title: Weekly chemotherapy with carboplatin, docetaxel and irinotecan in advanced non-small-cell-lung cancer: a phase II study.
abstract: The aim of this study was to evaluate the efficacy and tolerability of carboplatin, docetaxel plus irinotecan given weekly to patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). 50 patients with previously untreated NSCLC (stage IIIB 10; stage IV 40; 44% squamous cell carcinoma; median Eastern Cooperative Oncology Group (ECOG) status 1) received intravenous (i.v.) carboplatin area under the curve (AUC) 2, docetaxel 20 mg/m(2) and irinotecan 60 mg/m(2) on days 1, 8 and 15, repeated every 5 weeks. Prophylactic granulocyte colony-stimulating factor (G-CSF) 150 ug/m(2) was given from days 3 to 6 and 10 to 13. Response was evaluated every two cycles. Four complete responses (8%) and 24 (48%) partial responses were observed, giving an overall intent-to-treat response rate of 56%. 8 patients (16%) achieved stable disease and 14 (28%) progressed. The median time to progression (TTP) was 9.6 months (range 2.5-21.8 months), median survival was 14.8 months (range 0.3-27+ months) and actuarial 1-year survival time was 55%. Grade 3/4 anaemia and thrombocytopenia occurred in 18 and 22% of patients, respectively; 13 patients (26%) developed grade 3/4 neutropenia and 7 (14%) had neutropenic fever that required hospitalisation, but was successfully treated with antibiotics and G-CSF support. One patient developed a severe allergy during docetaxel administration and was withdrawn. Other grade 3/4 adverse events included diarrhoea (n=14; 3 required hospitalisation), nausea/vomiting (n=9), neurotoxicity (n=5) and fatigue (n=5). 6 patients required a dose reduction. This combination of i.v. carboplatin AUC 2, docetaxel 20 mg/m(2) and irinotecan 60 mg/m(2) given weekly is highly effective in the treatment of chemotherapy-naïve advanced NSCLC. Toxicity was moderate, but manageable.
authors.affiliation: 1st Department of Medical Oncology, Metaxas Memorial Cancer Hospital, 51 Botassi, Str. 18537, Piraeus, Greece. pectasid@otenet.gr
authors.forename: D
authors.initials: D
authors.lastname: Pectasides
authors.forename: A
authors.initials: A
authors.lastname: Visvikis
authors.forename: A
authors.initials: A
authors.lastname: Kouloubinis
authors.forename: J
authors.initials: J
authors.lastname: Glotsos
authors.forename: N
authors.initials: N
authors.lastname: Bountouroglou
authors.forename: N
authors.initials: N
authors.lastname: Karvounis
authors.forename: N
authors.initials: N
authors.lastname: Ziras
authors.forename: A
authors.initials: A
authors.lastname: Athanassiou
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003907:Dexamethasone / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016019:Survival Analysis; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D003907:Dexamethasone; D016190:Carboplatin; D017239:Paclitaxel; D002166:Camptothecin