Surgical Data Support Nivolumab Plus Chemotherapy for Resectable NSCLC

Administration of neoadjuvant nivolumab plus chemotherapy did not affect the feasibility or timing of surgery or the extent of surgical resection compared with chemotherapy alone in patients with resectable non-small cell lung cancer (NSCLC), according to the results of the CheckMate 816 study presented at the 2021 American Society of Clinical Oncology Annual Meeting.

Previously presented results from this study revealed that neoadjuvant nivolumab plus chemotherapy significantly improved the pathological complete response compared with chemotherapy. At this year’s meeting, Jonathan Spicer, MD, of McGill University Health Center in Canada, presented additional results on key surgical outcomes.

The study included adults with stage IB-IIIA disease with an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less and no known EGFR/ALK alterations. Patients were randomly assigned to receive nivolumab 360 mg plus a platinum-doublet or chemotherapy alone. Surgery was to be performed within 6 weeks of the last treatment.

Eighty-three percent of patients who received nivolumab and 75% of patients who received chemotherapy alone could undergo surgery. Median duration of operation was 184 minutes for patients in the nivolumab arm compared with 217 minutes for patients in the chemotherapy alone arm.

“This half hour difference in procedure time may indicate that surgical complexity was not increased by virtue of the addition of nivolumab to the preoperative treatment regimen,” Dr Spicer said.

Common reasons for cancelled surgical procedures included disease progression (12 patients in the nivolumab arm and 17 patients in the chemotherapy alone arm), adverse events (2 patients in each arm), or other scenarios. Surgery was delayed for 21% of patients in the nivolumab arm compared with 18% of patients who received chemotherapy alone.

Thoracotomy was the most frequent surgical approach in both arms. Minimally invasive surgery could be performed in 30% of patients who received nivolumab and in 22% of patients who received chemotherapy alone. In patients with stage IIIA disease these rates were 30% and 19% for nivolumab and chemotherapy alone arms, respectively. Only 11% of patients who received nivolumab transitioned from minimally invasive surgery to an open procedure compared with 20% of patients in the chemotherapy alone arm.

Lobectomy was performed in 77% of patients who received nivolumab and 61% of patients who received chemotherapy alone; pneumonectomy in 17% and 25%, respectively.

The majority of patients in both the nivolumab (83%) and chemotherapy (78%) arms had complete surgical resection. Median residual viable tumor cells in the primary tumor bed occurred in 10% of patients who received nivolumab and 74% of patients who received chemotherapy alone.

Finally, there was no increase in the length of hospital stay when comparing the study arms. Further, the addition of nivolumab to chemotherapy did not increase surgery-related complications in this study as the complication rates were within expected ranges, Dr Spicer said.

“The safety and surgical outcome data reported thus far from CheckMate816, along with significant improvement in pathologic complete response, support nivolumab in combination with chemotherapy as an attractive neoadjuvant option for patients with resectable NSCLC,” Dr Spicer said.

Disclosure: This research was supported by Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Spicer J, Wang C, Tanaka F, et al. Surgical outcomes form the phase 3 CheckMate 816 trial: nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). J Clin Oncol. 2021:39;(suppl 15; abstr 8503). doi:10.1200/JCO.2021.39.15_suppl.8503

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