National Cancer Center Hospital, Tokyo, Japan.
Cancer Sci. 2011 Feb;102(2):425-31. doi: 10.1111/j.1349-7006.2010.01810.x. Epub 2010 Dec 22.
Erlotinib combined with gemcitabine has not been evaluated in Japanese patients with unresectable pancreatic cancer. This two-step phase II study assessed the safety and pharmacokinetics of erlotinib 100 mg/day (oral) plus gemcitabine 1000 mg/m(2) (i.v. days 1, 8, 15) in a 28-day cycle in the first step, and efficacy and safety in the second step. The primary end-point was safety. One hundred and seven patients were enrolled (first step, n = 6; second step, n = 101). The most common adverse event was RASH (compiled using the preferred terms rash, acne, exfoliative rash, dermatitis acneiform, erythema, eczema, dermatitis and pustular rash) in 93.4% of patients. One treatment-related death occurred. While interstitial lung disease-like events were reported in nine patients (8.5%; grade 1/2/3, 3.8/2.8/1.9%), all patients recovered or improved. The median overall survival, the 1-year survival rate and median progression-free survival were 9.23 months, 33.0% and 3.48 months, respectively. The overall response and disease control rates were 20.3% and 50.0%, respectively. In Japanese patients with unresectable pancreatic cancer, erlotinib plus gemcitabine had acceptable toxicity and efficacy that was not inferior to that seen in Western patients.
厄洛替尼联合吉西他滨尚未在日本不可切除胰腺癌患者中进行评估。这项两阶段 II 期研究评估了厄洛替尼 100mg/天（口服）联合吉西他滨 1000mg/m²（静脉注射，第 1、8、15 天）在 28 天周期中的安全性和药代动力学，第二阶段评估了疗效和安全性。主要终点是安全性。共入组 107 例患者（第一阶段，n=6；第二阶段，n=101）。最常见的不良反应是皮疹（采用首选术语皮疹、痤疮、剥脱性皮疹、痤疮样皮炎、红斑、湿疹、皮炎和脓疱性皮疹），发生率为 93.4%。发生 1 例与治疗相关的死亡事件。9 例（8.5%；1/2/3 级分别为 3.8/2.8/1.9%）报告有间质性肺病样事件，但所有患者均恢复或改善。中位总生存期、1 年生存率和中位无进展生存期分别为 9.23 个月、33.0%和 3.48 个月。总缓解率和疾病控制率分别为 20.3%和 50.0%。在日本不可切除的胰腺癌患者中，厄洛替尼联合吉西他滨的毒性可接受，疗效不劣于西方患者。
