Abstract P5-08-12: Association of Baseline Global Inflammation Score with Clinical Outcomes: Secondary Analysis from Alliance A011502

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Abstract Background: A011502 is a phase 3 randomized double-blind clinical trial that randomized high risk nonmetastatic breast cancer (BC) patients (pts) to aspirin 300 mg daily vs placebo. We previously reported on the association of lifestyle factors (linked with inflammation) with clinical outcomes and found that high perceived stress scale (PSS) scores and moderate/severe pain assessed with Brief Pain Inventory (BPI) were significantly associated with worse invasive disease free (iDFS) and overall survival (OS). We hypothesized that a global inflammation score encompassing lifestyle measures associated with inflammation (stress, poor sleep quality, depression, pain, being overweight/obese) could predict a subset of pts who are at the highest risk of worse outcomes. Methods: 2257 BC pts enrolled on A011502 answered 4 validated questionnaires at baseline that, along with BMI, were used to calculate global inflammation score. These questionnaires included PSS, categorized as low: 0-13 (=0 (these patients were given a score = ‘0’)) or moderate: 14-26 (=0.5) or high stress: 27-40 (=1); BPI, categorized as none: 0/mild: 1-3 (=0) or moderate/severe pain: 4-10 (=1); Pittsburgh Sleep Quality Index: PSQI, categorized as good: 0-5 (=0) or poor sleep quality: 6-10 (=1); Center for Epidemiologic Studies Depression Scale Revised: CESD-R, categorized as no depression (=0) or depression (=1); and BMI, categorized as normal weight = 0; overweight = 0.5; obese = 1. Thus, global inflammation score per pt was obtained by summing the individual scores and ranged from 0 to 5. Association between global inflammation score (both as a continuous and categorical variable as tertiles (T1: 0-1, T2: 1.5-2, T3: 2.5-5)) and iDFS and OS was performed with multivariable Cox models controlling for age, cancer stage, time since diagnosis, race, ethnicity, hormone receptor status and treatment arm. Results: Median age was 53 (23-69) years, 83.2% White, 69.2% stage II, 89.1% hormone receptor positive; median time from diagnosis to answering questionnaires was 12.9 months. Median follow-up was 35 months. Median global inflammation score was 1.5. Pts with higher global inflammation score (continuous) had worse iDFS (events/total=195/2257), hazard ratio (HR) 1.14 (95% CI: 1.00, 1.30), p=0.04; and worse OS (events/total=89/2257), HR 1.24 (95% CI: 1.04, 1.49), p=0.02. Categorizing global inflammation score into tertiles revealed a non-linear relationship for iDFS: T1 reference, T2 HR 1.09 (95% CI: 0.77, 1.54), and T3 HR 1.44 (95% CI: 1.01, 2.05); and a non-linear relationship for OS: T1 reference, T2 HR 1.59 (95% CI: 0.92, 2.74), and T3 HR 2.04 (95% CI: 1.19, 3.51). Based on this, we dichotomized the global inflammation score as low (score in T1 or T2) and high (score in T3). Pts in high group had worse iDFS (events/total=68/643): HR 1.38 (95% CI: 1.02, 1.86), p=0.04; and worse OS (events/total=35/643): HR 1.59 (95% CI: 1.03, 2.45), p=0.04 compared to low group. There was no difference in iDFS for high or low inflammation group by treatment arm. Conclusions: Pts with higher global inflammation score at baseline had worse iDFS and OS in a randomized controlled trial of aspirin vs placebo in high-risk BC survivors. It is possible that some measures may be related to other non-cancer issues (e.g., chronic comorbidities, social determinants of health, endocrine therapy adherence) that were not captured in our study. Moreover, use of aspirin did not influence outcomes regardless of inflammation score. These results highlight the need for clinical trials to consider including measures affiliated with inflammation and BMI. Future studies are warranted to determine if measures that reduce inflammation would improve BC outcomes. Support: U10CA180821, U10CA180882; U10CA180820, U10CA180868, U10CA180888 https://acknowledgements.alliancefound.org; NCT02927249 Citation Format: Shipra Gandhi, Karla V. Ballman, Sarah K. Reed, Michelle D. Holmes, Kala Visvanathan, Banu Symington, Margaret Carvan, Carol Matyka, Anna Weiss, Eric P. Winer, Wajeeha Razaq, Paula R. Pohlmann, Lisa A. Carey, Ann H. Partridge, Wendy Y. Chen. Association of Baseline Global Inflammation Score with Clinical Outcomes: Secondary Analysis from Alliance A011502 [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P5-08-12.

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