Tetsuya Mitsudomi, MD
Tetsuya Mitsudomi, MD, Professor at Kindai University in Japan and President of the International Association for the Study of Lung Cancer, commented on the negative results of the phase III randomized ITACA trial of adjuvant therapy customization.
“This trial confirmed that there is no biomarker strong enough to predict the efficacy of cytotoxic chemotherapy; however, the concept of customizing adjuvant therapy according to the genomic status of patients’ tumors is valid, leading to the recent demonstration in the ADAURA study1 of the superiority of osimertinib in delaying the postoperative recurrence of disease in patients with EGFR-mutated non–small cell lung cancer,” Dr. Mitsudomi said.
“The ITACA study is the largest adjuvant study tailored to ERCC1 and thymidylate synthase status, and the results have been long awaited. This trial should be praised for the mandated genomic analysis that was accomplished within a reasonably short time frame before random assignment,” he commented.
DISCLOSURE: Dr. Mitsudomi has received honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharma, Daiichi Sankyo, Ethicon, Guardant Health, Janssen Oncology, Kyowa Hakko Kirin, Lilly, Merck KGaA, MSD KK, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, Takeda, and Thermofisher Scientific Biomarkers; has served as a consultant or advisor to Amgen, AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Lilly, MSD Oncology, Novartis, Ono Pharmaceutical, Pfizer, and Thermo Fisher Scientific; and has received institutional research funding from AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Kyowa Hakko Kirin, MSD KK, Ono Pharmaceutical, Pfizer, Sanofi/Aventis, and Taiho Pharmaceutical.
1. Herbst RS, Tsuboi M, John T, et al: Osimertinib as adjuvant therapy in patients with stage IB-IIIA EGFR mutation positive NSCLC after complete tumor resection: ADAURA. ASCO20 Virtual Scientific Program. Abstract LBA5.
Tailoring adjuvant chemotherapy based on the expression of two molecular markers did not lead to a survival advantage in patients with completely resected stage II to III non–small cell lung cancer (NSCLC) in the phase III ITACA trial. This result was presented during the virtual edition of the...