RESUMO
BACKGROUND: Increased global cancer incidence rates have led to a growing demand for cancer diagnosis and treatment, as well as basic and clinical research on the subject. The expansion of clinical cancer trials beyond the borders of highly developed countries has aided the arrival of these assessments in South American countries. In this context, this study's objective is to highlight clinical cancer trial profiles developed and sponsored by pharmaceutical companies and conducted in South American countries from 2010 to 2020. METHODS: This study comprises descriptive and retrospective research conducted following a search for clinical trials (phases I, II and III), registered at clinicaltrials.gov, carried out in Latin American countries and sponsored by pharmaceutical companies ("Argentina", "Brazil", "Chile", "Peru", "Colombia", "Ecuador", "Uruguay", "Venezuela", "Paraguay", "Bolivia"), registered between 1 January 2010 and 31 December 2020. A total of 1451 clinical trials were retrieved, of which 200 trials unrelated to cancer were excluded and 646 duplicates were removed, leading to a final total of 605 clinical trials employing qualitative and quantitative analyses. RESULTS: A 122% increase in the number of clinical trial registrations from 2010 to 2020 was noted, with a prevalence of phase III studies (431 trials of a total of 605). Lung (119), breast (100), leukemia (42), prostate (39) and melanoma (32) were the main cancers tested for new drugs. CONCLUSIONS: The data reported herein indicate the need for strategic basic and clinical research planning that considers South American epidemic cancer profiles.
RESUMO
BACKGROUND: The treatment of choice for advanced non-small cell lung cancer is selected according to the presence of specific alterations. Patients should undergo molecular testing for relevant modifications and the mutational status of EGFR and translocation of ALK and ROS1 are commonly tested to offer the best intervention. In addition, the tests costs should also be taken in consideration. Therefore, this work was performed in order to evaluate the cost-effectiveness of a unique exam using NGS (next generation sequencing) versus other routinely used tests which involve RT-PCR and FISH. METHODS: The target population was NSCLC, adenocarcinoma, and candidates to first-line therapy. Two strategies were undertaken, strategy 1 corresponded to sequential tests with EGFR RT-PCR, then FISH for ALK and ROS1. Strategy 2 differed from 1 in that ALK and ROS1 translocation testing were performed simultaneously by FISH. Strategy 3 considered single test next-generation sequencing, a platform that includes EGFR, ALK and ROS1 genes. A decision tree analysis was used to model genetic testing options. From the test results, a microsimulation model was nested to estimate survival outcomes and costs of therapeutic options. RESULTS: The use of NGS added 24% extra true cases as well as extra costs attributed to the molecular testing. The ICER comparing NGS with sequential tests was US$ 3479.11/correct case detected. The NGS improved a slight gain in life years and QALYs. CONCLUSION: Our results indicated that, although precise, the molecular diagnosis by NGS of patients with advanced stage NSCLC adenocarcinoma histology was not cost-effective in terms of quality-adjusted life years from the perspective of the Brazilian supplementary health system.