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ASCO GI 2022 | Investigating the treatment of patients with gastric or GEJ cancer with FTD/TPI plus ramucirumab

Rutika Mehta, MD, MPH, Moffit Cancer Center, Tampa, FL, discusses the results of the Phase II clinical trial that investigated FTD/TPI in combination with ramucirumab that was presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2022. The current standard of care (SOC) second-line treatment for patients with gastric or gastroesophageal junction (GEJ) cancer with ramucirumab in combination with paclitaxel or as a monotherapy. Dr. Mehta explains that one of the major disadvantages of the current second-line treatment for this patient population is the rate of neuropathy, which can affect up to 46% of patients. There has therefore been a sustained motivation for researchers to find novel second-line treatment combinations that have the potential to be effective but also provide an improved quality of life (QoL) whilst relieving the incidence of neuropathy. In this Phase II study, patients were treated with ramucirumab given at 8mg/kg intravenously plus FTD/TPI at the FDA-approved dose off 35mg/m2. The primary endpoint was overall survival at 6 months and the secondary endpoints were progression-free survival (PFS), overall response rate (ORR) and safety profile. 23 patients were enrolled in to the trial, 19 with GEJ cancer and 4 with gastric cancer. The six-month OS rate was 56.2%, with a median of 6.2 months, and the median PFS rate was 4.9 months. 6% of patients had partial response and 88% had stable disease. 48% of patients had grade 3-4 treatment-related adverse events, including neutropenia and amenia, resulting in many patients discontinuing treatment. However, Dr. Mehta emphasizes the combination of FTD/TPI plus ramucirumab should be explored in Phase III trials in comparison to the second-line SOC. This interview took place at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.