PURPOSE: The prognosis of patients with advanced non-small-cell lung cancer (NSCLC) is extremely poor. Many prospective randomized trials on patients with advanced NSCLC suggested systemic chemotherapy improves both the survival and quality of life. A phase II trial was conducted to evaluate the efficacy and safety profile of the combination chemotherapy of gemcitabine and cisplatin in advanced NSCLC. MATERIALS AND METHODS: Forty-four patients with locally advanced or metastatic NSCLC were enrolled. The patients received a cisplatin, 75 mg/m(2), infusion over 30 minutes on days 1, followed by a gemcitabine, 1,250 mg/m(2), infusion over 30 minutes on days 1 and 8 every 3 weeks. RESULTS: The median age of the patients was 64 years (range: 27 approximately 75). Forty-one patients were assessable for response and toxicity analyses. The overall response rate was 53.6%, but with no complete remissions. The median time to progression was 5.6 months (range: 1 approximately 15.4). The median survival was 14.2 months (95% confidence interval (CI), 13.8 approximately 22.5). A total of 179 cycles were administered, with a median of 4 cycles of chemotherapy, ranging from 2 to 9 cycles. The most common hematological toxicities were NCI grades 3/4 neutropenia (24%) and thrombocytopenia (7.8%). The most common non-hematological toxicity was fatigue (42.4%). There were no life-threatening toxicity or treatment related mortalities. The median duration of follow up was 9.4 months, ranging from 1.6 to 30.3 months. CONCLUSION: In this trial, the combination of gemcitabine and cisplatin showed significant activity, with acceptable and manageable toxicities as a first-line regimen for patients with advanced NSCLC.
PURPOSE: The prognosis of patients with advanced non-small-cell lung cancer (NSCLC) is extremely poor. Many prospective randomized trials on patients with advanced NSCLC suggested systemic chemotherapy improves both the survival and quality of life. A phase II trial was conducted to evaluate the efficacy and safety profile of the combination chemotherapy of gemcitabine and cisplatin in advanced NSCLC. MATERIALS AND METHODS: Forty-four patients with locally advanced or metastatic NSCLC were enrolled. The patients received a cisplatin, 75 mg/m(2), infusion over 30 minutes on days 1, followed by a gemcitabine, 1,250 mg/m(2), infusion over 30 minutes on days 1 and 8 every 3 weeks. RESULTS: The median age of the patients was 64 years (range: 27 approximately 75). Forty-one patients were assessable for response and toxicity analyses. The overall response rate was 53.6%, but with no complete remissions. The median time to progression was 5.6 months (range: 1 approximately 15.4). The median survival was 14.2 months (95% confidence interval (CI), 13.8 approximately 22.5). A total of 179 cycles were administered, with a median of 4 cycles of chemotherapy, ranging from 2 to 9 cycles. The most common hematological toxicities were NCI grades 3/4 neutropenia (24%) and thrombocytopenia (7.8%). The most common non-hematological toxicity was fatigue (42.4%). There were no life-threatening toxicity or treatment related mortalities. The median duration of follow up was 9.4 months, ranging from 1.6 to 30.3 months. CONCLUSION: In this trial, the combination of gemcitabine and cisplatin showed significant activity, with acceptable and manageable toxicities as a first-line regimen for patients with advanced NSCLC.
Entities:
Keywords:
Chemotherapy; Cisplatin; Gemcitabine; Non-small-cell lung cancer
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Authors: M H Cullen; L J Billingham; C M Woodroffe; A D Chetiyawardana; N H Gower; R Joshi; D R Ferry; R M Rudd; S G Spiro; J E Cook; C Trask; E Bessell; C K Connolly; J Tobias; R L Souhami Journal: J Clin Oncol Date: 1999-10 Impact factor: 44.544
Authors: L Crinò; G Scagliotti; M Marangolo; F Figoli; M Clerici; F De Marinis; F Salvati; G Cruciani; L Dogliotti; F Pucci; A Paccagnella; V Adamo; G Altavilla; P Incoronato; M Trippetti; A M Mosconi; A Santucci; S Sorbolini; C Oliva; M Tonato Journal: J Clin Oncol Date: 1997-01 Impact factor: 44.544
Authors: U Gatzemeier; F A Shepherd; T Le Chevalier; P Weynants; B Cottier; H J Groen; R Rosso; K Mattson; H Cortes-Funes; M Tonato; R L Burkes; M Gottfried; M Voi Journal: Eur J Cancer Date: 1996-02 Impact factor: 9.162