医学
帕尼单抗
实体瘤疗效评价标准
临床终点
毒性
内科学
进行性疾病
化疗
临床研究阶段
不利影响
外科
放射治疗
肿瘤科
胃肠病学
临床试验
西妥昔单抗
癌症
结直肠癌
作者
Matthew Foote,Margaret McGrath,Alexander Guminski,Brett Hughes,J. W. Meakin,Damien Thomson,Dannie Zarate,Fiona Simpson,Sandro Porceddu
标识
DOI:10.1093/annonc/mdu368
摘要
BackgroundAlthough advanced cutaneous squamous cell carcinoma (CSCC) is quite common, there are few prospective trials regarding its optimal management. This study evaluated the efficacy and safety of single-agent panitumumab in the treatment of patients with CSCC not suitable for local therapy.Patients and methodsSixteen patients received single-agent panitumumab at a dose of 6 mg/kg repeated every 2 weeks for a minimum of three cycles and continued until progression, a maximum of nine cycles or dose-limiting toxicity. The primary end point was the best overall response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) criteria. Secondary end points included evaluation of safety, toxicity and progression-free survival (PFS).ResultsBetween May 2010 and May 2012, 16 patients were recruited. Fourteen patients were male and the median age was 68 years. Fifteen patients had locoregionally advanced or recurrent disease with 14 patients receiving previous radiotherapy and 7 receiving previous cytotoxic chemotherapy. The best ORR [partial (PR) or complete response (CR)] was 31% (3/16 PR, 2/16 CR) with a further 6 of 16 patients achieving SD. The median PFS and overall survival were 8 and 11 months respectively. Grade 3 or 4 events were observed in five patients (four being skin toxicity) with one patient ceasing due to skin toxicity. With a median follow-up of 24 months, 10 patients died due to progressive disease, 6 are alive, one patient with no evidence of disease at the time of analysis.ConclusionsSingle-agent panitumumab is safe and effective in the management of patients with advanced CSCC even in a previously extensively pre-treated cohort.
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