A phase I/II trial of weekly docetaxel and gefitinib in elderly patients with stage IIIB/IV non-small cell lung cancer

Lung Cancer : Journal of the International Association for the Study of Lung Cancer
Thomas E StinchcombeMark A Socinski

Abstract

Phase III trials in elderly patients with advanced (stage IIIB/IV) non-small cell lung cancer (NSCLC) reveal treatment with single agent chemotherapy improves survival. The role of double agent therapy in this patient population is an area of investigation. A phase I/II trial was performed in elderly patients (age>or=70 years) with stage IIIB/IV disease and Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients were treated with gefitinib 250 mg daily. Patients received docetaxel on a treatment schedule of days 1, 8, 15 of an every 28 days schedule. The phase I portion of the trial consisted of dose escalation docetaxel from 30 to 36 mg/m2 using a three patient cohort design. The trial design contained continuous monitoring for excessive toxicity with pre-selected toxicity boundaries. Twenty-six patients were evaluable for efficacy and toxicity analysis. The median age was 75.5 years. The majority of the patients had stage IV disease (85%), ECOG functional status of 0-1 (81%), were male (65%), and current or former smokers (88%). Eleven patients experienced National Cancer Institute Common Toxicity Criteria grades 3-5 non-hematologic toxicity during the first cycle. The toxicity was determined to be unexp...Continue Reading

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Citations

Oct 31, 2008·ANZ Journal of Surgery·Lie S ChanChristopher Christophi
Dec 11, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Taofeek K OwonikokoSuresh S Ramalingam
Jul 23, 2013·PloS One·Wayne XuRobert Kratzke

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