Completion Lymph Node Dissection for Melanoma Before and After the Multicenter Selective Lymphadenectomy Trial-II in the United States.

BACKGROUND: The Multicenter Selective Lymphadenectomy Trial-II (MSLT-II) revealed completion lymph node dissection (CLND) after positive sentinel lymph node biopsy (SLNB) did not improve melanoma-specific survival compared with surveillance. Given these findings and the morbidity associated with CLND, this study investigated trends in rates and predictors of CLND after MSLT-II. METHODS: Analysis of the National Cancer Database was performed for all patients aged ≥18 years with melanoma and a positive SLNB for 2012-2019. Rates of CLND before and after publication of MSLT-II were identified and logistic regression used to identify factors associated with CLND. RESULTS: Patients undergoing CLND declined from 55.9% pre-MSLT-II (n = 9725) to 19.5% post-MSLT-II (n = 9419) (odds ratio [OR] 0.32, 95% confidence interval [CI] 0.29-0.35). CLND was less likely in females (OR 0.83; 95% CI 0.78-0.89), older patients (vs. 18-39 yr; 40-64 yr OR 0.80, 95% CI 0.65-0.98; 65-79 yr OR 0.67, 95% CI 0.53-0.84; >80 yr OR 0.38, 95% CI 0.30-0.49), sicker patients (Deyo category ≥2 OR 0.85, 95% CI 0.73-0.99), thinner primary lesions (vs. 0.01-0.79 mm; 1.01-4.00 mm OR 1.16, 95% CI 1.01-1.33; ≥4.01 mm OR 1.31, 95% CI 1.08-1.59), patients from metro areas (Rural OR 1.31, 95% CI 1.00-1.70; Urban OR 1.15, 95% CI 1.03-1.29), and those treated at lower-volume centers (vs. lowest-volume; highest-volume OR 1.31, 95% CI 1.14-1.50; high-volume OR 1.40, 95% CI 1.24-1.57). CONCLUSIONS: MSLT-II has impacted clinical care; however, male gender, thicker lesions, rural/urban residence, younger age, fewer comorbidities, and treatment at higher-volume centers confer a greater likelihood of undergoing CLND. Further investigations should focus on whether these populations benefit from more aggressive surgical care.

Surgical management of melanoma.

Surgery remains one of the key treatment modalities for melanoma. Wide excision of the primary site with sentinel lymph node biopsy for selected patients has been recognized as the standard surgical approach for patients with early-stage disease. Controversies persist regarding margin width, indications for sentinel lymph node biopsy, and surgical management of regional nodal basins. Additionally, new therapies such as intralesional therapies as well as new systemic therapies are changing the role for surgery in patients with recurrent local-regional as well as metastatic disease. In this chapter, we discuss the current recommendations as well as the topics of debate in the surgical management of melanoma.

Prognostic Factors for Metachronous Contralateral Breast Cancer: Implications for Management of the Contralateral Breast.

The absolute number of breast cancer survivors who are at risk for metachronous contralateral breast cancer (mCBC) has dramatically increased. The objectives of this study were to identify factors predictive of survival for patients with mCBC and to determine clinicopathological factors predictive of advanced mCBC. Using the Surveillance, Epidemiology, and End Results data base, we identified women, ages 18-80, diagnosed with invasive breast cancer from 1992 to 2010. We excluded patients with bilateral and stage IV primary breast cancer. Patients who developed mCBC ≥12 months from initial diagnosis were identified. Kaplan-Meier methods and Cox proportional hazards modeling were used to determine survival of patients with mCBC. Multivariate logistic regression was utilized to determine factors associated with advanced mCBC. We identified 6,673 patients who developed mCBC during our study period. The median interval between initial breast cancer and mCBC was 5 years. The strongest predictor of overall survival was the nodal status of the mCBC. Other significant prognostic factors included patient age; race; size, nodal status, estrogen receptor status, grade, and type of surgery of the initial breast cancer; grade of the mCBC; and use of radiation therapy for the mCBC. Overall, 25% of mCBCs were node positive. Younger age, black race, and characteristics of the initial breast cancer (increased size, invasive lobular histology, mastectomy treatment, and node-positivity) were significantly associated with node-positive mCBC (all p < 0.0.05). The most powerful predictor of survival for patients with mCBC is the nodal status of mCBC. Patients with advanced initial breast cancers are more likely to develop node-positive mCBC. Adherence to current surveillance and adjuvant therapy guidelines may minimize the risk and mortality of mCBCs.

A comparative analysis of survival outcomes between pancreatectomy and chemotherapy for elderly patients with adenocarcinoma of the pancreas.

BACKGROUND: The survival rates after pancreatectomy for elderly patients with adenocarcinoma of the pancreas remain poor. Elderly patients have increased perioperative mortality rates, higher morbidity rates, and higher rates of continued inpatient nursing care after pancreatectomy. The objective of the current study was to evaluate the outcomes of surgical resection versus chemotherapy (with or without radiotherapy) for elderly patients with potentially resectable adenocarcinoma of the pancreas. METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data for 2000 through 2010, the authors examined the relationship between patient characteristics and receipt of surgery using multivariate logistic regression. The patient cohort was restricted to patients with American Joint Committee on Cancer stage I and stage II disease and Charlson Comorbidity index of ≤2. The association between treatment (surgery or chemotherapy without surgery) and hazard of death was evaluated using Kaplan-Meier Cox proportional hazards modeling. RESULTS: The authors identified 2629 patients with pancreatic adenocarcinoma who underwent either surgery (pancreatectomy) or chemotherapy without surgery. Younger patient age and smaller tumor size were found to be significantly associated with receipt of surgery. For the overall cohort, the median survival rate was significantly longer for those patients treated with surgery compared with those who received chemotherapy (15 months vs 10 months). However, the absolute survival benefit attenuated as the cohort became older. CONCLUSIONS: The survival benefit associated with surgical resection compared with chemotherapy was very small for certain subgroups of patients (those aged ≥80 years and those with lymph node metastases). The results of the current study indicate that although surgery is associated with a survival benefit in the elderly, chemotherapy should be considered as a legitimate therapeutic alternative. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:3378-3385. © 2016 American Cancer Society.

Completion Lymph Node Dissection or Observation for Melanoma Sentinel Lymph Node Metastases: A Decision Analysis.

BACKGROUND: Long-term, randomized trial results comparing completion lymph node dissection (CLND) with observation for patients with sentinel lymph node (SLN) metastases are not available. Our goal was to determine whether melanoma patients with SLN metastases should undergo CLND. METHODS: We developed a Markov model to simulate the prognosis of hypothetical cohorts of patients with SLN metastases who underwent either immediate CLND or observation with delayed CLND if macroscopic disease developed. Model parameters were derived from published studies and included the likelihood of non-SLN metastases, risk of dying from melanoma, CLND complication rates, and health-related quality-of-life weights. Outcomes included 5-year overall survival (OS), life expectancy (LE), and quality-adjusted life expectancy (QALE). RESULTS: The projected 5-year OS for 50-year-old patients with SLN metastases who underwent immediate CLND was 67.2 % compared with 63.1 % for the observation group. The LE gained by undergoing immediate CLND ranged from 2.19 years for patients aged 30 to 0.64 years for patients aged 70 years. The QALE gained by undergoing immediate CLND ranged from 1.39 quality-adjusted life years for patients aged 30 to 0.36 for patients aged 70 years. In sensitivity analysis over a clinically plausible range of values for each input parameter, immediate CLND was no longer beneficial when the rate of long-term complications increased and the quality-of-life weight for long-term complications decreased. CONCLUSIONS: Immediate CLND following positive SLN biopsy was associated with OS and QALE gains compared with observation and delayed CLND for those who develop clinically apparent LN metastases.

Perceptions of Contralateral Breast Cancer Risk: A Prospective, Longitudinal Study.

PURPOSE: An increasing proportion of breast cancer patients undergo contralateral prophylactic mastectomy (CPM) to reduce their risk of contralateral breast cancer (CBC). Our goal was to evaluate CBC risk perception changes over time among breast cancer patients. METHODS: We conducted a prospective, longitudinal study of women with newly diagnosed unilateral breast cancer. Patients completed a survey before and approximately 2 years after treatment. Survey questions used open-ended responses or 5-point Likert scale scoring (e.g., 5 = very likely, 1 = not at all likely). RESULTS: A total of 74 women completed the presurgical treatment survey, and 43 completed the postsurgical treatment survey. Baseline characteristics were not significantly different between responders and nonresponders of the follow-up survey. The mean estimated 10-year risk of CBC was 35.7 % on the presurgical treatment survey and 13.8 % on the postsurgical treatment survey (p < 0.001). The perceived risks of developing cancer in the same breast and elsewhere in the body significantly decreased between surveys. Both CPM and non-CPM (breast-conserving surgery or unilateral mastectomy) patients' perceived risk of CBC significantly decreased from pre- to postsurgical treatment surveys. Compared with non-CPM patients, CPM patients had a significantly lower perceived 10-year risk of CBC (5.8 vs. 17.3 %, p = 0.046) on postsurgical treatment surveys. CONCLUSIONS: The perceived risk of CBC significantly attenuated over time for both CPM and non-CPM patients. These data emphasize the importance of early physician counseling and improvement in patient education to provide women with accurate risk information before they make surgical treatment decisions.

Prophylactic mastectomy: who needs it, when and why.

Prophylactic mastectomy generally occurs in two different patient populations: (1) high-risk women without breast cancer who undergo bilateral prophylactic mastectomy (BPM) to reduce their risk of developing breast cancer and (2) women with unilateral breast cancer who choose contralateral prophylactic mastectomy (CPM) to prevent cancer in the contralateral breast. The purpose of this article is to review the indications, outcomes, and trends in the use of BPM and CPM.

Religion as a means to assure paternity.

The sacred texts of five world religions (Buddhism, Christianity, Hinduism, Islam, and Judaism) use similar belief systems to set limits on sexual behavior. We propose that this similarity is a shared cultural solution to a biological problem: namely male uncertainty over the paternity of offspring. Furthermore, we propose the hypothesis that religious practices that more strongly regulate female sexuality should be more successful at promoting paternity certainty. Using genetic data on 1,706 father-son pairs, we tested this hypothesis in a traditional African population in which multiple religions (Islam, Christianity, and indigenous) coexist in the same families and villages. We show that the indigenous religion enables males to achieve a significantly (P = 0.019) lower probability of cuckoldry (1.3% versus 2.9%) by enforcing the honest signaling of menstruation, but that all three religions share tenets aimed at the avoidance of extrapair copulation. Our findings provide evidence for high paternity certainty in a traditional African population, and they shed light on the reproductive agendas that underlie religious patriarchy.

Trends in the use of pre-operative radiation for adenocarcinoma of the pancreas in the United States.

BACKGROUND: The benefit and timing of radiation therapy (RT) for patients undergoing a resection for pancreatic adenocarcinoma remains unclear. This study identifies trends in the use of radiation over a 10-year period and factors associated with the use of pre-operative radiation, in particular. METHODS: The Surveillance, Epidemiology and End Results registry was used to identify patients aged ≥18 years with pancreatic adenocarcinoma who underwent a surgical resection between 2000 and 2010. Logistic regression was used to identify time trends and factors associated with the use of pre-operative radiation. RESULTS: The overall use of radiation decreased with time among the 8474 patients who met the inclusion criteria. However, the use of pre-operative radiation increased from 1.8% to 3.9% (P ≤ 0.05). Factors significantly associated with receipt of pre-operative radiation were younger age, treatment in more recent years and having an advanced T-stage tumour. The 5-year hazard of death was significantly less for those who received pre-operative radiation versus surgery alone [hazard ratio (HR) 0.64, 95% confidence interval (CI) 0.55-0.74] and for those who received post-operative radiation versus surgery alone (HR 0.69, 95% CI 0.65-0.73). DISCUSSION: The use of pre-operative radiation significantly increased during the study period. However, the overall use of pre-operative radiation therapy remains low in spite of the potential benefits.

The Development of Investigator-Initiated Clinical Trials in Surgical Oncology.

Investigator-initiated trials (IITs) are designed by principal investigators who identify important, unaddressed clinical gaps and opportunities to answer these questions through clinical trials. Surgical oncologists are poised to lead IITs due to their multidisciplinary clinical practice and substantial research background. The process of developing, organizing, and implementing IITs is multifaceted and involves important steps including (but not limited to) navigating regulatory requirements, obtaining funding, and meeting enrollment targets. Here, the authors explore the steps, methodology, and barriers of IIT development by surgical oncologists and highlight the importance of IITs in oncology.

Improvements in medical school wellness and career counseling: A comparison of one-on-one advising to an Advisory College Program.

BACKGROUND: Medical students have unmet needs in the areas of career and wellness advising. AIMS: The goal of this study is to describe the development of an Advisory College Program (ACP) and assess its effectiveness compared to a traditional one-on-one faculty advisor system. METHODS: The ACP, consisting of four colleges co-led by Advisory College Directors and supported by key Faculty, was developed to provide structured career and wellness advising. The authors compared the ACP to the former Faculty Advisory Program (FAP) using two parallel questionnaires. RESULTS: Surveys were completed by 74% of first-year students, 60% of second-year students, and 88% of third-year students. Survey data demonstrated a significant increase in the number of students who could identify their advisor, the frequency of student-advisor contacts, and the perceived accessibility of advisors in the ACP compared to the FAP. While an ordinal logistic regression model did not demonstrate a significant effect of the new advising system on overall satisfaction, univariate analysis demonstrated a significant increase in student satisfaction with wellness and career counseling. CONCLUSIONS: The ACP was more effective in promoting student wellness and career counseling than the traditional one-on-one faculty advisor system. Similar college-based programs may be beneficial to students at other medical school programs.

US Women's Perceptions and Acceptance of New Reproductive Health Technologies.

Background: Women have faced persistent problems accessing reproductive health care. New applications of health technologies to reproductive health, specifically online fertility specialist consultations and reproductive hormone self-collection tests (SCTs), present unique opportunities to overcome these issues. This article uses the technology acceptance model to examine factors that influence women's intentions to use these new reproductive health technologies. Materials and Methods: Participants (n = 327 US women) completed an online survey assessing perceptions related to both of these reproductive health technologies, including usefulness, ease of use, risk, trust, subjective norms, and personal responsibility, to learn about fertility. Results: Participants indicated high perceptions of usefulness, ease of use, and trust, as well as low perceptions of risk and subjective norms for both online fertility consultations (OFCs) and reproductive hormone SCTs. Women indicated low perceptions of responsibility to use OFCs, but high perceptions of responsibility to use reproductive hormone SCTs. Structural equation modeling indicated that intentions to use OFCs were predicted by usefulness, subjective norms, and responsibility; intentions to use reproductive hormone SCTs were predicted by usefulness, ease of use, subjective norms, and responsibility. Conclusions: Fertility specialist consultations and reproductive hormone testing can provide women with essential fertility information that facilitates informed reproductive decisions; however, these services have historically been difficult to access. Widespread uptake of new reproductive health technologies could promote positive advances in women's reproductive health outcomes.

Implant-sparing Mastectomy: An Alternative for Women Undergoing Mastectomy With Retropectoral Implants.

INTRODUCTION: Implant-sparing mastectomy (ISM) is a skin-sparing mastectomy that preserves a retropectoral implant and potentially eliminates the need for tissue expansion or complex reconstruction. This study aimed to determine oncologic and surgical outcomes and reconstructive patterns in patients undergoing ISM. PATIENTS AND METHODS: A single-institution, retrospective review of patients undergoing ISM from 2006 to 2018 was performed. Patient/tumor characteristics, stage, adjuvant therapy use, 90-day complication rates, reconstruction type, and disease recurrence were collected. RESULTS: A total of 121 ISMs in 73 women were performed. Seventy (57.9%) ISMs were for breast cancer (BC) treatment and 51 (42.1%) for prophylaxis. Among BC cases, 72.3% were cT1/cT2 and 73.8% were cN0; 72.3% received systemic therapy and 33.8% received radiation therapy. There were 3 deaths owing to BC at the median follow-up of 35 months. Among 5 recurrences, only 1 was local. There was no BC identified after prophylactic ISM. Total 90-day complication rate per ISM was 15.7%. Rates were 0.8% for both seroma and wound infection, 2.5% for wound dehiscence, 3.3% for hematoma, and 8.2% for skin necrosis. The majority (72.6%) of patients required only implant exchange for reconstruction. Overall use of autologous reconstruction was low (12.3%); 77.8% of flaps were performed in patients receiving radiation therapy. CONCLUSION: ISM is a unique approach for patients pursuing mastectomy for BC treatment or prevention with equivalent oncologic outcomes and complication rates to mastectomy with reconstruction. Reconstruction for the majority was markedly simplified by elimination of tissue expansion while maintaining a low rate of flap reconstruction.

Vaccine Therapies for Breast Cancer.

Vaccines can be a cost effective preventive measure for both primary prevention of disease and prevention of disease recurrence. Several vaccines targeting breast cancer oncodrivers are currently being tested in clinical trials. Whereas clinical response rates to breast cancer vaccines have been modest despite the induction of strong antitumor T cell responses, it is through these approaches that valuable insight and knowledge have been gained about tumor immunology. With the emergence of new immunotherapies, there is renewed excitement for effective breast cancer vaccine development.

Concordance of Fingerstick and Venipuncture Sampling for Fertility Hormones.

BACKGROUND: Minimally invasive fingerstick sampling allows testing of reproductive hormone levels at home, providing women with increased access to tests that can screen for conditions such as polycystic ovarian syndrome, primary ovarian insufficiency, and pituitary and thyroid dysfunction. METHOD: We present a measurement procedure comparison study of matched venipuncture and fingerstick samples from 130 women aged 18-40 years, tested on menstrual cycle day 3. Samples were measured for anti-müllerian hormone, estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), testosterone, thyroid-stimulating hormone (TSH), and free thyroxine (T4) levels. Samples were tested using U.S. Food and Drug Administration-cleared immunoassays, with a modified reconstitution step for fingerstick samples. EXPERIENCE: Venipuncture and fingerstick hormone values were concordant and linear across all assay ranges. There was no evidence of systematic bias across the assay ranges, and bias measures were below recommended guidelines. The correlation between venipuncture and fingerstick was between 0.99 and 1.0 for each hormone. Each assay displayed a high degree of precision (less than 13% coefficient of variation) and a high level of accuracy (average recovery equaled 95.5-102.3%). CONCLUSION: Venipuncture and fingerstick samples can be used interchangeably to measure anti-müllerian hormone, E2, FSH, LH, PRL, testosterone, TSH, and free T4 levels. Fingerstick sampling provides doctors and women more convenient testing options. FUNDING SOURCE: The study was sponsored by Modern Fertility.