The FDA's recent approval of trifluridine/tipiracil tablets (Lonsurf®, Taiho Pharmaceutical Co., Ltd.) for heavily pretreated metastatic gastric adenocarcinoma and gastroesophageal junction adenocarcinoma represents a significant development for patients with gastric cancer, the third most frequent cause of cancer-related death. In this interview with i3 Health, Kohei Shitara, MD, speaks about the significance of this approval. Dr. Shitara was the lead author of the phase 3 TAGS study (NCT02500043), on which the approval was based.
What is the significance of the recent FDA approval of trifluridine/tipiracil for patients with heavily pretreated metastatic gastric cancer?
Kohei Shitara, MD: There are still limited treatment options for unresectable gastric cancer. In addition, after initial treatment, many patients maintain sufficient general health status to receive additional treatments. Trifluridine/tipiracil has become an important option for such patients. This approval is good news for patients as well as physicians.
What should physicians consider in balancing trifluridine/tipiracil against other options that they have for heavily pretreated metastatic gastric cancer?
Dr. Shitara: The phase 3 TAGS trial showed that trifluridine/tipiracil significantly improved patients' survival of gastric cancer after two or more previous lines of chemotherapy. Bone marrow suppression is a major side effect, but this is usually quite manageable. In contrast, other third-line options such as irinotecan or anti–PD-1 targeting treatments were associated with distinguishing toxicities such as gastrointestinal (GI) toxicity or immune-related toxicities, which are rarely observed with trifluridine/tipiracil.
How do you think that the treatment of metastatic gastric cancer will evolve in the future?
Dr. Shitara: Trifluridine/tipiracil is one of the cytotoxic agents for which predictive biomarkers may be hard to find. In contrast, several clinicopathologies are associated with the efficacy of anti–PD-1 treatment. Additionally, molecular targeting agents are still under development, not only for human epidermal growth factor receptor 2 (HER2) but also for other targets. Therefore, stratification of gastric cancer by molecular profiles will be more and more important.
Do you have any final words of advice for community gastroenterologists and oncologists treating patients with metastatic gastric cancer?
Dr. Shitara: Gastric cancer is still a major issue worldwide. We should maintain global collaboration in order to establish better treatment strategies and find effective agents to improve patient outcomes.
About Dr. Shitara
Kohei Shitara, MD, is Chief of the Department of Experimental Therapeutics and Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan. Dr. Shitara's primary research interests include the development of new cancer treatments, the optimization of chemotherapy regimens for gastrointestinal cancer, and translational research through the development of molecular targeted agents. Dr. Shitara has published more than 140 peer-reviewed articles in these fields.
For More Information
Shitara K, Doi T, Dvorkin M, et al (2018). Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol, 19(11):1437-1448. DOI:10.1016/S1470-2045(18)30739-3
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily represent the views of i3 Health.