Ovarian Cancer Risk-Reduction and Screening in BRCA1/2 Mutation Carriers.

Objective: To determine the utilization of risk-reducing strategies and screening protocols for ovarian cancer in female BRCA1/2 carriers. Methods: This study was a sub-analysis of female participants from a larger multicenter, cross-sectional survey of BRCA1/2 mutation carriers unaffected by cancer. The questionnaire was administered electronically via email at four institutions located in the northeast United States. Data were analyzed with Fisher's exact test. Results: The survey was completed by 104 female BRCA mutation carriers. BRCA subtypes included 54.3% BRCA2, 41.0% BRCA1, and 2.9% both. The age at which patients underwent genetic testing varied 21.2% were 18-24 years, 25.0% were 25-34 years, 29.8% were 35-44 years, and 24.0% were 45 years or older. Nearly, all respondents (97.1%) reported that a provider had discussed risk-reducing surgeries. Of the 79 females who underwent genetic testing before 45 years of age, 53.2% reported that a health care provider recommended taking combined oral contraceptive pills (COCs) to reduce their risk of ovarian cancer, and, of these women, 88.1% chose to use them. COCs were offered at higher rates among women who were younger at the age of genetic testing (18-24: 86%, 25-34: 62%, 35-44: 23%; p < 0.0001). Approximately half (55.8%) of the respondents reported having been offered increased screening for possible early detection of ovarian cancer, of which 81.0% chose to undergo screening. The majority utilized a combination of transvaginal ultrasound and serum CA125 measurements. There were no differences observed in screening utilization based on BRCA mutation type. Conclusion: In our cohort of female BRCA mutation carriers, risk-reducing surgery was offered to almost all women, whereas only half were offered risk-reducing medication and/or increased screening. Further investigation is needed to identify barriers to the utilization of risk-reducing strategies among this high-risk population.

Sexual Health in Women Affected by Gynecologic or Breast Cancer.

Sexual health problems are prevalent among women affected by gynecologic or breast cancer. It is important to understand the effects cancer treatment can have on sexual health and to have the tools necessary to identify and treat sexual health problems. This Clinical Expert Series discusses practical methods for routinely screening for sexual dysfunction and reviews sexual health treatment options for women affected by cancer. We review the limitations of the current literature in addressing sexual health problems among sexually and gender minoritized communities. Finally, we discuss appropriate timing of referrals to sexual health experts, physical therapists, and sex therapists. Multiple resources available for both patients and clinicians are included.

The impact of converting to telehealth for cancer genetic counseling and testing during the COVID-19 pandemic.

The COVID-19 outbreak in March 2020 resulted in a shift to telemedicine for cancer genetic counseling (GC). The objective of this study was to determine the effect of telehealth (TH) services on patient acceptance of recommended genetic testing, time to test completion, and follow-up test-disclosure GC appointment, as well as compliance with National Comprehensive Cancer Network (NCCN) recommendations for medical screenings when testing positive for a genetic variant. Data for this retrospective cohort study were collected at a tertiary-care academic health center using the electronic medical record and laboratory portal. Patients with traditional in-person visits (the 2019 control group) and date-matched TH visits (2020) were compared. In total, 206 new GC appointments occurred in the in-person group and 184 new appointments occurred in the TH group. The in-person group was more likely to consent to testing than the TH cohort (92.6% vs. 82.1%, p = 0.003) and had increased rates of sample submission (99.5% vs. 93.75%, p < 0.01), as well as a shorter turn-around time between their initial appointment and laboratory result reporting (34.24 vs. 20.32 days, p < 0.01). There was no increase in time from initial to follow-up GC appointments (67.87 days for control, 62.39 days for THs, p = 0.37). With >2.5 years of follow-up for all study participants, there were no statistically significant differences in pathogenic variant (PV) carrier compliance with screening recommendations. During the COVID-19 pandemic, use of TH allowed patients to access GC with no significant differences in time between initial consultation and follow-up. However, in-person visits were associated with increased patient willingness to consent to and complete genetic testing. This work offers a nuanced look at the success of TH GC during the pandemic and follow-up with screening recommendations, while offering future opportunities to address the acceptance of testing as GC is practiced in a virtual or hybrid model.

Survey of young women with breast cancer to identify rates of fertility preservation (FP) discussion and barriers to FP care.

PURPOSE: To identify the proportion of reproductive age women with breast cancer that engaged in a fertility preservation discussion and reproductive endocrinology and infertility (REI) consultation. METHODS: This cross-sectional survey recruited women 18-42 years who were diagnosed with breast cancer from 2006 to 2016 by phone or email and asked them to complete an online survey. Demographic characteristics, barriers to FP, utilization of FP consultation, and FP procedures (oocyte and embryo cryopreservation) were analyzed. RESULTS: A majority of women (64%) did not have FP discussed by any provider. Older women and those who were parents at the time of diagnosis were less likely to engage in a FP discussion. However, there were no significant differences in partner status or cancer stage between women with or without FP discussions. Of the women who desired future children prior to the cancer diagnosis, 93% received chemotherapy; however, only 34% of these women had a consultation with an REI. The most common reasons for declining FP consultation were already having their desired number of children (41%), financial barriers (14%), and concern about delaying cancer treatment and cancer recurrence (12%). Forty percent of women who desired future children and met with an REI pursued FP procedures. CONCLUSION: Younger women were more likely to receive FP counseling. FP consultations and procedures were low even in women who desired future fertility, with the predominant barriers being cost, fears concerning a delay in cancer treatment, and future cancer recurrence.

Barriers to hormone therapy following prophylactic bilateral salpingo-oophorectomy in BRCA1/2 mutation carriers.

OBJECTIVE: This study aimed to identify barriers to hormone therapy (HT) use among women with BRCA1/2 mutations after prophylactic bilateral salpingo-oophorectomy (BSO). METHODS: A cross-sectional, electronic survey was conducted of BRCA1/2 mutation carriers at Women and Infants Hospital, Yale Medical Center, Hartford Healthcare, and Maine Medical Center. This study was a subanalysis of a subset of female BRCA1/2 mutation carriers who had undergone a prophylactic BSO. Data were analyzed using the Fisher's exact test or t test. RESULTS: We performed a subanalysis of 60 BRCA mutation carriers who underwent a prophylactic BSO. Only 24 women (40%) reported ever using HT. HT use was higher in women who underwent their prophylactic BSO at age younger than 45 years (51% vs. 25%, P = 0.06). Among all women who had a prophylactic BSO, the majority (73%) reported that a provider talked to them about using HT. Two thirds reported having seen contradictory information in the media about long-term consequences of HT. Seventy percent listed their provider as the primary influence in their decision to start HT. The most common reasons for not starting HT included it not being recommended by their physician (46%) and that it was not necessary (37%). CONCLUSIONS: BRCA mutation carriers frequently undergo prophylactic BSO at young ages, and less than half report using HT. This study highlights barriers to HT use, such as patient fears and physician discouragement, and identifies potential areas to improve educational efforts.

Endometrial Cancer Surgery With or Without Concomitant Stress Urinary Incontinence Surgery.

OBJECTIVE: To compare quality of life (QOL) among patients with endometrial intraepithelial neoplasia or early-stage endometrial cancer and stress urinary incontinence (SUI) who chose to have concomitant surgery with cancer surgery alone. METHODS: A multicenter, prospective cohort study was conducted across eight U.S. sites. Potentially eligible patients were screened for SUI symptoms. Those who screened positive were offered referral to urogynecology and incontinence treatment, including concomitant surgery. Participants were categorized into two groups: 1) concomitant cancer and SUI surgery or 2) cancer surgery alone. The primary outcome was cancer-related QOL as measured by the FACT-En (Functional Assessment of Cancer Therapy-Endometrial) (range 0-100; higher score indicates better QOL). The FACT-En and questionnaires assessing urinary symptom-specific severity and effects were assessed before surgery and 6 weeks, 6 months, and 12 months after surgery. Adjusted median regression accounting for clustering was used to examine the relationship between SUI treatment group and FACT-En scores. RESULTS: Of 1,322 (53.1%) patients, 702 screened positive for SUI with 532 analyzed; 110 (21%) chose concomitant cancer and SUI surgery, and 422 (79%) chose cancer surgery alone. FACT-En scores increased for both the concomitant SUI surgery and cancer surgery-only groups from the preoperative to the postoperative period. After adjustment for timepoint and preoperative covariates, the median change in FACT-En score (postoperative-preoperative) was 1.2 points higher (95% CI -1.3 to 3.6) for the concomitant SUI surgery group compared with the cancer surgery-only group across the postoperative period. Median time until surgery (22 days vs 16 days; P <.001), estimated blood loss (150 mL vs 72.5 mL; P <.001), and operative time (185.5 minutes vs 152 minutes; P <.001) were all greater for the concomitant cancer and SUI surgery group compared with the cancer-only group, respectively. CONCLUSION: Concomitant surgery did not result in improved QOL compared with cancer surgery alone for endometrial intraepithelial neoplasia and patients with early-stage endometrial cancer with SUI. However, FACT-En scores were improved in both groups.

Financial toxicity in BRCA1 and BRCA2 carriers.

OBJECTIVE: Financial toxicity (FT), the cumulative financial burden experienced due to medical care, is a well-established adverse effect of healthcare. Patients with BRCA mutations have significantly increased cancer risks compared to non-affected individuals, requiring more frequent screenings and, at times, prophylactic surgery, increasing their risk for FT. Our primary aim in this study was to describe rates of FT among BRCA carriers. METHODS: We performed a novel, cross-sectional study of FT in BRCA1/2 carriers. Participants were recruited via phone and/or email to complete consents and surveys on REDCap. The FACIT-COST tool, a validated tool for measuring FT, was used to assess FT; scores were divided into tertiles, with high FT defined as COST score < 24. RESULTS: 265 BRCA positive female participants met enrollment criteria; 76 (28.7%) consented to participate and completed the survey. Participants were primarily non-Hispanic White (97.4%), privately insured (82.9%), and employed full time (67.1%). A significant proportion (22.7%) of participants reported delaying or avoiding care secondary to finances. No statistically significant association was seen between financial toxicity groups and analyzed demographics. Participants with high FT were more likely to engage in all surveyed cost-saving measures, with 41.7% of participants reporting delays/avoidance of care due to cost (p = 0.02). CONCLUSIONS: This study of FT in BRCA carriers shows that financial toxicity exists as an issue in this high-risk patient population. This work serves as the first description of FT in BRCA mutation carriers and highlights the importance of incorporating routine counseling on cost when discussing recommendations for screening and clinical care with this patient population.

Superficial versus deep inguinal nodal dissection for vulvar cancer staging.

OBJECTIVE: The objective of this study was to compare the rate of groin recurrence among women undergoing superficial or deep inguinal lymph node dissections in suspected early-stage vulvar carcinoma. Secondary objectives included comparison of overall survival and post-operative morbidity between the study groups. METHODS: A retrospective cohort of 233 patients with squamous cell carcinoma (SCC) of the vulva who underwent an inguinal lymph node dissection at two major academic institutions from 1999 to 2017 were analyzed. Demographic, surgical, recurrence, survival, and post-operative morbidity data were collected for 233 patients, resulting in a total of 400 groin node dissections analyzed. RESULTS: Rates of overall primary recurrence of disease between superficial and deep inguinal LND (42.5 vs. 39.8%, p = 0.70) and rates of inguinal recurrence (3.4 vs. 8.3%, p = 0.16) were similar. Overall rates of postoperative morbidity were significantly higher in the cohort undergoing deep LND (70.3% vs 44.3%, p < 0.01). Rates of lymphedema (42.4 vs 15.9%, p < 0.01), readmission (26.3 vs 6.8%, p < 0.01), and infection (40.7 vs 14.8%, p < 0.01) were all significantly higher among patients undergoing deep LND. There was no significant difference noted in overall survival between the study groups when adjusting for stage and age (HR 1.08, p = 0.84). CONCLUSION: Superficial inguinal LND had no significant difference in rate of recurrence or overall survival when compared to deep inguinal LND in patients with vulvar SCC. Those who received a deep LND had a significant increase in overall morbidity, including lymphedema, readmission, and infection. For patients who cannot undergo or fail sentinel lymph node mapping, a superficial inguinal lymph node dissection may have similar outcomes in recurrence and overall survival with a reduction in overall morbidity as compared to a complete, or deep, lymph node dissection.

Sexual health and function among patients receiving systemic therapy for primary gynecologic cancers.

OBJECTIVE: Sexual dysfunction has been reported after gynecologic cancer treatment but few studies have examined sexual function during treatment. Our objectives were to describe sexual function among women receiving systemic therapy for gynecologic cancers and to compare sexual function between women receiving upfront treatment versus treatment for cancer recurrence. METHODS: We conducted a prospective study of women 18yo and older receiving systemic therapy for gynecologic cancer in the upfront or recurrent setting. Patients receiving radiation were excluded. Participants completed a survey with questions from the Patient Reported Outcome Measurement Information System (PROMIS) SexFS and Female Sexual Function Index (FSFI). Clinical information was collected from chart review. Statistical analysis included t-test, Wilcoxon rank sum test, and Fisher's exact test. RESULTS: Of 145 patients approached, 100 (69%) enrolled and 97 (67%) completed the survey. Median age was 65yo. Most patients had ovarian cancer (58%), then endometrial cancer (34%) and cervical cancer (8%). Fifty-two (54%) were receiving recurrent treatment and 45 (46%) upfront treatment. Thirty-eight (76%) in the recurrent group and 34 (75%) in the upfront group hadn't been sexually active in the last month (p = 1.0); however, 61 (67%) participants reported a desire for future sexual activity. Of the 31 patients who completed all FSFI questions, the median FSFI score was 24.0 and 21 (68%) had sexual dysfunction. Vaginal dryness was more common among patients receiving recurrent treatment (p = 0.09) while a "health condition" was a more common reason for sexual inactivity in the upfront setting (p = 0.07). CONCLUSION: Many patients receiving systemic therapy for gynecologic cancers are willing to discuss sexual function. Most patients reported sexual dysfunction and weren't currently sexually active. Understanding patients' sexual function concerns will allow providers to intervene.

Family planning in carriers of BRCA1 and BRCA2 pathogenic variants.

BRCA1 and BRCA2 pathogenic variant carriers have a high lifetime risk of developing breast and ovarian malignancies. Given the risks and significant ramifications of undergoing risk-reducing surgeries, many pathogenic variant carriers unaffected by cancer (previvors) struggle with family planning and reproductive decision making. The objective of this study was to determine the attitudes and practices of BRCA1 and BRCA2 pathogenic variant carriers with respect to family planning decision making. A cross-sectional survey was conducted of BRCA1 and BRCA2 previvors at four Northeastern medical centers. The survey was administered electronically via email using REDCap. The survey included demographic information as well as questions about genetic testing, prophylactic surgeries, family planning, and partnering. Data were analyzed with Fisher's exact tests and t tests. The survey was completed by 139 of 422 BRCA1 and BRCA2 pathogenic variant carriers (response rate 33%). Thirteen were excluded from analysis due to self-reported cancer history. Of the remaining 126, 21 (16.7%) were male and 105 (83.3%) were female. Female participants <35 years old at the time of genetic testing were significantly more likely than those 35 or greater to report feeling urgency to have a family after finding out about their BRCA1 and BRCA2 pathogenic variant (p < 0.0001). Younger women also reported their genetic status had a stronger impact on their romantic relationships (p = 0.029). Men were significantly more likely to report that they felt no urgency to have a family compared to women (p < 0.0001). Our study reflects the complex decision making for previvors and the intricacies of family planning in this population. Providers can use this knowledge as a guide to counsel patients about reproductive options.

Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39).

PURPOSE: To evaluate the addition of the humanized monoclonal antiprogrammed death ligand-1 (PD-L1) antibody, atezolizumab, to platinum-based chemotherapy and bevacizumab in newly diagnosed stage III or IV ovarian cancer (OC). METHODS: This multicenter placebo-controlled double-blind randomized phase III trial (ClinicalTrials.gov identifier: NCT03038100) enrolled patients with newly diagnosed untreated International Federation of Gynecology and Obstetrics (FIGO) stage III or IV OC who either had undergone primary cytoreductive surgery with macroscopic residual disease or were planned to receive neoadjuvant chemotherapy and interval surgery. Patients were stratified by FIGO stage, Eastern Cooperative Oncology Group performance status, tumor immune cell PD-L1 staining, and treatment strategy and randomly assigned 1:1 to receive 3-weekly cycles of atezolizumab 1,200 mg or placebo (day 1, cycles 1-22), with paclitaxel plus carboplatin (day 1, cycles 1-6) plus bevacizumab 15 mg/kg (day 1, cycles 2-22), omitting perioperative bevacizumab in neoadjuvant patients. The co-primary end points were investigator-assessed progression-free survival and overall survival in the intention-to-treat and PD-L1-positive populations. RESULTS: Between March 8, 2017, and March 26, 2019, 1,301 patients were enrolled. The median progression-free survival was 19.5 versus 18.4 months with atezolizumab versus placebo, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.07; stratified log-rank P = .28), in the intention-to-treat population and 20.8 versus 18.5 months, respectively (hazard ratio, 0.80; 95% CI, 0.65 to 0.99; P = .038), in the PD-L1-positive population. The interim (immature) overall survival results showed no significant benefit from atezolizumab. The most common grade 3 or 4 adverse events were neutropenia (21% with atezolizumab v 21% with placebo), hypertension (18% v 20%, respectively), and anemia (12% v 12%). CONCLUSION: Current evidence does not support the use of immune checkpoint inhibitors in newly diagnosed OC. Insight from this trial should inform further evaluation of immunotherapy in OC.

Cervical Cancer Prevention: Screening Among Undocumented Hispanic Women Compared With Documented Hispanic Women.

OBJECTIVE: This study compared cervical cancer knowledge, screening practices, and barriers to screening among undocumented and documented Hispanic women. MATERIALS AND METHODS: An anonymous cross-sectional survey was administered to self-identifying Hispanic women older than 21 years at community-based clinics and health care-focused community sites in Rhode Island. The survey included demographics, immigration status, questions related to cervical cancer knowledge, screening practices, and barriers to screening. Participants were stratified based on their immigration status. Categorical variables were compared by χ2 or Fisher exact test. Knowledge scores and the number of barriers were compared by t test and Wilcoxon rank sum test, respectively. p values of less than .05 were considered statistically significant. RESULTS: Seventy-three undocumented women and 70 documented women were enrolled. Undocumented women had a significantly lower mean cervical cancer knowledge score (3.53, SD =1.97) compared with documented women (4.43, SD = 2.04; p = .0085) and also experienced more barriers to having cervical cytology or a human papillomavirus test (p = .001). Eighty-eight percent of the undocumented women and 47% of the documented women did not have health insurance (p < .0001). Sixty-two percent of the undocumented women felt that their lack of documentation was a barrier to cervical cancer screening. Fifty percent of the undocumented and 47% of the documented women had never heard of the human papillomavirus vaccine. CONCLUSIONS: Undocumented women have significantly lower mean cervical cancer knowledge scores compared with documented women. A lack of legal documentation is a significant barrier to cervical cancer screening among Hispanic women. Challenges inherent to being undocumented may contribute to women's lower knowledge scores and more pronounced barriers.

Ready for the robot? A cross-sectional survey of OB/GYN fellowship directors' experience and expectations of their incoming fellow's robotic surgical skills.

To describe OB/GYN fellowship directors' (FDs) observations, expectations, and preferences of incoming fellow's robotic surgery preparedness. Cross-sectional study. OB/GYN FDs in gynecologic oncology, minimally invasive gynecologic surgery, female pelvic medicine and reconstructive surgery, and reproductive endocrinology and infertility in the United States. 60 FDs answered the questionnaire. Participants completed an online questionnaire about their preferences and expectations of robotic surgery experience for incoming fellows. FDs observed that many incoming first-year fellows had a baseline understanding of robotic technology (60%) and robotic bedside assist experience (53%). However, few could perform more advanced robotic tasks; with FDs indicating fellows could infrequently robotically suture (18%), or perform the entire hysterectomy (15%). FDs reported higher composite observation than expectation scores (34.3 versus 22.2, p < 0.0001), and higher preference than expectation scores (34.0 versus 22.2, p < 0.0001). The composite expectation score of high-volume divisions was greater than of low-volume divisions (23.7 versus 14.0, p = 0.04). Among the domains identified, FDs most strongly preferred their fellows be able to bedside assist, have a basic understanding of robotic technology, and have basic robotic operative skills. While incoming fellows have more robotic skill than their FDs expect, few are deemed competent to independently operate the robot. Higher volume robotic surgery divisions have higher expectations of the robotic skills of their incoming fellows compared to low-volume divisions; however, FDs neither expected nor preferred their incoming fellows to be fully competent in all aspects of robotic surgery.

Phase II study of intraperitoneal submicron particle paclitaxel (SPP) plus IV carboplatin and paclitaxel in patients with epithelial ovarian cancersurgery.

Submicron particles (~800 nm) of paclitaxel (SPP) contain 1-2 billion molecules of pure drug that release tumoricidal levels of paclitaxel over many weeks. This study compared two dose-levels of SPP instilled into the peritoneal cavity (IP) in 200 ml of saline post-cytoreductive surgery. Eligible patients with primary (n = 6) or recurrent (n = 4) epithelial ovarian cancer who underwent complete cytoreductive surgery were enrolled to receive a single instillation of IP SPP followed by standard IV carboplatin and paclitaxel. Endpoints were PFS and evaluation of treatment emergent adverse events. Clinical response was determined by symptoms, physical exams, CT scans, and serum CA-125 measurements. Of the 24 subjects screened, 10 were enrolled and received treatment: seven patients received 100 mg/m2 and three received 200 mg/m2. Seven subjects completed the 12-month follow-up period. Six patients were evaluable due to one subject who had unevaluable scans throughout the follow-up period and was thus excluded from PFS determination. Upon completion of planned chemotherapy post-SPP instillation, the PFS at 6 months was 66% (4/6) and at 12-months 66% (4/6) using RECIST 1.1. One subject had a complete response at the end of IV treatment but died (unrelated to study treatment) before PFS evaluation. There was one case of incision dehiscence and one case of vaginal cuff leakage after surgery. This pilot study supports further evaluation of IP SPP to treat peritoneal carcinomas.

Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study.

INTRODUCTION: To describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab. METHODS: Summarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240. RESULTS: Of the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain. DISCUSSION: Patients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.

Sensation of Pain Using Buffered Lidocaine for Infiltration Before Vulvar Biopsy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effects of buffered lidocaine on pain scores during vulvar biopsy. METHODS: We conducted a double-blind, randomized controlled trial, using prefilled, sequentially numbered, randomized syringes to infiltrate either 3 mL of buffered or nonbuffered lidocaine before vulvar biopsy. The primary outcome was a pain score marked on a 100-mm visual analog scale during infiltration. Secondary outcomes included pain scores after the procedure and change from baseline to infiltration. Participants were recruited to detect a clinically meaningful 15-mm difference in pain scores between groups. Sample size was calculated based on the null hypothesis that the mean pain score would be the same in women treated with buffered lidocaine as in those treated with nonbuffered placebo based on prior studies. Categorical data were compared by Fisher exact test, and continuous data were compared between groups by t-test or Wilcoxon rank sum test. RESULTS: From July 2015 to April 2018, 129 participants were randomized to one of two groups: nonbuffered lidocaine or buffered lidocaine. One hundred twenty-five were analyzed (nonbuffered n=62, buffered n=63). Four patients were excluded. The majority of participants were non-Hispanic white women with a mean age of 59 years. There was no difference in the primary outcome of pain during infiltration with a mean pain score of 35.8 mm in the buffered lidocaine group compared with 42.2 in the nonbuffered lidocaine group (mean difference -6.4; 95% CI -18.4 to 5.6; P=.3 by Wilcoxon rank sum test). There was also no difference in secondary outcomes of pain over the entire procedure (mean difference -0.3, 95% CI -9.7 to 9.2; P=.7) or change in pain from baseline to infiltration (mean difference -6.9, 95% CI -18.4 to 4.7; P=.2). CONCLUSION: There was no difference in pain scores during vulvar biopsy infiltration between the buffered and nonbuffered lidocaine groups. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02698527.

The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy.

STUDY OBJECTIVE: To describe the association between preoperative dispositional mindfulness (the personality trait of being mindful) and postoperative pain in gynecologic oncology patients undergoing minimally invasive hysterectomy. DESIGN: Prospective cohort study. SETTING: University-affiliated teaching hospital. PATIENTS: Gynecologic oncology patients (n = 126) planning minimally invasive hysterectomy. INTERVENTIONS: Minimally invasive hysterectomy. MEASUREMENTS AND MAIN RESULTS: Baseline mindfulness was assessed at the preoperative visit using the Five Facet Mindfulness Questionnaire (FFMQ). Postoperative pain and opioid usage were evaluated via chart review and surveys at postoperative visits at 1 to 2 weeks and 4 to 6 weeks. Higher baseline mindfulness was correlated with lower postoperative pain as measured by both the average and highest numeric pain scores during the inpatient stay (r = -.23, p = .020; r = -.21, p = .034). At the initial postoperative visit, pain score was also inversely correlated with preoperative mindfulness score (r = -.26, p = .008). This relationship was not observed at the final postoperative visit (r = -.08, p = .406). Pre-operative mindfulness and opioid usage were also inversely associated, though this relationship did not reach statistical significance (r = -.18, p = .066). CONCLUSION: Mindfulness was previously shown to be a promising intervention for chronic pain treatment. Our study demonstrates that higher preoperative dispositional mindfulness is associated with more favorable postoperative pain outcomes, including lower pain scores but not lower opioid consumption. This relationship provides an opportunity to target the modifiable personality characteristic of mindfulness, to reduce postoperative pain in patients following gynecologic surgery.

Opioid use after minimally invasive hysterectomy in gynecologic oncology patients.

OBJECTIVES: To quantify, and identify predictors of, post-discharge opioid use in gynecologic oncology patients undergoing minimally invasive hysterectomy (MIH). METHODS: For this prospective cohort study, gynecologic oncology patients planning to undergo MIH were recruited at a single institution. Post-operative opioid usage was evaluated via chart review and surveys at 1-2-week and 4-6-week post-operative visits. Opioids are converted to oral morphine milligram equivalents (MME) for standardization. Descriptive statistics and modified Poisson regression were used to quantify opioid requirements and evaluate predictors of post-discharge opioid use respectively. RESULTS: One hundred eighteen eligible women underwent MIH. Of these, 108 had complete data at both follow-up timepoints. Malignancy was present in 79% of cases, 71% of which were endometrial cancer. Most surgeries were laparoscopic (73%). Median hospital stay was 1 night (IQR 1-1). Inpatients received a median of 30.75 MME (IQR 7.5-52.5 MME). Twenty-three women (21.3%) used no opioids while inpatient. At the 1-2-week follow-up median usage was 6 pills of 5 mg oxycodone, or 45 MME (IQR 0-15.5 pills). After complete follow-up, median post-discharge usage was 10 pills, or 75 MME (IQR 0-22.5 pills) and 36 participants (33.33%) used no opioids after hospital discharge. The median prescription was for 30 pills (range 10-60). Above median inpatient opioid use was associated with an increased risk of above median opioid usage after hospital discharge (RR 2.31, 95% CI 1.38-3.87) on multivariable analysis. CONCLUSIONS: In this cohort, opioids were overprescribed relative to use. Inpatient use was the strongest predictor of post-discharge opioid use. More restrictive, and personalized, opioid prescribing practices may be a pathway to reduce opioid misuse and diversion. PRéCIS: Opioids were overprescribed by a factor of three to gynecologic oncology patients, whose inpatient opioid requirement predicted post-discharge opioid needs after minimally invasive hysterectomy.