Secondary analyses of a phase 3 clinical trial have revealed that breast cancer patients who reported high levels of pain and stress were more likely than their study peers to experience worse invasive disease-free survival (iDFS) and worse overall survival (OS).
Shipra Gandhi, MD, MS, Associate Professor of Oncology in the Department of Medicine, Roswell Park Comprehensive Cancer Center, discussed the study as first and presenting author of “Association of higher baseline stress and pain with clinical outcomes: Secondary analysis from Alliance A011502” at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, May 31-June 4.
Alliance A011502, a randomized, double-blind clinical trial, enrolled 3,021 patients with high-risk, human epidermal growth factor receptor 2 (HER2)-positive breast cancer between January 2017 and December 2020. Its primary objective: to compare invasive disease-free survival between patients who received 300 mg of aspirin daily vs. those who received placebo. While the resulting data showed no difference in iDFS between the two groups, the study’s secondary objective — to look for links between inflammation-related factors such as stress, depression, poor sleep quality and pain — led to the observation that patients who self-reported higher stress and pain at the time of randomization had worse outcomes than other participants.
At baseline, 2,735 study participants completed the Perceived Stress Scale (PSS); 2,720 completed the Brief Pain Inventory (BPI); 2,422 completed the Pittsburgh Sleep Quality Index (PSQI); and 2,610 completed the Center for Epidemiologic Studies Depression Scale Revised (CESD-R). Stress was categorized by PSS scores: low (0-13), moderate (14-26) or high (27-40). Pain was categorized by BPI scores: none/mild (0-3) or moderate/severe (≥16). Median follow-up was 35 months.
While poor sleep quality and depression were associated with worse iDFS and OS, they were not statistically significant. However, high PSS correlated with significantly worse iDFS and (non-significant) worse OS. Moderate/severe average pain was significantly associated with worse iDFS and OS.
Roswell Park Comprehensive Cancer Center release on Newswise
