Immunotherapy Plus Chemoradiation Followed by Nivolumab Maintenance in Unresectable NSCLC
Posted: Tuesday, November 16, 2021
A phase I/II study performed by Casey Liveringhouse, MD, of the H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, and colleagues explored the safety and tolerability of the addition of concurrent ipilimumab to chemoradiotherapy followed by nivolumab maintenance in patients with unresectable stage III non–small cell lung cancer (NSCLC). Ultimately, the toxicity associated with this regimen appeared to be unfavorable. The trial results were presented during the 2021 American Society for Radiation Oncology (ASTRO) Annual Meeting (Abstract 5).
“The combination of concurrent ipilimumab with standard chemoradiation followed by maintenance nivolumab for unresectable stage III NSCLC is associated with significant toxicity, which may limit opportunities for improved outcomes, although the sample size in this trial is small,” the investigators concluded. “Alternative strategies or sequencing should be explored to integrate immunotherapy with cytotoxic chemotherapy and radiation for patients with unresectable stage III NSCLC.”
A total of 19 patients with unresectable stage III NSCLC were administered platinum-based chemotherapy with concurrent radiotherapy, and two doses of concurrent ipilimumab. Participants received maintenance nivolumab 1 to 3 weeks after the previous treatment, which was given for up to 12 cycles.
The median follow-up was 21 months. The 12-month progression-free survival estimate was 54%, and the median progression-free survival was 19 months. Although the median overall survival was not reached, the 12-month overall survival estimate was 60%.
The trial was ultimately discontinued due to exceeding the futility boundary for toxicity. Grade 2 or higher pneumonitis was observed in 10 patients, with a median time to development of 5.5 months. Grade 3 or higher treatment-related toxicities affected 16 patients, with the most common being pulmonary (n = 8) and cytopenias (n = 7). Additionally, three of five patients with possible grade 5 toxicity experienced pulmonary toxicity.
Disclosure: For full disclosures of the study authors, visit plan.core-apps.com.