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Drug Safety Evaluation

The safety of trifluridine and tipiracil for the treatment of metastatic colorectal cancer

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Pages 643-650 | Received 19 Feb 2018, Accepted 08 May 2018, Published online: 23 May 2018

References

  • Siegel RL, Miller KD, Fedewa SA, et al. Colorectal cancer statistics, 2017. Ca Cancer J Clin. 2017;67:177–193.
  • Van Cutsem E, Cervantes A, Adam R, et al. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016;27(8):1386–1422.
  • National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology (NCCN Guidelines), Colon Cancer, Version 2. 2018 [cited 2018 Feb 9]. Available from: www.nccn.org/professionals/physician_gls/f_guidelines.asp.
  • Heinemann V, von Weikersthal LF, Decker T, et al. FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(10):1065–1075.
  • Venook AP, Niedzwiecki D, Lenz HJ, et al. Effect of first-line chemotherapy combined with cetuximab or bevacizumab on overall survival in patients with KRAS wild-type advanced or metastatic colorectal cancer: a randomized clinical trial. JAMA. 2017;317(23):2392–2401.
  • Grothey A, Van Cutsem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381(9863):303–312.
  • Mayer R, Van Cutsem E, Falcone A, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372:1909–1919.
  • Heidelberger C, Parsons DG, Remy DC. Syntheses of 5-trifluoromethyluracil and 5trifluoromethyl-2′-deoxyuridine. J Med Chem. 1964;7(1):1–5.
  • Emura T, Suzuki N, Fujioka A, et al. Potentiation of the antitumor activity of alpha, alpha, alpha- trifluorothymidine by the co-administration of an inhibitor of thymidime phosphorylase at a suitable molar ratio in vivo. Int J Oncol. 2005;27(2):449–455.
  • Suzuki N, Emura T, Fukushima M. Mode of action of trifuorothymidine (TFT) against DNA replication and repair enzymes. Int J Oncol. 2011;39(1):263–270.
  • Lenz HJ, Stintzing S, Loupakis F. TAS-102, a novel antitumor agent: a review of the mechanism of action. Cancer Treat Rev. 2015;41(9):777–783.
  • Yoshino T, Kojima T, Bando H, et al. Effect of food on the pharmacokinetics of TAS-102 and its efficacy and safety in patients with advanced solid tumors. Cancer Sci. 2016;107(5):659–665.
  • Lonsurf (trifluridine and tipiracil) prescribing information. Princeton (NJ): Taiho Pharmaceutical Co., Ltd; 2015 Sep [cited 2018 Feb 9]. Available from: www.taihooncology.com/us/prescribing-information.pdf.
  • Yoshino T, Mizunuma N, Yamazaki K, et al. TAS-102 monotherapy for pretreated metastatic colorectal cancer: a double-blind, randomised, placebo-controlled phase 2 trial. Lancet Oncol. 2012;13(10):993–1001.
  • Marcus L, Lemery SJ, Khasar S, et al. FDA approval summary: TAS-102. Clin Cancer Res. 2017 Jun 15;23(12):2924–2927.
  • European Medicines Agency. Lonsurf (trifluridine/tipiracil): summary of product characteristics; 2016 [cited 2018 Feb 9]. Available at: www.ema.europa.eu/
  • Hong DS, Abbruzzese JL, Bogaard K, et al. Phase I study to determine the safety and pharmacokinetics of oral administration of TAS-102 in patients with solid tumors. Cancer. 2006;107(6):1383–1390.
  • Overman MJ, Varadhachary G, Kopetz S, et al. Phase 1 study of TAS-102 administered once daily on a 5-day-per-week schedule in patients with solid tumors. Invest New Drugs. 2008;26(5):445–454.
  • Overman MJ, Kopetz S, Varadhachary G, et al. Phase I clinical study of three times a day oral administration of TAS-102 in patients with solid tumors. Cancer Invest. 2008;26(8):794–799.
  • Doi T, Ohtsu A, Yoshino T, et al. Phase I study of TAS-102 treatment in Japanese patients with advanced solid tumours. Br J Cancer. 2012;107(3):429–434.
  • Bendell JC, Rosen LS, Mayer RJ, et al. Phase 1 study of oral TAS-102 in patients with refractory metastatic colorectal cancer. Cancer Chemother Pharmacol. 2015;76(5):925–932.
  • Xu J, Kim TW, Shen L, et al. Results of a randomized, double-blind, placebo-controlled, Phase III Trial of Trifluridine/Tipiracil (TAS-102) monotherapy in Asian patients with previously treated metastatic colorectal cancer: the TERRA study. J Clin Oncol. 2018;36(4):350–358.
  • Shinozaki E, Laurent S, Grávalos C, et al. Timing of adverse events (AEs) in the phase 3 RECOURSE trial of TAS-102 versus placebo in patients with metastatic colorectal cancer (mCRC) (abstract 2151). Eur J Cancer. 2015;51(Suppl 3):S383.
  • Kotani D, Shitara K, Kawazoe A, et al. Safety and efficacy of trifluridine/tipiracil monotherapy in clinical practice for patients with metastatic colorectal cancer: experience at a single institution. Clin Colorectal Cancer. 2016;15(3):109–115.
  • O’Brien C, Callaghan S, Papaxoinis G, et al. TAS 102 in refractory metastatic colorectal cancer: UK Expanded Access Programme experience. J Clin Oncol. 2017;35(15):e15043.
  • Yoshino T, Uetake H, Fujita N, et al. TAS-102 safety in metastatic colorectal cancer: results from the first postmarketing surveillance study. Clin Colorectal Cancer. 2016;15(4):205–211.
  • Sunakawa Y, Izawa N, Mizukami T, et al. Profile of trifluridine/tipiracil hydrochloride in the treatment of metastatic colorectal cancer: efficacy, safety, and place in therapy. Onco Targets Ther. 2017;10:4599–4605.
  • Kwakman JJM, Vink G, Vestjens JH, et al. Feasibility and effectiveness of trifluridine/tipiracil in metastatic colorectal cancer: real-life data from The Netherlands. Int J Clin Oncol. 2018;23(3):482-489.
  • Masuishi T, Taniguchi H, Hamauchi S, et al. Regorafenib versus trifluridine/tipiracil for refractory metastatic colorectal cancer: a retrospective comparison. Clin Colorectal Cancer. 2017;16(2):15–22.
  • Kotaka M, Satake H, Okita Y, et al. Regorafenib vs. TAS-102 as salvage-line treatment in patients with metastatic colorectal cancer refractory to standard chemotherapies: A multicenter retrospective comparison study. Ann Oncol. 2016;27(Suppl 2):47.
  • Sueda T, Sakai D, Kudo T, et al. Efficacy and safety of regorafenib or TAS-102 in patients with metastatic colorectal cancer refractory to standard therapies. Anticancer Res. 2016;36(8):4299–4306.
  • Abrahao ABK, Ko YJ, Berry S, et al. Efficacy and safety of regorafenib compared to TAS-102 for metastatic colorectal cancer: a systematic review and network meta-analysis. Clin Colorectal Cancer. 2017 [Epub ahead of print].
  • Weinberg BA, Marshall JL, Salem ME. Trifluridine/tipiracil and regorafenib: new weapons in the war against metastatic colorectal cancer. Clin Adv Hematol Oncol. 2016;14(8):630–638.
  • Kimura M, Usami E, Iwai M, et al. Comparison of cost-effectiveness of regorafenib and trifluridine/tipiracil combination tablet for treating advanced and recurrent colorectal cancer. Mol Clin Oncol. 2016;5(5):635–640.
  • Townsend AR, Bishnoi S, Broadbridge V, et al. Rechallenge with oxaliplatin and fluoropyrimidine for metastatic colorectal carcinoma after prior therapy. Am J Clin Oncol. 2013;36(1):49–52.
  • Wadlow RC, Hezel AF, Abrams TA, et al. Panitumumab in patients with KRAS wild-type colorectal cancer after progression on cetuximab. Oncologist. 2012;17(1):14.
  • Yeoh C, Chau I, Cunningham D, et al. Impact of 5-fluorouracil rechallenge on subsequent response and survival in advanced colorectal cancer: pooled analysis from three consecutive randomized controlled trials. Clin Colorectal Cancer. 2003;3(2):102–107.
  • Kasi PM, Kotani D, Cecchini M, et al. Chemotherapy induced neutropenia at 1-month mark is a predictor of overall survival in patients receiving TAS-102 for refractory metastatic colorectal cancer: a cohort study. BMC Cancer. 2016;16:467.
  • Ohtsu A, Yoshino T, Falcone A, et al. Onset of neutropenia as an indicator of treatment response in the phase 3 RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo in patients with metastatic colorectal cancer. J Clin Oncol. 2017;35(Suppl 4S):Abstr 775.
  • Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017;357(6349):409–413.
  • Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med. 2015;372(26):2509–2520.
  • Overman MJ, McDermott R, Leach JL, et al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017;18(9):1182–1191.
  • Overman MJ, Lonardi S, Wong KYM, et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA mismatch repair-eficient/microsatellite instability-high metastatic colorectal cancer. J Clin Oncol. 2018;36(8):773–779.

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