最佳靶向治疗管理获得最大生存获益.ppt

总体而言，索坦相关的不良反应易管理，大多数能够得到控制，从而确保患者达到最大临床获益1–7 索坦-related hypertension, diarrhoea, fatigue and hypothyroidism should not require dose modification Stomatitis, neutropenia, thrombocytopenia, HFS and cardiotoxicities may require temporary or permanent dose modification or treatment discontinuation EAP研究设计 在RCC患者中进行的开放性、扩大使用(EAP)研究，主要目的在于为那些不符合各国家/地区当地监管机构临床试验入组条件的RCC患者提供使用索坦的机会。 入组标准：先前接受过治疗或初治mRCC，≥18岁。给予索坦 50 mg(4/2)方案 数据来自全部4371例患者(校正后ITT人群，即接受过≥1剂索坦) ITT人群中 2974例(68%)先前接受过细胞因子治疗，238例(5%)接受过抗血管生成治疗 3489例(80%)转移灶数量≥2个，其中321例(7%)为脑转移 582例(13%)ECOG PS≥2 1418例(32%)年龄≥65 1930例(44%)为改良后MSKCC中危组，375例(9%)为高危组 截至2007年12月，共入组4565例患者，4371例可供安全性、治疗时间、肿瘤反应以及生成分析。 索坦治疗相关的最常见AE为腹泻(44%)与乏力(37%) 最常见的非血液学AE为腹泻、乏力、恶心、粘膜炎，多为1~2度 最常见的非血液学3~4度AE为乏力、HFS、虚弱、高血压、腹泻 索坦治疗相关的最常见的3~4度血液学不良事件为中性粒细胞减少、血小板减少。 Prompt and proactive recognition and management of treatment-related side effects can help to avoid 索坦 dose reductions and treatment interruptions in patients with mRCC1–3 This, in turn, can help physicians to achieve dose optimisation with 索坦 and maintain patients on treatment, and thus provide maximum clinical benefit4 In the phase III trial of sunitinib vs IFN-α for first-line treatment mRCC, ORR increased with longer sunitinib treatment duration1–3 The tabulated data given above present the findings for sunitinib and IFN-α from the interim and final analyses of the trial.1–3 Duration of therapy is given as a median value, presented in months ORR were derived from central independent review, given as percentages and 95% confidence intervals P-values are for the comparison of ORR between sunitinib and IFN-α at the two timepoints These findings of greater benefit in terms of ORR with longer duration of treatment suggest that exposure to sunitinib should be maintained for as long as clinical benefit is observed4 References 1. Motzer RJ, et al. N Engl J Med 2007 2. Motzer RJ, et al. J Clin Oncol 2009. In press 3. Figlin RA, et al. ASCO 2008 4. Porta C, et al. ASCO 2008 Prompt and