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Weekly gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase II study.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 1999 Feb; Vol. 10 (2), pp. 217-21. - Publication Year :
- 1999
-
Abstract
- Background: The combination of gemcitabine and cisplatin has proven effective in the treatment of advanced non-small-cell lung cancer (NSCLC). However, the optimal schedule for administration of the two drugs has not yet been determined. In this study we evaluated the activity and toxicity of a weekly gemcitabine and cisplatin schedule.<br />Patients and Methods: Thirty-six untreated patients with stage IIIB IV NSCLC entered the study. Treatment consisted of gemcitabine 1000 mg/m2 i.v. and cisplatin 35 mg/m2 i.v., both given weekly on day 1,8, and 15, followed by one week of rest.<br />Results: Ninety-seven courses (273 weekly administrations) were delivered. The median dose-intensity was 612 mg/m2 per week for gemcitabine (82%) and 21 mg/m2 per week for cisplatin (80%). All 36 of the patients were evaluable for toxicity, and 30 for response. Partial remissions were observed in 12 patients, for an overall response rate of 40% (95% confidence interval (95% CI): 22.5%-57.5%). Most of the partial remissions were seen in IIIB patients (54% of the stage IIIB and 22% of the stage IV patients responded). According to the intent-to-treat principle, the response rate was 33.3% (12 of 36 patients). The median response duration was 9.9 months (range 4-23) and the median survival time 11.8 months (range 1-24). World Health Organization (WHO) grade 3-4 myelotoxicity was: thrombocytopenia in nine patients (25%), neutropenia in six (16.6%) and anemia in six (16.6%); there was very little additional major toxicity.<br />Conclusions: This regimen appears to be active and to have a favourable toxicity profile.
- Subjects :
- Adult
Aged
Carcinoma, Non-Small-Cell Lung mortality
Cisplatin adverse effects
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Female
Humans
Lung Neoplasms mortality
Male
Middle Aged
Gemcitabine
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carcinoma, Non-Small-Cell Lung drug therapy
Cisplatin administration & dosage
Deoxycytidine analogs & derivatives
Lung Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0923-7534
- Volume :
- 10
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 10093692
- Full Text :
- https://doi.org/10.1023/a:1008323604269