Intensive Weight Loss Intervention and Cancer Risk in Adults with Type 2 Diabetes: Analysis of the Look AHEAD Randomized Clinical Trial.

OBJECTIVE: This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality. METHODS: Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer. RESULTS: After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). CONCLUSIONS: An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.

Predictors of Follow-Up in Women with Cervical Intraepithelial Neoplasia 2-3.

OBJECTIVE: To describe a cohort of women receiving care after abnormal Pap smears and to assess predictors of follow-up in a cohort of women with cervical intraepithelial neoplasia (CIN) 2-3. STUDY DESIGN: This was a retrospective cohort study of women attending a colposcopy clinic in 2011. Data was collected by chart review and a bivariate analysis was performed to identify predictors of follow-up. RESULTS: In 2011, 21% (156/745) of women attending a colposcopy clinic at a tertiary medical center were diagnosed with CIN 2-3. Of those women 79% returned to the clinic for their recommended follow-up procedures within 8 months. Of the following factors-severity of diagnosis, age, race/ethnicity, health insurance status, language, distance to clinic, and tobacco/contraception! condom use-only young age (< 29 years) was associated with late or lack of follow-up in bivariate analysis (odds ratio 2.67, 95% confidence interval 1.10-6.83). When women under age 21 were excluded, this association was no longer observed (OR 2.31, 95% CI 0.92-6.06). CONCLUSION: In this cohort of mostly uninsured women, overall follow-up for a CIN 2-3 diagnosis was high. No single factor predictive for follow-up was identified in appropriately screened women.

Topical 5-fluorouracil for treatment of cervical intraepithelial neoplasia 2: a randomized controlled trial.

OBJECTIVE: The objective of the study was to evaluate the efficacy of intravaginal application of 5% 5-fluorouracil (5-FU) for the treatment of cervical intraepithelial neoplasia (CIN) 2 in women. STUDY DESIGN: Women aged 18-29 years with CIN 2 were recruited for this randomized controlled trial of observation vs treatment with intravaginal 5-FU. Women in the observation group returned in 6 months for a Papanicolaou smear, colposcopy, and a human papillomavirus (HPV) deoxyribonucleic acid test. Women in the 5-FU group were treated with intravaginal 5-FU once every 2 weeks for a total of 16 weeks and were similarly evaluated at 6 months. All women who had a baseline visit were included in the intention-to-treat analysis. Values of P < .05 were considered statistically significant. RESULTS: Between August 2010 and June 2013, 60 women were randomized and had a baseline visit for intervention (n = 31) vs observation (n = 29). Of women who had cervical biopsy results at 6 months, regression of disease was demonstrated in 93% of women in the 5-FU group (26 of 28) and 56% of women in the observation group (15 of 27). Under the intention-to-treat analysis, a relative risk for cervical disease regression of 1.62 (95% confidence interval [CI], 1.10-2.56) was found between the 5-FU and observation arms (P = .01). When the cervical biopsy, Papanicolaou smear, and HPV results were combined for the 6 month follow-up visit, 50% of the 5-FU group (14 of 28) had a documented normal biopsy, normal Papanicolaou smear, and negative HPV test compared with 22% in the observation group (6 of 27) (relative risk, 2.25; 95% confidence interval, 1.05-5.09; P < .05). There were no moderate or severe side effects in the intervention group. CONCLUSION: Topical 5-FU appears to be an effective medical therapy for CIN 2 in young women. 5-FU is readily available and may be considered as an off-label treatment option for young women with CIN 2 who are interested in the treatment of disease but want to avoid excisional procedures.