A phase II study of enzastaurin in combination with erlotinib in patients with previously treated advanced non-small cell lung cancer

Christelle Clément-Duchêne, Ronald B. Natale, Thierry Jahan, Yelena Krupitskaya, Raymond Osarogiagbon, Rachel E. Sanborn, Eric D. Bernstein, Arkadiusz Z. Dudek, Jane E. Latz, Peipei Shi, Heather A. Wakelee

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7 Scopus citations

Abstract

Introduction: Regardless of epidermal growth factor receptor (EGFR) mutation status, erlotinib improves survival for patients with advanced non-small cell lung cancer (NSCLC) after one or more chemotherapy regimens. Enzastaurin is an oral serine/threonine kinase inhibitor. This phase II study was designed to evaluate the efficacy and safety of erlotinib and enzastaurin in NSCLC, a combination with promise to overcome EGFR resistance based on preclinical models. Methods: Eligible patients with advanced NSCLC (IIIB or IV) who had failed one or two prior systemic treatment regimen(s) were enrolled and received erlotinib 150. mg/day and enzastaurin 500. mg/day (after a 1125-mg loading dose on day 1, cycle 1), both orally in 28-day cycles. The primary endpoint was progression-free survival (PFS). Results: From January 2008 to July 2009, 49 patients were enrolled: 29 (59%) men and 20 (41%) women; 8 (16%) were non-smokers. The median PFS was 1.7. months (one-sided 90% CI: 1.5-NA) and median overall survival (OS) was 8.3. months (95% CI: 5.3-14.3). Five patients had partial response, for an overall response rate of 10.2%; the disease control rate was 30.6% (responders. +. 10 patients with stable disease). Grade 3-4 drug-related adverse events in ≥5% of patients were diarrhea, acne, and nausea. One possibly drug-related death due to interstitial lung disease occurred during the study. Conclusions: In previously treated, unselected, advanced NSCLC patients, the addition of enzastaurin to erlotinib did not improve PFS, response, or OS compared with historical data of single-agent erlotinib, but was well tolerated.

Original languageEnglish (US)
Pages (from-to)57-62
Number of pages6
JournalLung Cancer
Volume78
Issue number1
DOIs
StatePublished - Oct 1 2012

Keywords

  • Enzastaurin
  • Erlotinib
  • NSCLC

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    Clément-Duchêne, C., Natale, R. B., Jahan, T., Krupitskaya, Y., Osarogiagbon, R., Sanborn, R. E., Bernstein, E. D., Dudek, A. Z., Latz, J. E., Shi, P., & Wakelee, H. A. (2012). A phase II study of enzastaurin in combination with erlotinib in patients with previously treated advanced non-small cell lung cancer. Lung Cancer, 78(1), 57-62. https://doi.org/10.1016/j.lungcan.2012.06.003