Real-World Use of Trifluridine/Tipiracil for Patients with Metastatic Colorectal Cancer in Canada

Abstract

Background Outcomes for patients with metastatic colorectal cancer (mcrc) are improving with the introduction of new treatments. Treatment for patients who are still fit after failure of all available therapies represents a significant unmet need. In the present study, we analyzed real-world treatment patterns for patients enrolled in Health Canada’s trifluridine/tipiracil (ftd/tpi) Special Access Program (sap) and Taiho Pharma Canada’s Patient Support Program (psp).Methods Demographic information and clinical treatment data were collected from adults with mcrc who were previously treated with, or were not candidates for, available therapies and who were enrolled in the sap and psp. For all patients, ftd/tpi treatment status, discontinuation reasons, and prior therapies were examined.Results The analysis included 717 Canadian patients enrolled in the ftd/tpi sap and psp from September 2017 to October 2018. In that cohort, 59.7% were men, median age was 65 years, and median duration of therapy was 77 days (25%–75% interquartile range: 43–106 days). Of treated patients, 67.1% maintained the same dose for the duration of therapy; 28.0% had a dose reduction. On multivariable analysis, duration of therapy was not influenced by sex, age, province, RAS mutation status, or prior therapies. However, prior oxaliplatin-based chemotherapy (capox or folfox) appeared to be associated with higher rates of discontinuation because of death or disease progression.Conclusions In advanced mcrc, ftd/tpi is a well-tolerated therapy. The large number of patients enrolled in the access programs within a short period of time is reflective of major clinical need in this area, with many patients being eligible and interested in pursuing treatment in the refractory setting.

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

“…Meanwhile, the median PFS of our cohort was concordant with that of patients with advanced gastric/gastroesophageal cancer treated with FTD/TPI alone in recent Denmark-and Japan-based studies [26,27]. Prolonged FTD/TPI treatment durations in compassionate use programs versus clinical trial cohorts have been well-documented in metastatic colorectal cancer [28][29][30][31], and may be by virtue of the enhanced feasibility of administration in non-trial settings. Although we could not examine treatment outcomes relative to a comparator group, treatment duration and PFS in our cohort were both longer than expected and, together, represent evidence of drug effectiveness in practice.…”

“…At our data cut-off date, 39 patients (24%) never received FTD/TPI, despite enrolling in the program initially. The foremost reason, death, parallels the findings of a previous study from our group on FTD/TPI use in refractory metastatic colorectal cancer [28]. It also reinforces the necessity of timely treatment for advanced gastric/gastroesophageal cancer, whether to palliate or prolong survival.…”

Long Term Real-World Outcomes of Trifluridine/Tipiracil in Metastatic Colorectal Cancer—A Single UK Centre Experience

“…Median PFS was 2.8 months, an improvement on the results of RECOURSE. Other data available include published retrospective data, meta-analysis and abstracts [ 10 , 11 , 12 , 13 , 14 , 15 ]. Their reported outcomes are summarised in Table 1 .…”

Quality of Life in a Real-World Study of Patients with Metastatic Colorectal Cancer Treated with Trifluridine/Tipiracil

“…Patients with refractory mcrc have an unmet need and high demand for a tolerable therapy. A previous study reported that more than 700 Canadian patients applied for the drug through the tcan patient support program over a 12-month period 9 . As of February 2020, the number of patients who have accessed ftd/tpi through the tcan patient support program has increased by 1497, including 982 patients who received ftd/tpi in 2019, most with mcrc.…”