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Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trials
- Publication Year :
- 2005
-
Abstract
- Summary Background Chemotherapy is the standard treatment for advanced non-small-cell lung cancer, and myelosuppression is a common side-effect. We aimed to assess whether haematological toxic effects could be a biological measure of drug activity and a marker of efficacy. Methods We analysed data for 1265 patients who received chemotherapy (vinorelbine, gemcitabine, gemcitabine and vinorelbine, cisplatin and vinorelbine, or cisplatin and gemcitabine) within three randomised trials. Primary landmark analyses were restricted to 436 patients who received all six planned chemotherapy cycles and who were alive 180 days after randomisation. Neutropenia was categorised on the basis of worst WHO grade during chemotherapy: absent (grade 0), mild (grade 1–2), or severe (grade 3–4). All statistical analyses were stratified by treatment allocation. Analyses were repeated in the out-of-landmark group (829 patients), stratifying by treatment allocation and number of chemotherapy cycles. The primary endpoint was overall survival. Findings In the landmark group, hazard ratios of death were 0·65 (0·46–0·93) for patients with severe neutropenia and 0·74 (0·56–0·98) for those with mild neutropenia. Median survival after the landmark time of 180 days was 31·4 weeks (95% CI 25·7–39·6) for patients without neutropenia compared with 42·0 weeks (32·7–59·7) for patients with severe neutropenia, and with 43·7 weeks (36·6–66·0) for those with mild neutropenia (severe vs mild vs no neutropenia p=0·0118). Findings were much the same for the out-of-landmark group. Interpretation Neutropenia during chemotherapy is associated with increased survival of patients with advanced non-small-cell lung cancer, and its absence might be a result of underdosing. Prospective trials are needed to assess whether drug dosing guided by the occurrence of toxic effects could improve efficacy of standard regimens.
- Subjects :
- Adult
Male
Oncology
medicine.medical_specialty
Lung Neoplasms
Neutropenia
medicine.medical_treatment
Antineoplastic Agents
Vinorelbine
Severity of Illness Index
Carcinoma, Non-Small-Cell Lung
Internal medicine
medicine
Humans
Lung cancer
Survival rate
Aged
Proportional Hazards Models
Randomized Controlled Trials as Topic
Aged, 80 and over
Chemotherapy
Dose-Response Relationship, Drug
business.industry
Standard treatment
Hazard ratio
Middle Aged
randomized clinical trial
medicine.disease
Gemcitabine
Surgery
Survival Rate
landmark analysis
non-small-cell lung cancer
Italy
chemotherapy-induced neutropenia
Female
Drug Monitoring
business
Biomarkers
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....3ff9a39779231189dc92cea5de709894