Phase II trial of temozolomide and irinotecan as second-line treatment for advanced non-small cell lung cancer

Nicholas W. Choong, Ann M. Mauer, Philip C. Hoffman, Charles M. Rudin, Jerome D. Winegarden, J. Lee Villano, Mark Kozloff, James L. Wade, David F. Sciortino, Livia Szeto, Everett E. Vokes

Research output: Contribution to journalArticlepeer-review

21 Scopus citations


BACKGROUND: This study was performed to evaluate the tolerability and efficacy of temozolomide and irinotecan as a second-line regimen in recurrent/metastatic non-small cell lung cancer (NSCLC). METHODS: Patients with recurrent/metastatic NSCLC, including those with treated brain metastases, following one prior platinum-based regimen received temozolomide 75 mg/m daily on days 1 through 15 and irinotecan 100 mg/m on days 8 and 15 every 21 days. RESULTS: The authors treated 46 patients, of whom more that 90% had a performance status of 0 or 1. Four patients (8.7%) attained partial response and 17 (37.0%) had disease stabilization as their best response. The median time to progression was 1.8 months, median overall survival was 9.8 months, and 1-year overall survival was 34%. Grade 1/2 fatigue (63%), anemia (61%), nausea (52%), and diarrhea (44%) were the most common toxicities. Grade 3/4 leukopenia and diarrhea were each observed in 9% of patients. One unexpected death occurred, possibly related to the regimen. CONCLUSION: Second-line treatment with temozolomide and irinotecan showed tolerable toxicities. The response rates, median survival times, and 1-year survival rates were comparable to other active NSCLC agents.

Original languageEnglish
Pages (from-to)245-251
Number of pages7
JournalJournal of Thoracic Oncology
Issue number3
StatePublished - Mar 2006


  • Irinotecan
  • Metastasis
  • Non-small cell lung cancer
  • Temozolomide

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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