Intensive anti-inflammatory therapy with dexamethasone in patients with non-small cell lung cancer: effect on chemotherapy toxicity and efficacy.
Cancer Chemother Pharmacol
; 63(4): 731-43, 2009 Mar.
Article
em En
| MEDLINE
| ID: mdl-18500521
ABSTRACT
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 (122) 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.
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Dexametasona
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Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma Pulmonar de Células não Pequenas
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Glucocorticoides
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Neoplasias Pulmonares
Idioma:
En
Ano de publicação:
2009
Tipo de documento:
Article