Phase II study of paclitaxel, carboplatin, and cetuximab as first line treatment, for patients with advanced non-small cell lung cancer (NSCLC): Results of OPN-017

Hossein Borghaei, Corey J. Langer, Michael Millenson, Karen J. Ruth, Samuel Litwin, Holly Tuttle, Judie Sylvester Seldomridge, Marc Rovito, David Mintzer, Roger Cohen, Joseph Treat

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

Background: Cetuximab has demonstrated synergy with taxanes in preclinical models; as well as single agent activity. We assessed the activity of cetuximab with carboplatin and paclitaxel given on a 4-week schedule, in advanced, chemo-naive non-small cell lung cancer. Patients and Methods: This phase II, single arm, multi-institution study featured standard dosage of cetuximab 400 mg/m day 1, then 250 mg/m with paclitaxel (100 mg/m/wk, for 3 weeks), and carboplatin (area under curve = 6) day 1 of each 28 day cycle. After 4 to 6 cycles, in the absence of disease progression or excess toxicity, cetuximab was continued weekly. Primary end point was response rate. Results: Fifty-three patients (median age 63, 51% male) participated. Response rate was 57% (3 complete response and 27 partial response). At a median follow-up of 12.5 months, the estimated overall survival is 13.8 months (95% CI: 9.08-16.02) with an event-free survival rate of 5.53 months (95% CI: 4.77-7.99), 18.9% remain free from progression at 1 year. Improved survival was associated with female gender, absence of prior radiation, PS 0 and epidermal growth factor receptor expression. Toxicities included rash (28% grade 3), nail changes (3.7% grade 3), hypomagnesemia (7.5% grade 3 and 3.7% grade 4), and neutropenia (25% grade 3 and 13% grade 4) in addition to other typical side effects anticipated with paclitaxel/carboplatin. There were no grade 5 toxicities. Conclusion: Combination of cetuximab/paclitaxel/carboplatin in non-small cell lung cancer was well tolerated and clinically active with manageable toxicities. This unique schedule, integrating weekly paclitaxel and cetuximab has not yet been tested in a randomized trial.

Original languageEnglish (US)
Pages (from-to)1286-1292
Number of pages7
JournalJournal of Thoracic Oncology
Volume3
Issue number11
DOIs
StatePublished - Jan 1 2008

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

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    Borghaei, H., Langer, C. J., Millenson, M., Ruth, K. J., Litwin, S., Tuttle, H., Seldomridge, J. S., Rovito, M., Mintzer, D., Cohen, R., & Treat, J. (2008). Phase II study of paclitaxel, carboplatin, and cetuximab as first line treatment, for patients with advanced non-small cell lung cancer (NSCLC): Results of OPN-017. Journal of Thoracic Oncology, 3(11), 1286-1292. https://doi.org/10.1097/JTO.0b013e318189f50e