10.6084/m9.figshare.9696506.v2 Connie Kang Connie Kang Sohita Dhillon Sohita Dhillon Emma D. Deeks Emma D. Deeks Trifluridine/Tipiracil: A Review in Metastatic Gastric Cancer Adis Journals 2020 Trifluridine/tipiracil Lonsurf Metastatic gastric cancer Review Adis Drug Evaluation Mechanism of action (MOA) video abstract Metastatic Gastroesophageal junction carcinoma 2020-01-19 18:34:40 Media https://adisjournals.figshare.com/articles/media/Trifluridine_Tipiracil_A_Review_in_Metastatic_Gastric_Cancer/9696506 <p>Compliance with Ethical Standards</p><p><i>Funding</i>: The preparation of this review was not supported by any external funding.<br></p> <p><i>Conflicts of interest: </i>Connie Kang, Sohita Dillon and Emma D. Deeks are salaried employees of Adis International Ltd/Springer Nature, are responsible for the article content and declare no relevant conflicts of interest.<br></p> <p>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a><br></p> <p><br></p><p>Abstract<br></p> <p>Trifluridine/tipiracil (Lonsurf®) is a fixed-dose combination tablet comprising trifluridine, an antineoplastic nucleoside analogue, and tipiracil, a thymidine phosphorylase inhibitor. Trifluridine/tipiracil has recently been granted an additional indication in the USA for the treatment of metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, in patients who have been previously treated with at least two systemic treatment regimens, and has received a positive opinion for this indication in the EU. In the large pivotal phase III TAGS trial, trifluridine/tipiracil plus best supportive care (BSC) significantly prolonged overall survival (OS; primary endpoint) compared with placebo plus BSC in this patient group. Progression-free survival (PFS) and the disease control rate were also improved with trifluridine/tipiracil relative to placebo. Health-related quality of life was not adversely affected by the addition of trifluridine/tipiracil to BSC and time to deterioration of Eastern Cooperative Oncology Group (ECOG) performance status was significantly delayed. The most common adverse events were mainly haematological (neutropenia, leucopenia and anaemia) and gastrointestinal (nausea, vomiting and diarrhoea), and were generally manageable with dosage modifications and/or supportive care. Adverse events ≥ Grade 3 were most frequently haematological in nature. Thus, trifluridine/tipiracil provides a valuable and much needed treatment option for patients with metastatic gastric or gastroesophageal junction adenocarcinoma that has progressed on at least two prior therapies.<br></p> <p>© Springer Nature Switzerland AG 2019</p><p></p>