Abstract P3-15-02: Latin American participation in practice-changing breast cancer trials in the last 25 years

Abstract

Abstract Introduction: Latin America (LATAM) is among the so-called emerging regions for conducting clinical trials. Complex not-harmonized regulatory frameworks and lengthy approval timelines (among other factors) present challenges for increased LATAM trial participation. Objective: to assess LATAM contribution to clinical trials, we conducted a descriptive analysis of the region participation in practice-changing breast cancer (BC) trials. Methodology: we defined practice-changing trial as any one that supported FDA approval of a new drug or a new indication for a previously approved drug; we excluded trials that only led to approval of changes in regimen/doses. Through the FDA website we searched all drugs approved for BC treatment between January 1992 and December 2017. For each FDA-approved drug we identified applicable practice-changing trials in the latest package insert. We analyzed each applicable published article for data of interest: drug approval year, indication, participating countries, number of sites per country, trial start year of enrollment, authors per country, among others. If all these data was not available in the article we searched for it in clinicaltrials.gov. If all data was neither in the article nor clinicaltrials.gov, the trial was excluded from our analysis. Results: 31 trials that led to the approval of 17 drugs were included in our analysis. LATAM participated in 21 trials (67.7%), mean number of LATAM countries per trial = 3.3 and mean number of sites per trial = 13.5. The region participated in 90% of (neo)adjuvant and in 57% of metastatic trials. Additional data is in Table 1. As an average, LATAM contributed with 4.9% of all trial sites. Argentina, Brazil and Mexico had 84% of LATAM sites, Peru and Colombia 8%, and the remaining 8% were distributed among 15 LATAM countries. The 5-year periods with highest number of trials in the region was 2001-05 and 2006-10 (Table 2). Fifteen LATAM authors (87% from Argentina and Brazil) from a total of 530 authors (2.8%) were identified in the primary publication, none of them as first or last author. Conclusion: over the last 25 years the number of practice-changing BC trials conducted in LATAM has increased since 1990s, remained stable from 2001-10 and recently decreased. LATAM participated in the majority of (neo)adjuvant trials; longer time for enrollment and duration of these trials could explain this finding since these would allow for inclusion of regions with longer regulatory timelines. Region's contribution in terms of countries, sites and authors is minor. Disparities within LATAM countries are remarkable and, as expected, the 3 largest countries are the key contributors. A comparison with other emerging regions will be presented. LATAM participation in practice- changing BC trialsCharacteristicsTotalLATAMNumber of trials3121Mean number of sites/trial188.513.5Indication (Neo) adjuvant trials109Metastatic trials2112Drug Type Endocrine therapy105Chemotherapy64Anti HER2109CDK4/6 inhibitors42Other11 LATAM participation per 5-year periodPeriod (per year of trial enrollment start)Number of LATAM trialsLATAM sites per trial1986-1990001991-1995210.51996-2000414.32001-2005614.72006-2010614.72011-2015312.0 Citation Format: Machado A, Migliaro A, Fresco R. Latin American participation in practice-changing breast cancer trials in the last 25 years [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P3-15-02.