Purpose: Pre-clinical and early-phase clinical studies have demonstrated that dexamethasone (DEX) administration prior to chemotherapy reduces toxicity and enhances efficacy in the treatment of cancer. We undertook a randomized, phase II multi-institutional trial to evaluate these effects in patients with Stage IV non-small cell lung cancer. Methods: Patients were treated with carboplatin on day 1 and gemcitabine on days 1 and 8 every 21 days, for up to 6 cycles. Patients were randomized not to receive (Arm 1, n = 25) or to receive (Arm 2, n = 31) DEX orally for 4 days prior to chemotherapy on days 1 and 8. The primary endpoint was the incidence/course of grade 3 and 4 hematologic toxicity. Secondary endpoints included efficacy [response and overall survival (OS)] and evaluation of the Glasgow Prognostic Score (GPS), based on C-reactive protein and albumin levels, to predict survival and toxicity. Results: The incidence/course of grade 3 and 4 hematologic toxicity was significantly reduced in Arm 2 (DEX) versus Arm 1 (no DEX): neutrophils = 13 versus 40 % (p = 0.009) and platelets = 23 versus 44 % (p = 0.03). Response rates and OS were higher in Arm 2 versus Arm 1: 8/31 versus 2/25 (partial response, p = ns) and 378 versus 291 days (p = ns). The GPS significantly predicted survival OS (p = 0.04) but not toxicity. Conclusions: Pre-treating patients with DEX is a safe, effective, and economic method of reducing the hematologic toxicity of carboplatin and gemcitabine. Our data suggest efficacy may also be enhanced by DEX pre-treatment.
|Number of pages||9|
|Journal||Cancer Chemotherapy and Pharmacology|
|State||Published - May 2013|
Bibliographical noteFunding Information:
Role of the funding sources This study was funded by grants from the Kentucky Clinical Trials Network and Eli Lilly, Inc. Neither organization contributed to the design of the study, played a direct role in collection of data, or aided in development of this report. Money from the grantors was used to fund an independent clinical research organization and support on-site data management.
Acknowledgments The study was supported by Kentucky Lung Cancer Clinical Trials Network, Eli Lilly and Company, the Buck-Kentucky Lung Cancer Research Chair, and the Markey Cancer Center. Funding was provided by the Kentucky Clinical Trials Network and Eli Lilly, Inc.
ASJC Scopus subject areas
- Cancer Research
- Pharmacology (medical)