Department of Internal Medicine, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai, Japan.
Clin Lung Cancer. 2011 Nov;12(6):387-92. doi: 10.1016/j.cllc.2011.02.004. Epub 2011 May 10.
Efficacy of first-line gefitinib for elderly epidermal growth factor receptor mutated patients with lung adenocarcinoma is uncertain. This study was aimed to investigate efficacy of gefitinib for such population. The primary endpoint was response rate (RR) and at least 12 cases were needed. Overall RR was 59% (95% confidence interval, 33%-81%) and first-line gefitinib was effective for elderly patients.
Feasibility of gefitinib therapy in elderly patients with non-small-cell lung cancer is uncertain. This phase II study aimed to investigate the efficacy and usefulness of gefitinib therapy as a first-line treatment for elderly patients who have advanced lung adenocarcinoma with epidermal growth factor receptor (EGFR) mutations.
We enrolled chemotherapy-naïve advanced lung adenocarcinoma patients aged 75 years or older. Patients were administered gefitinib (250 mg) once daily until progression or unacceptable toxicity. The primary endpoint was response rate (RR), and secondary endpoints were disease control rate (DCR; defined as complete response [CR] plus partial response [PR] plus stable disease [SD]), progression-free survival (PFS), overall survival (OS), and toxicity profile.
Between April 2008 and November 2009, 17 lung adenocarcinoma patients were enrolled. Overall RR was 59% (95% confidence interval [CI]: 33% to 81%), with 2 patients achieving CR and 8 PR. SD was noted in 5 patients, and DCR was 88% (95% CI: 62% to 98%). Median PFS was 12.9 months (95% CI: 2.2 to 23.6 months), and median OS had not yet been reached. Major grade 3 toxicities were skin rash (12%) and increased levels of aspartate aminotransferase or alanine aminotransferase (18%).
First-line treatment with gefitinib was effective and well-tolerated in elderly patients with EGFR mutations.
探讨表皮生长因子受体（EGFR）突变的老年肺腺癌患者一线使用吉非替尼的疗效。
我们招募了未接受过化疗的年龄在 75 岁或以上的晚期肺腺癌患者。患者每日口服吉非替尼（250mg），直至疾病进展或出现不可耐受的毒性。主要终点为缓解率（RR），次要终点为疾病控制率（DCR；定义为完全缓解[CR]加部分缓解[PR]加稳定疾病[SD]）、无进展生存期（PFS）、总生存期（OS）和毒性谱。
2008 年 4 月至 2009 年 11 月期间，共纳入 17 例肺腺癌患者。总体 RR 为 59%（95%置信区间：33%至 81%），2 例患者达到 CR，8 例患者达到 PR。5 例患者疾病稳定，DCR 为 88%（95%置信区间：62%至 98%）。中位 PFS 为 12.9 个月（95%置信区间：2.2 至 23.6 个月），中位 OS 尚未达到。主要的 3 级毒性为皮疹（12%）和天冬氨酸转氨酶或丙氨酸转氨酶升高（18%）。
EGFR 突变的老年患者一线使用吉非替尼治疗有效且耐受良好。
