Perceptions of Readiness for Practice After Complex General Surgical Oncology Fellowship: A Survey Study.

BACKGROUND: Surgical subspecialty training aims to meet the needs of practicing surgeons and their communities. This study investigates career preparedness of Complex General Surgical Oncology (CGSO) fellowship graduates, identifies factors associated with practice readiness, and explores potential opportunities to improve the current training model. METHODS: The Society of Surgical Oncology partnered with the National Cancer Institute to conduct a 36-question survey of CGSO fellowship graduates from 2012 to 2022. RESULTS: The overall survey response rate was 38% (221/582) with a slight male predominance (63%). Forty-six percent of respondents completed their fellowship after 2019. Factors influencing fellowship program selection include breadth of cancer case exposure (82%), mentor influence (66%), and research opportunities (38%). Overall, graduates reported preparedness for practice; however, some reported unpreparedness in research (18%) and in specific clinical areas: thoracic (43%), hyperthermic intraperitoneal chemotherapy (HIPEC) (15%), and hepato-pancreato-biliary (15%) surgery. Regarding technical preparedness, 70% reported being "very prepared". Respondents indicated lack of preparedness in robotic (63%) and laparoscopic (33%) surgery approaches. Suggestions for training improvement included increased autonomy and case volumes, program development, and research infrastructure. Current practice patterns by graduates demonstrated discrepancies between ideal contracts and actual practice breakdowns, particularly related to the practice of general surgery. CONCLUSIONS: This study of CGSO fellowship graduates demonstrates potential gaps between trainee expectations and the realities of surgical oncology practice. Although CGSO fellowship appears to prepare surgeons for careers in surgical oncology, there may be opportunities to refine the training model to better align with the needs of practicing surgical oncologists.

RAS/TP53 Co-mutation is Associated With Worse Survival After Concurrent Resection of Colorectal Liver Metastases and Extrahepatic Disease.

OBJECTIVE: To determine if tumor genetics are associated with overall survival (OS) after concurrent resection of colorectal liver metastases (CLM) and extrahepatic disease (EHD). SUMMARY BACKGROUND DATA: The prognosis for patients who undergo concurrent resection of CLM/EHD is unclear and the impact of somatic mutations has not been reported. METHODS: Patients undergoing concurrent resection of CLM and EHD from 2007 to 2017 were identified from 2 academic centers. From 1 center, patients were selected from a pre-existing database of patients undergoing cytore-ductive surgery with hyperthermic intraperitoneal chemotherapy. The Kaplan-Meier method was used to construct survival curves, compared using the log-rank test. Multivariable Cox analysis for OS was performed. RESULTS: One hundred nine patients were included. Most common EHD sites included lung (33 patients), peritoneum (32), and portal lymph nodes (14). TP53 mutation was the most common mutation, identified in 75 patients (69%), and RAS/TP53 co-mutation was identified in 31 patients (28%). The median OS was 49 months (interquartile range, 24-125), and 3- and 5-year OS rates were 66% and 44%, respectively. Compared to patients without RAS/ TP53 co-mutation, patients with RAS/TP53 co-mutation had lower median OS: 39 vs. 51 months ( P = 0.02). On multivariable analysis, lung EHD [hazard ratio (HR), 0.7; 95% confidence intervals (CI), 0.3-1.4], peritoneal EHD (HR, 2.2; 95% CI, 1.1-4.2) and RAS/TP53 co-mutation (HR, 2.8; 95% CI, 1.1-7.2) were independently associated with OS. CONCLUSIONS: RAS/TP53 co-mutation is associated with worse OS after concurrent CLM/EHD resection. Mutational status and site of EHD should be included in the evaluation of patients considered for concurrent resection.

Clinical Manifestations and Surgical Management of Breast Implant-Associated Anaplastic Large Cell Lymphoma: Beyond the NCCN Guidelines.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon peripheral T cell lymphoma arising in response to textured-surface breast implants. Frequently, BIA-ALCL is indolent and typically presents with peri-implant swelling after breast reconstruction or cosmetic augmentation. However, patients can present with an invasive breast or chest wall mass, palpable lymphadenopathy, or metastatic disease. The current literature is limited regarding surgical recommendations for patients with a more aggressive presentation of BIA-ALCL. This report aims to review the various clinical manifestations of BIA-ALCL, including the more advanced and less frequently encountered presentations, with an emphasis on a multidisciplinary approach, with early involvement of a surgical oncologist.

Utilization and evolving prescribing practice of opioid and non-opioid analgesics in patients undergoing lymphadenectomy for cutaneous malignancy.

BACKGROUND AND OBJECTIVES: Opioids are commonly prescribed following surgery and can lead to persistent opioid use. We assessed changes in prescribing practices following an opioid education initiative for patients undergoing lymphadenectomy for cutaneous malignancy. METHODS: A single-institution retrospective study of all eligible patients (3/2016-3/2020) was performed. RESULTS: Indications for lymphadenectomy in 328 patients were metastatic melanoma (84%), squamous cell carcinoma (10%), and Merkel cell carcinoma (5%). At discharge, non-opioid analgesics were increasingly utilized over the 4-year study period, with dramatic increases after education initiatives (32%, 42%, 59%, and 79% of pts, respectively each year; p < 0.001). Median oral morphine equivalents (OMEs) prescribed also decreased dramatically starting in year 3 (250, 238, 150, and 100 mg, respectively; p < 0.001). Patients discharged with 200 mg OMEs were less likely to also be discharged with non-opioid analgesics (40% vs. 64%. respectively, p < 0.001). CONCLUSIONS: Analgesic prescribing practices following lymphadenectomy for cutaneous malignancy improved significantly over a 4-year period, with use of non-opioids more than doubling and a 60% reduction in median OME. Opportunities exist to further increase non-opioid use and decrease opioid dissemination after lymphadenectomy for cutaneous malignancy.

Comprehensive Complication Index Validates Improved Outcomes Over Time Despite Increased Complexity in 3707 Consecutive Hepatectomies.

OBJECTIVE: The aim of this study was to evaluate trends over time in perioperative outcomes for patients undergoing hepatectomy. BACKGROUND: As perioperative care and surgical technique for hepatectomy have improved, the indications for and complexity of liver resections have evolved. However, the resulting effect on the short-term outcomes over time has not been well described. METHODS: Consecutive patients undergoing hepatectomy during 1998 to 2015 at 1 institution were analyzed. Perioperative outcomes, including the comprehensive complication index (CCI), were compared between patients who underwent hepatectomy in the eras 1998 to 2003, 2004 to 2009, and 2010 to 2015. RESULTS: The study included 3707 hepatic resections. The number of hepatectomies increased in each era (794 in 1998 to 2003, 1402 in 2004 to 2009, and 1511 in 2010 to 2015). Technical complexity increased over time as evidenced by increases in the rates of major hepatectomy (20%, 23%, 30%, P < 0.0001), 2-stage hepatectomy (0%, 3%, 4%, P < 0.001), need for portal vein embolization (5%, 9%, 9%, P = 0.001), preoperative chemotherapy for colorectal liver metastases (70%, 82%, 89%, P < 0.001) and median operative time (180, 175, 225 minutes, P < 0.001). Significant decreases over time were observed in median blood loss (300, 250, 200 mL, P < 0.001), transfusion rate (19%, 15%, 5%, P < 0.001), median length of hospitalization (7, 7, 6 days, P < 0.001), rates of CCI ≥26.2 (20%, 22%, 16%, P < 0.001) and 90-day mortality (3.1%, 2.6%, 1.3%, P < 0.01). On multivariable analysis, hepatectomy in the most recent era 2010 to 2015 was associated with a lower incidence of CCI ≥26.2 (odds ratio 0.7, 95% confidence interval 0.6-0.8, P < 0.0001). CONCLUSION: Despite increases in complexity over an 18-year period, continued improvements in surgical technique and perioperative outcomes yielded a resultant decrease in CCI in the most current era.

A New Surveillance Algorithm After Resection of Colorectal Liver Metastases Based on Changes in Recurrence Risk and RAS Mutation Status.

BACKGROUND: The optimal surveillance strategy after resection of colorectal liver metastases (CLM) is unknown. We evaluated changes in recurrence risk after CLM resection and developed a surveillance algorithm. METHODS: Patients undergoing CLM resection during 1998 to 2015 were identified from a prospectively compiled database and analyzed if they had the potential for follow-up longer than the longest observed time to recurrence in this cohort. Changes in recurrence risk and risk factors for recurrence were evaluated. All statistical tests were 2-sided. RESULTS: Among 2,105 patients who were initially identified and underwent CLM resection, the latest recurrence was observed at 87 months; 1,221 consecutive patients from 1998 through 2011 with the potential for at least 87 months of follow-up were included. The risk of recurrence was highest at 0 to 2 years after CLM resection, lower at 2 to 4 years after CLM resection, and steadily lower after 4 years after CLM resection. Factors associated with increased recurrence risk at the time of surgery were primary lymph node metastasis (hazard ratio [HR], 1.54; 95% CI, 1.21-1.97; P<.001), multiple CLM (HR, 1.31; 95% CI, 1.06-1.63; P=.015), largest liver metastasis diameter >5 cm (HR, 1.64; 95% CI, 1.23-2.19; P<.001), and RAS mutation (HR, 1.29; 95% CI, 1.04-1.59; P=.020). In patients without recurrence at 2 years, the only factor still associated with increased recurrence risk was RAS mutation. In those patients, the recurrence rate at 4 years was 59.3% in patients with RAS mutation versus 27.8% in patients with RAS wild-type (P=.019). CONCLUSIONS: For patients who have undergone CLM resection, we propose surveillance every 3 to 4 months during years 0 to 2, every 3 to 4 months (if mutant RAS) versus every 4 to 6 months (if RAS wild-type) during years 2 to 4, and every 6 to 12 months if recurrence-free at 4 years.

Perceptions of opioid use and prescribing habits in oncologic surgery: A survey of the society of surgical oncology membership.

BACKGROUND: The objective of this study was to assess current perceptions surrounding opioid prescribing in surgical oncology to inform perioperative quality improvement initiatives. METHODS: After the Society of Surgical Oncology (SSO) approval, a survey was distributed to its membership. Five sample procedures were used to assess provider perceptions and prescribing habits. Data were summarized and compared by self-reported demographics. RESULTS: One hundred and seventy-five participants completed the survey: 149 (85%) faculty, 24 (14%) trainees, and 2 (1%) advanced practice providers. Most participants (76%) practiced in academic programs and 21% practiced in non-US locations. Few differences were identified based on clinical role, academic rank, or practice years. Compared with non-US providers, US providers expected higher pain scores at discharge, recommended greater opioid prescriptions, and estimated more days of opioid use for almost every procedure. More non-US providers believed discharge opioids should not be distributed to patients who are opioid-free in their last 24 inpatient hours (80% vs 50%, P = .001). All providers ranked education as "very important" for reducing opioid prescriptions. CONCLUSIONS: Compared with their international counterparts, US surgical oncology providers expected greater opioid needs and recommended higher prescription numbers. Educating providers on multimodal opioid-sparing bundles, accelerated weaning protocols, and standardized discharge prescribing habits could have a positive impact the US opioid epidemic.

Educating surgical oncology providers on perioperative opioid use: A departmental survey 1 year after the intervention.

BACKGROUND AND OBJECTIVES: A department-wide opioid reduction education program resulted in a 1-month change in perceptions of opioid needs and prescribing recommendations for surgical oncology patients. This study's aim was to re-evaluate if early trends were retained 1 year later. METHODS: Surgical Oncology attendings, fellows, and advanced practice providers at a Comprehensive Cancer Center were surveyed 1-year after an August 2018 opioid reduction education program, to compare departmental and individual opioid prescribing habits. RESULTS: The September 2019 response rate was 54/93 (58%), with 41 completing both the post-education and 1-year follow-up surveys. The departmental and matched cohort continued to recommend a lower quantity of discharge opioids for all five index operations (by >50%) and expected less postoperative days to zero opioid needs, when compared to pre-education perceptions. Providers continued to agree that discharge opioid prescriptions should be based on a patient's last 24 hours of inpatient opioid use. There was universal agreement that each respondent's opioid administration had decreased in the past year. CONCLUSIONS: The initial 1-month improvements in perioperative opioid prescribing perceptions were retained 1 year later by Surgical Oncology providers who recommended fewer discharge opioids, faster weaning to zero opioids, and standardized patient-specific discharge opioid volume calculations.

Treatment Options for Metastatic Gastrointestinal Stromal Tumors to the Liver: A Review.

Up to half of patients with a gastrointestinal stromal tumor (GIST) will present with metastatic disease, most commonly involving the liver. Prior to the introduction of tyrosine kinase inhibitors, treatment options were limited for patients with metastatic GIST to the liver resulting in dismal survival rates. However, with the advent of effective systemic chemotherapy and continued advancements in both surgical and local adjunctive therapy options, significant improvements in survival have been achieved. In this review, the authors characterize the evolution of the treatment approach for metastatic GIST to the liver, including the roles of both surgical resection and adjunctive therapies in today's practice.

Facilitation of Surgical Innovation: Is It Possible to Speed the Introduction of New Technology While Simultaneously Improving Patient Safety?

OBJECTIVE: To review efficiency metrics and patient safety data before and after implementation of a structured review process for surgical innovations. SUMMARY BACKGROUND DATA: Surgical innovation ranges from minor incremental improvement to radical experimentation. Although innovation paradigms have been described, these are not widely adopted or enforced in the surgical community. METHODS: A Continuous Quality Improvement Team (CQIT) of surgical quality officers and perioperative nurses was organized to perform structured reviews of proposed new surgical devices and procedures at a large quaternary cancer care center. The CQIT process was placed to precede an established Value Analysis Team business evaluation. Pre- and post-CQIT implementation metrics of approval process efficiency and patient safety data were compared. Seven novel procedures were also vetted by the CQIT. RESULTS: Forty-six product requests were evaluated after CQIT implementation. Compared with 34 products evaluated prior to CQIT establishment, the total mean evaluation time decreased from 124 to 51 days (P= 0.007). For new devices requiring intraoperative trial, the time between product proposal and trial decreased from a mean of 260 to 99 days (P= 0.014). The rate of device-related complications in the pre-CQIT group was 10% compared with 0% post-CQIT. Two devices, which administratively bypassed CQIT review, had both minor and major complications, including a mortality. Five novel procedures approved by CQIT with simulation were performed without complications. CONCLUSIONS: Using novel algorithms, the addition of a dedicated team of surgical quality officers to the surgical innovation evaluation process improved both the efficiency and the safety associated with introducing new devices and procedures into practice.

Severe Preoperative Symptoms Delay Readiness to Return to Intended Oncologic Therapy (RIOT) After Liver Resection.

BACKGROUND: Symptom burden, as measured by patient-reported outcome (PRO) metrics, may have prognostic value in various cancer populations, but remains underreported. The aim of this project was to determine the predictive impact of preoperative patient-reported symptom burden on readiness to return to intended oncologic therapy (RIOT) after oncologic liver resection. METHODS: Preoperative factors, including anthropometric analysis of sarcopenia, were collected for patients undergoing oncologic liver resection from 2015 to 2018. All patients reported their preoperative symptom burden using the MD Anderson Symptom Inventory, Gastrointestinal version (MDASI-GI). Time to RIOT readiness was compared using standard statistics. RESULTS: Preoperative symptom burden was measured in 107 consecutive patients; 52% had at least one moderate symptom score and 21% reported at least one severe score. Highest rated symptoms were fatigue, disturbed sleep, and distress. For patients reporting a severe preoperative symptom burden, the median time to RIOT readiness was 35 days (interquartile range [IQR] 28-42), compared with 21 days (IQR 21-28) for those without severe symptoms (p < 0.001). On multivariable analysis, severe preoperative symptom burden was independently associated with longer time to RIOT readiness (estimate +7.5 days, 95% confidence interval 2.6-12.3; p = 0.002). CONCLUSIONS: Preoperative symptom burden has a substantial impact on time to RIOT readiness, leading to, on average, a 7-day delay in RIOT readiness compared with patients without severe preoperative symptoms. Identifying and targeting severe preoperative symptoms may hasten recovery and improve time to necessary adjuvant therapies.

Complex General Surgical Oncology Fellowship Applicants: Trends over Time and the Impact of Board Certification Eligibility.

BACKGROUND: Complex general surgical oncology (CGSO) fellowships recently obtained Accreditation Council for Graduate Medical Education (ACGME) accreditation and board certification eligibility. We aimed to characterize the applicant pool and identify factors predictive of matching into our program. METHODS: We conducted a retrospective review of CGSO fellowship applications to a major cancer center from 2008 to 2018. Data were analyzed for trends over time, including a comparison of pre- versus post-American Board of Surgery (ABS) certification eligibility. RESULTS: A total of 846 applications were reviewed. Most applicants (86.2%) trained in a US residency program; 58.4% performed ≥ 1 research year during residency; 29.6% had a dual degree. Fewer applicants (34.5%) were female, a trend which did not change over time. Post-ABS, applicants were more likely to complete ≥ 1 year between residency and fellowship (20.9% versus 13.2%, p = 0.003), to be in practice at the time of application (12.2% versus 6.6%, p = 0.005), and to reapply (5.5% versus 1.0%, p < 0.001). Post-ABS applicants listed more peer-reviewed publications (8 [interquartile range (IQR) 4, 15] versus 5 [IQR 2, 10]; p < 0.001). On multivariable analysis, factors associated with matching into our program included: US allopathic medical school graduation [odds ratio (OR) 4.6, 95% confidence interval (CI) 1.8-11.7], Alpha Omega Alpha (AOA) Honor Medical Society distinction (OR 2.7, 95% CI 1.6-4.7), dual degree (OR 2.0, 95% CI 1.1-3.4), and performance of a clinical/research rotation at our institution (OR 4.9, 95% CI 2.2-10.7). CONCLUSIONS: After establishment of CGSO board certification eligibility, applicants were more likely to apply while in practice and to reapply. A number of factors, including having a dual degree and rotating at our institution, were associated with matriculation.

Educating Surgical Oncology Providers on Perioperative Opioid Use: Results of a Departmental Survey on Perceptions of Opioid Needs and Prescribing Habits.

BACKGROUND: Patients undergoing oncologic surgery are at risk for persistent postoperative opioid use. As a quality improvement initiative, this study sought to characterize provider perceptions regarding opioid-prescribing after oncologic procedures. METHODS: Surgical oncology attending physicians, clinical fellows, and advanced practice providers (APPs) at a high-volume cancer center were surveyed before and after educational sessions focusing on the opioid epidemic with review of departmental data. RESULTS: The pre-education response rates were 72 (70%) of 103: 22 (65%) of 34 attending physicians, 19 (90%) of 21 fellows, and 31 (65%) of 48 APPs. For five index operations (open abdominal resection, laparoscopic colectomy, wide local excision, thyroidectomy, port), the fellows answered that patients should stop receiving opioids sooner than recommended by the attending surgeons or APPs. For four of five procedures, the APPs recommended higher discharge opioid prescriptions than the attending surgeons or fellows. Almost half of the providers (n = 46, 45%) responded to both the pre- and post-education surveys. After the intervention, the providers recommended lower numbers of opioid pills and indicated that patients should be weaned from opioids sooner for all the procedures. Compared with pre-education, more providers agreed post-education that discharge opioid prescriptions should be based on a patient's last 24 h of inpatient opioid use (83 vs 91%; p = 0.006). The providers who did not attend a session showed no difference in perceptions or recommendations at the repeat assessment. CONCLUSIONS: Variation exists in perioperative opioid-prescribing among provider types, with those most involved in daily care and discharge processes generally recommending more opioids. After education, providers lowered discharge opioid recommendations and thought patients should stop receiving opioids sooner. The next steps include assessing for quantitative changes in opioid-prescribing and implementing standardized opioid prescription algorithms.

Determining the Safety and Efficacy of Enhanced Recovery Protocols in Major Oncologic Surgery: An Institutional NSQIP Analysis.

BACKGROUND: Enhanced-recovery (ER) protocols are increasingly being utilized in surgical practice. Outside of colorectal surgery, however, their feasibility, safety, and efficacy in major oncologic surgery have not been proven. This study compared patient outcomes before and after multispecialty implementation of ER protocols at a large, comprehensive cancer center. METHODS: Surgical cases performed from 2011 to 2016 and captured by an institutional NSQIP database were reviewed. Following exclusion of outpatient and emergent surgeries, 2747 cases were included in the analyses. Cases were stratified by presence or absence of ER compliance, defined by preoperative patient education and electronic medical record order set-driven opioid-sparing analgesia, goal-directed fluid therapy, and early postoperative diet advancement and ambulation. RESULTS: Approximately half of patients were treated on ER protocols (46%) and the remaining on traditional postoperative (TP) protocols (54%). Treatment on an ER protocol was associated with decreased overall complication rates (20% vs. 33%, p < 0.0001), severe complication rates (7.4% vs. 10%, p = 0.010), and median hospital length of stay (4 vs. 5 days, p < 0.0001). There was no change in readmission rates (ER vs. TP, 8.6% vs. 9.0%, p = 0.701). Subanalyses of high magnitude cases and specialty-specific outcomes consistently demonstrated improved outcomes with ER protocol adherence, including decreased opioid use. CONCLUSIONS: This assessment of a large-scale ER implementation in multispecialty major oncologic surgery indicates its feasibility, safety, and efficacy. Future efforts should be directed toward defining the long-term oncologic benefits of these protocols.

Follow-up imaging of traumatic vertebral artery dissections is unnecessary in asymptomatic patients.

OBJECTIVE: Routine computed tomography (CT) imaging in trauma patients has led to increased recognition of blunt vertebral artery injuries (BVIs). We sought to determine the prevalence of strokes, injury progression, and need for intervention in patients with BVI. METHODS: Consecutive patients presenting with BVI during 2 years were identified from the institutional trauma registry. Inpatient records, imaging studies, and follow-up data were reviewed in detail from the electronic medical record. RESULTS: There were 76 BVIs identified in 70 patients (64% male; mean age, 47 ± 19 years); bilateral injuries occurred in 6 patients. Five patients who arrived at the hospital intubated had evidence of posterior circulation infarcts on admission CT, whereas one additional patient had evidence of a posterior circulation infarct attributed to complications of late spinal surgery. Four of the five patients with infarcts on admission CT survived to discharge, but only one had residual stroke symptoms. Minor (grade 1 or grade 2) injuries occurred in 25 (36%) patients; severe (grade 3 or grade 4) injuries occurred in 45 (64%). Twelve patients died of associated injuries (eight with severe BVI, four with minor BVI). Stepwise logistic regression analysis selected age (odds ratio, 1.14; confidence interval, 1.04-1.25; P < .001) and intubation on arrival (odds ratio, 450.4; confidence interval, 17.41-1645.51; P < .001) as independent predictors of hospital stroke and death. Of the 58 surviving to discharge, 31 (53%) returned for follow-up CT scans. Six of 10 (60%) patients with minor injuries had resolution or improvement compared with 3 of 21 (14%) with severe injuries (P = .027). One patient (10%) with a minor BVI and two patients (10%) with severe BVI had radiologic progression, but none were clinically significant. During a mean follow-up of 15 ± 13 months, none of the study patients had treatment (surgical or interventional) for BVI, and there were no delayed strokes. Only five patients in this series had vertebral pseudoaneurysms, which limits conclusions about this type of BVI. CONCLUSIONS: These data suggest that BVI-related strokes are present at the time of admission and do not have clinical sequelae. No late strokes occurred in this series, and no surgical or interventional treatments were required even in the presence of radiographic worsening. The relatively few cases of vertebral pseudoaneurysms in this series limit any conclusions about these specific lesions. However, these data indicate that follow-up imaging of nonaneurysmal BVI is not necessary in adults who are found to be asymptomatic on follow-up.

Dealing with an insufficient future liver remnant: Portal vein embolization and two-stage hepatectomy.

Colorectal liver metastases (CLM) are not always resectable at the time of diagnosis. An insufficient future liver remnant is a factor excluding patients from curative intent resection. To deal with this issue, two-stage hepatectomy was introduced approximately 20 years ago. It is a sequential treatment strategy for bilateral CLM, which consists of preoperative chemotherapy, portal vein embolization, and planned first and second liver resections. This study reviews current evidence supporting use of two-stage hepatectomy.

Next-generation transcriptome sequencing of the premenopausal breast epithelium using specimens from a normal human breast tissue bank.

INTRODUCTION: Our efforts to prevent and treat breast cancer are significantly impeded by a lack of knowledge of the biology and developmental genetics of the normal mammary gland. In order to provide the specimens that will facilitate such an understanding, The Susan G. Komen for the Cure Tissue Bank at the IU Simon Cancer Center (KTB) was established. The KTB is, to our knowledge, the only biorepository in the world prospectively established to collect normal, healthy breast tissue from volunteer donors. As a first initiative toward a molecular understanding of the biology and developmental genetics of the normal mammary gland, the effect of the menstrual cycle and hormonal contraceptives on DNA expression in the normal breast epithelium was examined. METHODS: Using normal breast tissue from 20 premenopausal donors to KTB, the changes in the mRNA of the normal breast epithelium as a function of phase of the menstrual cycle and hormonal contraception were assayed using next-generation whole transcriptome sequencing (RNA-Seq). RESULTS: In total, 255 genes representing 1.4% of all genes were deemed to have statistically significant differential expression between the two phases of the menstrual cycle. The overwhelming majority (221; 87%) of the genes have higher expression during the luteal phase. These data provide important insights into the processes occurring during each phase of the menstrual cycle. There was only a single gene significantly differentially expressed when comparing the epithelium of women using hormonal contraception to those in the luteal phase. CONCLUSIONS: We have taken advantage of a unique research resource, the KTB, to complete the first-ever next-generation transcriptome sequencing of the epithelial compartment of 20 normal human breast specimens. This work has produced a comprehensive catalog of the differences in the expression of protein-coding genes as a function of the phase of the menstrual cycle. These data constitute the beginning of a reference data set of the normal mammary gland, which can be consulted for comparison with data developed from malignant specimens, or to mine the effects of the hormonal flux that occurs during the menstrual cycle.