BACKGROUND:Bevacizumab is a monoclonal antibody with high antitumor activity against malignant diseases. Previous studies have demonstrated the efficacy of first-line bevacizumab combination therapy in advanced, non-squamous non-small cell lung cancer (NS-NSCLC). SAiL (MO19390), an open-label, multicenter, single-arm study, evaluated the safety and efficacy of first-line bevacizumab-based treatment in clinical practice. This report presents the results of a subgroup analysis of Chinese patients enrolled in SAiL. METHODS:Chemo-naive Chinese patients with locally advanced, metastatic or recurrent NSCLC were randomized to receive Bev 15 mg/kg every 3 weeks plus carboplatin + paclitaxel for maximum of six cycles, followed by single-agent bevacizumab until disease progression. The primary endpoint was safety. Secondary endpoints included time to progression and overall survival. RESULTS: The Chinese intent-to-treat (ITT) population consists of 198 Chinese patients, among whom 107 (54 %) were non-smokers and 90 (45.5 %) were female. The median cycle of bevacizumab administration was 10 and median duration of bevacizumab treatment was 29.5 weeks. Only eight cases of severe adverse events were observed in the study, which were deemed to be related to bevacizumab. The incidence of AEs over grade 3 in Chinese ITT patients was generally low (<9 %). No new safety signals were reported. Objective response rate in 195 evaluable Chinese patients was 68.8 %, including four complete responses (2.1 %). Time to disease progression (TTP) and overall survival were 8.8 and 18.5 months, respectively. CONCLUSIONS: The safety and efficacy of first-line bevacizumab-based treatment in Chinese population with advanced NS-NSCLC are consistent with those in previous studies as well as in Asian subgroup population from SAiL study. No new safety signals were reported.
RCT Entities:
BACKGROUND:Bevacizumab is a monoclonal antibody with high antitumor activity against malignant diseases. Previous studies have demonstrated the efficacy of first-line bevacizumab combination therapy in advanced, non-squamous non-small cell lung cancer (NS-NSCLC). SAiL (MO19390), an open-label, multicenter, single-arm study, evaluated the safety and efficacy of first-line bevacizumab-based treatment in clinical practice. This report presents the results of a subgroup analysis of Chinese patients enrolled in SAiL. METHODS: Chemo-naive Chinese patients with locally advanced, metastatic or recurrent NSCLC were randomized to receive Bev 15 mg/kg every 3 weeks plus carboplatin + paclitaxel for maximum of six cycles, followed by single-agent bevacizumab until disease progression. The primary endpoint was safety. Secondary endpoints included time to progression and overall survival. RESULTS: The Chinese intent-to-treat (ITT) population consists of 198 Chinese patients, among whom 107 (54 %) were non-smokers and 90 (45.5 %) were female. The median cycle of bevacizumab administration was 10 and median duration of bevacizumab treatment was 29.5 weeks. Only eight cases of severe adverse events were observed in the study, which were deemed to be related to bevacizumab. The incidence of AEs over grade 3 in Chinese ITT patients was generally low (<9 %). No new safety signals were reported. Objective response rate in 195 evaluable Chinese patients was 68.8 %, including four complete responses (2.1 %). Time to disease progression (TTP) and overall survival were 8.8 and 18.5 months, respectively. CONCLUSIONS: The safety and efficacy of first-line bevacizumab-based treatment in Chinese population with advanced NS-NSCLC are consistent with those in previous studies as well as in Asian subgroup population from SAiL study. No new safety signals were reported.
Authors: L G Presta; H Chen; S J O'Connor; V Chisholm; Y G Meng; L Krummen; M Winkler; N Ferrara Journal: Cancer Res Date: 1997-10-15 Impact factor: 12.701
Authors: Ahmedin Jemal; Freddie Bray; Melissa M Center; Jacques Ferlay; Elizabeth Ward; David Forman Journal: CA Cancer J Clin Date: 2011-02-04 Impact factor: 508.702
Authors: Martin Reck; Joachim von Pawel; Petr Zatloukal; Rodryg Ramlau; Vera Gorbounova; Vera Hirsh; Natasha Leighl; Jörg Mezger; Venice Archer; Nicola Moore; Christian Manegold Journal: J Clin Oncol Date: 2009-02-02 Impact factor: 44.544
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: Paola Mazzanti; Cristian Massacesi; Marco B L Rocchi; Rodolfo Mattioli; Paolo Lippe; Raffaele Trivisonne; Franco Buzzi; Giorgio De Signoribus; Guido Tuveri; Giorgio Rossi; Liberato Di Lullo; Fabio Sturba; Donatella Morale; Sergio Catanzani; Alberta Pilone; Maurizio Bonsignori; Tullio Battelli Journal: Lung Cancer Date: 2003-07 Impact factor: 5.705
Authors: David H Johnson; Louis Fehrenbacher; William F Novotny; Roy S Herbst; John J Nemunaitis; David M Jablons; Corey J Langer; Russell F DeVore; Jacques Gaudreault; Lisa A Damico; Eric Holmgren; Fairooz Kabbinavar Journal: J Clin Oncol Date: 2004-06-01 Impact factor: 44.544
Authors: Manuel Cobo; Dolores Isla; Bartomeu Massuti; Ana Montes; Jose Miguel Sanchez; Mariano Provencio; Nuria Viñolas; Luis Paz-Ares; Guillermo Lopez-Vivanco; Miguel Angel Muñoz; Enriqueta Felip; Vicente Alberola; Carlos Camps; Manuel Domine; Jose Javier Sanchez; Maria Sanchez-Ronco; Kathleen Danenberg; Miquel Taron; David Gandara; Rafael Rosell Journal: J Clin Oncol Date: 2007-07-01 Impact factor: 44.544