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.

Risk and Protective Factors for COVID-19 Infection among Pregnant Women with Sickle Cell Trait.

Pregnant women and individuals with sickle cell trait (SCT) and underlying comorbidities are both independently more vulnerable to severe illness from coronavirus disease 2019 (COVID-19) compared to nonpregnant women and those without SCT. However, our understanding of the specific factors influencing susceptibility to COVID-19 infection among pregnant women with SCT is currently constrained by limited available data. This study aims to determine the risk and protective factors that influence the likelihood of COVID-19 infection in this population. A retrospective analysis was done among 151 women with SCT in the reproductive age group. Multivariable analysis was performed to determine the various factors affecting COVID-19 infection among pregnant women with SCT. The study found that COVID-19-vaccinated pregnant women with SCT had a 90% lower risk of contracting COVID-19 and were 9 times more likely to have a COVID-19 infection if they had a history of pulmonary conditions such as asthma or chronic obstructive pulmonary disease. The present study further emphasizes the importance of the COVID-19 vaccine in preventing infection and safeguarding the health of pregnant women with SCT, particularly those with underlying comorbidities.

A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms: Results from ECOG-ACRIN E1Z11.

PURPOSE: Aromatase inhibitor (AI)-associated musculoskeletal symptoms (AIMSS) are common and frequently lead to AI discontinuation. SNPs in candidate genes have been associated with AIMSS and AI discontinuation. E1Z11 is a prospective cohort study designed to validate the association between 10 SNPs and AI discontinuation due to AIMSS. PATIENTS AND METHODS: Postmenopausal women with stage I to III hormone receptor-positive breast cancer received anastrozole 1 mg daily and completed patient-reported outcome measures to assess AIMSS (Stanford Health Assessment Questionnaire) at baseline, 3, 6, 9, and 12 months. We estimated that 40% of participants would develop AIMSS and 25% would discontinue AI treatment within 12 months. Enrollment of 1,000 women with a fixed number per racial stratum provided 80% power to detect an effect size of 1.5 to 4. SNPs were found in ESR1 (rs2234693, rs2347868, and rs9340835), CYP19A1 (rs1062033 and rs4646), TCL1A (rs11849538, rs2369049, rs7158782, and rs7159713), and HTR2A (rs2296972). RESULTS: Of the 970 evaluable women, 43% developed AIMSS and 12% discontinued AI therapy within 12 months. Although more Black and Asian women developed AIMSS than White women (49% vs. 39%, P = 0.017; 50% vs. 39%, P = 0.004, respectively), the AI discontinuation rates were similar across groups. None of the SNPs were significantly associated with AIMSS or AI discontinuation in the overall population or in distinct cohorts. The OR for rs2296972 (HTR2A) approached significance for developing AIMSS. CONCLUSIONS: We were unable to prospectively validate candidate SNPs previously associated with AI discontinuation due to AIMSS. Future analyses will explore additional genetic markers, patient-reported outcome predictors of AIMSS, and differences by race.

Primary Small Cell Carcinoma of the Breast: An Approach to Medical and Surgical Management.

Primary small cell carcinoma of the breast (PSCCB) is a rare and aggressive tumor. Due to the small number of PSCCB cases, there are no established treatment protocols. We report a case of a 55-year-old perimenopausal woman who presented with a palpable left breast mass. A breast mass biopsy was performed, and pathology was consistent with poorly differentiated neuroendocrine small cell carcinoma. Imaging with magnetic resonance imaging (MRI) and positron emission tomography (PET) excluded metastatic disease. Due to recurrent positive margins, the patient underwent two lumpectomies and received neoadjuvant chemotherapy in between procedures. She ultimately underwent a left mastectomy and received postoperative radiation therapy. This case report aims to highlight the challenges that ensue following a diagnosis of PSCCB and underscores the need for creating a standardized treatment model for these vulnerable patients.

Delayed Diagnosis of Duodenal Metastasis From Primary Lung Adenocarcinoma: A Case Report.

The incidence of lung cancer metastasizing to the duodenum is rare, and its clinical presentation is still not fully understood due to its low frequency. It can be asymptomatic or present symptomatically in various ways. Here, we present the case of a 63-year-old female with an unusual case of duodenal metastasis from pulmonary adenocarcinoma, presenting with a new-onset seizure complicated by a fracture from a post-ictal fall. The diagnosis of anemia secondary to duodenal metastasis from lung cancer was delayed due to this sequence of events. The patient was ultimately found to have a circumferential mass in the third portion of the duodenum on esophagogastroduodenoscopy, which was found to be consistent with metastatic pulmonary adenocarcinoma on pathological examination.

Spinal Cord Compression as Initial Presentation in Hepatocellular Carcinoma.

Hepatocellular carcinoma (HCC) is the most common primary hepatic malignancy and aggressive neoplasms with high metastatic potential to the lung, regional lymph nodes, and bone. Metastatic spinal cord compression due to HCC is a rare, unusual initial presentation and is a neurosurgical emergency. We present two cases of HCC where spinal cord compression was the initial presentation before the diagnosis of HCC. Our first patient presented with bilateral flank pain. The biopsy of the chest wall showed HCC. However, a CT scan of the abdomen showed metastatic involvement of the T11 vertebra. He was found to have severe spinal canal stenosis on MRI of the back without neurological deficit. He underwent an emergent tumor decompression of the T11 vertebra with kyphoplasty. Our second patient was a young man who presented with cord compression symptoms, which included bilateral leg weakness and an inability to void. An urgent laminectomy with decompression of the lumbar spine was performed. He received radiotherapy for spinal metastasis and started systemic therapy for HCC. Unfortunately, he failed multiple lines of systemic therapy, and the progression of the disease complicated his clinical course with spinal cord compression for the second time.