BACKGROUND: The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). METHODS: Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m(2) on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. RESULTS: Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively). CONCLUSIONS: Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.
BACKGROUND: The aim of this phase II study was to evaluate the feasibility and safety of a carboplatin and gemcitabine combination regimen in the treatment of completely resected non-small cell lung cancer (NSCLC). METHODS:Patients with completely resected pathologically documented stage IB, II or IIIA NSCLC were treated with carboplatin and gemcitabine. Chemotherapy consisted of 4 cycles of carboplatin at an area under the curve of 5 (level 1) or 4 (level 2) on day 1 combined with gemcitabine 1,000 mg/m(2) on days 1 and 8 every 3 weeks. The primary endpoint of this study was the completion rate of 4 cycles. RESULTS: Twenty patients were treated, and the patient's demographics were: median age 61 years (range 51-74), gender male (n = 13, 65%)/female (n = 7, 35%), stage IB (n = 8, 40%), IIA (n = 1, 5%), IIB (n = 6, 30%), IIIA (n = 5, 25%). Seventeen patients (85%, 95% confidence interval 64.0-94.8) received the planned 4 cycles of the chemotherapy regimen at level 1 every 3 weeks. Among the 3 patients who failed to complete 4 cycles, the reasons for stopping were refusal (n = 1), thrombocytopenia (n = 1) and rash (n = 1). The main adverse effects were hematological toxicity as well as grade 3/4 neutropenia and thrombocytopenia (which occurred in 65% and 40% of the patients, respectively). CONCLUSIONS: Adjuvant chemotherapy with a carboplatin and gemcitabine combination regimen has an acceptable toxicity profile, and the majority of patients completed 4 cycles of therapy.
Authors: K Kelly; J Crowley; P A Bunn; C A Presant; P K Grevstad; C M Moinpour; S D Ramsey; A J Wozniak; G R Weiss; D F Moore; V K Israel; R B Livingston; D R Gandara Journal: J Clin Oncol Date: 2001-07-01 Impact factor: 44.544
Authors: G V Scagliotti; F De Marinis; M Rinaldi; L Crinò; C Gridelli; S Ricci; E Matano; C Boni; M Marangolo; G Failla; G Altavilla; V Adamo; A Ceribelli; M Clerici; F Di Costanzo; L Frontini; M Tonato Journal: J Clin Oncol Date: 2002-11-01 Impact factor: 44.544
Authors: T Le Chevalier; G Scagliotti; R Natale; S Danson; R Rosell; R Stahel; P Thomas; R M Rudd; J Vansteenkiste; N Thatcher; C Manegold; J-L Pujol; N van Zandwijk; C Gridelli; J P van Meerbeeck; L Crino; A Brown; P Fitzgerald; M Aristides; J H Schiller Journal: Lung Cancer Date: 2005-01 Impact factor: 5.705
Authors: Giorgio Vittorio Scagliotti; Purvish Parikh; Joachim von Pawel; Bonne Biesma; Johan Vansteenkiste; Christian Manegold; Piotr Serwatowski; Ulrich Gatzemeier; Raghunadharao Digumarti; Mauro Zukin; Jin S Lee; Anders Mellemgaard; Keunchil Park; Shehkar Patil; Janusz Rolski; Tuncay Goksel; Filippo de Marinis; Lorinda Simms; Katherine P Sugarman; David Gandara Journal: J Clin Oncol Date: 2008-05-27 Impact factor: 44.544
Authors: Jean-Pierre Pignon; Hélène Tribodet; Giorgio V Scagliotti; Jean-Yves Douillard; Frances A Shepherd; Richard J Stephens; Ariane Dunant; Valter Torri; Rafael Rosell; Lesley Seymour; Stephen G Spiro; Estelle Rolland; Roldano Fossati; Delphine Aubert; Keyue Ding; David Waller; Thierry Le Chevalier Journal: J Clin Oncol Date: 2008-05-27 Impact factor: 44.544