Trifluridine/Tipiracil in the Real-World Management of Metastatic Gastric and Gastroesophageal Junction Cancers in Canada

Abstract

Background: Gastric cancer mortality remains among the highest of all cancers. Trifluridine/tipiracil (FTD/TPI) represents Canada’s first standard-of-care, third-line, systemic therapy for metastatic gastric/gastroesophageal cancer. We characterized real-world treatment patterns in patients enrolled to receive FTD/TPI through Taiho Pharma Canada’s Patient Support Program. Methods: Demographic and clinical information were collected from November 2019 to November 2021 for adult patients with refractory metastatic gastric/gastroesophageal cancer throughout Canada. We examined all variables using descriptive statistics and performed survival and association analyses. Results: 162 patients enrolled to receive FTD/TPI with a median age of 65 years, 12 of whom had HER2 positive disease. Among 123 patients who started FTD/TPI, median follow-up was 3.1 months and median progression-free survival (PFS) was 3.5 months (95% CI 3.2–4.0). Among 121 patients who discontinued FTD/TPI, median treatment duration was 2.39 cycles (IQR 1.14–3.86). A total of 52% discontinued treatment due to disease progression, and 27% had a dose reduction or delay. On multivariable logistic regression, prior FOLFIRI was a statistically significant predictor of treatment modification. Conclusions: Through the Patient Support Program, FTD/TPI is an actively utilized treatment option in heavily pretreated metastatic gastric/gastroesophageal cancer, despite its recent introduction. With longer-than-expected treatment duration and PFS, FTD/TPI likely addresses an important unmet need for effective and tolerable therapies in this setting.

Data collection within patient support programs in Canada and implications for real-world evidence generation: the authors’ perspective

“…To illustrate the current state of PSP data collection in Canada, Figure 1 lists six studies in which Canadian PSPs collected data [14][15][16][17][18][19]. Examples of types of data collected through the PSPs in these studies include patient characteristics, prior therapies, lab results, doses and dosing changes, reasons for discontinuation, and treatment outcomes.…”

“…Patient-reported outcomes collected include the Harvey-Bradshaw Index, Partial Mayo Score, and EuroQol-5D (EQ5D). Half of these studies [14,15,17] filled an evidence gap where there was a high unmet patient need and/or an inability to conduct additional randomized controlled trials due to ethical concerns or limited patient populations.…”

“…A closer look at 3 of the studies [14,17,19] in Figure 1 illustrates the range of RWD that can be captured from PSPs:…”

“…• Case 2: LONSURF (trifluridine/tipiracil) for metastatic stomach cancer. [14] The study assessed the use of trifluridine/tipiracil (TFD/TPI) for the management of metastatic gastric and gastroesophageal junction cancers. TFD/TPI represents Canada's first standard-of-care, thirdline systemic therapy for these cancers.…”

“…In some instances, researchers are linking PSP data to other datasets, such as Health Canada's Special Access Program data [24] and global safety databases [17]. A few are using predictive analytics and other advanced research methods to arrive at key safety and efficacy outcomes-including overall survival [14].…”