Phase II clinical trial of chemotherapy-naive patients ≥ 70 years of age treated with erlotinib for advanced non-small-cell lung cancer
Phase II clinical trial of chemotherapy-naive patients ≥ 70 years of age treated with erlotinib for advanced non-small-cell lung cancer
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DOI：
10.1200/jco.2006.07.5754
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发表时间：
2007-03-01
影响因子：
45.3
通讯作者：
Jaenne, Pasi A.
中科院分区：
文献类型：
--
作者：
Jackman, David M.;Yeap, Beow Y.;Jaenne, Pasi A.
目的：本研究是一项II期、多中心、开放性研究，对年龄≥ 70岁、未经化疗的非小细胞肺癌（NSCLC）患者进行厄洛替尼治疗，并评估其中位、1年和2年生存率。次要终点包括放射学反应率，进展时间（TTP），毒性和症状improvementation.Patients和MethodsEligible与NSCLC患者进行厄洛替尼150 mg/d，直到疾病进展或显着的毒性治疗。使用实体瘤疗效评价标准，每8周通过计算机断层扫描评估一次肿瘤缓解。肿瘤样本进行了分析，EGFR和KRAS的体细胞突变的存在下。ResultsEighty符合条件的患者开始厄洛替尼治疗之间的2003年3月和2005年5月。有8例部分缓解（10%），另外33例患者（41%）病情稳定2个月或更长时间。中位TTP为3.5个月（95% CI，2.0 - 5.5个月）。中位生存期为10.9个月（95%CI，7.8 ~ 14.6个月）。1年和2年生存率分别为46%和19%。最常见的毒副反应为痤疮样皮疹（79%）和腹泻（69%）。4例患者发生3级或3级以上的间质性肺病，1例治疗相关死亡。在研究的43例患者中，有9例检测到EGFR突变。EGFR突变的存在是密切相关的疾病控制，延长TTP，和survival.ConclusionErlotinib单药治疗是积极的，相对耐受性较好的化疗初治的老年晚期NSCLC患者。厄洛替尼值得考虑作为老年患者的一线治疗选择进行进一步研究。
PurposeThis is a phase II, multicenter, open-label study of chemotherapy-naive patients with non-small-cell lung cancer (NSCLC) and age >= 70 years who were treated with erlotinib and evaluated to determine the median, 1-year, and 2-year Survival. The secondary end points include radiographic response rate, time to progression (TTP), toxicity, and symptom improvement.Patients and MethodsEligible patients with NSCLC were treated with erlotinib 150 mg/d until disease progression or significant toxicity. Tumor response was assessed every 8 weeks by computed tomography scan using Response Evaluation Criteria in Solid Tumors. Tumor samples were analyzed for the presence of somatic mutations in EGFR and KRAS.ResultsEighty eligible patients initiated erlotinib therapy between March 2003 and May 2005. There were eight partial responses (10%), and an additional 33 patients (41%) had stable disease for 2 months or longer. The median TTP was 3.5 months (95% Cl, 2.0 to 5.5 months). The median survival time was 10.9 months (95% Cl, 7.8 to 14.6 months). The 1- and 2- year survival rates were 46% and 19%, respectively. The most common toxicities were acneiform rash (79%) and diarrhea (69%). Four patients developed interstitial lung disease of grade 3 or higher, with one treatment-related death. EGFR mutations were detected in nine of 43 patients studied. The presence of an EGFR mutation was strongly correlated with disease control, prolonged TTP, and survival.ConclusionErlotinib monotherapy is active and relatively well tolerated in chemotherapy-naive elderly patients with advanced NSCLC. Erlotinib merits consideration for further investigation as a first-line therapeutic option in elderly patients.