Phase I/II study of vinorelbine and exisulind as first-line treatment of advanced non-small cell lung cancer in patients at least 70 years old: a wisconsin oncology network study.

J Thorac Oncol 2008 Sep;3(9):1018-25

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, USA.

Introduction: Exisulind is an apoptotic agent with preclinical activity in non-small cell lung cancer (NSCLC). Vinorelbine is safe and effective in older patients with advanced NSCLC. We assessed these agents together as palliative treatment for older patients with advanced NSCLC.

Methods: Chemotherapy-naive patients >/=70-years-old with stage IIIB-IV NSCLC and a performance status (PS)
Results: Fourteen phase I patients (median PS 1; median age 78 years) were enrolled. Dose-limiting toxicities included grade 3 constipation (one patient), grade 3 febrile neutropenia (one patient) and grade 3 diarrhea (one patient). The maximum tolerated dose of oral exisulind with 25 mg/m/wk of intravenous vinorelbine was 125 mg twice daily. Thirty phase II patients (median PS 1; median age 78 years) were enrolled. Grade >/=3 neutropenia occurred in 14/30 patients. Two patients experienced neutropenic fever. There were no complete responses, one partial response and 12 patients with stable disease as their best response. The objective response rate was 4.0% (95% CI: 0.1-20.4%). Phase II median time-to-progression was 4.7 months (95% CI: 3.1-9.3 months) and median OS was 9.6 months (95% CI: 6.6-19.1 months).

Conclusions: This combination is safe, seems to have activity in the elderly with advanced NSCLC and a PS

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http://dx.doi.org/10.1097/JTO.0b013e3181834fa1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2562273PMC
September 2008
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