In February 2020, the Andalusian Health Technology Assessment Department (AETSA) published an assessment report on the evaluation of validity, clinical utility, and safety of the next-generation sequencing genomic platform FoundationOne® in non-small cell lung cancer and other solid tumors in Spain.
A systematic review of the scientific literature has been conducted in PubMed, the Cochrane Library, Centre for Reviews and Dissemination, and on the websites Health Technology Assessment Agencies and clinical trials. The search was limited to original studies published from 2012, including a minimum of 10 patients with non-small-cell lung cancer, breast cancer, colorectal, ovary, or melanoma cancer, in whom the genomic profile study with F1/F1CDx had been performed. The variables of results have been the detected GAs, the TMB and expression of PD-1 or PD-L1, the targeted drugs or immunotherapy indicated in each case, the number of patients treated, tumor response to treatment, overall survival, and disease-free survival, time until obtaining the results of F1/F1CDx.
The following results were outlined by AETSA:
- The literature search located 2,320 references from electronic databases and hand-searched:
- Twenty duplicates were excluded, and another 2,242 were discarded after reading the title and abstract. The remaining 58 references were retrieved to full text for in-depth reading, which led to the exclusion of 23 articles, leaving 33 original articles finally selected, 1 article reviewing the evidence on F1 and another F1 validation article
- Of the 33 articles included, 10 studied F1/F1CDx in patients with NSCLC; 17 articles, in patients with breast cancer; 1 article, in CCR; 3 publications in melanoma and 2 in the ovary
- A review of these articles has confirmed the ability of F1/F1CDx to detect GAs in the five types of tumors studied
- In addition, according to the data reported by the authors, 23% of patients with NSCLC received treatment after the results of F1/F1CDx were available
- More than 68% of the patients presented an objective response (complete and partial) and 17.50%, stable disease. F1/F1CDx seems to have influenced the therapeutic decision in 19% of patients
- Only two articles evaluated possible adverse events related to the treatment recommended by F1/F1CDx
- The low methodological quality of the included articles and a marked underreporting of results should be noted.
The following conclusion was provided by AETSA:
- F1/F1CDx has the diagnostic capacity to identify genomic alterations and therapeutic targets in patients with cancer. Still, due to the low quality of the included studies, it is necessary to carry out new studies to confirm the diagnostic results and the clinical usefulness of the test, as well as to evaluate both the potential toxicity associated with the therapies recommended by the test and the toxicity avoided by ruling out the use of ineffective drugs.
See the full health technology assessment report in Spanish here.
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