First Nationwide Molecular Screening Program in Spain for Patients With Advanced Breast Cancer: Results From the AGATA SOLTI-1301 Study.

BACKGROUND

The SOLTI-1301 AGATA study aimed to assess the feasibility of a multi-institutional molecular screening program to better characterize the genomic landscape of advanced breast cancer (ABC) and to facilitate patient access to matched-targeted therapies in Spain.

METHODS

DNA sequencing of 74 cancer-related genes was performed using FFPE tumor samples in three different laboratories with three different gene panels. A multidisciplinary advisory board prospectively recommended potential targeted treatments. The primary objective was to determine the success of matching somatic DNA alteration to an experimental drug/drug class.

RESULTS

Between September 2014 and July 2017, 305 patients with ABC from 10 institutions were enrolled. Tumor sequencing was successful in 260 (85.3%) patients. Median age was 54 (29-80); most tumors were hormone receptor-positive/HER2-negative (74%), followed by triple-negative (14.5%) and HER2-positive (11.5%). Ninety-seven (37%) tumor samples analyzed proceeded from metastatic sites. Somatic mutations were identified in 163 (62.7%) patients, mostly in

CONCLUSIONS

AGATA is the first nationwide molecular screening program carried out in Spain and we proved that implementing molecular data in the management of ABC is feasible. Although these results are promising, only 11% of the patients with genome-driven cancer therapy received it.

Informations de copyright

Copyright © 2021 Pernas, Villagrasa, Vivancos, Scaltriti, Rodón, Burgués, Nuciforo, Canes, Paré, Dueñas, Vidal, Cejalvo, Perelló, Llommbard-Cussac, Dorca, Montaño, Pascual, Oliveira, Ribas, Rapado, Prat and Ciruelos.

Déclaration de conflit d'intérêts

SP reports advisor/consultant role for AstraZeneca, Daiichi-Sankyo, Polyphor, Novartis, SeattleGenetics, Pierre Fabre, Eisai, and Roche. Advisory role of A.P. for Nanostring Technologies, Pierre Fabre, Roche, Pfizer, Novartis, BMS and Roche. MO reports Grant/Research Support (to the Institution) from AstraZeneca, Philips Healthcare, Genentech, Roche, Novartis, Immunomedics, Seattle Genetics, GSK, Boehringer-Ingelheim, PUMA Biotechnology, and Zenith Epigenetics; personal fees from Roche, Seattle Genetics, and Novartis; consultant role for Roche/Genentech, GSK, PUMA Biotechnology, AstraZeneca, and Seattle Genetics; and travel Grants from Roche, Pierre-Fabre, Novartis, and Eisai. APr has declared personal honoraria from Pfizer, Novartis, Roche, MSD Oncology, Lilly and Daiichi Sankyo, travel, accommodations, and expenses paid by Daiichi Sankyo, research funding from Nanostring Technologies, Roche and Novartis, consulting/advisory role for Nanostring Technologies, Roche, Novartis, Pfizer, Oncolytics Biotech, Amgen, Lilly, MSD, PUMA and Daiichi Sankyo, Inc. EC reports personal fees from Pfizer and non-financial support from Pfizer during the conduct of the study; personal fees from Roche, personal fees from Lilly, personal fees from Astra Zeneca, personal fees from Novartis, and personal fees from MSD. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.