Pemetrexed and Erlotinib as a Salvage Treatment in Patients With Metastatic Biliary Tract Cancer Who Failed Gemcitabine-containing Chemotherapy: A Phase II Single-arm Prospective Study
- Authors
- Lim, S.H.[Lim, Sung Hee]; Hong, J.Y.[Hong, Jung Yong]; Park, J.O.[Park, Joon Oh]; Park, Y.S.[Park, Young Suk]; Kim, S.T.[Kim, Seung Tae]
- Issue Date
- 1-Sep-2023
- Publisher
- NLM (Medline)
- Keywords
- Biliary tract cancer; efficacy; erlotinib; pemetrexed; second-line treatment
- Citation
- Anticancer research, v.43, no.9, pp.4161 - 4167
- Indexed
- SCIE
SCOPUS
- Journal Title
- Anticancer research
- Volume
- 43
- Number
- 9
- Start Page
- 4161
- End Page
- 4167
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/108387
- DOI
- 10.21873/anticanres.16607
- ISSN
- 0250-7005
- Abstract
- 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. PATIENTS AND METHODS: 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/m2 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). RESULTS: 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%). CONCLUSION: Salvage chemotherapy with pemetrexed plus erlotinib was well-tolerated and showed marginal clinical activity in BTC patients after failure to gemcitabine-based chemotherapy. Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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