Oral Nelfinavir With Chemoradiotherapy for Locally Advanced Lung Cancer
Posted: Wednesday, September 25, 2019
The results of a phase I/II clinical trial suggest that nelfinavir—long used to treat HIV infection—may improve progression-free and overall survival in patients with locally advanced non–small cell lung cancer (NSCLC), when administered with concurrent chemoradiotherapy. Ramesh Rengan, MD, PhD, of the University of Washington School of Medicine, and colleagues said these results, published in JAMA Oncology, would require further clarification in a randomized phase III setting.
The study involved 35 patients (aged 18 to 89) with unresectable stage IIIA/IIIB NSCLC who were treated between January 2007 and February 2012. Using two different dosages, the investigators treated patients with the oral protease inhibitor nelfinavir, in combination with concurrent chemoradiotherapy. The first phase of the study tested dosages (625 mg twice daily or 1,250 mg twice daily for 7 to 14 days before and during concurrent chemoradiotherapy)—taking dose-limiting toxic effects into consideration—and the second phase tested overall survival and other outcomes.
“Local failure after chemoradiotherapy significantly contributes to mortality in patients with locally advanced NSCLC,” the investigators explained. “One approach to improve local control is through targeted radiosensitization of the tumor.”
The results showed a median progression-free survival of 11.7 months and a median overall survival of 41.1 months; the 5-year mean overall survival rate was 37.1%. In terms of response, 33 of the 35 study patients had an objective response rate of 94%. The cumulative incidence of local failure was 39%.
“These data suggest that nelfinavir may enhance the efficacy of standard [chemoradiotherapy] in this disease,” the investigators said, noting that more testing was needed to confirm these early study findings.
Disclosure: The study authors’ disclosure information may be found at jamanetwork.com.