Adding Stereotactic Body Radiotherapy to Immunotherapy for Early-Stage NSCLC
Posted: Tuesday, August 3, 2021
According to a single-center, open-label, randomized, controlled, phase II trial published in The Lancet Oncology, neoadjuvant treatment with the anti–PD-L1 antibody durvalumab plus stereotactic body radiotherapy was found to be well tolerated, safe, and associated with a high major pathologic response rate in patients with early-stage non–small cell lung cancer (NSCLC). However, Nasser K. Altorki, MD, of Weill Cornell Medicine/New York Presbyterian Hospital, and colleagues explained that a larger trial is needed to validate these findings.
“In contrast to prevailing strategies, combining immunotherapy with stereotactic body radiotherapy might be associated with a more favorable safety profile and higher patient compliance than is currently reported using combinations with full-dose chemotherapy or chemoradiation,” the investigators commented.
A total of 60 patients were randomly assigned in a 1:1 ratio to receive neoadjuvant durvalumab with or without stereotactic body radiotherapy. Most patients in each treatment arm (87%) underwent surgical resection.
Major pathologic responses were observed in 16 and 2 patients treated with and without radiotherapy, respectively. The rates of major pathologic responses seemed to significantly differ between the treatment arms (crude odds ratio = 16.0; P < .0001). Half of the patients treated with radiotherapy who achieved a major pathologic response (50%) also achieved a complete pathologic response.
Due to immune-related adverse events, the second cycle of durvalumab was withheld in 10% of the patients treated with radiotherapy. The incidence rate of grade 3 to 4 adverse events was higher with radiotherapy than without (20% vs. 17%). Hyperlipasemia (10%) and hyponatremia (10%) were the most frequently reported grade 3 to 4 adverse events in patients treated with and without radiotherapy, respectively. Two patients in each group experienced serious adverse events. The investigators did not report any treatment-related deaths or deaths within 30 days of surgery.
Disclosure: For full disclosures of the study authors, visit thelancet.com.
