Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomised multicentre trial

• Published in: Lancet (British edition) Vol. 357; no. 9267; pp. 1478 - 1484
• Main Authors: Georgoulias, V, Papadakis, E, Alexopoulos, A, Tsiafaki, X, Rapti, A, Veslemes, M, Palamidas, Ph, Vlachonikolis, I
• Format: Journal Article Conference Proceeding
• Language: English
• Published: London Elsevier Ltd 12-05-2001; Lancet; Elsevier Limited
• Subjects: Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; Clinical trials; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Lung cancer; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Neoplasm Staging; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Paclitaxel - analogs & derivatives; Pharmacology. Drug treatments; Platinum; Survival; Survival Rate; Taxoids; Antineoplastic agent; Human; Lung disease; Drug combination; Gemcitabine; Respiratory disease; Toxicity; Treatment efficiency; Docetaxel; Malignant tumor; Bronchopulmonary; Cisplatin; Chemotherapy; Treatment; Follow up study; Taxane derivatives; Bronchus disease; Clinical trial; Fluorine Organic compounds; Pyrimidine nucleoside; Non small cell carcinoma; Platinum II Complexes
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(00)04644-4

Docetaxel in combination with cisplatin or gemcitabine are active chemotherapy reigimes against non-small-cell lung cancer. We compared the efficacy and safety of a combination of cisplatin and docetaxel (group 1) with that of gemcitabine and docetaxel (group 2) in the treatment of advanced non-small-cell lung cancer in a prospective, randomised, multicentre trial.
Patients with stage 1MB or IV lung cancer who had not had prior chemotherapy were allocated either to group 1 and treated with docetaxel (100 mg/m2, day 1) and cisplatin (80 mg/m2, day 2) or to group 2 and treated with gemcitabine (1100 mg/m2, days 1 and 8) and docetaxel (100 mg/m2, day 8). All patients received recombinant human granulocyte colony-stimulating factor (150 μg/m2). All patients received recombinant human granulocyte colony-stimulating factor (150mg/m2) had appropriate standard premedication. Response and toxicity were assessed using WHO criteria. Analysis was by intention to treat.
441 patients were randomly assigned to receive docetaxel/cisplatin (group 1, n=219) or gemcitabine/ docetaxel (group 2, n=222). 14 patients in group 1 and 21 patients in group 2 were not evaluable. Objective response rates were similar in the two groups: group 1, 32·4% (95% CI 26·2–38·6%; 1·4% complete response and 31% partial response); group 2, 30·2% (24·5–36·2%; 0·9% complete response and 29·3% partial response). The two groups did not differ in median duration of response, time to tumour progression, overall survival, or 1 year or 2 year survival rates.
Both drug combinations had comparable activity in patients with advanced cancer who had not previously had chemotherapy; however, gemcitabine and docetaxel had the most favourable toxicity profile.