigue (35%), back pain (31%), joint pain (31%), and anxiety (30%). The PRO assessment was revised to clarify symptom causality and desire to discuss with a provider. In a follow-up pilot study with 20 survivors, the most common symptoms were chest/breast discomfort (50%) and anxiety (25%). Conclusions: We leveraged stakeholder input to develop a comprehensive PRO assessment to use to assess breast cancer survivors’ well-being. Our PRO assessment is acceptable to survivors. Future research will focus on the integration of the PRO assessment into clinical care. [ABSTRACT FROM AUTHOR]

Background: Patient engagement in decision making can improve satisfaction with care. Studies demonstrate that patients' emotional states can be significant barriers to engaging in shared decision making. Objective: We sought to examine how emotion associated with a breast cancer diagnosis impacts patient experiences during the surgical consultation, and explore opportunities for surgeons to mitigate the impact of emotion. Methods: We conducted 30 semi-structured interviews with patients who participated in the decision aid arm of Alliance A231701CD, had low engagement, and experienced barriers to engagement. We used qualitative content analysis to analyze the interview data and organize it into overarching themes. Results: Participants recalled strong emotions with their diagnosis, describing it as devastating and shocking. Although several participants said that their emotional reaction to the diagnosis lessened over time, others expressed still feeling very anxious. Participants described ways in which their surgeon helped to de-escalate their emotional state, beginning with the establishment of rapport and continuing through treatment planning. Participants valued surgeons who they perceived to be personable and compassionate, treated them as an individual, provided reassuring and matter-of-fact information about their cancer, and efficiently communicated plans for next steps. Conclusions: Patients with breast cancer are often emotionally overwhelmed during their surgical consults, which impedes their ability to listen and participate in decision making. However, surgeon behaviors can help de-escalate emotions. Addressing emotion is critical to support patients in reaching a decision for breast cancer surgery and is likely to improve patient satisfaction with the decision process. Clinical Trials Registration: ClinicalTrials.gov identifier: NCT03766009 [ABSTRACT FROM AUTHOR]

Background: The technical aspects of cancer surgery have a significant impact on patient outcomes. To monitor surgical quality, in 2020, the Commission on Cancer (CoC) revised its accreditation standards for cancer surgery and introduced the synoptic operative reports (SORs). The standardization of SORs holds promise, but successful implementation requires strategies to address key implementation barriers. This study aimed to identify the barriers and facilitators to implementing breast SOR within diverse CoC-accredited programs. Methods: In-depth semi-structured interviews were conducted with 31 health care professionals across diverse CoC-accredited sites. The study used two comprehensive implementation frameworks to guide data collection and analysis. Results: Successful SOR implementation was impeded by disrupted workflows, surgeon resistance to change, low prioritization of resources, and poor flow of information despite CoC's positive reputation. Participants often lacked understanding of the requirements and timeline for breast SOR and were heavily influenced by prior experiences with templates and SOR champion relationships. The perceived lack of monetary benefits (to obtaining CoC accreditation) together with the significant information technology (IT) resource requirements tempered some of the enthusiasm. Additionally, resource constraints and the redirection of personnel during the COVID-19 pandemic were noted as hurdles. Conclusions: Surgeon behavior and workflow change, IT and personnel resources, and communication and networking strategies influenced SOR implementation. During early implementation and the implementation planning phase, the primary focus was on achieving buy-in and initiating successful roll-out rather than effective use or sustainment. These findings have implications for enhancing standardization of surgical cancer care and guidance of future strategies to optimize implementation of CoC accreditation standards. [ABSTRACT FROM AUTHOR]

Background: The 8th edition American Joint Committee on Cancer staging system combined anatomic stage (AS) with receptor status and grade to create prognostic stage (PS). PS has been validated in single-institution and cancer registry studies; however, missing human epidermal growth factor receptor 2 (HER2) status and variable treatment and follow-up create limitations. Objective: Our objective was to compare the relative prognostic ability of PS versus AS to predict survival using breast cancer clinical trial data. Methods: Women with non-metastatic breast cancer enrolled in six Alliance for Clinical Trials in Oncology trials were included (enrollment years 1997–2010). AS and PS were constructed using pathological tumor size, nodal status, estrogen receptor (ER), progesterone receptor (PR), HER2 status, and grade. Unadjusted Cox proportional hazard models were estimated to predict overall survival within 5 years, with AS and PS as predictor variables. The relative predictive power of staging models was assessed by comparing Harrell concordance indices (C-indices). Kaplan–Meier-based mortality estimates were compared by stage. Results: Overall, 6924 women were included (median age 53 years); 45.2% were diagnosed with ER+/PR+/HER2− tumors, 26.2% with HER2+ tumors, and 17.1% with ER−/PR−/HER2− tumors. Median follow-up time was 5 years (interquartile range 2.95–5.00). PS significantly improved predictive performance (C-index 0.721) for overall survival compared with AS (0.700) (p = 0.020). Kaplan–Meier hazard estimates suggested PS did not distinguish mortality risk between patients with IIB and IIIA or IB and IIA disease. Conclusions: PS has significantly improved predictive performance for OS compared with AS. As systemic therapies evolve, it will be important to re-evaluate the prognostic staging system, particularly for patients with intermediate-stage cancers. ClinicalTrials.gov Identifier: NCT02171078 [ABSTRACT FROM AUTHOR]

Background: Radioactive tracer injections for breast cancer sentinel lymph node mapping can be painful. In this randomized trial, we compared four approaches to topical pain control for radiotracer injections. Methods: Breast cancer patients were randomized (9 April 2021–8 May 2022) to receive the institutional standard of ice prior to injection (n = 44), or one of three treatments: ice plus a vibrating distraction device (Buzzy®; n = 39), 4% lidocaine patch (n = 44), or 4% lidocaine patch plus ice plus Buzzy® (n = 40). Patients completed the Wong-Baker FACES® pain score (primary outcome) and a satisfaction with pain control received scale (secondary). Nuclear medicine technologists (n = 8) rated perceived pain control and ease of administration for each patient. At study conclusion, technologists rank-ordered treatments. Data were analyzed as intention-to-treat. Wilcoxon rank-sum tests were used to compare pain scores of control versus pooled treatment arms (primary) and then control to each treatment arm individually (secondary). Results: There were no differences in pain scores between the control and treatment groups, both pooled and individually. Eighty-five percent of patients were 'satisfied/very satisfied' with treatment received, with no differences between groups. No differences in providers' perceptions of pain were observed, although providers perceived treatments involving Buzzy© more difficult to administer (p < 0.001). Providers rated lidocaine patch as the easiest, with ice being second. Conclusion: In this randomized trial, no differences in patient-reported pain or satisfaction with treatment was observed between ice and other topical treatments. Providers found treatments using Buzzy® more difficult to administer. Given patient satisfaction and ease of administration, ice is a reasonable standard. [ABSTRACT FROM AUTHOR]

Purpose: Socioeconomic disparities in post-mastectomy breast reconstruction exist. Key informants have suggested that finding providers who accept Medicaid insurance and longer travel time to a plastic surgeon are important barriers. Our objective was to assess the relationship between these factors and reconstruction for socioeconomically disadvantaged women in Wisconsin. Methods: We identified women < 75 years of age with stage 0-III breast cancer who underwent mastectomy using the Wisconsin Cancer Reporting System. Women in the most disadvantaged state-based tertile of the Area Deprivation Index were included (n = 1809). Geocoding determined turn-by-turn drive time from women's address to the nearest accredited Commission on Cancer or National Accreditation Program for Breast Centers. Multivariable logistic regression determined the relationship between reconstruction, Medicaid, and travel time, controlling for patient factors known to impact reconstruction. Average adjusted predicted probabilities of receiving reconstruction were calculated. Results: Most patients had early-stage breast cancer (51% stage 0/I) and 15.2% had Medicaid. 37% of women underwent reconstruction. Socioeconomically disadvantaged women with Medicaid (OR = 0.62, 95% CI 0.46–0.84) and longer travel times (OR = 0.99, 95% CI 0.99–1.0) were less likely to receive reconstruction. Patients with the lowest predicted probability of reconstruction were those with Medicaid who lived furthest from a plastic surgeon. Conclusion: Among socioeconomically disadvantaged women, Medicaid and travel remained associated with lower rates of reconstruction. Further work will explore opportunities to improve access to reconstruction for women with Medicaid. This is particularly challenging as it may require socioeconomically disadvantaged women to travel further to receive care. [ABSTRACT FROM AUTHOR]

Background: Minimally invasive inguinal lymphadenectomy (MILND) is safe and feasible, but limited data exist regarding oncologic outcomes. Methods: This study performed a multi-institutional retrospective cohort analysis of consecutive MILND performed for melanoma between January 2009 and June 2016. The open ILND (OILND) comparative cohort comprised patients enrolled in the second Multicenter Selective Lymphadenectomy Trial (MSLT-II) between December 2004 and March 2014.The pre-defined primary end point was the same-basin regional nodal recurrence, calculated using properties of binomial distribution. Time to events was calculated using the Kaplan–Meier method. The secondary end points were overall survival, progression-free survival, melanoma-specific survival (MSS), and distant metastasis-free survival (DMFS). Results: For all the patients undergoing MILND, the same-basin regional recurrence rate was 4.4 % (10/228; 95 % confidence interval [CI], 2.1–7.9 %): 8.2 % (4/49) for clinical nodal disease and 3.4 % (6/179) for patients with a positive sentinel lymph node (SLN) as the indication. For the 288 patients enrolled in MSLT-II who underwent OILND for a positive SLN, 17 (5.9 %) had regional node recurrence as their first event. After controlling for ulceration, positive LN count and positive non-SLNs at the time of lymphadenectomy, no difference in OS, PFS, MSS or DMFS was observed for patients with a positive SLN who underwent MILND versus OILND. Conclusion: This large multi-institutional experience supports the oncologic safety of MILND for melanoma. The outcomes in this large multi-institutional experience of MILND compared favorably with those for an OILND population during similar periods, supporting the oncologic safety of MILND for melanoma. [ABSTRACT FROM AUTHOR]

Background: Cutaneous melanoma survivors are at increased risk of a second primary melanoma. Valid estimates facilitate counseling on recommended surveillance after a melanoma diagnosis. However, most estimates of 5- and 10-year incidences of second melanomas are from older cohorts and/or single institutions. This study aimed to determine the 5- and 10-year incidences of second primary cutaneous melanomas in survivors of cutaneous melanoma. Methods: The Surveillance, Epidemiology, and End Results (SEER) database was used to identify cases of non-metastatic, first cutaneous melanoma diagnosed between 1998 and 2012 (follow-up through December 2017). Eligible survivors were 18 years old or older who underwent surgery as a treatment component. Kaplan-Meier survival analysis was used to estimate 5- and 10-year incidences of a second melanoma, excluding new diagnoses within 3 months after the initial diagnosis. Patients were censored at second melanoma diagnosis, death, or 10-years, whichever was first. Multivariable Cox regression analysis was used to identify factors associated with a second cutaneous melanoma diagnosis. Results: The study cohort comprised 152,811 patients. The incidence of second primary melanoma was 3.9% at 5 years (95% confidence interval [CI], 3.8–4.0%) and 6.7% at 10 years (95% CI, 6.6–6.9%). Older age, male sex, and regional disease were associated with increased risk of a second primary melanoma diagnosis. Conclusion: Melanoma survivors are at risk of a second primary melanoma, making routine skin surveillance part of recommended follow-up evaluation. A higher incidence of second melanoma with older age and regional disease at presentation is possibly explained by increased health care use providing more diagnostic opportunities, whereas male sex may represent an inherent risk factor. [ABSTRACT FROM AUTHOR]

Background: Phyllodes tumors are rare fibroepithelial neoplasms that are classified by tiered histopathologic features. While there are protocols for the reporting of cancer specimens, no standardized reporting protocol exists for phyllodes. Methods: We performed an 11-institution contemporary review of phyllodes tumors. Granular histopathologic details were recorded, including the features specifically considered for phyllodes grade classification. Results: Of 550 patients, median tumor size was 3.0 cm, 68.9% (n = 379) of tumors were benign, 19.6% (n = 108) were borderline, and 10.5% (n = 58) were malignant. All cases reported the final tumor size and grade classification. Complete pathologic reporting of all histopathologic features was present in 15.3% (n = 84) of cases, while an additional 35.6% (n = 196) were missing only one or two features in the report. Individual details regarding the degree of stromal cellularity was not reported in 53.5% (n = 294) of cases, degree of stromal atypia in 58.0% (n = 319) of cases, presence of stromal overgrowth in 56.2% (n = 309) of cases, stromal cell mitoses in 37.5% (n = 206) of cases, and tumor border in 54.2% (n = 298) of cases. The final margin status (negative vs. positive) was omitted in only 0.9% of cases, and the final negative margin width was specifically reported in 73.8% of cases. Reporting of details was similar across all sites. Conclusion: In this academic cohort of phyllodes tumors, one or more histopathologic features were frequently omitted from the pathology report. While all features were considered by the pathologist for grading, this limited reporting reflects a lack of reporting consensus. We recommend that standardized reporting in the form of a synoptic-style cancer protocol be implemented for phyllodes tumors, similar to other rare tumors. [ABSTRACT FROM AUTHOR]

Background: A paucity of data exists regarding inherited mutations associated with phyllodes tumors (PT); however, some are reported (TP53, BRCA1, and RB1). A PT diagnosis does not meet NCCN criteria for testing, including within Li-Fraumeni Syndrome (TP53). We sought to determine the prevalence of mutations associated with PT. Methods: We performed an 11-institution review of contemporary (2007–2017) PT practice. We recorded multigenerational family history and personal history of genetic testing. We identified patients meeting NCCN criteria for genetic evaluation. Logistic regression estimated the association of select covariates with likelihood of undergoing genetic testing. Results: Of 550 PT patients, 59.8% (n = 329) had a close family history of cancer, and 34.0% (n = 112) had ≥ 3 family members affected. Only 6.2% (n = 34) underwent genetic testing, 38.2% (n = 13) of whom had only BRCA1/BRCA2 tested. Of 34 patients tested, 8.8% had a deleterious mutation (1 BRCA1, 2 TP53), and 5.9% had a BRCA2 VUS. Of women who had TP53 testing (N = 21), 9.5% had a mutation. Selection for testing was not associated with age (odds ratio [OR] 1.01, p = 0.55) or PT size (p = 0.12) but was associated with grade (malignant vs. benign: OR 9.17, 95% CI 3.97–21.18) and meeting NCCN criteria (OR 3.43, 95% confidence interval 1.70–6.94). Notably, an additional 86 (15.6%) patients met NCCN criteria but had no genetic testing. Conclusions: Very few women with PT undergo germline testing; however, in those selected for testing, a deleterious mutation was identified in ~ 10%. Multigene testing of a PT cohort would present an opportunity to discover the true incidence of germline mutations in PT patients. [ABSTRACT FROM AUTHOR]

Opinion Statement: As the use of neoadjuvant systemic therapy (NAST) increases, the optimal management of the axilla has become increasingly complex. Consensus among professional organizations is that those patients with clinically negative axillary nodes who are being considered for NAST should undergo a sentinel lymph node (SLN) biopsy following NAST. If a positive SLN is subsequently identified, an axillary lymph node dissection (ALND) is the current standard of care. For patients with clinically node-positive disease, SLN biopsy is a reasonable option for those with a good response to NAST. Patients should undergo SLN mapping with a dual dye technique. Additionally, at least 2 lymph nodes should be removed, including the previously biopsied and marked lymph node with cancer. In this setting, the identification and false negative rates are acceptable. Patients found to have a negative SLN at this time may be spared the morbidity associated with ALND. Patients found to have persistently positive lymph nodes following NAST, either clinically or pathologically, should undergo a complete ALND. [ABSTRACT FROM AUTHOR]

Purpose: Randomized controlled trials demonstrate that omission of radiation therapy (RT) in older women with early-stage cancer undergoing breast conserving surgery (BCS) is an "acceptable choice." Despite this, high RT rates have been reported. The objective was to evaluate the impact of patient- and system-level factors on RT rates in a contemporary cohort. Methods: Through the National Cancer Data Base, we identified women with clinical stage I estrogen receptor-positive breast cancer who underwent BCS (n = 84,214). Multivariable logistic regression identified patient, tumor, and system-level factors associated with RT. Joinpoint regression analysis calculated trends in RT use over time stratified by age and facility-type, reporting annual percent change (APC). Results: RT rates decreased from 2004 (77.2%) to 2015 (64.3%). The decline occurred earliest and was most pronounced in older women treated at academic facilities. At academic facilities, the APC was − 5.6 (95% CI − 8.6, − 2.4) after 2009 for women aged > 85 years, − 6.4 (95% CI − 9.0, − 3.8) after 2010 for women aged 80 − < 85 years, − 3.7 (95% CI − 5.6, − 1.9) after 2009 for women aged 75 − < 80, and − 2.4 (95% CI, − 3.1, − 1.6) after 2009 for women aged 70 − < 75. In contrast, at community facilities rates of RT declined later (2011, 2012, and 2013 for age groups 70–74, 75–79, and 80–84 years). Conclusions: RT rates for older women with early-stage breast cancer are declining with patient-level variation based on factors related to life expectancy and locoregional recurrence. Facility-level variation suggests opportunities to improve care delivery by focusing on barriers to de-implementation of routine use of RT. [ABSTRACT FROM AUTHOR]

Background: Reduction mammaplasty is a common operation performed for healthy women. The estimated incidence of breast cancer diagnosed at the time of reduction mammaplasty varies from 0.06 to 4.5%, and information on the care of these patients is limited. This study aimed to determine the incidence of breast cancer identified incidentally during reduction mammaplasty and to characterize preoperative imaging. Methods: Women 18 years of age or older who underwent reduction mammaplasty from 2013 to 2015 were identified from the Truven Health MarketScan® Research Databases. Patients with prior breast cancer were excluded. Descriptive statistics were calculated for patient characteristics, incidental breast cancer, preoperative breast imaging, and postoperative treatment. Results: Reduction mammaplasty was performed for 18,969 women with a mean age of 42.5 years. Of these patients, 186 (0.98%) were incidentally found to have breast cancer, with 134 (0.71%) having invasive breast cancer and 52 (0.27%) having carcinoma in situ. The patients with incidentally found cancer were older than the patients without cancer (50.8 vs. 42.5 years; p < 0.001). Overall, 58.2% of the patients had undergone mammography before reduction mammoplasty. The rates were higher (> 80%) for the patients older than 40 years. Preoperative mammography was performed for 76.3% of those with a diagnosis of breast cancer at time of reduction mammoplasty. Conclusions: Breast cancer diagnosed incidentally at the time of reduction mammaplasty is uncommon and often radiographically occult. The majority of women older than 50 years appropriately received preoperative mammography. These data can be used to manage patient expectations about the potential for the incidental diagnosis of breast cancer at reduction mammaplasty, even with a negative preoperative mammography. [ABSTRACT FROM AUTHOR]

Background: Patient participation in treatment decision-making is a health care priority. This study hypothesized that providing a decision aid before surgical consultation would better prepare patients for decision-making. The objective was to examine the impact of a decision aid versus high-quality websites on patients' perceptions of information conveyed during surgical consultation and satisfaction with the decision process. Methods: Patients with stages 0 to 3 breast cancer were randomized. Surveys assessed perceptions of information conveyed, being asked surgical preference, and satisfaction with the decision process. Multivariable logistic regression assessed associations between outcomes and randomization arm, patient factors, and surgeon. Change in Pseudo-R2 assessed the comparative effect of these factors on perceptions of the information conveyed. Results: The median patient age was 59 years. Most of the patients (98%) were white, and 62% were college educated (n = 201). The findings showed no association between randomization arm and perceptions of information conveyed, being asked surgical preference, or satisfaction with the decision process. Most of the patients reported discussing both breast-conserving therapy and mastectomy (69%) and being asked their surgical preference (65%). The surgeon seen was more important than the randomization arm or the patient factors in predicting patients' perceptions of information conveyed (explained 64-69% of the variation), and 63% of the patients were satisfied with the decision process. Conclusion: Use of a decision aid compared with high-quality websites did not increase patients' perceptions of information conveyed or satisfaction with the decision process. Although the surgeon seen influenced aspects of the patient experience, the surgeon was not associated with satisfaction. Understanding the factors driving low satisfaction is critical because this is increasingly used as a marker of health care quality. [ABSTRACT FROM AUTHOR]

Phase I testing of the hu14.18-IL2 immunocytokine (IC) in melanoma patients showed immune activation, reversible toxicities, and a maximal tolerated dose of 7.5 mg/m2/day. Preclinical data in IC-treated tumor-bearing mice with low tumor burden documented striking antitumor effects. Patients with completely resectable recurrent stage III or stage IV melanoma were scheduled to receive 3 courses of IC at 6 mg/m2/day i.v. on days 1, 2 and 3 of each 28-day course. Patients were randomized to complete surgical resection either following neoadjuvant (Group A) or prior to adjuvant (Group B) IC course 1. Primary objectives were to: (1) evaluate histological evidence of anti-tumor activity and (2) evaluate recurrence-free survival (RFS) and OS. Twenty melanoma patients were randomized to Group A (11 patients) or B (9 patients). Two Group B patients did not receive IC due to persistent disease following surgery. Six of 18 IC-treated patients remained free of recurrence, with a median RFS of 5.7 months (95% confidence interval (CI) 1.8-not reached). The 24-month RFS rate was 38.9% (95% CI 17.5-60.0%). The median follow-up of surviving patients was 50.0 months (range: 31.8-70.4). The 24-month OS rate was 65.0% (95% CI 40.3-81.5%). Toxicities were similar to those previously reported. Exploratory tumor-infiltrating lymphocyte (TIL) analyses suggest prognostic value of TILs from Group A patients. Prolonged tumor-free survival was seen in some melanoma patients at high risk for recurrence who were treated with IC. [ABSTRACT FROM AUTHOR]

Patients facing decisions for breast cancer surgery commonly search the internet. Directing patients to high-quality websites prior to the surgeon consultation may be one way of supporting patients' informational needs. The objective was to test an approach for delivering web-based information to breast cancer patients. The implementation strategy was developed using the Replicating Effective Programs framework. Pilot testing measured the proportion that accepted the web-based information. A pre-consultation survey assessed whether the information was reviewed and the acceptability to stakeholders. Reasons for declining guided refinement to the implementation package. Eighty-two percent (309/377) accepted the web-based information. Of the 309 that accepted, 244 completed the pre-consultation survey. Participants were a median 59 years, white (98%), and highly educated (>50% with a college degree). Most patients who completed the questionnaire reported reviewing the website (85%), and nearly all found it helpful. Surgeons thought implementation increased visit efficiency (5/6) and would result in patients making more informed decisions (6/6). The most common reasons patients declined information were limited internet comfort or access (n = 36), emotional distress (n = 14), and preference to receive information directly from the surgeon (n = 7). Routine delivery of web-based information to breast cancer patients prior to the surgeon consultation is feasible. High stakeholder acceptability combined with the low implementation burden means that these findings have immediate relevance for improving care quality. [ABSTRACT FROM AUTHOR]

Background: Current guidelines recommend counseling on risk-reduction strategies, including lifestyle modification, endocrine therapy, and bilateral mastectomy, for patients with classic-type lobular carcinoma in situ (LCIS) detected on core biopsy or surgical excision. Importantly, current diagnosis and treatment guidelines for classic-type LCIS do not include unilateral mastectomy for primary treatment or risk reduction. Prior studies reporting national practice patterns suggest increasing use of mastectomy for management of LCIS, with considerable variation by geographic region. However, these studies did not distinguish between uni- and bilateral mastectomies. This study aimed to investigate national practice patterns and factors associated with unilateral mastectomy.Methods: The study used the National Cancer Database to identify women with a diagnosis of LCIS from 2004 to 2013. Descriptive statistics were used to describe surgical treatment, and multinomial logistic regression was used to identify temporal, patient, and facility-level factors associated with receipt of uni- and bilateral mastectomy.Results: The study identified 30,105 women with LCIS. Of these woman, 5.4% received no surgery, 84.8% had surgical excision, 4% underwent unilateral mastectomy, and 5.1% underwent bilateral mastectomy. Adjusted analysis showed that young age, white race, insurance coverage, greater comorbidity, and geographic region (p < 0.001) were associated with receipt of both uni- and bilateral mastectomy. Additionally, more recent year of diagnosis was associated with receipt of bilateral mastectomy. Unilateral mastectomy rates within geographic regions ranged from 2.7% in New England to 8% in the South.Conclusions: Nearly as many patients underwent unilateral (4%) as bilateral mastectomy (5.1%), representing inappropriate care. These findings highlight an opportunity to reduce unnecessary care through improved provider and patient education regarding optimal management of LCIS. [ABSTRACT FROM AUTHOR]

Background: Annual mammography is recommended after breast cancer treatment. However, studies suggest its under-utilization for Medicare patients. Utilization in the broader population is unknown, as is the role of breast magnetic resonance imaging (MRI). Understanding factors associated with imaging use is critical to improvement of adherence to recommendations.Methods: A random sample of 9835 eligible patients receiving surgery for stages 2 and 3 breast cancer from 2006 to 2007 was selected from the National Cancer Database for primary data collection. Imaging and recurrence data were abstracted from patients 90 days after surgery to 5 years after diagnosis. Factors associated with lack of imaging were assessed using multivariable repeated measures logistic regression with generalized estimating equations. Patients were censored for death, bilateral mastectomy, new cancer, and recurrence.Results: Of 9835 patients, 9622, 8702, 8021, and 7457 patients were eligible for imaging at surveillance years 1 through 4 respectively. Annual receipt of breast imaging declined from year 1 (69.5%) to year 4 (61.0%), and breast MRI rates decreased from 12.5 to 5.8%. Lack of imaging was associated with age 80 years or older and age younger than 50 years, black race, public or no insurance versus private insurance, greater comorbidity, larger node-positive hormone receptor-negative tumor, excision alone or mastectomy, and no chemotherapy (p < 0.005). Receipt of breast MRI was associated with age younger than 50 years, white race, higher education, private insurance, mastectomy, chemotherapy, care at a teaching/research facility, and MRI 12 months before diagnosis (p < 0.05).Conclusion: Under-utilization of mammography after breast cancer treatment is associated with sociodemographic and clinical factors, not institutional characteristics. Effective interventions are needed to increase surveillance mammography for at-risk populations.ClinicalTrials.gov Identifier: NCT02171078. [ABSTRACT FROM AUTHOR]

The article discusses the preferences of breast cancer survivors on the provision of breast cancer follow-up by oncologists. Topics include preferences for ensuring that cancer hasn't recurred, the involvement of primary care providers in follow-up care, and survivor perspectives on standard follow-up protocols.

Background: Post-mastectomy reconstruction is a critical component of high-quality breast cancer care. Prior studies demonstrate socioeconomic disparity in receipt of reconstruction. Our objective was to evaluate trends in receipt of immediate reconstruction and examine socioeconomic factors associated with reconstruction in a contemporary cohort. Methods: Using the National Cancer Database, we identified women <75 years of age with stage 0-1 breast cancer treated with mastectomy ( n = 297,121). Trends in immediate reconstruction rates (2004-2013) for the overall cohort and stratified by socioeconomic factors were examined using Join-point regression analysis, and annual percentage change (APC) was calculated. We then restricted our sample to a contemporary cohort (2010-2013, n = 145,577). Multivariable logistic regression identified socioeconomic factors associated with immediate reconstruction. Average adjusted predicted probabilities of receiving reconstruction were calculated. Results: Immediate reconstruction rates increased from 27 to 48%. Although absolute rates of reconstruction for each stratification group increased, similar APCs across strata led to persistent gaps in receipt of reconstruction. On multivariable logistic regression using our contemporary cohort, race, income, education, and insurance type were all strongly associated with immediate reconstruction. Patients with the lowest predicted probability of receiving reconstruction were patients with Medicaid who lived in areas with the lowest rates of high-school graduation (Black 42.4% [95% CI 40.5-44.3], White 45.7% [95% CI 43.9-47.4]). Conclusions: Although reconstruction rates have increased dramatically over the past decade, lower rates persist for disadvantaged patients. Understanding how socioeconomic factors influence receipt of reconstruction, and identifying modifiable factors, are critical next steps towards identifying interventions to reduce disparities in breast cancer surgical care. [ABSTRACT FROM AUTHOR]

Background: Outcomes of surgical trials hinge on surgeon selection and their underlying expertise. Assessment of expertise is paramount. We investigated whether surgeons' performance measured by the fundamentals of laparoscopic surgery (FLS) assessment program could predict their performance in a surgical trial.Methods: As part of a prospective multi-institutional study of minimally invasive inguinal lymphadenectomy (MILND) for melanoma, surgical oncologists with no prior MILND experience underwent pre-trial FLS assessment. Surgeons completed MILND training, began enrolling patients, and submitted videos of each MILND case performed. Videos were scored with the global operative assessment of laparoscopic skills (GOALS) tool. Associations between baseline FLS scores and participant's trial performance metrics were assessed.Results: Twelve surgeons enrolled patients; their median total baseline FLS score was 332 (range 275-380, max possible 500, passing >270). Participants enrolled 87 patients in the study (median 6 per surgeon, range 1-24), of which 72 (83%) videos were adequate for scoring. Baseline GOALS score was 17.1 (range 9.6-21.2, max possible score 30). Inter-rater reliability was excellent (ICC = 0.85). FLS scores correlated with improved GOALS scores (r = 0.57, p = 0.05) and with decreased operative time (r = -0.6, p = 0.02). No associations were found with the degree of patient recruitment (r = 0.02, p = 0.7), lymph node count (r = 0.01, p = 0.07), conversion rate (r = -0.06, p = 0.38) or major complications(r = -0.14, p = 0.6).Conclusions: FLS skill assessment of surgeons prior to their enrollment in a surgical trial is feasible. Although better FLS scores predicted improved operative performance and operative time, other trial outcome measures showed no difference. Our findings have implications for the documentation of laparoscopic expertise of surgeons in practice and may allow more appropriate selection of surgeons to participate in clinical trials. [ABSTRACT FROM AUTHOR]

Background: The current guidelines do not delineate the types of providers that should participate in early breast cancer follow-up care (within 3 years after completion of treatment). This study aimed to describe the types of providers participating in early follow-up care of older breast cancer survivors and to identify factors associated with receipt of follow-up care from different types of providers. Methods: Stages 1-3 breast cancer survivors treated from 2000 to 2007 were identified in the Surveillance, Epidemiology and End results Medicare database ( n = 44,306). Oncologist (including medical, radiation, and surgical) follow-up and primary care visits were defined using Medicare specialty provider codes and linked American Medical Association (AMA) Masterfile. The types of providers involved in follow-up care were summarized. Stepped regression models identified factors associated with receipt of medical oncology follow-up care and factors associated with receipt of medical oncology care alone versus combination oncology follow-up care. Results: Oncology follow-up care was provided for 80 % of the patients: 80 % with a medical oncologist, 46 % with a surgeon, and 39 % with a radiation oncologist after radiation treatment. The patients with larger tumor size, positive axillary nodes, estrogen receptor (ER)-positive status, and chemotherapy treatment were more likely to have medical oncology follow-up care than older patients with higher Charlson comorbidity scores who were not receiving axillary care. The only factor associated with increased likelihood of follow-up care with a combination of oncology providers was regular primary care visits (>2 visits/year). Conclusions: Substantial variation exists in the types of providers that participate in breast cancer follow-up care. Improved guidance for the types of providers involved and delineation of providers' responsibilities during follow-up care could lead to improved efficiency and quality of care. [ABSTRACT FROM AUTHOR]

Background: Although breast cancer follow-up guidelines emphasize the importance of clinical examinations, prior studies suggest a small fraction of local-regional events occurring after breast conservation are detected by examination alone. Our objective was to examine how local-regional events are detected in a contemporary, national cohort of high-risk breast cancer survivors. Methods: A stage-stratified sample of stage II/III breast cancer patients diagnosed in 2006-2007 ( n = 11,099) were identified from 1217 facilities within the National Cancer Data Base. Additional data on local-regional and distant breast events, method of event detection, imaging received, and mortality were collected. We further limited the cohort to patients with breast conservation ( n = 4854). Summary statistics describe local-regional event rates and detection method. Results: Local-regional events were detected in 5.5 % ( n = 265) of patients. Eighty-three percent were ipsilateral or contralateral in-breast events, and 17 % occurred within ipsilateral lymph nodes. Forty-eight percent of local-regional events were detected on asymptomatic breast imaging, 29 % by patients, and 10 % on clinical examination. Overall, 0.5 % of the 4854 patients had a local-regional event detected on examination. Examinations detected a higher proportion of lymph node events (8/45) compared with in-breast events (18/220). No factors were associated with method of event detection. Discussion: Clinical examinations, as an adjunct to screening mammography, have a modest effect on local-regional event detection. This contradicts current belief that examinations are a critical adjunct to mammographic screening. These findings can help to streamline follow-up care, potentially improving follow-up efficiency and quality. [ABSTRACT FROM AUTHOR]

Introduction: National Comprehensive Cancer Network (NCCN) guidelines recommend wide excision without axillary staging to treat phyllodes tumors of the breast. Without prospective trials to guide management, NCCN also recommends consideration of radiation therapy (XRT). We describe current patterns of care for the multidisciplinary management of phyllodes tumors. Methods: Using Surveillance, Epidemiology, and End Results Program (SEER) data, we identified women diagnosed with phyllodes tumors between 2000 and 2012 who underwent surgical therapy. Trends in breast-conserving surgery (BCS), nodal sampling, and XRT were assessed using the Cochrane-Armitage test. Multivariable logistic regression was used to identify factors associated with treatment. Results: Of 1238 patients, 56.9 % underwent BCS and 23.6 % underwent nodal sampling (10.5 % after BCS vs. 40.9 % after mastectomy). After surgery, 15.4 % received adjuvant XRT (BCS 12.9 %, and mastectomy 18.8 %). XRT utilization increased significantly over the study period (BCS, p = < 0.0001; mastectomy, p = 0.0003), while nodal sampling did not change significantly. Women were more likely to receive mastectomy if they were older or had larger tumors. Nodal sampling was also associated with older age, larger tumor size, and receipt of mastectomy. Receipt of XRT was associated with later year of diagnosis, larger tumors, and nodal assessment. Conclusion: Over time, an increasing number of women received XRT after surgical management of phyllodes tumor, and one in four women underwent nodal sampling. While some of this practice can be attributed to concern about more advanced disease in the absence of strong data, there may be an educational gap regarding current guidelines and appropriate management. [ABSTRACT FROM AUTHOR]

Background: Re-excision surgeries for the treatment of ductal carcinoma in situ (DCIS) put a strain on patients and healthcare resources; however, intraoperative pathologic assessment of DCIS may lead to a reduction in these additional surgeries. This study examined the relationship between intraoperative pathologic assessment and subsequent operations in patients with a diagnosis of DCIS. Methods: Surveillance, Epidemiology, and End Results-Medicare patients diagnosed with DCIS from 1999 to 2007 who initially underwent partial mastectomy, without axillary surgery, were included in this study. Use of intraoperative frozen section or touch preparation during the initial surgery was assessed. Multivariable logistic regression was used to describe the relationship between the use of intraoperative pathologic assessment and any subsequent mastectomy or partial mastectomy within 90 days of the initial partial mastectomy. Results: Of 8259 DCIS patients, 3509 (43 %) required a second surgery, and intraoperative pathologic assessment was performed for 2186 (26 %). Intraoperative pathologic assessment had no statistically significant effect on whether or not a subsequent breast surgery occurred (adjusted odds ratio 1.07, 95 % confidence interval 0.95-1.21; p = 0.293). Patient residence in a rural area, tumor size ≥2 cm, and poorly differentiated tumor grade were associated with a greater likelihood of subsequent surgery, while age 80 years and older was associated with a lower likelihood of subsequent surgery. Conclusions: The use of intraoperative frozen section or touch preparation during partial mastectomy from 1999 to 2007 was not associated with a reduction in subsequent breast operations in women with DCIS. These results highlight the need to identify cost-effective tools and strategies to reduce the need for additional surgery in patients with DCIS. [ABSTRACT FROM AUTHOR]

Effective uptake of tumor cell-derived antigens by antigen-presenting cells is achieved pre-clinically by in situ labeling of tumor with α-gal glycolipids that bind the naturally occurring anti-Gal antibody. We evaluated toxicity and feasibility of intratumoral injections of α-gal glycolipids as an autologous tumor antigen-targeted immunotherapy in melanoma patients (pts). Pts with unresectable metastatic melanoma, at least one cutaneous, subcutaneous, or palpable lymph node metastasis, and serum anti-Gal titer ≥1:50 were eligible for two intratumoral α-gal glycolipid injections given 4 weeks apart (cohort I: 0.1 mg/injection; cohort II: 1.0 mg/injection; cohort III: 10 mg/injection). Monitoring included blood for clinical, autoimmune, and immunological analyses and core tumor biopsies. Treatment outcome was determined 8 weeks after the first α-gal glycolipid injection. Nine pts received two intratumoral injections of α-gal glycolipids (3 pts/cohort). Injection-site toxicity was mild, and no systemic toxicity or autoimmunity could be attributed to the therapy. Two pts had stable disease by RECIST lasting 8 and 7 months. Tumor nodule biopsies revealed minimal to no change in inflammatory infiltrate between pre- and post-treatment biopsies except for 1 pt (cohort III) with a post-treatment inflammatory infiltrate. Two and four weeks post-injection, treated nodules in 5 of 9 pts exhibited tumor cell necrosis without neutrophilic or lymphocytic inflammatory response. Non-treated tumor nodules in 2 of 4 evaluable pts also showed necrosis. Repeated intratumoral injections of α-gal glycolipids are well tolerated, and tumor necrosis was seen in some tumor nodule biopsies after tumor injection with α-gal glycolipids. [ABSTRACT FROM AUTHOR]

Background: Improving the quality of follow-up provided to the 3 million U.S. breast cancer survivors is a high priority. Current guidelines do not provide guidance regarding who should participate in follow-up or what providers' specific responsibilities should be. Given the multidisciplinary nature of breast cancer care, this results in significant variation and creates the potential for redundancy and/or gaps. Our objective was to provide insight into why different types of oncologists believe their participation in follow-up is necessary. Methods: A purposeful sample of breast medical, radiation, and surgical oncologists was identified ( n = 35) and in-depth one-on-one interviews were conducted. Data were analyzed using content analysis. Results: Medical oncologists were driven by a sense of Responsibility for Ongoing Therapy, perceived Strong Patient Relationship, and belief that their systemic approach to follow-up represented a Specific Skillset beneficial to patients. In contrast, surgical and radiation oncologists were selective about which patients they followed, participating when they perceived their Specific Skillset of enhanced local-regional assessments would be valuable. Additionally, they endorsed participating to Ensure Follow- up is Received or not participating to Minimize Redundancy. These individual decisions led to either a Complementary Oncologist Team or Primary Oncologist follow-up approach. Conclusions: Oncologists' feel responsible for the cancer-related components of follow-up. Differences amongst oncology specialists' perceived responsibilities influenced decisions to provide ongoing follow-up. Based on these individual decisions, a Complementary Oncologist Team or Primary Oncologist model of care evolves organically. Guidelines that explicitly direct patients into a care model have the potential to significantly improve care quality and efficiency. [ABSTRACT FROM AUTHOR]

Background: Survival benefit from adjuvant chemotherapy is established for stage III colon cancer; however, uncertainty exists for stage II patients. Tumor heterogeneity, specifically microsatellite instability (MSI), which is more common in right-sided cancers, may be the reason for this observation. We examined the relationship between adjuvant chemotherapy and overall 5-year mortality for stage II colon cancer by location (right- vs left-side) as a surrogate for MSI. Methods: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified Medicare beneficiaries from 1992 to 2005 with AJCC stage II ( n = 23,578) and III ( n = 17,148) primary adenocarcinoma of the colon who underwent surgery for curative intent. Overall 5-year mortality was examined with Kaplan-Meier survival analysis and Cox proportional hazards regression with propensity score weighting. Results: It was found that 18 % of stage II patients ( n = 2941) with right-sided cancer and 22 % ( n = 1693) with left-sided cancer received adjuvant chemotherapy. After adjustment, overall 5-year survival benefit from chemotherapy was observed only for stage III patients (right-sided: hazard ratio [HR], 0.64; 95 % CI, 0.59-0.68; p < .001 and left-sided: HR, 0.61; 95 % CI, 0.56-0.68; p < .001). No survival benefit was observed for stage II patients with either right-sided (HR, 0.97; 95 % CI, 0.87-1.09; p = .64) or left-sided cancer (HR, 0.97; 95 % CI, 0.84-1.12; p = .68). Conclusions: Among Medicare patients with stage II colon cancer, a substantial number receive adjuvant chemotherapy. Adjuvant chemotherapy did not improve overall 5-year survival for either right- or left-sided colon cancers. Our results reinforce existing guidelines and should be considered in treatment algorithms for older adults with stage II colon cancer. [ABSTRACT FROM AUTHOR]

Background: American College of Surgeons Oncology Group (ACOSOG) Z0011 demonstrated that eligible breast cancer patients with positive sentinel lymph nodes (SLN) could be spared an axillary lymph node dissection (ALND) without sacrificing survival or local control. Although heralded as a “practice-changing trial,” some argue that the stringent inclusion criteria limit the trial’s clinical significance. The objective was to assess the potential impact of ACOSOG Z0011 on axillary surgical management of Medicare patients and examine current practice patterns. Methods: Medicare beneficiaries aged ≥66 years with nonmetastatic invasive breast cancer diagnosed from 2001 to 2007 were identified from the Surveillance, Epidemiology and End Results-Medicare database ( n = 59,431). Eligibility for ACOSOG Z0011 was determined: SLN mapping, tumor <5 cm, no neoadjuvant treatment, breast conservation; number of positive nodes was determined. Actual surgical axillary management for eligible patients was assessed. Results: Twelve percent (6,942/59,431) underwent SLN mapping and were node positive. Overall, 2,637 patients (4.4 % (2,637/59,431) of the total cohort, but 38 % (2,637/6,942) of patients with SLN mapping and positive nodes) met inclusion criteria for ACOSOG Z0011, had 1 or 2 positive lymph nodes, and could have been spared an ALND. Of these 2,637 patients, 46 % received a completion ALND and 54 % received only SLN biopsy. Conclusions: Widespread implementation of ACOSOG Z0011 trial results could potentially spare 38 % of older breast cancer patients who undergo SLN mapping with positive lymph nodes an ALND. However, 54 % of these patients are already managed with SLN biopsy alone, lessening the impact of this trial on clinical practice in older breast cancer patients. [ABSTRACT FROM AUTHOR]

Background: Although recommendations for breast cancer follow-up frequency exist, current follow-up guidelines are standardized, without consideration of individual patient characteristics. Some studies suggest oncologists are using these characteristics to tailor follow-up recommendations, but it is unclear how this is translating into practice. The objective of this study was to examine current patterns of oncologist breast cancer follow-up and determine the association between patient and tumor characteristics and follow-up frequency. Methods: The Surveillance, Epidemiology, and End Results (SEER)-Medicare database was used to identify stage I–III breast cancer patients diagnosed 2000–2007 ( n = 39,241). Oncologist follow-up visits were defined using Medicare specialty provider codes and the linked AMA Masterfile. Multinomial logistic regression determined the association between patient and tumor characteristics and oncologist follow-up visit frequency. Results: Younger age ( p < 0.001), positive nodes ( p < 0.001), estrogen receptor/progesterone receptor positivity ( p < 0.001), and increasing treatment intensity ( p < 0.001) were most strongly associated with more frequent follow-up. However, after accounting for these characteristics, significant variation in follow-up frequency was observed. In addition to patient factors, the number and types of oncologists involved in follow-up were associated with follow-up frequency ( p < 0.001). Types of oncologists providing follow-up varied, with medical oncologists the sole providers of follow-up for 19–51 % of breast cancer survivors. Overall, 58 % of patients received surgical oncology, and 51 % undergoing radiation received radiation oncology follow-up, usually in combination with medical oncology. Conclusions: Significant variation in breast cancer follow-up frequency exists. Developing follow-up guidelines tailored for patient, tumor, and treatment characteristics while also providing guidance on who should provide follow-up has the potential to increase clinical efficiency. [ABSTRACT FROM AUTHOR]

Retroperitoneal sarcomas form a group of rare malignancies that require expertise in every aspect of management. Patients benefit from referral to cancer centers that can provide comprehensive, multidisciplinary, oncologic management. The role of radiation in retroperitoneal sarcoma management is, appropriately, the subject of considerable controversy due to the absence of high-level evidence proving its efficacy. Nonetheless, the preponderance of available data suggests that radiation therapy likely improves local control and, in some settings, may favorably impact resectability and survival. These outcome observations coupled with the lower doses (45-54 Gy) and normal tissue displacement characteristic of preoperative radiation therapy leads us to favor preoperative radiotherapy followed by oncologic resection for most retroperitoneal sarcomas. This strategy appears to provide the highest chance of safe and successful delivery of multimodal therapy, which can otherwise be hindered by postoperative complications as a result of technically challenging surgery and normal tissue radiation dose tolerances. Dose-escalation and selective integrative boosts to 'at-risk' margins are attractive strategies that merit, and arguably require, further clinical evaluation. We believe that postoperative radiotherapy should be reserved for very high-risk cases and should be treated to a dose of ≥60 Gy respecting normal tissue dose tolerances. An additional approach that we consider in the postoperative setting is close surveillance with consideration of preoperative radiotherapy at recurrence before repeat surgical resection. Highly conformal radiotherapy techniques, such as IMRT with image guidance, should be employed to minimize dose to normal tissues and thereby allow delivery of efficacious radiation doses. If feasible, referral to a treatment facility with proton beam therapy should be discussed with the patient, especially if normal tissue dose constraints cannot be met using IMRT/IGRT. Participation in prospective studies should be highly encouraged. [ABSTRACT FROM AUTHOR]

Background: In the treatment of melanoma, inguinal lymph node dissection (ILND) is the standard of care for palpable or biopsy-proven lymph node metastases. Wound complications occur frequently after ILND. In the current study, the multicenter American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) was utilized to examine the frequency and predictors of wound complications after ILND. Methods: Patients with cutaneous melanoma who underwent superficial and superficial with deep ILND from 2005-2010 were selected from the ACS NSQIP database. Standard ACS NSQIP 30-day outcome variables for wound occurrences-superficial surgical site infection (SSI), deep SSI, organ space SSI, and disruption-were defined as wound complications. Results: Of 281 total patients, only 14 % of patients had wound complications, a rate much lower than those reported in previous single institution studies. In a multivariable model, superficial with deep ILND, obesity, and diabetes were significantly associated with wound complications. There was no difference in the rate of reoperation in patients with and without wound complications. Conclusions: ACS NSQIP appears to markedly underreport the actual incidence of wound complications after ILND. This may reflect the program's narrow definition of wound occurrences, which does not include seroma, hematoma, lymph leak, and skin necrosis. Future iterations of the ACS NSQIP for Oncology and procedure-specific modules should expand the definition of wound occurrences to incorporate these clinically relevant complications. [ABSTRACT FROM AUTHOR]

Background: Individuals ≥80 years of age represent an increasing proportion of colon cancer diagnoses. Selecting these patients for elective surgery is challenging because of diminished overall health, functional decline, and limited data to guide decisions. The objective was to identify overall health measures that are predictive of poor survival after elective surgery in these oldest-old colon cancer patients. Methods: Medicare beneficiaries ≥80 years who underwent elective colectomy for stage I-III colon cancer from 1992-2005 were identified from the Surveillance, Epidemiology and End Results(SEER)-Medicare database. Kaplan-Meier survival analysis determined 90-day and 1-year overall survival. Multivariable logistic regression assessed factors associated with short-term postoperative survival. Results: Overall survival for the 12,979 oldest-old patients undergoing elective colectomy for colon cancer was 93.4 and 85.7 %, at 90 days and 1 year. Older age, male gender, frailty, increased hospitalizations in prior year, and dementia were most strongly associated with decreased survival. In addition, AJCC stage III (vs stage I) disease and widowed (vs married) were highly associated with decreased survival at 1 year. Although only 4.4 % of patients were considered frail, this had the strongest association with mortality, with an odds ratio of 8.4 (95 % confidence interval, 6.4-11.1). Conclusions: Although most oldest-old colon cancer patients do well after elective colectomy, a significant proportion (6.6 %) die by postoperative day 90 and frailty is the strongest predictor. The ability to identify frailty through billing claims is intriguing and suggests the potential to prospectively identify, through the electronic medical record, patients at highest risk of decreased survival. [ABSTRACT FROM AUTHOR]

Background: Data from randomized controlled trials support use of a diverting stoma in rectal cancer patients with low anastomoses, but there is little data on how this impacts patient quality of life (QOL). This study prospectively evaluates QOL in stage I-III rectal cancer patients undergoing sphincter-preserving surgery (SPS) with a temporary diverting stoma. Materials and Methods: Patents were identified from a prospective single-institution study of stage I-III rectal cancer patients undergoing SPS. Patients completed the EORTC C30/CR38 QOL scale preoperatively, at stoma closure, and at 6 months. The Stoma Quality of Life (SQOL) was administered at stoma closure. Subscales of the EORTC hypothesized to be affected by a diverting stoma were identified a priori. Longitudinal trends were analyzed using repeated measures ANOVA. Frequencies for responses on specific SQOL items were tabulated, and correlations between SQOL subscales and EORTC Global QOL assessed with Pearson correlation coefficient. Results: Global QOL was reportedly good (mean score 70.2) and did not change with a temporary stoma ( P = .83). Physical ( P = .33), role ( P = .07), and social function ( P = .48) were also stable. Decreased body image was observed ( P = .03). Stoma-related difficulties identified by the SQOL included sexual activity (53%), leakage (39%), discomfort in clothing (34%), concerns regarding privacy to empty pouch (32%), and feeling unattractive (31%). 'Overall satisfaction with life,' Work/social function ( P < .001), sexuality/body image ( P = .01), and stoma function ( P = .01) subscales of the SQOL correlated strongly with the EORTC Global QOL score ( P < .001). Conclusion: In this longitudinal study of QOL in rectal cancer patients with a temporary stoma, Global QOL was good despite significant stoma-related difficulties. Use of alternative research methodology is necessary to provide insight into why this contradiction exists. [ABSTRACT FROM AUTHOR]

The timing of sentinel lymph node (SLN) biopsy in patients with operable breast cancer scheduled to undergo neoadjuvant chemotherapy is controversial. Pre-neoadjuvant chemotherapy SLN biopsy is associated with a higher rate of successful mapping and the lowest false-negative rate; however, it requires an additional surgical procedure and commits all patients with a positive SLN to a completion axillary lymph node dissection. Conversely, post-neoadjuvant chemotherapy SLN biopsy can theoretically identify those patients with a pathologic complete response in the axilla as a result of neoadjuvant chemotherapy and thereby spare them a completion axillary lymph node dissection. False negative rates are higher, however. Because there are merits for both pre- and post-neoadjuvant chemotherapy SLN mapping, the timing best suited for an individual patient should be selected. [ABSTRACT FROM AUTHOR]

Survival of patients with stage IV melanoma is poor. In the current American Joint Committee on Cancer (AJCC) staging system, site of distant disease and lactate dehydrogenase (LDH) are the only prognostic factors included for stage IV disease. We sought to validate the current AJCC staging system in a contemporary, prospectively collected cohort of patients and explore additional factors that may influence prognosis. Our prospective database was searched to identify patients with stage IV melanoma; only patients seen at our institution before developing stage IV disease were included ( n = 589). Demographic, clinical, and tumor characteristics were abstracted. Univariate and multivariate assessment of prognostic factors associated with survival were performed by Cox regression. Overall median survival was 9 months. Differential survival by AJCC substage was observed ( P < .001). For each site of disease described within the AJCC staging system, an abnormal LDH level was associated with a poorer prognosis. By multivariate analysis, older age at diagnosis (as a continuous variable, hazard ratio [HR] 1.02, 95% confidence interval [95% CI]) 1.01–1.02), an abnormal LDH (HR 1.42, 95% CI 1.11–1.82), site of disease (lung HR 1.22, 95% CI .89–1.66; other viscera 1.61, 95% CI 1.18–2.21), more than one organ involvement (HR 1.27, 95% CI 1.01–1.60), and more than one metastasis (HR 2.27, 95% CI 1.65–3.14) were independently associated with poorer survival. Sex, antecedent stage, and disease-free interval were not statistically significant. In our patient cohort, the AJCC staging system was valid. The strongest predictor of survival—the number of metastases present at the diagnosis of stage IV disease—represents a variable to consider in future staging systems. [ABSTRACT FROM AUTHOR]

Breast desmoid tumors are rare and often clinically mistaken for carcinoma. We reviewed our 25-year institutional experience with breast desmoid tumors. A search of pathology and sarcoma databases (1982–2006) identified 32 patients with pathologically confirmed breast desmoids. Records were retrospectively reviewed. Median presentation age was 45 years (range, 22–76). Eight patients (25%) had prior history of breast cancer and 14 (44%) of breast surgery, with desmoids diagnosed a median of 24 months postoperatively. All presented with physical findings. Mammography visualized the mass in 6/16, ultrasound in 9/9, and magnetic resonance imaging (MRI) in 8/8 patients in whom it was performed. In 15 patients with attempted needle biopsy, fine needle aspiration was inconclusive (9/9 patients), and core biopsy demonstrated a spindle cell lesion (6/7 patients). Treatment was surgical, with median tumor size of 2.5 cm (range, 0.3–15). Eight patients (29%) had recurring tumors at a median 15 months. Patients with recurring tumors were younger (median age: 28 vs. 46 years, p = 0.03). A trend toward more frequent recurrences in patients with positive (5/9 patients) versus negative (3/19 patients) margins ( p = 0.07) and larger tumors ( p = 0.12) was observed. In our series, breast desmoids presented as palpable masses suspicious for carcinoma clinically and radiographically. Therapy remains primarily surgical, and core biopsy aided in operative planning. Recurrences are common, with younger age and possibly positive margin status and larger tumor size associated with increased risk of recurrence. As 5/9 patients with positive and 3/19 patients with negative margins experienced recurrences, clinical judgment should be used prior to extensive and potentially deforming resections. [ABSTRACT FROM AUTHOR]

We reviewed a contemporary, single-institution experience to evaluate the natural history of stage-IV melanoma metastatic to the lung and identify factors predictive of survival. A search of our prospective database was performed to identify patients with stage-IV melanoma and pulmonary metastases as the initial disease site; only patients seen at our institution prior to developing stage-IV disease and in whom treatment response was available were included. Patients’ demographic, clinical, and treatment variables were recorded. Cox regression was used to identify factors independently predictive of survival. The study cohort was comprised of 122 patients. Median survival was 14 months (5-year survival of 8%). Clinical factors at time of diagnosis of stage IV independently predictive of survival were a solitary pulmonary metastasis (HR 2.7, CI 1.6–4.4, P<0.0005) and absence of extra-pulmonary disease (HR 1.9, CI 1.2–3.1, P = 0.01). Among treatment factors, only metastasectomy was independently predictive of survival (HR 0.42, CI 0.21–0.87, P = 0.02). Of the patients, 26 (21%) underwent metastasectomy, with a median survival of 40 months compared with 13 months in patients not selected for surgical treatment. Of these 26, 23 (88%) experienced recurrence at a median of 5 months after the procedure. No survival difference was seen between responders and non-responders to systemic therapy ( P = 0.55). In stage-IV melanoma with pulmonary metastases, a solitary metastasis and absence of extra-pulmonary disease are predictive of survival. While these factors are often present in patients selected for pulmonary metastasectomy, this independently predicts survival. However, response to systemic therapy does not correlate with a survival difference. [ABSTRACT FROM AUTHOR]

Bowel function is an important outcome after rectal cancer surgery that affects quality of life (QOL). Postoperative bowel function is often assessed with QOL instruments, but their ability to detect functional differences has not been evaluated. This study evaluated the efficacy of the European Organization for the Research and Treatment of Cancer (EORTC) Core (C)-30 and Colorectal (CR)-38 QOL instruments in identifying functional differences among patients undergoing sphincter-preserving surgery, grouped by clinical and treatment-related factors known to be associated with bowel function. A total of 123 patients who underwent sphincter-preserving surgery for stage I to III rectal cancer completed the EORTC C-30 and CR-38 a median of 22.9 months after restoration of bowel continuity. The global QOL, Social and Physical Function subscales of the EORTC C-30, and Gastrointestinal (GI) Symptom and Defecation subscales of the EORTC CR-38 were hypothesized to be affected by bowel function. Known factors associated with function (age, sex, radiation, procedure, rectal reconstruction) were used to group patients. Differences in the QOL scores between patient groups were evaluated ( t-test or analysis of variance). The global QOL was high, with a mean score of 76.84 ± 18.6. The Defecation subscale detected differences in patients grouped by age ( P = .002), use of radiation ( P = .04), and procedure type ( P = .05). However, the remaining subscales failed to identify any differences. We found neither the EORTC C-30 nor CR-38 to be sensitive instruments in delineating differences in bowel function. The use of a validated instrument designed to assess function in patients with rectal cancer will more effectively and efficiently identify those patients with poor postoperative function. [ABSTRACT FROM AUTHOR]