Regorafenib Versus Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: A Retrospective Comparison

Masuishi, Toshiki; Taniguchi, Hiroya; Hamauchi, Satoshi; Komori, Azusa; Kito, Yosuke; Narita, Yuji; Tsushima, Takahiro; Ishihara, Makoto; Todaka, Akiko; Tanaka, Tsutomu; Yokota, Tomoya; Kadowaki, Shigenori; Machida, Nozomu; Umemura, Takashi; Fukutomi, Akira; Ando, Masashi; Onozawa, Yusuke; Tajika, Masahiro; Yasui, Hirofumi; Muro, Kei; Mori, Keita; Yamazaki, Kentaro

doi:10.1016/j.clcc.2016.07.019

Cited by 70 publications

(62 citation statements)

References 18 publications

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“…In a network meta-analysis, investigators have made indirect comparisons and draw the conclusion that regorafenib and TAS-102 seem to have comparable ability to prolong survival with different toxicity profiles 24. This conclusion is in coincidence with results from some retrospective analysis 25,26. Furthermore, the best sequence of the two drugs is temporarily unreported.…”

Section: Discussionmentioning

confidence: 78%

Efficacy and safety of TAS-102 in refractory metastatic colorectal cancer: a meta-analysis

Chen¹,

Wu²,

Lin³

et al. 2018

CMAR

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BackgroundTAS-102 has been applied to metastatic colorectal cancer (mCRC) patients who had received at least two prior regimens of standard chemotherapy. This meta-analysis is designed to assess the efficacy and safety of TAS-102 in patients with mCRC.MethodsWe searched randomized controlled trials (RCTs) through PubMed, Embase, Web of Science and Cochrane clinical trial databases and clinicaltrial.gov from database initiation to March 2018. The overall survival (OS), progression-free survival (PFS), disease control rate (DCR) and incidence of adverse events were summarized with the use of hazard ratio (HR) or risk ratio (RR).ResultsThree RCTs with 1318 patients were included. Results showed that TAS-102 significantly improved OS (HR 0.70, 95% confidence interval [CI] 0.62–0.79) and PFS (HR 0.46, 95% CI 0.40–0.52) in patients who were intolerant or refractory to fluoropyrimidine, irinotecan and oxaliplatin. The pooled odds ratio of DCR was 4.15 (95% CI 3.18–5.43). Notably, there were significant OS benefits both in patients with KRAS mutation (HR 0.76, 95% CI 0.63–0.92) and those with wild-type KRAS (HR 0.66, 95% CI 0.55–0.79). These benefits were also observed in patients with different numbers of metastatic sites. However, patients with >18 months since the diagnosis of first metastases seemed to have better OS (HR 0.65, 95% CI 0.55–0.77). The most common toxicities associated with TAS-102 were neutropenia (RR 116.51, 95% CI 23.51–577.33), leucopenia (RR 67.70, 95% CI 13.63–336.29), anemia (RR 4.28, 95% CI 2.70–6.79) and diarrhea (RR 5.10, 95% CI 1.40–18.61).ConclusionTAS-102 significantly improves OS, PFS and DCR in refractory mCRC patients with tolerable toxicity. Meanwhile, the OS benefits have nothing to do with KRAS status and the number of metastatic sites.

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Section: Discussionmentioning

confidence: 78%

Efficacy and safety of TAS-102 in refractory metastatic colorectal cancer: a meta-analysis

Chen¹,

Wu²,

Lin³

et al. 2018

CMAR

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“…These drugs have been approved for clinical use in the U.S., Europe, and Japan. However, limited data comparing the efficacy and safety of regorafenib and TFTD are available in patients with mCRC refractory to standard chemotherapy [9,10]. We performed a large observational study to determine the necessity of randomized trials in comparing the efficiency of two regimens; similar OS between regorafenib and TFTD has been observed in a cross-trial comparison [6,8].…”

Section: Discussionmentioning

confidence: 99%

“…Although the choice of the drug by age might affect survival, a clearly predictive biomarker to distinguish the two drugs should be identified in further studies. The Oncologist 2018;23: [7][8][9][10][11][12][13][14][15] …”

mentioning

confidence: 99%

Propensity Score Analysis of Regorafenib Versus Trifluridine/Tipiracil in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy (REGOTAS): A Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study

et al. 2017

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Background. This study compared the efficacy of regorafenib and trifluridine/tipiracil (TFTD) in patients with metastatic colorectal cancer (mCRC) who are refractory to standard chemotherapy, because despite their clinical approval, it still remains unclear which of these two drugs should be used as initial treatment. Materials and Methods. The clinical data of patients with mCRC who were treated with regorafenib or TFTD and those of

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“…Thirty-two retrieved articles were clinical trials or series. After exclusion of 12 reports describing phase I, II and III trials and eight case reports or series with few patients, 12 retrospective series remained to be included in the current analysis (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). These reports were published between 2015 and 2017 and described a total of 702 patients (Table I).…”

Section: Resultsmentioning

confidence: 99%

A Systematic Review and Meta-analysis of Retrospective Series of Regorafenib for Treatment of Metastatic Colorectal Cancer

Mercier

Voutsadakis

2017

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Colorectal cancer is the most common gastrointestinal malignancy in the Western world and remains a prominent cause of cancer morbidity and mortality, despite progress in its management. It affects approximately 746,000 men and 614,000 women yearly and it is the 3rd most common cancer in the former and the 2nd most common in the latter (1). About one fourth of newly-diagnosed colorectal cancers are already in a metastatic stage and of those that are diagnosed in a localized stage nearly 50% will go on to develop metastatic disease, in most cases becoming unresectable. Metastatic colorectal cancer treatment options have been broadened to include regimens of oxaliplatin or irinotecan added to a fluoropyrimidine backbone, as well as targeted treatments with bevacizumab and, for KRAS wild-type tumors, cetuximab or panitumumab (2-4). These treatments have extended the median survival of patients with metastatic colorectal cancer to over 2 years. Nevertheless, the disease remains incurable in most patients and when the above drug options have been exhausted, there is a paucity of other options. This therapeutic vacuum has been partially filled recently with the approval of the tyrosine kinase inhibitor regorafenib, a fluorinated derivative of sorafenib, for the third line treatment of metastatic colorectal cancer patients (5).Regorafenib (formerly known as BAY 73-4506; chemical formula: C 21 H 17 CIF 4 N 4 O 4 ) is a small molecule multi-kinase inhibitor of fms-related tyrosine kinase 1 (FLT1, also known as vascular endothelial growth factor receptor 1, VEGFR1), 5925

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Regorafenib Versus Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: A Retrospective Comparison

Cited by 70 publications

References 18 publications

Efficacy and safety of TAS-102 in refractory metastatic colorectal cancer: a meta-analysis

Efficacy and safety of TAS-102 in refractory metastatic colorectal cancer: a meta-analysis

Propensity Score Analysis of Regorafenib Versus Trifluridine/Tipiracil in Patients with Metastatic Colorectal Cancer Refractory to Standard Chemotherapy (REGOTAS): A Japanese Society for Cancer of the Colon and Rectum Multicenter Observational Study

A Systematic Review and Meta-analysis of Retrospective Series of Regorafenib for Treatment of Metastatic Colorectal Cancer

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