舒尼替尼治疗胰腺神经内分泌肿瘤.4000.pptVIP

Updated Safety and Efficacy Results of the Phase III Trial of Sunitinib vs. Placebo for Treatment of Pancreatic NET Patricia Niccoli,1 Jean-Luc Raoul,2 Yung-Jue Bang,3 Ivan Borbath,4 Catherine Lombard-Bohas,5 Juan Valle,6 Shem Patyna,7Dongrui-Ray Lu,7 Richard Chao,7 Eric Raymond8 1Assistance Publique, H?pitaux de Marseille CHU Timone, Institut Paoli-Calmettes and RENATEN network, Marseille, France; 2Eugène Marquis Centre and European University in Brittany, Rennes, France; 3Seoul National University Hospital, Seoul, Korea; 4Cliniques Universitaires Saint-Luc, Brussels, Belgium; 5H?pital Edouard Herriot, Hospices Civils de Lyon, Lyon, France; 6Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK; 7Pfizer Oncology, Development, La Jolla, CA, USA; 8Service Inter-Hospitalier de Cancérologie et Service de Gastroenteropancréatologie, H?pital Beaujon, Clichy, France Demographic and Baseline Characteristics A total of 171 patients were enrolled between June 2007 and April 2009 Tumor Characteristics at Baseline Baseline Characteristics: Extent of Disease Prior Treatments and Somatostatin Analog Use Progression-Free Survival Overall Survival Overall Survival RECIST-Defined Objective Tumor Response Complete Response in a Patient Receiving Sunitinib CDD Sunitinib Effective Across All Patient Subsets Most Frequent All-Causality Adverse Events Most Frequent Grade 3+ Adverse Events Summary In patients with pancreatic NET, sunitinib 37.5 mg/day improved: PFS: 11.4 vs. 5.5 mo, HR=0.418, P=0.0001 OS: HR=0.409, P=0.0204 ORR: 9.3% vs. 0%, P=0.0066 Sunitinib improved PFS across all patient subgroups Continuous daily dosing with sunitinib was well tolerated in this patient population These data support the clinical safety and efficacy of sunitinib in patients with progressive, well-differentiated, advanced pancreatic NET Discussion for Abstract No. 4000 舒尼替尼组的ORR、PFS、OS明显优于安慰剂组； IDMC在入组171例患者的数据分析后，就提前终止； 化疗对胰腺神经内分泌肿瘤的疗效差； 本研究是胰腺神经内分泌肿瘤的突破性进展； 舒尼替