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Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2004 May 01; Vol. 22 (9), pp. 1589-97. - Publication Year :
- 2004
-
Abstract
- Purpose: To compare the efficacy and toxicity of pemetrexed versus docetaxel in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy.<br />Patients and Methods: Eligible patients had a performance status 0 to 2, previous treatment with one prior chemotherapy regimen for advanced NSCLC, and adequate organ function. Patients received pemetrexed 500 mg/m(2) intravenously (i.v.) day 1 with vitamin B(12), folic acid, and dexamethasone or docetaxel 75 mg/m(2) i.v. day 1 with dexamethasone every 21 days. The primary end point was overall survival.<br />Results: Five hundred seventy-one patients were randomly assigned. Overall response rates were 9.1% and 8.8% (analysis of variance P =.105) for pemetrexed and docetaxel, respectively. Median progression-free survival was 2.9 months for each arm, and median survival time was 8.3 versus 7.9 months (P = not significant) for pemetrexed and docetaxel, respectively. The 1-year survival rate for each arm was 29.7%. Patients receiving docetaxel were more likely to have grade 3 or 4 neutropenia (40.2% v 5.3%; P <.001), febrile neutropenia (12.7% v 1.9%; P <.001), neutropenia with infections (3.3% v 0.0%; P =.004), hospitalizations for neutropenic fever (13.4% v 1.5%; P <.001), hospitalizations due to other drug related adverse events (10.5% v 6.4%; P =.092), use of granulocyte colony-stimulating factor support (19.2% v 2.6%, P <.001) and all grade alopecia (37.7% v 6.4%; P <.001) compared with patients receiving pemetrexed.<br />Conclusion: Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel in the second-line treatment of patients with advanced NSCLC and should be considered a standard treatment option for second-line NSCLC when available.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents administration & dosage
Antineoplastic Agents adverse effects
Antineoplastic Agents, Phytogenic administration & dosage
Antineoplastic Agents, Phytogenic adverse effects
Carcinoma, Non-Small-Cell Lung pathology
Docetaxel
Female
Glutamates administration & dosage
Glutamates adverse effects
Guanine administration & dosage
Guanine adverse effects
Humans
Lung Neoplasms pathology
Male
Middle Aged
Neutropenia chemically induced
Pemetrexed
Survival Analysis
Taxoids administration & dosage
Taxoids adverse effects
Treatment Outcome
Antineoplastic Agents therapeutic use
Antineoplastic Agents, Phytogenic therapeutic use
Carcinoma, Non-Small-Cell Lung drug therapy
Glutamates therapeutic use
Guanine analogs & derivatives
Guanine therapeutic use
Lung Neoplasms drug therapy
Taxoids therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 0732-183X
- Volume :
- 22
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 15117980
- Full Text :
- https://doi.org/10.1200/JCO.2004.08.163