Elsevier

Annals of Oncology

Volume 25, Issue 2, February 2014, Pages 409-415
Annals of Oncology

original articles
thoracic tumors
Phase II study of everolimus–erlotinib in previously treated patients with advanced non-small-cell lung cancer

https://doi.org/10.1093/annonc/mdt536Get rights and content
Under an Elsevier user license
open archive

ABSTRACT

Background

Preclinical data suggest combining a mammalian target of rapamycin inhibitor with erlotinib could provide synergistic antitumor effects in advanced non-small-cell lung cancer (NSCLC).

Patients and methods

In this multicenter, open-label, phase II study, patients with advanced NSCLC that progressed after one to two previous chemotherapy regimens were randomized 1:1 to erlotinib 150 mg/day ± everolimus 5 mg/day. Primary end point was the disease control rate (DCR) at 3 months; secondary end points included progression-free survival (PFS) and safety.

Results

One hundred thirty-three patients received everolimus–erlotinib (n = 66) or erlotinib alone (n = 67). The DCR at 3 months was 39.4% and 28.4%, respectively. The probability for the difference in disease control at 3 months to be ≥15% was estimated to be 29.8%, which was below the prespecified probability threshold of ≥40%. Median PFS was 2.9 and 2.0 months, respectively. Grade 3/4 adverse events occurred in 72.7% and 32.3% of patients, respectively. Grade 3/4 stomatitis was observed in 31.8% of combination therapy recipients.

Conclusions

Everolimus 5 mg/day plus erlotinib 150 mg/day was not considered sufficiently efficacious per the predefined study criteria. The combination does not warrant further investigation based on increased toxicity and the lack of substantial improvement in disease stabilization.

Key words

disease control rate
erlotinib
everolimus
non-small-cell lung cancer
progression-free survival
stomatitis

Cited by (0)