期刊
CANCER CHEMOTHERAPY AND PHARMACOLOGY
卷 63, 期 4, 页码 731-743出版社
SPRINGER
DOI: 10.1007/s00280-008-0767-x
关键词
Dexamethasone; Hematologic toxicity; Chemotherapy; Lung cancer
资金
- Eli Lilly and Company ( JJR)
- Buck-Kentucky Lung Cancer Research Chair
- Markey Cancer Center and the Markey Foundation
Background Our preclinical and clinical data suggest that pretreatment with dexamethasone 4 days prior to chemotherapy increased the efficacy and decreased the toxicity of carboplatin and gemcitabine. To translate these findings to patients, we have undertaken a Phase 1/2 clinical trial. Methods Thirty patients with advanced non-small cell lung cancer (NSCLC) received gemcitabine, 1,000 mg/m(2) on days 1 and 8, and carboplatin, AUC 5.5 on day 1. Patients were randomized (1: 2: 2) to receive, no dexamethasone (cohort 1), or oral dexamethasone at 8 mg (cohort 2) or 16 mg (cohort 3) twice per day, 4 days before and of the day of chemotherapy. Dexamethasone was administered to patients in cohorts 2 and 3 during courses 2-4. Results In cohorts 1, 2, and 3, patients completing four planned courses of therapy were: 1/6, 6/12, 9/12. Partial responses (RECIST) were: 2/6, 6/12, and 7/12. Overall, dexamethasone significantly improved AGC and platelet nadirs and recovery times. There were no significant differences in non-hematologic toxicities between cohorts and no significant differences in pharmacokinetic parameters between course 1 and 2 in any cohort. Conclusions These data support our previous preclinical and clinical observations that dexamethasone pre-treatment decreases hematopoietic toxicity and improves efficacy of this chemotherapeutic regimen in patients with metastatic non-small cell lung cancer and suggests that further randomized trials should be undertaken.
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