Summary

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• Lonsurf (trifluridine and tipiracil) is indicated for the treatment of adult patients with metastatic colorectal cancer, either as a single agent or in combination with bevacizumab, who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Additionally, it is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma who have been previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
• This summary is based on the review of 15 systematic review(s)/meta-analysis(es). ^[1-15]
• Overall Survival (OS): TAS-102 improved OS in metastatic colorectal cancer (mCRC) patients compared to placebo and/or best supportive care (BSC), regardless of KRAS mutation status. TAS-102 combined with bevacizumab showed a median OS of 8.6 to 14.4 months in refractory mCRC, outperforming TAS-102 monotherapy. In network meta-analysis, TAS-102 had an OS hazard ratio (HR) of 0.62 compared to BSC, with efficacy comparable to regorafenib and fruquintinib.
• Progression-Free Survival (PFS): TAS-102 enhanced PFS in mCRC patients versus placebo and/or BSC. The combination of TAS-102 and bevacizumab yielded a median PFS of 3.7 to 6.8 months, better than TAS-102 alone. Fruquintinib demonstrated superior PFS compared to TAS-102.
• Disease Control Rate (DCR): TAS-102 achieved a higher DCR in mCRC patients versus placebo and/or BSC. TAS-102 plus bevacizumab had a DCR of 64%, outperforming TAS-102 monotherapy, which had a DCR of 43%. Fruquintinib exhibited a better DCR than TAS-102.
• Time to Treatment Failure (TTF): TAS-102 led to a longer TTF in mCRC patients compared to placebo and/or BSC.
• Adverse Events (AEs): TAS-102 did not significantly increase the incidence of serious adverse events (SAEs) compared to placebo and/or BSC. In combination with bevacizumab, the most common grade ≥3 adverse event was neutropenia, with a higher incidence of grade ≥3 neutropenia in combination therapy compared to monotherapy (29%-67% vs. 5%-41%).
• Specific Adverse Events: TAS-102 was associated with more hematological adverse events (neutropenia, leukopenia, anemia) compared to regorafenib, which had a higher incidence of non-hematological adverse events such as hand-foot skin reaction, fatigue, diarrhea, and hypertension.
• Discontinuation Rates Due to AEs: Discontinuation rates due to adverse events for TAS-102 plus bevacizumab ranged from 0%-11% for combination therapy.
• TAS-102 improved overall survival (OS) and progression-free survival (PFS) regardless of KRAS mutation status, with TAS-102 plus bevacizumab being effective across various subgroups including age, gender, and ECOG performance status, though it showed no benefit in patients with peritoneal metastases.