非小细胞肺癌的治疗近展课件.pptVIP

* * * Previous studies identified pulmonary haemorrhage (haemoptysis) as a side effect of Avastin in patients with lung cancer; squamous cell histology was identified as a risk factor for this adverse event.1 In this phase III study, patients with squamous cell tumours were excluded. Although an increased incidence of haemorrhage was observed in the Avastin arm,2 restricting the population to patients with non-squamous histology and minimal baseline haemoptysis substantially decreased the incidence of severe pulmonary bleeding from 9% in the pivotal phase II trial to 1.9% in this phase III trial.2 Hypertension, a recognised side effect of Avastin, was also observed in this study.2 There was a non-significant trend for increased thrombosis with the addition of Avastin. This relatively uncommon side effect has also been reported in other clinical trials with Avastin; however, the incidence of arterial thrombosis reported here is lower than in previous reports.3 Johnson DH, Fehrenbacher L, Novotny WF, et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2004;22:2184–91. Sandler AB, Gray R, Brahmer J, et al. Randomized phase II/III trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): an Eastern Cooperative Oncology Group (ECOG) trial – E4599. J Clin Oncol 2005;23(June 1 Suppl.):2s (Abstract LBA4). Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol 2005;23:3706–12. * * * * * * * * INTEREST is h-2-h with standard of care (docetaxel), predominantly in 2nd line setting Over 1000 / 1400 pts already randomised Unselect