Verrucous carcinoma of the vulva: Patterns of care and treatment outcomes.

BACKGROUND: Verrucous vulvar carcinoma (VC) is an uncommon and distinct histologic subtype of squamous cell carcinoma (SCC). The available literature on VC is currently limited to case reports and small single institution studies. AIMS: The goals of this study were to analyze data from the National Cancer Database (NCDB) to quantitate the incidence of VC and to investigate the effects of patient demographics, tumor characteristics, and treatment regimens on overall survival (OS) in women with verrucous vulvar carcinoma. METHODS AND RESULTS: Patients diagnosed with vulvar SCC or VC between the years of 2004 and 2016 were identified in the NCDB. OS was assessed with Kaplan-Meier curves and the log-rank test. Construction of a Cox model compared survival after controlling for confounding variables. The reported incidence of SCC of the vulva has significantly increased since 2004 (p < .0001). In contrast, the incidence of VC has remained stable (p = .344) since 2004. Compared to SCC, VC was significantly more likely to be diagnosed in older women (p < .0001) and treated with surgery alone (p < .0001). However, on propensity score weighted analysis there was a trend toward improved 5-year OS in women with VC compared to those with SCC (63.4% vs. 57.7%, p = .0794). Multivariable Cox survival analysis showed an improvement in OS in VC patients treated with both primary site and regional lymph node surgery compared to primary site surgery alone (adjusted hazard ratio [aHR] 0.67, 95% confidence interval [CI] 0.46-0.97, p = .0357). CONCLUSION: Verrucous carcinoma is more likely to present in older women. Regional lymph node surgery in addition to primary site surgery significantly improves OS in VC patients.

Role of adjuvant chemotherapy in patients with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma treated with surgery and post-operative radiotherapy.

BACKGROUND: The optimal treatment of patients with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma remains unknown. OBJECTIVE: To compare overall survival following treatment with a hysterectomy and adjuvant radiotherapy with or without chemotherapy in this group of patients. METHODS: Patients diagnosed between January 2004 and January 2016 with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma treated with hysterectomy and postoperative radiotherapy with or without adjuvant concurrent chemotherapy were identified in the National Cancer Database. Overall survival was assessed with Kaplan-Meier curves. A Cox model was constructed to evaluate survival after controlling for confounding variables. A logistic regression model was used to reveal predictors of chemotherapy use. RESULTS: A total of 2173 patients were included. The receipt of chemotherapy was associated with an increased 5-year overall survival from 67.6% to 75.6% (p=0.0313). This association trended toward statistical significance on multivariate analysis (adjusted HR (aHR) 0.80; 95% CI 0.63 to 1.01; p=0.0653). Other factors associated with improved survival were undergoing a lymphadenectomy, absence of lymphovascular space invasion, younger age, smaller tumor size, non-black race, and absence of comorbidities. Patients who underwent brachytherapy, had lymphovascular space invasion, were younger, were diagnosed in the more recent years, and were treated in higher volume centers were more likely to receive adjuvant chemotherapy. CONCLUSION: Adjuvant chemotherapy and radiation therapy were associated with an increase in survival in patients with FIGO stage IB grade 3 endometrial endometrioid adenocarcinoma compared with those treated with adjuvant radiotherapy alone.

Preliminary Trial of Intra-articular LMWF-5A for Osteoarthritis of the Knee.

This study was conducted to investigate the safety and efficacy of 3 intraarticular injections of the low-molecular-weight fraction of 5% human serum albumin (LMWF-5A) administered every 2 weeks for knee pain as a result of osteoarthritis. This single-center, randomized, vehicle-controlled, double-blind, phase II study was designed to ensure the safety of multiple intra-articular injections of LMWF-5A and to explore its efficacy in reducing pain as a result of knee osteoarthritis. Patients were randomized 1:1 to receive 3 biweekly intra-articular knee injections of either 4 mL LMWF-5A or vehicle control (saline), administered at weeks 0 (baseline), 2, and 4. Safety was examined as the incidence and severity of adverse events. Efficacy was assessed by the mean (SD) change between treatment groups in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 20. A total of 40 patients were randomized and received treatment. No drug-related serious adverse events and no deaths were reported. Adverse events were similar in patients who received saline (18, 90%) and LMWF-5A (19, 95%). Those treated with LMWF-5A had a significant decrease in pain at 20 weeks compared with the saline group (-1.41 [SD, 0.81] vs -0.85 [SD, 0.64], P=.02), corresponding to improvement in pain at week 20 of 64% with LMWF-5A compared with 40% with saline. This preliminary clinical trial showed that repeated intra-articular injections of LMWF-5A are safe when administered at 2-week intervals and are effective in providing relief of the pain of osteoarthritis of the knee at 20 weeks. [Orthopedics. 2017; 40(1):e49-e53.].