The first discussant of the NADIM II study, Corinne Faivre-Finn, MD, PhD, Professor of Thoracic Radiation Oncology, University of Manchester, and Honorary Consultant Clinical Oncologist at The Christie NHS Foundation Trust, Manchester, England, called the results “very impressive” but noted that overall survival was not the primary endpoint. “We need to have long-term overall survival data to validate the impact of immune checkpoint inhibition on overall survival,” said Dr. Faivre-Finn. “In my view, there is also clearly a risk of applying neoadjuvant chemoimmunotherapy to patients who are not suitable for surgery in the real world.”
She also highlighted several implementation challenges for this regimen, including major pathway changes required. “Rapid next-generation sequencing and PD-L1 testing should be done upfront, and circulating tumor DNA testing should be done in the future,” she said. “All of this needs to be done in the multidisciplinary setting and possibly specialist centers.”
Dr. Faivre-Finn concluded: “The time is ripe for a clinical trial comparing a surgical with a nonsurgical approach with good integration of biomarkers for patient selection.”
Corinne Faivre-Finn, MD, PhD
Masahiro Tsuboi, MD
Key Consideration: Patient Selection
The second discussant of the NADIM II trial, Masahiro Tsuboi, MD, Chief and Director of Thoracic Surgery and Oncology at National Cancer Center Hospital East, Kashiwa, Japan, called patient selection the most important consideration, because approximately 20% of patients with N2/IIIA and IIIB non–small cell lung cancer are cured with surgery alone.
“Neoadjuvant treatment over a period of 3 months is not free of toxicity,” said Dr. Tsuboi. “There are several patients who require corticosteroids due to the immune-related adverse events.” Therefore, in addition to appropriate patient selection, it is important that patients and their families understand and accept the treatment they receive.
For patients with confirmed N2 (two or three small nodes) disease, however, Dr. Tsuboi strongly recommended neoadjuvant chemotherapy plus nivolumab followed by surgery. This suggestion is for cases in which a complete resection can be achieved with a technique other than right pneumonectomy, based on data from NADIM II and CheckMate 816.
Dr. Tsuboi also underscored the importance of multidisciplinary care. “Multidisciplinary team discussion is essential,” he concluded. “It’s very important that it is performed in high-volume centers or facilities with experience in this treatment, including surgery.”
DISCLOSURE: Dr. Faivre-Finn disclosed financial relationships with AstraZeneca, Pfizer, MSD, and Elekta. Dr. Tsuboi disclosed financial relationships with Johnson & Johnson Japan, AstraZeneca, KK, Eli Lilly Japan, Chugai Pharmaceutical, Taiho Pharma, Medtronic Japan, Ono Pharmaceutica, MSD, Bristol Myers Squibb KK, Teijin Pharma, and Novartis.
