ABSTRACT
PURPOSE: Alcohol consumption is associated with an increase in breast cancer risk, but findings on the association of alcohol with survival after breast cancer diagnosis have been inconsistent. Further, whether these associations could differ by adjuvant hormone therapy status is unknown. We examined interactions between alcohol consumption and adjuvant hormone therapy in relation to breast cancer-free survival among women with a primary breast cancer diagnosis. METHODS: Participants in this study included 1,399 women diagnosed with primary breast cancer between 2007 and 2012 at the Moffitt Cancer Center. Alcohol consumption during the year preceding diagnosis was assessed in a patient survey. Information on tumor characteristics, breast cancer treatment and outcomes was available from the Moffitt Cancer Registry. Associations were examined using Cox proportional hazards models in stratified analyses by adjuvant hormone therapy status, after adjustment for potential confounders. RESULTS: Overall, alcohol consumption was associated with significantly improved breast cancer-free survival (any vs. none: hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65-0.92). Among women without adjuvant hormone therapy, alcohol consumption was associated with better survival in heavy drinkers (HR, 0.63; 95% CI, 0.43-0.93). Among women with adjuvant hormone therapy, survival was better in women consuming alcohol as compared to nondrinkers (moderate: HR, 0.69, 95% CI, 0.51-0.93; heavy: HR, 0.74, 95% CI, 0.57-0.96; any: HR, 0.71, 95% CI, 0.57-0.87). There was no significant interaction between alcohol and adjuvant hormone therapy (p-interaction=0.54 for alcohol modeled as none or any and p=0.34 for alcohol modeled as none, moderate, and heavy). CONCLUSION: Associations of alcohol consumption with breast cancer-free survival are similar in women with and without adjuvant hormone therapy. Future studies are warranted to elucidate potential mechanisms underlying the observed inverse associations.
ABSTRACT
INTRODUCTION: One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to painkillers. METHODS: We used 2015 and 2016 AE reports from the US FDA's Adverse Events Reporting System (FAERS) to conduct exploratory analysis on the demographics of those who reported painkiller-related AEs, examine the AEs most commonly associated with different types of painkillers, and identify potential safety signals. Summary descriptive statistics and proportional reporting ratios (PRRs) were performed. RESULTS: Out of over 2 million reports submitted to FAERS in 2015 and 2016, a total of 64,354 AE reports were associated with painkillers. Reports of opioid-associated AEs were more likely to be from males or younger patients (mean age 47.6 years). The highest numbers of AEs were reported for NSAID and opioid use, and the most commonly found AEs were related to drug ineffectiveness, administration issues, abuse, and overdose. Death was reported in 20.0% of the reports, and serious adverse reactions, including death, were reported in 67.0%; both adverse outcomes were highest among patients using opioids or combinations of painkillers and were associated with PRRs of 2.12 and 1.87, respectively. CONCLUSIONS: This study examined the AEs most commonly associated with varying classes of painkillers by mining the FAERS database. Our results and methods are relevant for future secondary analyses of big data and for understanding adverse outcomes related to painkillers.
