Phase II study of erlotinib in patients with advanced biliary cancer
Phase II study of erlotinib in patients with advanced biliary cancer
复制标题
DOI：
10.1200/jco.2005.05.3579
复制
发表时间：
2006-07-01
影响因子：
45.3
通讯作者：
Erlichman, Charles
中科院分区：
文献类型：
--
作者：
Philip, Philip A.;Mahoney, Michelle R.;Erlichman, Charles
表皮生长因子受体/人表皮生长因子受体1及其配体在胆管癌（BILI）中的表达是常见的，并可能与预后不良有关。本研究的主要目的是确定晚期BILI患者在6 months.MethodsPatients与不可切除或转移性疾病进行了研究。仅允许既往接受过一次全身或局部治疗。厄洛替尼连续给药的剂量为156毫克，每天口服。ResultsForty 2例BILI患者入组。中位年龄为67岁（范围：33 - 82岁）。52%的患者的东部肿瘤协作组体能状态为1。57%的患者既往接受过晚期BILL HER 1/EGFR化疗，在36例可评估患者中的29例（81%）中通过免疫组织化学检测到肿瘤细胞表达。7例患者（17%; 95% CI，7%-31%）在6个月时无进展。根据实体瘤组疗效评价标准分类，3例患者的部分缓解持续时间分别为4个月、4个月和14个月。所有缓解患者均有轻度（1/2级）皮疹，2例患者肿瘤HER 1/EGFR表达阳性。三名患者（7%）有毒性相关的剂量减少厄洛替尼由于2/3级skin rush.ConclusionResults表明EGFR阻断与厄洛替尼在胆道癌患者的治疗效益。厄洛替尼作为单一药物以及与其他靶向药物联合应用的其他研究在这种疾病中是必要的。
PurposeEpidermal growth factor receptor/human epidermal growth factor receptor 1 and ligand expression is common in biliary cancers (BILI) and may be associated with worse outcome. The primary objective of this study was to determine the proportion of patients with advanced BILI who were progression-free at 6 months.MethodsPatients with either unresectable or metastatic disease were studied. Only one prior systemic or locoregional therapy was allowed. Erlotinib was administered continuously at a dose of 156 mg per day orally.ResultsForty-two patients with BILI were enrolled. The median age was 67 years (range, 33 to 82 years). Fifty-two percent of patients had Eastern Cooperative Oncology Group performance status of 1 Fifty-seven percent of patients had received prior chemotherapy for advanced BILL HER1/EGFR expression by immunohistochemistry in tumor cells was detected in 29 (81%) of the 36 assessable patients. Seven of the patients (17%; 95% CI, 7% to 31%) were progression free at 6 months. Three patients had partial response by Response Evaluation Criteria in Solid Tumors Group classification of duration 4, 4, and 14 months, respectively. All responding patients had mild (grade 1/2) skin rash and two patients had positive tumoral HER1/EGFR expression. Three patients (7%) had toxicity-related dose reductions of erlotinib due to grade 2/3 skin rash.ConclusionResults suggest a therapeutic benefit for EGFR blockade with erlotinib in patients with biliary cancer. Additional studies with erlotinib as a single agent and in combination with other targeted agents are warranted in this disease.