Posted: Friday, August 5, 2022
The previously published NADIM trial reported that patients with resectable stage IIIA non–small cell lung cancer (NSCLC) treated with neoadjuvant nivolumab plus chemotherapy had significantly improved progression-free survival and pathologic complete response rates than patients treated with preoperative chemotherapy, the standard of care. In a follow-up study, recently published in the Journal of Clinical Oncology, Mariano Provencio, MD, PhD, of Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, and colleagues reported that this novel neoadjuvant regimen is supported by 3-year overall survival data. In addition, circulating tumor DNA (ctDNA) levels were linked to overall survival.
“Although our analysis is exploratory, the notable effect size (hazard ratio [HR] = .04) prompts us to postulate ctDNA as being a pivotal surrogate for long-term overall survival in the immunotherapy field, with a similar prognostication capacity as pathologic complete response,” the study authors concluded.
In this open-label, multicenter, phase II trial, the investigators evaluated patients with stage IIIA NSCLC whose cancer was deemed to be surgically resectable. Patients were treated with neoadjuvant paclitaxel and carboplatin plus nivolumab followed by adjuvant nivolumab monotherapy.
Among the intention-to-treat population, the 3-year overall survival rate was 81.9%—nearly triple the rates reported in historical data. Neither tumor mutation burden nor PD-L1 predicted survival rates, according to the study authors. By contrast, low pretreatment levels of ctDNA were significantly associated with improved progression-free (P = .006) and overall survival (P = .002). In addition, after neoadjuvant treatment, undetectable ctDNA levels were significantly associated with improved progression-free (P = .038) and overall survival (P = .015).
Disclosure: For full disclosures of the study authors, visit ascopubs.org.