Self-Reported Adherence to Trifluridine and Tipiracil Hydrochloride for Metastatic Colorectal Cancer: A Retrospective Cohort Study

Abstract

Background: A novel oral agent that consists of trifluridine and tipiracil hydrochloride (TFTD) has been established as salvage-line treatment for metastatic colorectal cancer (mCRC). Adherence to TFTD is crucial to maintaining appropriate curative effects. This study sought to clarify adherence to TFTD and identify candidate factors deteriorating adherence at our institution. Methods: A total of 50 consecutive mCRC patients who received TFTD monotherapy between June 1, 2014 and July 31, 2015 were analyzed in this study. Adherence to TFTD was checked by pharmacists using a self-reported treatment diary and interviewing nonadherents at a pharmaceutical outpatient clinic. The adherence rate was defined as the number of patient intakes per 20 scheduled intakes in one cycle. We retrospectively surveyed the factors from the electronic patient record associated with reduced adherence. We measured relative dose intensity, defined as the dose intensity divided by the initial dose (each in milligrams per square meter per week). Results: Patient characteristics were as follows: males/females, 20/30; median age, 61 years (range, 34-83 years); performance status 0/1, 37/13. Median relative dose intensity of TFTD was 91.0%. Adherence rates were 95.0% for the first cycle of TFTD, 97.3% for the second cycle, 98.0% for the third cycle, and 98.2% for the fourth cycle. Factors associated with deteriorated adherence to TFTD were nausea/vomiting/decreased appetite (27.1%, 23 instances), pain (25.9%, 22 instances), neutropenia (11.8%, 10 instances), and missed dose (4.7%, 4 instances). Increased nonadherence to TFTD was associated with Eastern Cooperative Oncology Group performance status 1, while increased TFTD adherence in the first cycle was associated with prior regimens ≥4. Conclusions: The high frequency of treatment-related gastrointestinal disorder is the main factor affecting adherence to TFTD. Intensive supportive care in the management of these symptoms could assist adequate adherence to TFTD in mCRC patients.

Association of Hand-Foot Skin Reaction with Regorafenib Efficacy in the Treatment of Metastatic Colorectal Cancer

“…Patients who were not treated in the Pharmaceutical Outpatient Clinic (POC) [9] or who were lost to follow-up were excluded. Patients who received preliminary treatment with steroids for any reason were also excluded.…”

Real-World Adherence in Patients with Metastatic Colorectal Cancer Treated with Trifluridine plus Tipiracil or Regorafenib

“…In that study, hand‐foot syndrome and liver dysfunction were much more common among patients treated with REG than those treated with FTD + TPI , and these two adverse events (AEs) are the most common causes of nonadherence to REG . Conversely, nausea and vomiting were more common among patients treated with FTD + TPI than those treated with REG, and these are among the most common factors associated with nonadherence to FTD + TPI . Therefore, these AEs appear likely to contribute to the difference in adherence observed in the current study, although this has not been formally evaluated.…”

“…To date, few studies have examined adherence to therapy in patients with mCRC using FTD + TPI or REG . A single‐center study using self‐reported treatment diaries to evaluate adherence in patients using FTD + TPI reported an adherence rate of 95.0%–98.2% .…”

Real-world Treatment Patterns Among Patients With Colorectal Cancer Treated With Trifluridine/Tipiracil and Regorafenib

“…One study showed a 95.0% to 98.2% adherence rate for FTD/TPI, which agrees with our reported mean MPR of 0.91. 20 In that study, Data presented as n (%) or mean AE standard deviation (median). Abbreviations: DOT ¼ duration of treatment; FTD/TPI ¼ trifluridine/tipiracil; MPR ¼ medication possession ratio; PDC ¼ proportion of days covered; REG ¼ regorafenib; TTD ¼ time to discontinuation.…”