The perioperative immunotherapyadded to chemotherapy, improves overall survival of patients with lung cancer Resectable stage IIIA non-small cell tumor without worrisome toxicities, study says NADIMpublished in The Lancet and which has had the participation of researchers from the Spanish Society of Thoracic Surgery (SECT).
Furthermore, the study indicates that 69% of patients still alive at 5 yearsso the results reinforce the idea of ​​using this combined treatment in patients who are candidates for surgery with this lung tumor subtype. Lung cancer is the leading cause of cancer-related mortality. cancer worldwide and, within this, non-small cell lung cancer (NSCLC) represents approximately 85% of all cases.
Furthermore, almost 30% of patients are susceptible to surgerybut, despite this, so far the studies carried out only provide five-year survival data that are not very encouraging. Recently, it has been seen that immunotherapy directed against specific targets, based on blocking PD-1 or PD-L1 proteins, has revolutionized treatment of this subtype of cancer, resectable NSCLC, administered either preoperatively or postoperatively.
To evaluate the results of this treatment in terms of survival, the study has been carried out NADIM. “Combining the advantages of neoadjuvant and adjuvant immunotherapy within perioperative regimens has the potential to further improve long-term results in the management of non-small cell lung cancer.
To the best of our knowledge, the study NADIM has been the first to evaluate the activity of chemoimmunotherapy perioperative in potentially resectable stage IIIA NSCLC and, now, within this phase II study, we have verified that it also improves long-term survival indicators,” stated the thoracic surgeon, coordinator of the SECT Scientific Committee and co-author of the study, David Gómez de Antonio.
The study and its results
The study NADIM is a multicenter, single-arm, phase 2 trial, conducted in 18 hospitals in Spainwhich assessed the eligibility of 51 patients with resectable stage IIIA NSCLC, over 18 years of age, of whom finally 46 were intention-to-treat patients, that is, those who could be offered treatment. Of these patients, 36 (74% of the sample) were men and 12 (26%) were women, with a median age of 63 years. The follow-up of the patients concluded after five years (60 months) and the cut-off date to begin the analysis of the results was July 11, 2023.
Before surgery, patients received neoadjuvant treatment consisting of three cycles of chemotherapy combined with a type of immunotherapy, nivolumab (360 mg). The patients then underwent surgery to remove the lung tumor and, after surgery, were given adjuvant treatment with intravenous nivolumab monotherapy for one year. The primary endpoint studied was progression-free survival at 24 months. The secondary objectives of the study included survival progression-free at five years, overall survival and toxicity profile.
Progression-free survival of the study population at five years it was 65%, while the overall survival was 69.3%. These survival rates were accompanied by a high rate of complete pathological responses. However, disease progression occurred in 11 of the patients, 24% of the sample, and 14 patients (30%) died, including nine (20%) from disease relapse and five (11%) from causes not related to the tumor.
Regarding toxicity, treatment-related adverse events occurred in 14 (30%) of 46 patients during neoadjuvant treatment, and in seven (19%) of 37 during adjuvant treatment. The most common adverse effects, rated grade 3 or higher, were increased lipase -an enzyme produced by the pancreas to break down fat in food- and febrile neutropenia -a decrease in neutrophils, a type of white blood cells or defense cells-. Each of these adverse effects occurred in three patients (7% of the sample).