First line chemotherapy with planned sequential administration of gemcitabine followed by docetaxel in elderly advanced non-small-cell lung cancer patients: a multicenter phase II study

• Published in: British journal of cancer Vol. 98; no. 3; pp. 558 - 563
• Main Authors: Tibaldi, C, Vasile, E, Antonuzzo, A, Di Marsico, R, Fabbri, A, Innocenti, F, Tartarelli, G, Amoroso, D, Andreuccetti, M, Dico, M Lo, Falcone, A
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 12.02.2008; Nature Publishing Group
• Subjects: Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cancer Research; Carcinoma, Non-Small-Cell Lung - drug therapy; Clinical Study; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Docetaxel; Drug Administration Schedule; Drug Resistance; Epidemiology; Female; Humans; Lung Neoplasms - drug therapy; Male; Medical sciences; Molecular Medicine; Oncology; Pneumology; Survival Analysis; Taxoids - administration & dosage; Tumors; Tumors of the respiratory system and mediastinum; elderly patients; gemcitabine; docetaxel; advanced NSCLC; Antineoplastic agent; Gemcitabine; Lung cancer; Multicenter study; non-small cell lung carcinoma; Cancerology; Sequential; Taxane derivatives; Phase II trial; Bronchus disease; Advanced stage; Antimitotic; Pyrimidine nucleoside; Human; Lung disease; Respiratory disease; Docetaxel; Malignant tumor; First line treatment; Antimetabolic; Pyrimidine derivatives; Fluorine Organic compounds; Elderly; Cancer
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/sj.bjc.6604187

This multicenter phase II study evaluated, in chemonaive patients with stage IIIB–IV NSCLC, age ⩾70 and with a performance status 0–2, the activity, efficacy and tolerability of planned sequential administration of gemcitabine 1200 mg m −2 on days 1 and 8 every 3 weeks for three courses followed by three cycles of docetaxel 37.5 mg m −2 on days 1 and 8 every 3 weeks, provided there was no evidence of disease progression. A total of 56 patients entered the study. According to intention-to-treat analysis, the objective response rate was 16.0% (95% CI 7.6–28.3%); 23 patients (41.0%) had stable disease and 24 patients (43%) had progressive disease. Five patients who had a stable disease after three courses of gemcitabine obtained a conversion to partial response by docetaxel. Median time to progression was 4.8 months (95% CI 3.6–6.0 months) and median duration of survival was 8.0 months (95% CI 5.6–10.5 months). The 1-year survival rate was 34%. No grade 4 haematological toxicity was observed and grade 3 neutropenia and thrombocytopenia were reported in 5.4 and 3.6% of the patients, respectively. Grade 3/4 mucositis and grade 3 diarrhoea, both occurred in 3.6% of the patients and grade 3 asthenia was observed in 9% of patients. One patient reported a grade 4 skin toxicity. No treatment-related deaths occurred. Sequential gemcitabine and docetaxel is a well-tolerated and effective regimen in elderly advanced NSCLC patients.