NRG-CC004 ancillary data study-exploring the effect of bupropion on sexual desire in female cancer survivors with and without vulvovaginal symptoms.

BACKGROUND: Female cancer survivors often experience estrogen-deprivation symptoms, which may lead to decreases in sexual desire, vulvovaginal health (lubrication, dryness, discomfort), and sexual satisfaction. Interventions are needed to address these concerns. AIM: The objective of this secondary analysis was to determine if women with higher (better) scores on the Female Sexual Function Index (FSFI) lubrication and pain subscales reported higher desire scores based on treatment with bupropion vs placebo. METHODS: Participants were part of NRG Oncology's NRG-CC004 (NCT03180294), a randomized placebo-controlled clinical trial evaluating bupropion (150 vs 300 mg) to improve sexual desire in survivors of breast or gynecologic cancer. All participants with baseline data from the FSFI lubrication, pain, and desire subscales with 5- and/or 9-week data were analyzed. The FSFI subscale scores were correlated using Spearman correlation coefficients. Logistic regression was used to determine associations between FSFI desire and other FSFI subscales while accounting for treatment arm and other covariates. OUTCOMES: The primary outcome of NRG Oncology's NRG-CC004 (NCT03180294) randomized phase II dose-finding trial was change from baseline to 9 weeks on the FSFI desire subscale score. Similar to the parent study, the primary outcome for this ancillary data study was the FSFI desire subscale score at 5 and 9 weeks. RESULTS: Overall, 230 participants completed the FSFI at baseline and 189 at 9 weeks. The strongest correlations were between lubrication and pain at baseline (all participants, rho = 0.77; bupropion arms, rho = 0.82), week 5 (all participants, rho = 0.71; bupropion arms, rho = 0.68), and week 9 (all participants, rho = 0.75; bupropion arms, rho = 0.78), and the weakest correlations were between desire and pain. In patients in the treatment arms there were no interactions between lubrication or pain.The impact of various covariates on the FSFI score for desire at 9 weeks demonstrated that participants of non-White race (odds ratio [OR], 0.42; 95% CI, 0.21-0.81; P = .010), with a high lubrication score (OR, 0.36; 95% CI, 0.21-0.61; P = .0002), with a high pain score (less pain) (OR, 0.50; 95% CI, 0.29-0.87; P = .014), or with prior pelvic surgery (OR, 0.38; 95% CI, 0.23-0.63; P = .0002) had lower odds of having low desire. CLINICAL IMPLICATIONS: Acute estrogen-deprivation symptoms should be addressed prior to sexual desire intervention. STRENGTHS AND LIMITATIONS: This secondary analysis was not powered to examine all variables. CONCLUSION: Lubrication and pain were predictors of low desire. Therefore, vulvovaginal atrophy and associated genitourinary symptoms of menopause such as vaginal dryness and dyspareunia should be addressed prior to or in parallel with interventions for sexual desire.

Palliative care in gynecologic oncology: a narrative review of current literature and vision for the future.

BACKGROUND AND OBJECTIVE: Several professional societies have recommended incorporating palliative care into routine oncology care, yet palliative care remains underutilized among women with gynecologic cancers. This narrative review highlights current evidence regarding utilization of palliative care in gynecologic oncology care. Additionally, the authors offer recommendations to increase early integration and utilization of palliative care services, improve education for current and future gynecologic oncology providers, and expand the palliative care workforce. METHODS: The authors reviewed studies of palliative care interventions in oncology settings, with an emphasis on studies that included women with gynecologic malignancies. A panel of author/experts were gathered for a semi-structured interview to discuss the future of palliative care in gynecologic cancer care. The interview was recorded and reviewed to highlight themes. KEY CONTENT AND FINDINGS: Data supports routine integration of palliative care into gynecologic oncology practice. To expand delivery of palliative care, additional research that investigates implementation of palliative care across different healthcare settings is needed. There is a shortage of palliative care providers in the United States. Therefore, it is critical for gynecologic oncologists to receive a robust education in primary palliative care skillsets. Additionally, to expand the specialty palliative care workforce, palliative medicine leaders should recruit more gynecologic oncologists and other surgeons into palliative care fellowship programs. CONCLUSIONS: Expanded utilization of palliative care offers an opportunity to improve quality of care and outcomes for women with gynecologic cancers.

A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45).

PURPOSE: ATHENA (ClinicalTrials.gov identifier: NCT03522246) was designed to evaluate rucaparib first-line maintenance treatment in a broad patient population, including those without BRCA1 or BRCA2 (BRCA) mutations or other evidence of homologous recombination deficiency (HRD), or high-risk clinical characteristics such as residual disease. We report the results from the ATHENA-MONO comparison of rucaparib versus placebo. METHODS: Patients with stage III-IV high-grade ovarian cancer undergoing surgical cytoreduction (R0/complete resection permitted) and responding to first-line platinum-doublet chemotherapy were randomly assigned 4:1 to oral rucaparib 600 mg twice a day or placebo. Stratification factors were HRD test status, residual disease after chemotherapy, and timing of surgery. The primary end point of investigator-assessed progression-free survival was assessed in a step-down procedure, first in the HRD population (BRCA-mutant or BRCA wild-type/loss of heterozygosity high tumor), and then in the intent-to-treat population. RESULTS: As of March 23, 2022 (data cutoff), 427 and 111 patients were randomly assigned to rucaparib or placebo, respectively (HRD population: 185 v 49). Median progression-free survival (95% CI) was 28.7 months (23.0 to not reached) with rucaparib versus 11.3 months (9.1 to 22.1) with placebo in the HRD population (log-rank P = .0004; hazard ratio [HR], 0.47; 95% CI, 0.31 to 0.72); 20.2 months (15.2 to 24.7) versus 9.2 months (8.3 to 12.2) in the intent-to-treat population (log-rank P < .0001; HR, 0.52; 95% CI, 0.40 to 0.68); and 12.1 months (11.1 to 17.7) versus 9.1 months (4.0 to 12.2) in the HRD-negative population (HR, 0.65; 95% CI, 0.45 to 0.95). The most common grade ≥ 3 treatment-emergent adverse events were anemia (rucaparib, 28.7% v placebo, 0%) and neutropenia (14.6% v 0.9%). CONCLUSION: Rucaparib monotherapy is effective as first-line maintenance, conferring significant benefit versus placebo in patients with advanced ovarian cancer with and without HRD.

High-dose-rate interstitial brachytherapy for vaginal endometrial cancer recurrence after prior surgery and radiotherapy.

PURPOSE: Characterize the clinical outcomes of endometrial cancer vaginal recurrences after previous surgery and radiation therapy treated with reirradiation including image-guided interstitial high-dose-rate (HDR) brachytherapy. METHODS AND MATERIALS: A single-institution retrospective study identifying women receiving reirradiation for vaginal recurrence of endometrial cancer between 2004 and 2017. RESULTS: Twenty-three women had vaginal recurrences of endometrial cancer, median 13.7 months (range 3.5-104.9) from initial radiation. All received reirradiation with interstitial HDR brachytherapy, and seven also received external beam radiation. Median reirradiation EQD2_10 was 48 Gy (range 24.0-68.81), and median cumulative EQD2_10 was 106.25 Gy (range 62.26-122.0). Median follow-up after reirradiation was 40.2 months (range 4.5-112.7). At 3 years, overall survival was 56%, cancer-specific survival was 61%, and disease-free survival was 46%. 14 patients experienced disease recurrence; 10 including distant sites, one at a regional node only. Three patients experienced local recurrences, two of whom did not complete the prescribed course of reirradiation. The overall crude local control rate was 87%. Three patients experienced Grade 3 vaginal toxicity. There was no bladder or rectal toxicity with Grade >2. CONCLUSIONS: Reirradiation including interstitial HDR brachytherapy is a promising option for vaginal recurrences of endometrial cancer after prior radiation, with high rate of local control and acceptable toxicity. However, distant failure is common. Further studies are needed to determine cumulative radiation dose limits and the role of systemic therapy in this scenario.

Top Ten Tips Palliative Care Clinicians Should Know About Caring for Patients with Cervical Cancer.

Cervical cancer is the most common gynecologic cancer worldwide. Almost all are related to human papillomavirus exposure. Cervical cancer treatment is associated with significant morbidity that is likely to require support from palliative care teams. In these pearls on cervical cancer, we hope to inform providers about the common treatments and issues for cervical cancer patients. Treatment modalities include surgery for early-stage disease, radiation therapy for locally advanced disease, and pelvic exenteration, chemotherapy, or immunotherapy for recurrent disease. Cervical cancer causes pain and bleeding. Radiation can affect ovarian, urinary, and bowel function. Chemotherapy and immunotherapy are associated with fatigue and nausea. Fistulas between the vagina and bowel or bladder can occur due to cancer or to cancer treatments. Physical and emotional supportive care is important for women with cervical cancer.

Streamlining genetic testing for women with ovarian cancer in a Northern California health care system.

OBJECTIVE: Referral to Genetics for pre-testing counseling may be inefficient for women with ovarian cancer. This study assesses feasibility of gynecologic oncologists directly offering genetic testing. METHODS: A prospective pilot study was conducted at two gynecologic oncology hubs in an integrated healthcare system from May 1 to November 6, 2019. Gynecologic oncologists offered multigene panel testing to women with newly diagnosed ovarian cancer, followed by selective genetic counseling. Outcomes were compared between study participants and women from other hubs in the health system. RESULTS: Of ovarian cancer patients at study sites, 40 participated and all underwent genetic testing. Of 101 patients diagnosed at other sites, 85% were referred to genetics (p = .0061 compared to pilot participants) and 67% completed testing (p < .0001). The time from diagnosis to blood draw and notification of result was 18.5 and 34 days for the pilot group compared to 25.5 and 53 days at other sites. Panel testing detected 9 (22.5%) and 7 (10.3%, p = .08) pathogenic mutations in each group, respectively. Patients and providers were highly satisfied with the streamlined process. CONCLUSION: Genetic testing performed at the gynecologic oncology point of care for patients with ovarian cancer is feasible, increases uptake of testing, and improves time to results.

Cytological sampling of fallopian tubes using a hysteroscopic catheter: A multi-center study.

OBJECTIVE: To assess the feasibility of a novel hysteroscopic catheter to collect fallopian tube cytologic samples and to correlate cytologic findings with histopathology. METHODS: This was a prospective, multicenter, single-arm pilot study. Women undergoing salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for prevention of cancer for BRCA mutation carriers were recruited from 3 gynecologic oncology centers (October 2016-August 2017). Cytologic samples were collected from the fallopian tube using a novel FDA-cleared hysteroscopic catheter and evaluated by a pathologist blinded to surgical or pathologic findings. The correlation between cytologic results and final surgical pathology was assessed. RESULTS: Of the 50 patients enrolled, 42 were eligible. Hysteroscopies were completed in 40 patients with 78 fallopian tubes, of which 65 ostia (83%) were identified. Of these, 61 (72%) were successfully catheterized resulting in 44 (68%) cytology samples adequate for further evaluation: 5 were classified as positive (3 neoplastic and 2 malignant) and 39 as negative (34 benign and 5 reactive/atypical). A comparison of cytology results with fallopian tube histopathology showed a concordance rate of 95% (42/44). Of the two samples with discordant results, both had positive cytology but negative tubal pathology, and both were stage I ovarian cancers with malignant ovary histology. CONCLUSIONS: Deployment of the device yielded an evaluable cytologic sample in 68% of cases with a high rate of concordance with histopathology. Further evaluation of the device's ability to detect malignancy in high risk populations is warranted.

Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer.

BACKGROUND: Data are limited regarding the use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors, such as veliparib, in combination with chemotherapy followed by maintenance as initial treatment in patients with high-grade serous ovarian carcinoma. METHODS: In an international, phase 3, placebo-controlled trial, we assessed the efficacy of veliparib added to first-line induction chemotherapy with carboplatin and paclitaxel and continued as maintenance monotherapy in patients with previously untreated stage III or IV high-grade serous ovarian carcinoma. Patients were randomly assigned in a 1:1:1 ratio to receive chemotherapy plus placebo followed by placebo maintenance (control), chemotherapy plus veliparib followed by placebo maintenance (veliparib combination only), or chemotherapy plus veliparib followed by veliparib maintenance (veliparib throughout). Cytoreductive surgery could be performed before initiation or after 3 cycles of trial treatment. Combination chemotherapy was 6 cycles, and maintenance therapy was 30 additional cycles. The primary end point was investigator-assessed progression-free survival in the veliparib-throughout group as compared with the control group, analyzed sequentially in the BRCA-mutation cohort, the cohort with homologous-recombination deficiency (HRD) (which included the BRCA-mutation cohort), and the intention-to-treat population. RESULTS: A total of 1140 patients underwent randomization. In the BRCA-mutation cohort, the median progression-free survival was 34.7 months in the veliparib-throughout group and 22.0 months in the control group (hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.28 to 0.68; P<0.001); in the HRD cohort, it was 31.9 months and 20.5 months, respectively (hazard ratio, 0.57; 95 CI, 0.43 to 0.76; P<0.001); and in the intention-to-treat population, it was 23.5 months and 17.3 months (hazard ratio, 0.68; 95% CI, 0.56 to 0.83; P<0.001). Veliparib led to a higher incidence of anemia and thrombocytopenia when combined with chemotherapy as well as of nausea and fatigue overall. CONCLUSIONS: Across all trial populations, a regimen of carboplatin, paclitaxel, and veliparib induction therapy followed by veliparib maintenance therapy led to significantly longer progression-free survival than carboplatin plus paclitaxel induction therapy alone. The independent value of adding veliparib during induction therapy without veliparib maintenance was less clear. (Funded by AbbVie; VELIA/GOG-3005 ClinicalTrials.gov number, NCT02470585.).

Advanced communication: A critical component of high quality gynecologic cancer care: A Society of Gynecologic Oncology evidence based review and guide.

Effective communication between gynecologic oncology providers and patients is vital to patient-centered care. Skilled communication improves the patient's knowledge retention, builds trust in providers, enhances shared decision-making, and alleviates anxiety of both patients and caregivers. Effective communication is also associated with reduced provider burnout due to improved comfort from possessing the skills to handle emotionally charged situations. Therefore, training in serious illness communication skills is critically important to gynecologic oncology practice and benefits patients, providers, and the healthcare system. Like surgical skills, communication skills can be learned and improved upon, particularly by making use of communication skills courses and other resources. While the purpose of each conversation will vary based on the medical setting, most communication roadmaps incorporate four basic components: 1) Assess patient knowledge and understanding, 2) inform patient in accordance with her communication preferences, 3) recognize and respond to emotion 4) elicit patient values, and create a plan that aligns with those values. Improved patient outcomes associated with addressing patient emotions underscore a critical need to recognize and address emotional cues during difficult conversations. We present strategies for delivering serious news, and for discussing prognosis and goals of care. In each strategy, we highlight skills for recognizing and responding to patient and family emotional cues.

Disparities in Human Papillomavirus Vaccine Completion Rates Among Females in an Integrated Health Care System.

OBJECTIVE: To estimate the rate of human papillomavirus (HPV) vaccine completion by race and ethnicity. METHODS: In this retrospective cohort study, we analyzed females aged 11-26 years who initiated HPV vaccination from 2008 through 2012 in a community-based health care system in California. Vaccine completion was defined as having received at least three injections. Demographic data including age, race, ethnicity, and language preferences were obtained. Among Hispanic patients, acculturation was categorized as low or high using written and spoken Spanish vs English language as a proxy. Age groups were defined as younger adolescents (11-14 years), teens (15-17 years), and young adults (18-26 years). Bivariate analyses using χ tests and age-adjusted logistic regression were performed. RESULTS: Among 102,052 females who initiated HPV vaccination, a total of 41,847 (41%) completed the series. Younger adolescents had the highest completion rates (43.4%, P<.001) vs teens and young adults (37.4% and 38.0%, respectively). By race and ethnicity, Asian patients had the highest completion rates (49.5%, 95% CI 48.8-50.2), and the lowest rates were seen among black and Hispanic patients (28.7% [95% CI 27.8-29.6] and 38.9% [95% CI 38.3-39.5], respectively). Among Hispanic patients, the adjusted odds for vaccine completion was 1.2-fold higher for the low acculturated vs the highly acculturated group (adjusted odds ratio 1.23 [95% CI 1.16-1.31]). CONCLUSION: More than half of the females who initiated HPV vaccination did not complete the series, and black and Hispanic patients were least likely to have completed the series. Among Hispanic patients, the highest acculturated group had the lowest completion rate. These disparities emphasize the need for cancer prevention across all racial and ethnic groups.

Pre-operative assessment and post-operative outcomes of elderly women with gynecologic cancers, primary analysis of NRG CC-002: An NRG oncology group/gynecologic oncology group study.

INTRODUCTION: CC-002 is a prospective cooperative group study conducted by NRG Oncology to evaluate whether a pre-operative GA-GYN score derived from a predictive model utilizing components of an abbreviated geriatric assessment (GA) is associated with major post-operative complications in elderly women with suspected ovarian, fallopian tube, primary peritoneal or advanced stage papillary serous uterine (GYN) carcinoma undergoing primary open cytoreductive surgery. METHODS: Patients 70 years or older with suspected advanced gynecologic cancers undergoing evaluation for surgery were eligible. A GA-GYN score was derived from a model utilizing the GA as a pre-operative tool. Patients were followed for six weeks post-operatively or until start of chemotherapy. Post-operative events were recorded either directly as binary occurrence (yes or no) using CTCAE version 4.0. RESULTS: There were 189 eligible patients, 117 patients with primary surgical intervention and 37 patients undergoing interval cytoreduction surgery. The association between higher GA-GYN score and major postoperative complications in patients undergoing primary surgery was not significant (p = 0.1341). In a subgroup analysis of patients with advanced staged malignant disease who underwent primary cytoreductive surgery, there was a trend towards an association with the GA-GYN score and post-operative complications. CONCLUSION: The pre-operative GA-GYN score derived from a predictive model utilizing components of an abbreviated geriatric assessment was not predictive of major post-operative complications in elderly patients undergoing primary open cytoreductive surgery. However, there was an association between GA-GYN score and post-operative complications in a subgroup of patients with advanced staged malignant disease.

Salpingectomy for Sterilization: Change in Practice in a Large Integrated Health Care System, 2011-2016.

OBJECTIVE: To evaluate the utilization rate of salpingectomy for cesarean deliveries and postpartum and interval tubal sterilization procedures. METHODS: This is a retrospective cohort study using the electronic medical record to identify women older than 18 years of age undergoing surgical sterilization from June 2011 to May 2016 in an integrated health care system. The primary objective is to describe the change in utilization rate of salpingectomy for tubal sterilization procedures over time and after a systemwide practice recommendation was issued in 2013. Rates of salpingectomy and tubal occlusion were calculated for each of the five 1-year intervals in the study. Secondary outcomes included blood loss, operating time, length of stay, readmission, and emergency department visits. RESULTS: A total of 10,741 tubal sterilization procedures were identified. There was an increase in salpingectomies from 0.4% (8/1,938; 95% CI 0.2-0.8) to 35.5% (902/2,538; 95% CI 33.7-37.4) of tubal sterilization procedures performed over the study period (test for trend, P<.001). Salpingectomy instead of tubal occlusion increased at cesarean delivery from 0.1% (1/1,141; 95% CI 0.0-0.5) to 9.2% (125/1,354; 95% CI 7.8-10.9) (test for trend, P<.001); postpartum from 0% (0/124; 95% CI 0.0-3.0) to 4.5% (9/201; 95% CI 2.4-8.3) (test for trend, P=.003); and as an interval (nonpartum) tubal sterilization procedure from 1% (7/673; 95% CI 0.5-2.1) to 78% (768/983; 95% CI 75.4-80.6) (test for trend, P<.001). Median operative minutes was increased from 52 (95% CI 51-52) to 61.5 (95% CI 57-64), from 33 (95% CI 32-34) to 50 (95% CI 35-64), and from 30 (95% CI 29-30) to 33 (95% CI 32-33), respectively, for salpingectomy compared with tubal occlusion at cesarean delivery and postpartum and interval sterilization. Median blood loss was similar for salpingectomy and tubal occlusion at cesarean delivery (660 mL; 95% CI 600-700 mL compared with 700 mL; 95% CI 680-700 mL) and interval sterilization (both 5 mL; 95% CI 5-5 mL) but was more for salpingectomy postpartum (250 mL; 95% CI 200-500 mL compared with 200 mL; 95% CI 200-200 mL). CONCLUSION: There was a significant increase in salpingectomy for sterilization from June 2011 to May 2016. In the final year of the study, salpingectomy accounted for 78% of interval laparoscopic tubal sterilization procedures and 9% of intrapartum and postpartum procedures.

Salvage high-dose-rate brachytherapy and external beam radiotherapy for isolated vaginal recurrences of endometrial cancer with no prior adjuvant therapy.

PURPOSE: To evaluate clinical outcomes for isolated vaginal recurrence of endometrial cancer without adjuvant therapy treated with salvage external beam radiation therapy (EBRT) and high-dose-rate CT-based inverse-planned brachytherapy. METHODS AND MATERIALS: Thirty women were included in this retrospective study. Median time to first recurrence was 16.7 months, and median age at recurrence was 73 years. Initial grade was 1 or 2 in 19 patients (63%), and 2009 FIGO stage IA in 19 patients. All patients received pelvic EBRT in 1.8 Gy daily fractions to a total of 45 or 50.4 Gy. Interstitial brachytherapy was used in 27 patients (90%). The median total EQD2 dose was 68.3 Gy. Kaplan-Meier estimates of overall survival (OS), cause-specific survival (CSS), progression free survival (PFS), locoregional failure-free survival, and distant failure-free survival (DFFS) were calculated. RESULTS: Median follow-up was 76.4 months for vital status and 57.7 months for disease status after salvage therapy. The 5-year OS, CSS, PFS, locoregional failure-free survival, and DFFS after salvage therapy were 77%, 83%, 75%, 87%, and 86%. Initial high-grade disease was prognostic for OS, CSS, and DFFS (5-year OS 95% vs. 29%, p = 0.005). Initial stage beyond IA was prognostic for CSS, PFS, and DFFS (5-year CSS 93% vs. 74%, p = 0.025). CONCLUSIONS: Salvage EBRT and high-dose-rate brachytherapy resulted in a high rate of locoregional control. Initial high-grade and advanced stage disease were associated with greater distant failure and cancer-related mortality after salvage therapy.

Adjuvant gemcitabine-docetaxel chemotherapy for stage I uterine leiomyosarcoma: Trends and survival outcomes.

OBJECTIVE: To assess recent trends of administering adjuvant gemcitabine-docetaxel (GD) chemotherapy for Stage I uterine leiomyosarcoma, and to compare disease-free and overall survival between women who received and did not receive adjuvant GD chemotherapy. METHODS: All patients diagnosed with Stage I uterine leiomyosarcoma in a California-Colorado population-based health plan inclusive of 2006-2013 were included in a retrospective cohort. Adjuvant GD chemotherapy rates, clinico-pathologic characteristics and survival estimates were assessed. RESULTS: Of 111 women with Stage I uterine leiomyosarcoma, 33 received adjuvant GD (median 4cycles), 77 received no chemotherapy, and 1 patient excluded for non-GD chemotherapy. GD-chemotherapy and no-chemotherapy groups were similar with respect to age, stage (IA/IB), uterine weight, mitotic index, body mass index, and Charlson comorbidity score. Non-Hispanic white women were twice as likely to receive adjuvant chemotherapy as non-white or Hispanic women (37.7 vs. 17.1%, P=0.02). The proportion of women receiving adjuvant GD chemotherapy increased from 6.5% in 2006-2008 to 46.9% in 2009-2013 (P<0.001). There was no significance difference in unadjusted Kaplan-Meyer estimated disease-free (P=0.95) or overall survival (P=0.43) between GD-chemotherapy and no-chemotherapy cohorts. Corresponding adjusted Cox proportional hazard ratios for adjuvant GD chemotherapy compared to no chemotherapy were 1.01 (95% confidence interval [CI] 0.57-1.80, P=0.97) for recurrence and 1.28 (95% CI 0.69-2.36, P-0.48) for mortality. CONCLUSIONS: Use of adjuvant GD chemotherapy for Stage I uterine leiomyosarcoma has increased significantly in the last decade, despite unclear benefit. Compared to no chemotherapy, 4-6cycles of adjuvant GD chemotherapy does not appear to alter survival outcomes.

Does Surgical Teaching Take Time? Resident Participation in Minimally Invasive Hysterectomy for Endometrial Cancer.

STUDY OBJECTIVE: To determine the association between resident involvement and operative time for minimally invasive surgery (MIS) for endometrial cancer. DESIGN: A retrospective cohort study (Canadian Task Force classification II-2). SETTING: An integrated health care system in Northern California. PATIENTS: A total of 1433 women who underwent MIS for endometrial cancer and endometrial intraepithelial neoplasia from January 2009 to January 2014. INTERVENTIONS: Resident participation in 430 of 688 laparoscopic cases (62%) and 341 of 745 robotic cases (46%). MEASUREMENTS AND MAIN RESULTS: The primary outcome was the impact of resident involvement on surgical time. When residents were involved in laparoscopic and robotic surgery, there was an increase of 61 minutes (median operative time, 186 vs 125 minutes; p < .001) and 31 minutes (median operative time, 165 vs 134 minutes; p < .001), respectively. Resident participation was associated with increased operative times in all levels of surgical complexity from hysterectomy alone to hysterectomy with pelvic and para-aortic lymph node dissection. Resident participation was also associated with increased major intraoperative complications (3.4% vs 1.8%, p = .02) as well as major postoperative complications (6.4% vs 3.8%, p = .003). CONCLUSION: The presence of a resident was associated with a 32% increase in operative time for minimally invasive cases in gynecologic oncology for endometrial cancer. Because of the retrospective nature, we cannot infer causality of operative outcomes because residents were also involved in more high-risk patients and complex cases. For health care systems using surgical metrics, there may be a need to allocate more time for resident involvement.

Classification of Postoperative Complications in Robotic-assisted Compared With Laparoscopic Hysterectomy for Endometrial Cancer.

STUDY OBJECTIVE: To compare intraoperative and postoperative surgical complications and outcomes between robotic-assisted and laparoscopic surgical management of endometrial cancer using a standardized classification system. DESIGN: A retrospective cohort study (Canadian Task Force classification II-2). SETTING: An integrated health care system in Northern California. PATIENTS: One thousand four hundred thirty-three women with a diagnosis of complex atypical hyperplasia and endometrial cancer managed by minimally invasive hysterectomy and surgical staging from January 2009 to January 2014. INTERVENTIONS: Seven hundred forty-five robotic-assisted and 688 laparoscopic hysterectomies were evaluated. MEASUREMENTS AND MAIN RESULTS: The primary outcome was intraoperative and postoperative complications within 30 days. All complications were categorized using the Clavien-Dindo classification system. Secondary outcomes included total operative time, estimated blood loss, transfusion rates, length of stay, conversion to laparotomy, and number of pelvic and para-aortic lymph nodes retrieved. The modality of hysterectomy was not associated with either overall intraoperative complications or major postoperative complications (p > .1). However, there were significantly fewer minor postoperative complications with robotic surgery (16.6% vs 25.6%, p < .01). Statistically significant differences were also noted in the following outcomes: decreased median operative time, length of stay, estimated blood loss, conversion to laparotomy, and median number of lymph nodes retrieved in the robotic group when compared with the laparoscopic group. CONCLUSION: There was no difference in the rate of major complication between robotic and laparoscopic surgery using the Clavien-Dindo system of categorizing surgical complications; however, there were clinically significant differences favoring the robotic approach, including a lower rate of minor complications and conversion rate to laparotomy.

Experience With Opportunistic Salpingectomy in a Large, Community-Based Health System in the United States.

OBJECTIVE: To evaluate the trend in uptake of salpingectomy at the time of hysterectomy and assess physicians' attitudes toward the practice. METHODS: This was a retrospective cohort study using the electronic medical record to identify women 18 years of age or older undergoing hysterectomy from June 2011 to May 2014 in a large integrated health care delivery system. The primary outcome was the change in rate of opportunistic salpingectomy over time and after a systemwide practice recommendation was issued in May 2013. Secondary outcomes included data on blood loss, operating time, and length of stay. RESULTS: Of the 12,143 hysterectomies performed over the 3-year study period, 7,498 were performed without oophorectomy. There was a statistically significant rise in rate of salpingectomy over time from 14.7% for June 2011 to May 2012 to 44.6% from June 2012 to May 2013 and to 72.7% from June 2013 to May 2014 (P<.001). Sixty-one percent of laparoscopic hysterectomies were performed with salpingectomy, whereas only 25% of abdominal and 17% of vaginal hysterectomies had salpingectomies. Median estimated blood loss was lower in the salpingectomy group, 100 compared with 150 mL (P<.01). There was a significantly shorter median operating time (147 compared with 154 minutes, P=.002) for laparoscopic hysterectomy with bilateral salpingectomy compared with laparoscopic hysterectomy alone. CONCLUSION: Rates of salpingectomy increased significantly over time, consistent with the high reported acceptance rate reported by health care providers and highlighting the importance of physician education to improve compliance with risk-reducing clinical strategies.

Venous thromboembolism following minimally invasive surgery among women with endometrial cancer.

OBJECTIVE: To determine the rate of venous thromboembolism (VTE) among women undergoing minimally invasive surgery (MIS) for endometrial cancer. METHODS: Women undergoing robotic or laparoscopic hysterectomy for endometrial carcinoma or complex hyperplasia with atypia were identified between January 2009 and 2014 in a community based health care system. Patient data including age, race, cancer stage, grade, procedure type, length of hospital stay, use of prophylaxis, and diagnosis of VTE were collected retrospectively. The primary outcome was the rate of VTE within 30days following surgery. Fischer's exact tests were performed to evaluate factors associated with VTE. RESULTS: During the study period, 1433 patients underwent MIS for endometrial cancer, with 20 excluded due to known thrombophilia, VTE history, or long-term anticoagulation. A total of 1413 patients were included (739 robotic and 674 laparoscopic cases). All women received mechanical prophylaxis per hospital policy and 61% had additional pharmacologic prophylaxis. The rate of VTE was 0.35% (5/1413), which did not differ among those who received pharmacologic compared to mechanical prophylaxis (0.23% [2/865] versus 0.55% [3/548] respectively, p=0.38). No factors were associated with increased risk of VTE due to the low event rate. CONCLUSION: VTE in patients undergoing MIS for endometrial cancer was very low irrespective of the mode of prophylaxis received in this large cohort. National guidelines for VTE prophylaxis need to differentiate the low risk associated with MIS surgery from the risk associated with laparotomy for endometrial cancer. We recommend mechanical prophylaxis is sufficient for these women undergoing MIS.

Occult Uterine Sarcoma and Leiomyosarcoma: Incidence of and Survival Associated With Morcellation.

OBJECTIVE: To estimate the incidence of occult uterine sarcoma and leiomyosarcoma in hysterectomies for leiomyomas and the risk associated with their morcellation. METHODS: We conducted a population-based cohort study. All uterine sarcomas from 2006-2013 in an integrated health care system were identified. Age- and race-specific incidences of occult uterine sarcoma were calculated. Kaplan-Meier survival analysis was performed. Crude and adjusted risk ratios of recurrence and death associated with morcellation at 1, 2, and 3 years were estimated using Poisson regression with inverse probability weighting. RESULTS: There were 125 hysterectomies with occult uterine sarcomas identified among 34,728 hysterectomies performed for leiomyomas. The incidence of occult uterine sarcoma and leiomyosarcoma was 1 of 278 or 3.60 (95% confidence interval [CI] 2.97-4.23) and 1 of 429 or 2.33 (95% CI 1.83-2.84) per 1,000 hysterectomies. For stage I leiomyosarcoma (n=111), eight (7.2%) were power and 27 (24.3%) nonpower-morcellated. The unadjusted 3-year probability of disease-free survival for no morcellation, power and nonpower morcellation was 0.54, 0.19, and 0.51, respectively (P=.15); overall survival was 0.64, 0.75, and 0.68, respectively (P=.97). None of the adjusted risk ratios for recurrence or death were significant except for death at 1 year for power and nonpower morcellation groups combined (6/33) compared with no morcellation (4/76) (5.12, 95% CI 1.33-19.76, P=.02). We had inadequate power to infer differences for all other comparisons including 3-year survival and power morcellation. CONCLUSION: Morcellation is associated with decreased early survival of women with occult leiomyosarcomas. We could not accurately assess associations between power morcellation and 3-year survival as a result of small numbers.