Weekly gemcitabine and cisplatin in advanced non-small-cell lung cancer: A phase II study

• Published in: Annals of oncology Vol. 10; no. 2; pp. 217 - 221
• Main Authors: Lippe, P., Tummarello, D., Monterubbianesi, M. C., Silva, R. R., Giuliodori, L., Mari, D., Santo, A., Pasini, F., Cetto, G. L., Rossi, D., Porfiri, E., Cascinu, S., Cellerino, R.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.02.1999
• Subjects: administration; Adult; Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Chemotherapy; cisplatin; Cisplatin - administration & dosage; Cisplatin - adverse effects; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Female; gemcitabine; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Male; Medical sciences; Middle Aged; NSCLC; Pharmacology. Drug treatments; weekly; Antineoplastic agent; Human; Lung disease; Drug combination; Intravenous administration; Gemcitabine; Respiratory disease; Toxicity; Treatment efficiency; Tolerance; Malignant tumor; Bronchopulmonary; Cisplatin; Chemotherapy; Treatment; Phase II trial; Bronchus disease; Advanced stage; Fluorine Organic compounds; Pyrimidine nucleoside; Non small cell carcinoma; Platinum II Complexes
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1023/A:1008323604269

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. 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 days 1,8, and 15, followed by one week of rest. 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 4ndash;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. Conclusions: This regimen appears to be active and to have a favourable toxicity profile.