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Phase 2 trial of docetaxel and gefitinib in the first‐line treatment of patients with advanced nonsmall‐cell lung cancer (NSCLC) who are 70 years of age or older
Author(s) -
Simon George R.,
Extermann Martine,
Chiappori Alberto,
Williams Charles C.,
Begum Mubeena,
Kapoor Rachna,
Haura Eric B.,
IsmailKhan Roohi,
Schell Michael J.,
Antonia Scott J.,
Bepler Gerold
Publication year - 2008
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.23360
Subject(s) - medicine , gefitinib , docetaxel , lung cancer , performance status , clinical endpoint , oncology , regimen , progression free survival , cancer , chemotherapy , clinical trial , epidermal growth factor receptor
BACKGROUND This is a phase 2 study of chemotherapy‐naive patients, 70 years of age or older, with nonsmall‐cell lung cancer (NSCLC) who were treated with docetaxel and gefitinib. The primary endpoint was response rate (RR). Secondary endpoints were overall survival (OS) and progression‐free survival (PFS). METHODS Eligible patients were treated with docetaxel 75 mg/m 2 every 3 weeks and gefitinib 250 mg orally, daily. Docetaxel and gefitinib were given for 2 cycles beyond maximal response. Gefitinib was continued until disease progression. Comorbidities and activities of daily living were assessed (IADL). RESULTS Forty‐four patients initiated therapy between March 2003 and May 2005. Seventeen patients (40%; 95% confidence interval [CI], 26%–57%) had a partial response and 48% had stable disease. The median PFS was 6.9 months (95% CI, 3.95–7.8 months). Median survival time was 9.6 months (95% CI, 4.6–16.3 months). On univariate analyses, sex, Eastern Cooperative Oncology Group Performance Status (ECOG PS), and Charlson comorbidities index (CCI) score were predictors of improved survival. On multivariate analyses female sex was a statistically significant predictor of survival. The median survivals were 22.8 months in women and 4.8 months in men. This regimen was well tolerated, with the most common adverse events being hyperglycemia, fatigue, and lymphopenia. CONCLUSIONS Docetaxel combined with gefitinib is active and well tolerated in patients with advanced NSCLC who are 70 years of age and older. This paradigm of treatment merits further investigation as a first‐line treatment strategy. Female sex‐specific confirmatory clinical trials with this regimen may be warranted. Cancer 2008. © 2008 American Cancer Society.