title: 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.
abstract: This multicenter phase II study evaluated, in chemonaive patients with stage IIIB-IV NSCLC, age >or=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.
authors.affiliation: Division of Oncology, Department of Oncology, UO Oncologia Medica, Presidio Ospedaliero, Azienda USL-6 of Livorno Viale Alfieri 36, Livorno 57100, Italy. tiby@katamail.com
authors.forename: C
authors.initials: C
authors.lastname: Tibaldi
authors.forename: E
authors.initials: E
authors.lastname: Vasile
authors.forename: A
authors.initials: A
authors.lastname: Antonuzzo
authors.forename: R
authors.initials: R
authors.lastname: Di Marsico
authors.forename: A
authors.initials: A
authors.lastname: Fabbri
authors.forename: F
authors.initials: F
authors.lastname: Innocenti
authors.forename: G
authors.initials: G
authors.lastname: Tartarelli
authors.forename: D
authors.initials: D
authors.lastname: Amoroso
authors.forename: M
authors.initials: M
authors.lastname: Andreuccetti
authors.forename: M
authors.initials: M
authors.lastname: Lo Dico
authors.forename: A
authors.initials: A
authors.lastname: Falcone
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage*; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine