Division of Hematology-Oncology, Department of Medicine, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea.
Division of Hematology-Oncology, Department of Medicine, Sungkyunkwan University, Samsung Medical Center, Seoul, Republic of Korea
Anticancer Res. 2023 Sep;43(9):4161-4167. doi: 10.21873/anticanres.16607.
BACKGROUND/AIM: No standard treatment is currently recommended for advanced biliary tract cancer (BTC) after first-line therapy with gemcitabine plus cisplatin. We aimed to evaluate the efficacy and safety of a pemetrexed and erlotinib combination in patients with BTC previously treated with gemcitabine.
This phase II, open-label, single-arm study enrolled patients with BTC who had previously failed gemcitabine-based first-line chemotherapy. Patients were treated with pemetrexed as a 500 mg/m intravenous infusion on day 1 for three weeks and erlotinib 100 mg daily until disease progression or unacceptable toxicity. The primary endpoint was the overall response rate (ORR).
The study enrolled 20 patients with BTC, including 12 (60%) with intrahepatic cholangiocarcinoma (IHCC), 3 (15%) with extrahepatic cholangiocarcinoma (EHCC), and 5 (25%) with gallbladder cancer (GBC). The ORR was 5%, and the disease control rate (DCR) was 55%. As of the cutoff point of March 31, 2023, the median progression-free survival (PFS) was 2.3 months [95% confidence interval (CI)=0.00-4.74] and the median overall survival (OS) was 5.6 months (95%CI=2.28-8.87). Patients with EHCC showed longer PFS and OS compared to patients with IHCC or GBC, but the differences were not significant. A baseline CEA greater than the upper normal limit was the only significant prognostic factor for a worse OS rate. The only treatment-related adverse event (TRAE) with severity grade ≥3 was anemia (5%).
Salvage chemotherapy with pemetrexed plus erlotinib was well-tolerated and showed marginal clinical activity in BTC patients after failure to gemcitabine-based chemotherapy.
背景/目的：吉西他滨联合顺铂一线治疗后，晚期胆道癌（BTC）目前尚无标准治疗方法。我们旨在评估培美曲塞联合厄洛替尼在吉西他滨治疗失败的 BTC 患者中的疗效和安全性。
这是一项 II 期、开放标签、单臂研究，纳入了吉西他滨为基础的一线化疗失败的 BTC 患者。患者接受培美曲塞 500 mg/m 静脉输注，第 1 天，每 3 周一次；厄洛替尼 100 mg 每日一次，直至疾病进展或不可接受的毒性。主要终点是总缓解率（ORR）。
该研究纳入了 20 例 BTC 患者，包括 12 例（60%）肝内胆管癌（IHCC）、3 例（15%）肝外胆管癌（EHCC）和 5 例（25%）胆囊癌（GBC）。ORR 为 5%，疾病控制率（DCR）为 55%。截至 2023 年 3 月 31 日截止点，中位无进展生存期（PFS）为 2.3 个月[95%置信区间（CI）=0.00-4.74]，中位总生存期（OS）为 5.6 个月（95%CI=2.28-8.87）。EHCC 患者的 PFS 和 OS 长于 IHCC 或 GBC 患者，但差异无统计学意义。基线 CEA 大于正常值上限是 OS 率较差的唯一显著预后因素。唯一的严重程度≥3 级的治疗相关不良事件（TRAE）是贫血（5%）。
在吉西他滨为基础的化疗失败的 BTC 患者中，培美曲塞联合厄洛替尼挽救性化疗耐受性良好，且具有一定的临床疗效。
