Abstract 225P
Background
NGS use improve outcomes in cancer patients. However, approved drugs in differents countries is a concern. The impact in intermediate-low income populations is less studied. We report the results about the utility of NGS at a comprehensive cancer center in Cali, Colombia. Country with less approved drugs by the national regulator (INVIMA) compared to populations such as in Europe (EMA) or United States (FDA).
Methods
Retrospective study of patients with advanced cancer who underwent NGS either by tissue or liquid biopsy, between March 2019 and March 2023 at The Comprehensive Cancer Center Clinica de Occidente in Cali-Colombia. Relevant sociodemographic, clinical, and molecular variables were included. We performed descriptive, Kaplan Meier and cox regression analysis. The study was approved by the institutional ethics committee. The information was analyzed with Stata 16.
Results
156 patients were identified. Median age was 66 years (20-89), 51% men. 18 different tumors types were included, with lung (39.1%), prostate (22.4%), breast (7.0%), colorectal (6.3), ovarian (5.1%), gastroesophageal (5.0%), between the principals. Actionable alterations (ESCAT I-V) were found in 49.6% of the patients, most were evidence I in 81% of them. 90% had FDA approval, 84% EMA, and 59% national approval by INVIMA. After the NGS result, clinical decision was modified in 46.4% of cases and match therapy was used in 57.5% of them. In those patients, there was better clinical benefit with OR 6 (95% CI 1.31-29.39, P=0.0059) and objective response OR 12 (95% CI 1.88-88.38, P=0.0012) There was significant improvement of PFS HR 0.27 (95% CI 0.13-0.56, P=0.000) and OS HR 0.34 (95% CI 0.15-0.73, P=0.002)
Conclusions
Genomic profiling through NGS had a significant impact on decision-making and patient prognosis, despite the fact that only 59% of the indicated matched drugs had national approval for their use.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Roche.
Disclosure
M. Lombana Quinonez: Financial Interests, Institutional, Invited Speaker: Roche. All other authors have declared no conflicts of interest.
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