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.