P Zatloukal1, F Cardenal2, A Szczesna3, V Gorbunova4, V Moiseyenko5, X Zhang6, L Cisar6, J-C Soria7, M Domine8, M Thomas9. 1. Department of Pneumology, Third Faculty of Medicine, Faculty Hospital Bulovka and Postgraduate Medical Institute, Charles University, Prague, Czech Republic. Electronic address: zatloukp@fnb.cz. 2. Department of Medical Oncology, Institut Català d'Oncologia, Barcelona, Spain. 3. Regional Lung Diseases Hospital, Otwock, Poland. 4. Department of Chemotherapy, Cancer Research Centre, Moscow, Russian Federation. 5. N.N. Petrov Research Institute of Oncology of Federal Agency of High-tech Medical Treatment, St Petersburgh, Russian Federation. 6. Pfizer Inc., New York, NY, USA. 7. Department of Medicine, Lung Cancer Unit, Institut Gustave Roussy, Villejuif, France. 8. Department of Medical Oncology, Hospital Fundación Jiménez Diaz, Madrid, Spain. 9. Department of Internal Medicine, Thoracic Oncology, Clinic for Thoracic Diseases at the University of Heidelberg, Heidelberg, Germany.
Abstract
BACKGROUND: This study compared irinotecan plus cisplatin (IP) with etoposide plus cisplatin (EP) in small-cell lung cancer patients with extensive disease. PATIENTS AND METHODS: Patients were randomly assigned to receive cisplatin 80 mg/m(2) and either irinotecan 65 mg/m(2), days 1 and 8 or etoposide 100 mg/m(2), days 1-3, every 3 weeks. RESULTS: Baseline characteristics were balanced between patients receiving IP (N = 202) or EP (N = 203). Median overall survival was nonsignificantly superior for patients receiving IP versus EP, 10.2 versus 9.7 months [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.65-1.01, P = 0.06] and 1- and 2-year survival rates were 41.9% versus 38.9% and 16.3% versus 8.2%, respectively. Noninferiority of IP versus EP was established, upper bound of the 95% CI of HR 1.01 (prespecified margin IP/EP <1.25). Overall response (39.1% versus 46.6%) and time to tumor progression (5.4 versus 6.2 months) were not superior for IP. Grade 3/4 vomiting (10.9% versus 4.4%) and diarrhea (15.4% versus 0.5%) were more common in the IP versus EP arm; grade 3/4 neutropenia was more frequent in the EP (59.6%) versus IP arm (38.1%). CONCLUSIONS: Our data demonstrate the noninferiority of IP versus EP for survival in primarily Western patients with SCLC-ED. A meta-analysis is required to finally assess the role of irinotecan in this setting.
RCT Entities:
BACKGROUND: This study compared irinotecan plus cisplatin (IP) with etoposide plus cisplatin (EP) in small-cell lung cancerpatients with extensive disease. PATIENTS AND METHODS: Patients were randomly assigned to receive cisplatin 80 mg/m(2) and either irinotecan 65 mg/m(2), days 1 and 8 or etoposide 100 mg/m(2), days 1-3, every 3 weeks. RESULTS: Baseline characteristics were balanced between patients receiving IP (N = 202) or EP (N = 203). Median overall survival was nonsignificantly superior for patients receiving IP versus EP, 10.2 versus 9.7 months [hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.65-1.01, P = 0.06] and 1- and 2-year survival rates were 41.9% versus 38.9% and 16.3% versus 8.2%, respectively. Noninferiority of IP versus EP was established, upper bound of the 95% CI of HR 1.01 (prespecified margin IP/EP <1.25). Overall response (39.1% versus 46.6%) and time to tumor progression (5.4 versus 6.2 months) were not superior for IP. Grade 3/4 vomiting (10.9% versus 4.4%) and diarrhea (15.4% versus 0.5%) were more common in the IP versus EP arm; grade 3/4 neutropenia was more frequent in the EP (59.6%) versus IP arm (38.1%). CONCLUSIONS: Our data demonstrate the noninferiority of IP versus EP for survival in primarily Western patients with SCLC-ED. A meta-analysis is required to finally assess the role of irinotecan in this setting.
Authors: Jarushka Naidoo; Maria L Santos-Zabala; Tunc Iyriboz; Kaitlin M Woo; Camelia S Sima; John J Fiore; Mark G Kris; Gregory J Riely; Piro Lito; Afsheen Iqbal; Stephen Veach; Stephanie Smith-Marrone; Inderpal S Sarkaria; Lee M Krug; Charles M Rudin; William D Travis; Natasha Rekhtman; Maria C Pietanza Journal: Clin Lung Cancer Date: 2016-01-21 Impact factor: 4.785
Authors: William R Schelman; Tabraiz A Mohammed; Anne M Traynor; Jill M Kolesar; Rebecca M Marnocha; Jens Eickhoff; Michael Keppen; Dona B Alberti; George Wilding; Naoko Takebe; Glenn Liu Journal: Invest New Drugs Date: 2013-07-17 Impact factor: 3.850