Randomized phase II study with two gemcitabine- and docetaxel-based combinations as first-line chemotherapy for metastatic non-small cell lung cancer

• Published in: Journal of translational medicine Vol. 6; no. 1; p. 65
• Main Authors: Passardi, Alessandro, Cecconetto, Lorenzo, Dall'agata, Monia, Dazzi, Claudio, Pasquini, Enzo, Oliverio, Giovanni, Zumaglini, Federica, Zoli, Wainer, Nanni, Oriana, Milandri, Carlo, Frassineti, Giovanni Luca, Amadori, Dino
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 31-10-2008; BioMed Central; BMC
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy, Combination; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Diagnosis; Disease Progression; Docetaxel; Dosage and administration; Drug therapy; Female; Gemcitabine; Health aspects; Humans; Lung cancer, Non-small cell; Male; Middle Aged; Neoplasm Metastasis - drug therapy; Neoplasm Metastasis - pathology; Taxoids - adverse effects; Taxoids - therapeutic use; Italy
• ISSN: 1479-5876; 1479-5876
• DOI: 10.1186/1479-5876-6-65

Docetaxel and gemcitabine combinations have proven active for the treatment of non-small cell lung cancer (NSCLC). The aim of the present study was to evaluate and compare two treatment schedules, one based on our own preclinical data and the other selected from the literature.
Patients with stage IV NSCLC and at least one bidimensionally-measurable lesion were eligible. Adequate bone marrow reserve, normal hepatic and renal function, and an ECOG performance status of 0 to 2 were required. No prior chemotherapy was permitted. Patients were randomized to arm A (docetaxel 70 mg/m2 on day 1 and gemcitabine 900 mg/m2 on days 3-8, every 3 weeks) or B (gemcitabine 900 mg/m2 on days 1 and 8, and docetaxel 70 mg/m2 on day 8, every 3 weeks).
The objective response rate was 20% (95% CI:10.0-35.9) and 18% (95% CI:8.6-33.9) in arms A and B, respectively. Disease control rates were very similar (54% in arm A and 53% in arm B). No differences were noted in median survival (32 vs. 33 weeks) or 1-year survival (33% vs. 35%). Toxicity was mild in both treatment arms.
Our results highlighted acceptable activity and survival outcomes for both experimental and empirical schedules as first-line treatment of NSCLC, suggesting the potential usefulness of drug sequencing based on preclinical models.
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