RESUMO
Background: Bevacizumab-awwb (MVASI®) was the first U.S. Food and Drug Administration-approved biosimilar to Avastin® (reference product [RP]) for the treatment of several different types of cancers, including metastatic colorectal cancer (mCRC), an indication approved based on extrapolation. Objectives: Evaluate treatment outcomes in mCRC patients who received first-line (1L) bevacizumab-awwb at treatment initiation or as continuing bevacizumab therapy (switched from RP). Design: A retrospective chart review study. Methods: Adult patients who had a confirmed diagnosis of mCRC (initial presentation of CRC on or after 01 January 2018) and initiated 1L bevacizumab-awwb between 19 July 2019 and 30 April 2020 were identified from the ConcertAI Oncology Dataset. A chart review was conducted to evaluate patient baseline clinical characteristics and effectiveness and tolerability outcomes during the follow-up. Study measures were reported stratified by prior use of RP: (1) naïve patients and (2) switchers (patients who switched to bevacizumab-awwb from RP without advancing the line of therapy). Results: At the end of study period, naïve patients (n = 129) had a median 1L progression-free survival (PFS) of 8.6 months [95% confidence interval (CI), 7.6-9.9] and a 12-month overall survival (OS) probability of 71.4% (95% CI, 61.0-79.5%). Switchers (n = 105) had a median 1L PFS of 14.1 months (95% CI, 12.1-15.8) and a 12-month OS probability of 87.6% (95% CI, 79.1-92.8%). During treatment with bevacizumab-awwb, 20 events of interest (EOIs) were reported in 18 naïve patients (14.0%) and 4 EOIs reported in 4 switchers (3.8%), of which the most commonly reported events were thromboembolic and hemorrhagic events. Most EOIs resulted in emergency department visit and/or treatment hold/discontinuation/switch. None of the EOIs resulted in death. Conclusion: In this real-world cohort of mCRC patients who were treated 1L with a bevacizumab biosimilar (bevacizumab-awwb), the clinical effectiveness and tolerability data were as expected and consistent with previously published findings from real-world studies of bevacizumab RP in mCRC patients.
RESUMO
With climate change, extreme heat (EH) events are increasing, so it is important to understand who is vulnerable to heat-associated morbidity. We determined the association between EH and hospitalizations for all natural causes; cardiovascular, respiratory, and renal diseases; diabetes mellitus; and acute myocardial infarction in Michigan, USA, at different intensities and durations. We assessed confounding by ozone and how individual characteristics and health insurance payer (a proxy for income) modified these associations. We obtained Michigan Inpatient Database, National Climatic Data Center, and US Environmental Protection Agency ozone data for May-September, 2000-2009 for three Michigan counties. We employed a case-crossover design and modeled EH as an indicator for temperature above the 95th, 97th, or 99th percentile thresholds for 1, 2, 3, or 4 days. We examined effect modification by patient age, race, sex, and health insurance payer and pooled the county results. Among non-whites, the pooled odds ratio for hospitalization on EH (97th percentile threshold) vs. non-EH days for renal diseases was 1.37 (95 % CI = 1.13-1.66), which increased with increasing EH intensity, but was null among whites (OR = 1.00, 95 % CI = 0.81, 1.25). We observed a null association between EH and cardiovascular hospitalization. EH (99th percentile threshold) was associated with myocardial infarction hospitalizations. Confounding by ozone was minimal. EH was associated with hospitalizations for renal disease among non-whites. This information on vulnerability to heat-associated morbidity helps characterize the public health burden of EH and target interventions including patient education.
