Disease progression, survival, and molecular disparities in Black and White patients with endometrioid endometrial carcinoma in real-world registries and GOG/NRG oncology randomized phase III clinical trials.

OBJECTIVE: Investigate racial disparities in outcomes and molecular features in Black and White patients with endometrioid endometrial carcinoma (EEC). METHODS: Black and White patients diagnosed with EEC who underwent hysterectomy ± adjuvant treatment in SEER, National Cancer Database (NCDB), the Genomics Evidence Neoplasia Information Exchange (GENIE) project (v.13.0), and eight NCI-sponsored randomized phase III clinical trials (RCTs) were studied. Hazard ratio (HR) and 95% confidence interval (CI) were estimated for cancer-related death (CRD), non-cancer death (NCD), and all-cause death. RESULTS: Black (n = 4397) vs. White (n = 47,959) patients in SEER had a HR (95% CI) of 2.04 (1.87-2.23) for CRD and 1.22 (1.09-1.36) for NCD. In NCDB, the HR (95% CI) for death in Black (n = 13,468) vs. White (n = 155,706) patients was 1.52 (1.46-1.58) dropping to 1.29 (1.23-1.36) after propensity-score matching for age, comorbidity, income, insurance, grade, stage, LVSI, and treatment. In GENIE, Black (n = 109) vs. White (n = 1780) patients had fewer PTEN, PIK3R1, FBXW7, NF1, mTOR, CCND1, and PI3K-pathway-related gene mutations. In contrast, TP53 and DNA-repair-related gene mutation frequency as well as tumor mutational burden-high status were similar in Black and White patients. In RCTs, Black (n = 187) vs. White (n = 2877) patients were more likely to have advanced or recurrent disease, higher grade, worse performance status and progressive disease. Risk of death in Black vs. White patients in RCTs was 2.19 (1.77-2.71) persisting to 1.32 (1.09-1.61) after matching for grade, stage, and treatment arm while balancing age and performance status. CONCLUSIONS: Differences exist in clinical presentation, outcomes, and molecular features in Black vs. White patients with EEC in real-world registries and RCTs. Targeted-drug development, strategies to modify social determinants, and diverse inclusion in RCTs are approaches to reduce disparities.

A reminder system for postpartum diabetes screening after gestational diabetes: a randomized clinical trial.

OBJECTIVE: To evaluate if a reminder postpartum screening system, providing patients with laboratory requisition on the postpartum ward followed by a telephone reminder one week prior to their 6 weeks appointment, would increase the diabetes mellitus screening rate. METHODS: Parallel group, open label, multicenter randomized trial. Patients were recruited between July 2015 and March 2016. All women with gestational diabetes mellitus in their index pregnancy with access to a mobile or landline phone were eligible for participation. Gestational diabetes mellitus diagnosis was made with a one-hour 50 g OGTT ≥135 mg/dl, and a subsequent 3 h OGTT with ≥2 values above fasting 95 mg/dl, 1 h 180 mg/dl, 2 h 155 mg/dl, and 3 h 140 mg/dl. Participants were assigned in a 1:1 ratio to "reminder system" (intervention group) or to "routine care (control group)." Those assigned to the reminder system were provided with two reminders. The first was a laboratory requisition slip given to them while on the postpartum ward. The second was a telephone reminder on the fifth week postpartum, consisting of a standardized script to encourage contacted participants to complete the screening test during the sixth week postpartum. The primary outcome was completion of the two-hour 75 g OGTT 6-12 weeks postpartum. RESULTS: A total of 75 patients were included in the study. Thirty-eight patients were randomized to the reminder system, and 37 patients were randomized to routine care. A total of 22 women (29.3%) completed the test. In the "reminder" group, 31.6% completed the test, and in the "routine care" group 27% of patients completed the test. This increase in screening uptake in the reminder group was not noted to be statistically significant (p=.8). When evaluating whether perinatal or sociodemographic factors influenced the effect of reminder systems on screening uptake, only insurance type was noted to have a statistically significant influence. Screening uptake was significantly increased in patients with public insurance assigned to "reminder group" (13.5%) compared to those assigned to "routine care" (0%). Of those women who completed the test, seven patients (31.8 %) were diagnosed with prediabetes and none with diabetes. CONCLUSIONS: Telephone reminders were not found to have a significant impact on increasing postpartum screening for diabetes. The exception was among the publicly insured population. These findings suggest a targeted role for reminder systems, particularly among those with socioeconomic disadvantage.