Abstract
1594 Background: OUTBACK was an international multi-center phase 3 trial investigating adjuvant chemotherapy following definitive chemoradiation in locally advanced cervix cancer. We analysed if baseline characteristics were associated with survival outcome. More specifically, we determined whether race held prognostic significance relative to established clinical factors. Methods: We compared baseline characteristics (encompassing demographics, biomarkers and participants’ self-ratings of EORTC QLQ-C30 scores) between racial groups using chi-squared tests. We then explored relationships between baseline characteristics and survival outcomes using univariable and multivariable Cox proportional hazards regression models with stepwise selection. Results: Black or African American participants accounted for 13% (n=121/919) of the OUTBACK study population. There were no evident differences in the proportion of Black or African American participants, as compared to other racial groups, across most baseline characteristics, except for country of residence (USA vs non-USA, p<0.01). When examining the impact of race (Black or African American vs other racial groups) on survival outcomes in locally advanced cervix cancer, we found no evident associations with overall survival (HR 1.2; 95%CI,0.84 – 1.72; p=0.32) or progression free survival (HR 1.29; 95%CI, 0.95 – 1.75; p=0.10). Multivariable analysis identified several independent prognostic factors for overall survival, including performance status (HR 1.43; 95%CI, 1.04-1.95; p=0.03), FIGO stage (HR 2.02; 95%CI, 1.48-2.75; p<0.01), nodal involvement (HR 1.59; 95%CI, 1.18-2.14; p<0.01), and elevated white cell count (HR 1.68; 95%CI, 1.21-2.33; p<0.01). Role function, social function, financial difficulties and eGFR showed significance in univariable analysis for overall survival but did not retain significance in multivariable analysis. These findings were consistent when examining progression-free survival. Conclusions: No discernible disparities in survival outcomes were observed between Black or African American participants and other racial groups undergoing primary treatment for locally advanced cervix cancer. The primary prognostic determinants for this disease continue to be cancer staging and clinical performance status. Enrolment into a clinical trial may have abrogated the historical disparities seen among ethnic and racial groups. Clinical trial information: 12610000732088.