Summary

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• Trifluridine and tipiracil (Lonsurf) is indicated for the treatment of adult patients with metastatic colorectal cancer as a single agent or in combination with bevacizumab who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. It is also used to treat metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy.
• Fifteen studies were reviewed, providing extensive analysis on the efficacy and safety of Lonsurf in treating metastatic colorectal cancer (mCRC) and metastatic gastric or gastroesophageal junction adenocarcinoma.
• Lonsurf demonstrated a consistent improvement in overall survival (OS), progression-free survival (PFS), and disease control rate across subgroups, including patients with KRAS wild-type tumors. This highlights its broad efficacy irrespective of genetic mutation status.
• Lonsurf combined with bevacizumab was particularly effective, showing increased median OS and PFS compared to Lonsurf monotherapy. Neutropenia was identified as the most common severe adverse event, followed by limited rates of discontinuation due to adverse events.
• Elevated incidences of hematological adverse events such as neutropenia, leukopenia, and anemia were noted to be more prevalent when combined with other antineoplastic agents including bevacizumab.
• The combination outperformed other treatments, offering significant OS benefit among regimens evaluated, indicating it as an optimal choice for this patient population.
• Lonsurf showed the best intervention for PFS compared to Selective Internal Radiation Therapy using yttrium-90 and regorafenib, while all active treatments showed improvement in OS. SIRT had the longest OS without statistically significant differences.
• Benefits extend to diverse patient subgroups, including those characterized by different KRAS mutation statuses, suggesting universal applicability across various patient demographics such as age, gender, and varying baseline performance statuses.