Introduction: Colorectal cancer (CRC) is a leading cause of cancer-related death worldwide. Over the last two decades, median overall survival (OS) for patients with metastatic CRC (mCRC) has increased to roughly 30 months due to the improvements in number and efficacy of systemic therapies. Recently, two novel drugs have been approved for the treatment of chemorefractory mCRC patients such as Regorafenib and Trifluridine/Tipiracil (TAS-102). However, despite their clinical approval, it still remains unclear which of these two drugs should be used first because of lack of head-to-head randomized trials. Methods: We have compared retrospectively the safety and efficacy between regorafenib and Tas-102 in patients with mCRC refractory to standard therapies who had access to both drugs at a single institution between January 2018 and February 2019, in a clinical practice setting. The progression-free survival (PFS) and overall survival (OS) were compared using a log-rank test with 95% confidence intervals (95% CIs) Results: Forty-six patients with mCRC treated with regorafenib or TAS102, in a clinical practice setting, after failure of standard therapies including fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF therapy and anti-EGFR agents in RAS wild type were included in the analysis. In particular, among them 25 patients were treated for the first time (primary treatment) with regorafenib whereas 21 patients were treated with TAS-102. Of these patients, 20 patients switched to crossover treatment. In particular, 12 went on to receive TAS-102 and 8 went on to receive regorafenib as secondary treatment. Baseline demographic and disease characteristics were well balanced between the two groups in terms of the primary treatment. No patient had complete response (CR) or partial response (PR). The median OS was 15 months for regorafenib and 15.2 months for TAS-102 and the corresponding values after crossover were 5.4 and 5.1 months respectively. Median PFS1 defined as the interval from the first administration of the primary treatment to the first radiological progression or death from any cause, whichever come first, was 4.2 months for regorafenib and 4 months for TAS-102. However, median PFS2 defined as the interval from the initiation of secondary treatment to secondary progression, for those who had undertaken crossover treatments after first progression was 4.7 months for regorafenib and 3.3 months for TAS-102. No unexpected adverse events (AEs) were found compared with previously reported data. Moreover, AEs were tolerable even after the crossover. Conclusion: No significant difference between regorafenib and TAS-102 sequence treatments was observed in patients with mCRC. Further analyses are ongoing to potentially identify a biomarker to distinguish the two drugs.
Retrospective study of Regorafenib versus Trifluridine/Tipiracil efficacy in chemorefractory metastatic colorectal cancer patients: a single Italian institution real-life clinical data
2019
Abstract
Introduction: Colorectal cancer (CRC) is a leading cause of cancer-related death worldwide. Over the last two decades, median overall survival (OS) for patients with metastatic CRC (mCRC) has increased to roughly 30 months due to the improvements in number and efficacy of systemic therapies. Recently, two novel drugs have been approved for the treatment of chemorefractory mCRC patients such as Regorafenib and Trifluridine/Tipiracil (TAS-102). However, despite their clinical approval, it still remains unclear which of these two drugs should be used first because of lack of head-to-head randomized trials. Methods: We have compared retrospectively the safety and efficacy between regorafenib and Tas-102 in patients with mCRC refractory to standard therapies who had access to both drugs at a single institution between January 2018 and February 2019, in a clinical practice setting. The progression-free survival (PFS) and overall survival (OS) were compared using a log-rank test with 95% confidence intervals (95% CIs) Results: Forty-six patients with mCRC treated with regorafenib or TAS102, in a clinical practice setting, after failure of standard therapies including fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF therapy and anti-EGFR agents in RAS wild type were included in the analysis. In particular, among them 25 patients were treated for the first time (primary treatment) with regorafenib whereas 21 patients were treated with TAS-102. Of these patients, 20 patients switched to crossover treatment. In particular, 12 went on to receive TAS-102 and 8 went on to receive regorafenib as secondary treatment. Baseline demographic and disease characteristics were well balanced between the two groups in terms of the primary treatment. No patient had complete response (CR) or partial response (PR). The median OS was 15 months for regorafenib and 15.2 months for TAS-102 and the corresponding values after crossover were 5.4 and 5.1 months respectively. Median PFS1 defined as the interval from the first administration of the primary treatment to the first radiological progression or death from any cause, whichever come first, was 4.2 months for regorafenib and 4 months for TAS-102. However, median PFS2 defined as the interval from the initiation of secondary treatment to secondary progression, for those who had undertaken crossover treatments after first progression was 4.7 months for regorafenib and 3.3 months for TAS-102. No unexpected adverse events (AEs) were found compared with previously reported data. Moreover, AEs were tolerable even after the crossover. Conclusion: No significant difference between regorafenib and TAS-102 sequence treatments was observed in patients with mCRC. Further analyses are ongoing to potentially identify a biomarker to distinguish the two drugs.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
