A phase I/II study published in JAMA Oncology found that the HIV protease inhibitor Viracept® (nelfinavir mesylate) administered with concurrent chemoradiotherapy improved survival in patients with locally advanced non-small cell lung cancer (NSCLC).
This prospective, open-label, single-group, single-institution study assessed nelfinavir in combination with concurrent chemoradiotherapy in 35 patients (median age, 60 years; range, 39-79 years) aged 18 to 89 years with biopsy-confirmed unresectable stage IIIA/IIIB locally advanced NSCLC between 2007 and 2012. Patients received nelfinavir 625 mg twice daily (n=5) or 1,250 mg twice daily (n=30) for seven to 14 days before and during concurrent chemoradiotherapy.
There were no dose-limiting toxicities at either dose level.
Most patients (n=33) had evaluable post-treatment computed tomographic scans; there was an objective response rate of 94% (n=31; 95% CI, 86-100). The cumulative incidence of local failure was 39% (95% CI, 30.5-47.5).
Improved survival with the addition of nelfinavir
Median progression-free survival was 11.7 months (95% CI, 6.2-17.1), and median overall survival (OS) was 41.1 months (95% CI, 19.0-63.1). The five-year mean OS rate was 37.1%.
Two patients receiving 624 mg and 18 patients receiving 1,250 mg experienced grade 3/4 leukopenia, but no patients required a dose reduction.
“Nelfinavir may enhance the efficacy of standard chemoradiotherapy in this disease,” the researchers concluded.