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2019 GI Cancers Symposium: Safety, Efficacy of Trifluridine/Tipiracil in Metastatic Gastric Cancer With or Without Gastrectomy

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Key Points

  • FTD/TPI is effective and safe in heavily pretreated patients with metastatic gastric cancer.
  • Prior gastrectomy did not affect outcomes.

In a poster session earlier today David Ilson, MD, of Memorial Sloan Kettering Cancer Center, and colleagues reported on a preplanned subgroup analysis of the double-blind phase III TAGS study looking at the safety and efficacy of the oral agent trifluridine/tipiracil (FTP/TPI) in heavily pretreated patients with metastatic gastric cancer, with or without prior gastrectomy. The results were presented at the 2019 Gastrointestinal Cancers Symposium in San Francisco (Abstract 3).

In the subanalysis, investigators reported on safety and efficacy endpoints in 221 patients (44%) (n = 507) who had undergone prior gastrectomy. The prior gastrectomy group included 147 of 337 patients who were randomized to receive 35 mg/m2 of FTD/TPI twice daily on days 1 to 5 and days 8 to 12 of each 28-day cycle, plus best supportive care, and 74 of 170 patients randomized to placebo, plus best supportive care. Patient characteristics were similar across all groups.

The most common adverse events occurring in 10% or more of patients in any group were neutropenia, anemia, and leukopenia. Investigators found that the frequency of adverse events was higher in the group with prior gastrectomy receiving FTD/TPI, but this higher frequency did not lead to more treatment discontinuations. Ten patients in the prior gastrectomy group who received FTD/TPI discontinued treatment vs 15 patients with no prior gastrectomy who received FTD/TPI and discontinued treatment.  

The investigators concluded that the oral oncolytic FTD/TPI is effective and safe in heavily pretreated patients with advanced gastric cancer, whether or not they had received prior gastrectomy. Final results of the TAGS study showed that the oral regimen reduced the risk of death by 31% in the study population of heavily pretreated patients with metastatic gastric cancer who received two or more prior chemotherapy regimens. These final results were reported earlier.

Disclosure: The study authors' full disclosures can be found at coi.asco.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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