Topical Imiquimod for the Treatment of High-Grade Squamous Intraepithelial Lesions of the Cervix: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream. METHODS: In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquimod cream applied to the cervix weekly for 12 weeks, followed by loop electrosurgical excision procedure (LEEP) without preceding treatment. The sample size was calculated based on the HSIL regression rates previously reported by Grimm et al. The primary outcome was rate of histologic regression (to CIN 1 or less) in LEEP specimens. Prespecified secondary endpoints included surgical margin status and adverse events. Outcomes were stratified by human papillomavirus type and lesion grade (CIN 2 or CIN 3). Results were reported according to per protocol (PP) and intention-to-treat (ITT) analyses. RESULTS: Ninety women were enrolled: 49 in the experimental group and 41 in the control group. In the PP population, histologic regression was observed in 23 of 38 participants (61%) in the experimental group compared with 9 of 40 (23%) in the control group (P=.001). Surgical margins were negative for HSIL in 36 of 38 participants (95%) in the experimental group and 28 of 40 (70%) in the control group (P=.004). In the ITT population, rates of histologic regression also were significantly higher in the experimental group. Rates of adverse events in the experimental group were 74% (28/38) in the PP population and 78% (35/45) in the ITT population. Adverse events were mild, with abdominal pain being the most common. Three patients in the experimental group had grade 2 adverse events, including vaginal ulcer, vaginal pruritus with local edema, and moderate pelvic pain. CONCLUSION: Weekly topical treatment with imiquimod is effective in promoting regression of cervical HSIL. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03233412.

Sentinel Lymph Node Mapping vs Systematic Lymphadenectomy for Endometrial Cancer: Surgical Morbidity and Lymphatic Complications.

STUDY OBJECTIVE: Sentinel lymph node (SLN) mapping has been proven to accurately stage endometrial cancer (EC). However, there is a lack of studies comparing the incidence of complications between different lymph node approaches in EC. The objective of the study was to define the complication rates of SLN biopsy in EC patients. DESIGN: A retrospective cohort study SETTING: A tertiary referral hospital PATIENTS: All patients who were surgically treated for EC form April 2013 to March 2018 INTERVENTIONS: Authors evaluated intraoperative complications and 30-day complications using the Memorial Sloan Lettering Cancer Center's Surgical Secondary Events Grading System, separating the patients into 4 groups: group I, hysterectomy (HT); group II, hysterectomy plus sentinel lymph node biopsy (HT+SLN); group III, hysterectomy plus pelvic lymphadenectomy, with or without para-aortic dissection (HT+LND); and group IV, hysterectomy plus lymphadenectomy and sentinel lymph node biopsy (HT+SLN+LND). MEASUREMENTS AND MAIN RESULTS: Authors identified a total of 250 cases. As compared with the HT group, the HT+SLN group did not show any increased risk of complications in terms of intraoperative complications (0 vs 1; p = 1.0) and 30-day complications (8 vs 7; p = .782), but surgical time was approximately 20 minutes longer (p = .016). Performing LND was associated with a greater risk of 30-day complications (hazard ratio [HR]: 3.11; 95% confidence interval [CI]: 1.62-5.98), intraoperative complications (HR: 14.25; 95% CI: 1.85-19.63), and lower-limb lymphedema (HR: 8.14; 95% CI: 1.01-65.27). CONCLUSION: SLN mapping does not increase morbidity in the surgical treatment of EC patients, and compared with comprehensive lymphadenectomy, it has a lower risk of complications. Our findings support the use of the SLN algorithm in EC patients.