Peoples, George E.

63 Background: A novel vaccine strategy may prevent recurrence in high-risk melanoma patients (pts). The TLPLDC vaccine uses yeast cell wall particles (YCWP) to load tumor lysate into autologous dendritic cells (DC). In this phase IIb trial of TLPLDC vs. placebo in resected stage III/IV pts, TLPLDC increased 24 month (mo) disease free survival (DFS) in the per treatment (PT) population. Here, we present a 24mo DFS subgroup analysis and estimated overall 36mo DFS. Methods: Disease-free pts were randomized 2:1 to the TLPLDC vaccine vs. unloaded YCWP+DC at 0, 1, 2, 6, 12, and 18mo. The protocol was amended to allow concurrent adjuvant checkpoint inhibitor (CPI) therapy once approved. The pre-specified PT population included only pts completing the primary vaccine/placebo series (PVS) at 6 mo. Kaplan-Meier estimates of DFS were used to compare treatment arms by stage (III or IV) and CPI therapy (yes/no) in the ITT and PT populations. Results: 144 pts were randomized (103 TLPLDC, 41 placebo); 98 pts (66 TLPLDC, 32 placebo) completed the PVS. There were no clinicopathologic differences between treatment groups. There was no difference in 24mo DFS in stage III pts (n = 112), but in stage IV pts (n = 32), the 24mo DFS was 44% vs 0% (TLPLDC vs placebo) (p = 0.41) in ITT and 73.3% vs. 0% (HR 0.14, p = 0.002) in PT. Stage IV pts were more likely to receive CPI than stage III pts (50% vs. 30%, p = 0.003). There was no difference in 24mo DFS for pts who did not receive CPI (n = 102), but in pts who received CPI (n = 42), the 24mo DFS was 49.3% vs. 31.3% (p = 0.71) in ITT and 68.8% vs. 41.7% (HR 0.46, p = 0.28) in PT, showing a trend toward improved DFS in pts who completed the PVS and received CPI (n = 31). Overall, the 36mo estimated DFS was 34.2% vs. 21.6% (p = 0.89) for ITT and 56.9% vs. 27.9% (p = 0.021) for PT. Conclusions: The TLPLDC vaccine improved DFS in patients completing the PVS at 24 and 36 mos, particularly in the resected stage IV subset. The apparent synergistic effect with TLPLDC + CPI will be confirmed in a phase III study evaluating adjuvant TLPLDC + CPI vs. CPI alone in resected stage IV melanoma pts. Clinical trial information: NCT02301611.

Background: Breast cancer (BC) remains one of the top causes of cancer-related deaths in women in the United States, and little is known about the differences in access to health care between military and civilians. This study compared the differences in access to health care between military and civilian female patients with BC. In particular, this study examined whether patients with BC, in an equal access health care system such as the military, are diagnosed at an earlier stage of disease process in comparison to the patients with BC in the civilian health care system. Methods: Independent variables included military versus civilian care and demographic variables. Dependent variable was the stage of cancer at diagnosis. This cross-sectional study of 2 groups included data from 2198 women with BC (439 military and 1759 civilian) for years 2004 through 2008. Multiple logistic regression was used to analyze the data. Results: There was no difference in the early BC stage (0, I, and II) diagnosis prevalence rate between the military and the civilian groups (95% confidence interval [CI], P = .15). The logistic regression analysis indicated that both the health systems had equal performance with respect to the stage at diagnosis indicator but found that black patients had higher odds of being in the late stage (III and IV) BC group at diagnosis (1.62 OR, 1.14-2.30 CI, P = .0068) than white patients. Conclusions: Although no difference was found between the performance of the 2 health systems in the early (0, I, and II) versus late stage (III and IV) at diagnosis indicator, this study further confirms the existence of racial disparities in late-stage BC regardless of whether the patient was diagnosed in the civilian or military health system. More research is needed to further investigate the potential explanations of racial disparities other than just differences in access to health care.