Background: Patients with locally advanced (stage III) non-small cell lung cancer (NSCLC) demonstrate broad anatomic heterogeneity with modest survival benefits. Immune checkpoint inhibitors (ICIs) have shown survival benefit in metastatic NSCLC. We conducted this study to evaluate the efficacy and safety of neoadjuvant nivolumab in combination with chemotherapy in the treatment of this population.
Methods: We retrospectively evaluated patients with locally advanced NSCLC receiving neoadjuvant nivolumab and chemotherapy (paclitaxel with carboplatin) followed by surgery at our institution from January 2019 to January 2020.
Results: A total of 46 eligible patients, 26 males, and 20 females were diagnosed with NSCLC in a stage IIIA (30 cases) and IIIB (16 cases) to receive neoadjuvant treatment. The treatment was well tolerated with just 7 (15.2%) typical immune-related adverse events (hyperthyroidism, hyperglycemia, and rash) recorded. A total of 45 patients underwent surgical resection, and 43 (95.6%) of them achieved a R0 resection. No major surgical complications were observed. There was a complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) in 2 (4.3%), 26 (56.5%), 17 (37.0%), 6 (26.1%), and 1 (2.2%) patients. Eight patients resulted in a major pathological response (MPR) (17.4%) and 24 patients had a pathological complete response (pCR) (52.2%). At the time of data cutoff (June 1, 2021), the median follow-up period was 15.5 months (IQR 3.9– 29) and 27 (60%) of 45 patients who had tumor resection were progression free. At 24 months, progression-free survival was 45.8% and overall survival was 79.9%.
Conclusion: Nivolumab plus paclitaxel and carboplatin could be a potential neoadjuvant regimen for patients with locally advanced NSCLC, rendering a potentially lethal disease to one that is curable.
Keywords: non-small cell lung cancer, neoadjuvant therapy, immunotherapy, chemotherapy, DFS, OS