Senderowicz Adrian M, Johnson John R, Sridhara Rajeshwari, Zimmerman Paul, Justice Robert, Pazdur Richard
Office of Oncology Drug Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
Oncology (Williston Park). 2007 Dec;21(14):1696-706; discussion 1706-9, 1712, 1715.
Erlotinib (Tarceva) is a human epidermal growth factor receptor type 1/epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor initially approved by the US Food and Drug Administration for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of at least one prior chemotherapy regimen. In this report, we present the pivotal study that led to the approval of erlotinib in combination with gemcitabine (Gemzar) in patients with locally advanced/metastatic chemonaive pancreatic cancer patients. The combination demonstrated a statistically significant increase in overall survival accompanied by an increase in toxicity. Physicians and patients now have a new option for the treatment of locally advanced/metastatic adenocarcinoma of the pancreas.
厄洛替尼(特罗凯)是一种人表皮生长因子受体1/表皮生长因子受体(HER1/EGFR)酪氨酸激酶抑制剂,最初由美国食品药品监督管理局批准用于治疗至少一种先前化疗方案失败后的局部晚期或转移性非小细胞肺癌患者。在本报告中,我们展示了一项关键研究,该研究促使厄洛替尼联合吉西他滨(健择)被批准用于局部晚期/转移性未经化疗的胰腺癌患者。该联合用药显示总生存期有统计学意义的增加,同时毒性也有所增加。医生和患者现在对于局部晚期/转移性胰腺腺癌的治疗有了一种新的选择。