Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004.

PURPOSE: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities. METHODS: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t-tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t-test. RESULTS: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups. CONCLUSION: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.

Somatic Tumor Profile Analysis in a Patient with Germline PMS2 Mutation and Synchronous Ovarian and Uterine Carcinomas.

Lynch syndrome patients with synchronous endometrial and ovarian cancer (SEOC) are rare. When these cases occur, they are most often endometrioid histology and early grade. Early-grade tumors are not often sent for somatic tumor profiling. We present a 39 year old SEOC patient with germline PMS2 Lynch syndrome and clinical tumor analysis leading to insight regarding the origin and cause of these tumors, with potential therapy options. PMS2-related SEOC is less common due to lower risks for these cancers associated with germline PMS2 mutation compared to other Lynch genes. While synchronous cancers are not common, they are more likely to occur with Lynch syndrome. Tumor profiling with next-generation sequencing of 648 genes identified sixteen shared somatic actionable and biologically relevant mutations. This case is a rare example of a patient with PMS2 germline Lynch syndrome with shared somatic variants that demonstrate clonality of the two tumors arising from one common site.

Predictors of cervical dysplasia after the loop electrosurgical excision procedure in an inner-city population.

OBJECTIVE: To identify factors associated with persistence or clearance of cervical intraepithelial neoplasia (CIN) following loop electrosurgical excision procedure (LEEP) in high-risk patients. STUDY DESIGN: In a retrospective database review, we identified 343 patients who had 2 LEEP procedures or LEEP followed by hysterectomy for CIN at Grady Memorial Hospital. We compared margin status, endocervical curettage (ECC) at LEEP and follow-up cytology for patients characterized as having persistent or nonpersistent dysplasia. RESULTS: Seventy-nine percent (71/90) of patients with positive LEEP margins had persistent disease vs. 50% (45/90) with negative margins (odds ratio [OR]=3.7, 95% confidence interval [CI] 1.9-7.2, P<.0001). Ninety-one percent (29/32) with positive margins and positive ECC had persistent disease vs. 47% (26/55) with negative margins and negative ECC (OR=10.8, 95% CI 2.9-39.6, P<.0001). Sixty-eight percent (149/218) with at least 1 positive Pap smear following LEEP had persistent disease vs. 37% (11/30) with all negative follow-up Pap smears (OR = 3.7, 95% CI 1.7-8.3, P = .0007). CONCLUSION: Although the risk of persistent CIN increased with positive LEEP margins, ECC and cytology, these variables, when negative, offered no ensurance of a future disease-free state in this high-risk population.