Abstract
e15556 Background: Trifluridine/tipiracil is currently approved for metastatic colorectal cancer (mCRC) refractory to available therapies. However, there is no consensus on factors that predict treatment outcomes in daily practice. We assessed the early clinical experience with trifluridine/tipiracil in Spain and potential survival markers. Methods: This was a retrospective cohort study of mCRC patients who participated in the trifluridine/tipiracil early clinical experience program in Spain. The primary outcome was overall survival (OS). Associations between OS and patient characteristics were assessed using multivariate Cox regression analyses. Results: A total of 379 patients were included in the study. Trifluridine/tipiracil was administered for a median of 3.0 cycles and discontinued mainly due to disease progression (79.2%). The median OS was 7.9 months, with a 12-month OS rate of 30.5%. Cox analyses revealed that the following variables independently favoured OS: ≤2 metastases, no liver metastasis, alkaline phosphatase < 300 IU, trifluridine/tipiracil dose reductions, and neutrophil/lymphocyte ratio < 5. Grade ≥3 toxicities were reported in 141 (37.2%) patients, including mainly afebrile neutropenia (23.2%), anaemia (12.1%), and thrombocytopenia (5.3%). Conclusions: This study supports the real-life efficacy and safety of trifluridine/tipiracil for refractory mCRC and identifies tumour burden, liver metastasis, alkaline phosphatase, dose reductions, and neutrophil/lymphocyte ratio as survival markers.
Highlights
Colorectal cancer is one of the three most commonly diagnosed cancers and the second leading cause of cancer death worldwide [1]
39% of colorectal cancer patients are diagnosed with localised disease, and despite the improvements achieved in its management, the 5-year survival of patients with distant metastases drops to 14% [2]
Trifluridine/tipiracil administration is currently approved as a salvage-line treatment in patients with metastatic colorectal cancer (mCRC) refractory to, or not candidates for, available therapies based on the pivotal phase III RECOURSE trial
Summary
Colorectal cancer is one of the three most commonly diagnosed cancers and the second leading cause of cancer death worldwide [1]. 39% of colorectal cancer patients are diagnosed with localised disease, and despite the improvements achieved in its management, the 5-year survival of patients with distant metastases drops to 14% [2]. Current therapies for metastatic colorectal cancer (mCRC) involve several active drugs administered either as monotherapy or in combination, including cytotoxic agents such as fluoropyrimidines, irinotecan or oxaliplatin, and targeted therapies against epidermal growth factor receptor (EGFR) or vascular endothelial growth factor (VEGF) [3,4]. Trifluridine/tipiracil administration is currently approved as a salvage-line treatment in patients with mCRC refractory to, or not candidates for, available therapies based on the pivotal phase III RECOURSE trial. Trifluridine/tipiracil improved OS irrespective of age, KRAS status, time from first metastasis or geographic region, and enhanced progression-free survival (PFS), disease control, and performance status [9,10,11]. Subsequent post hoc analyses pointed to neutropaenia as a surrogate marker of trifluridine/tipiracil efficacy [12], and supported low tumour burden, indolent disease, and absence of liver metastasis as prognostic factors [13]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
