Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial

Clinical and Translational Oncology

Volumn 19, Issue 2, 2017, Pages 227-235

  Longo Munoz F ^a   Argiles, G ^b   Tabernero, J ^b   Cervantes, A ^c   Gravalos, C ^d   Pericay, C ^e   Gil Calle, S ^f   Mizuguchi, H ^g   Carrato Mena, A ^a   Limon M L ^h   Garcia Carbonero, R ^d  

^a HOSPITAL RAMÓN Y CAJAL   (Spain)

^b INSTITUTO DE SALUD CARLOS III   (Spain)

^c UNIVERSITY OF VALENCIA   (Spain)

^d HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^e Servicio de Oncología Médica   (Spain)

^f HOSPITAL REGIONAL UNIVERSITARIO DE MÁLAGA   (Spain)

^g TAIHO   (United States)

^h HOSPITAL UNIVERSITARIO VIRGEN DEL ROCÍO   (Spain)

Author keywords

Fluoropyrimidine; Metastatic colorectal cancer; Spain; TAS 102; Tipiracil hydrochloride; Trifluridine

Indexed keywords

ALKALINE PHOSPHATASE; BILIRUBIN; PLACEBO; TIPIRACIL PLUS TRIFLURIDINE; ANTIVIRUS AGENT; DRUG COMBINATION; TRIFLURIDINE; URACIL;

ADULT; AGED; ANEMIA; ARTICLE; ASTHENIA; BACKACHE; BONE MARROW SUPPRESSION; CANCER GRADING; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; GENE MUTATION; HUMAN; LEUKOPENIA; LOSS OF APPETITE; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; METASTATIC COLORECTAL CANCER; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; ONCOGENE K RAS; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SPAIN; SPANIARD; THROMBOCYTOPENIA; TREATMENT OUTCOME; ANALOGS AND DERIVATIVES; CANCER STAGING; CLINICAL TRIAL; COLORECTAL NEOPLASMS; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; DRUG COMBINATION; FOLLOW UP; MIDDLE AGED; PALLIATIVE THERAPY; PROGNOSIS; SECONDARY; SURVIVAL RATE; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; COLORECTAL NEOPLASMS; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; PALLIATIVE CARE; PROGNOSIS; SPAIN; SURVIVAL RATE; TRIFLURIDINE; URACIL;

EID: 84979221788     PISSN: 1699048X     EISSN: 16993055     Source Type: Journal    
DOI: 10.1007/s12094-016-1528-7     Document Type: Article

References (18)

1. Emura T, Murakami Y, Nakagawa F, Fukushima M, Kitazato K. A novel antimetabolite, TAS-102 retains its effect on FU-related resistant cancer cells. Int J Med. 2004;13(4):545–9.
2. Tanaka N, Sakamoto K, Okabe H, Fujioka A, Yamamura K, Nakagawa F, et al. Repeated oral dosing of TAS-102 confers high trifluridine incorporation into DNA and sustained antitumor activity in mouse models. Oncol Rep. 2014;32(6):2319–26. doi:10.3892/or.2014.3487.
3. Nukatsuka M, Nakagawa F, Saito H, Sakata M, Uchida J, Takechi T. Efficacy of combination chemotherapy using a novel oral chemotherapeutic agent, TAS-102, with irinotecan hydrochloride on human colorectal and gastric cancer xenografts. Anticancer Res. 2015;35(3):1437–45.
4. Emura T, Suzuki N, Fujioka A, Ohshimo H, Fukushima M. Potentiation of the antitumor activity of alpha, alpha, alpha-trifluorothymidine by the co-administration of an inhibitor of thymidine phosphorylase at a suitable molar ratio in vivo. Int J Oncol. 2005;27(2):449–55.
5. Meyerhardt JA, Mayer RJ. Systemic therapy for colorectal cancer. N Engl J Med. 2005;352(5):476–87. doi:10.1056/NEJMra040958.
6. Overman MJ, Kopetz S, Varadhachary G, Fukushima M, Kuwata K, Mita A, 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):794–9. doi:10.1080/07357900802087242.
7. Overman MJ, Varadhachary G, Kopetz S, Thomas MB, Fukushima M, Kuwata K, 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):445–54. doi:10.1007/s10637-008-9142-3.
8. Doi T, Ohtsu A, Yoshino T, Boku N, Onozawa Y, Fukutomi A, et al. Phase I study of TAS-102 treatment in Japanese patients with advanced solid tumours. Br J Cancer. 2012;107(3):429–34. doi:10.1038/bjc.2012.274.
9. Yoshino T, Mizunuma N, Yamazaki K, Nishina T, Komatsu Y, Baba H, 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. doi:10.1016/S1470-2045(12)70345-5.
10. Bendell JC, Rosen LS, Mayer RJ, Goldman JW, Infante JR, Benedetti F, et al. Phase 1 study of oral TAS-102 in patients with refractory metastatic colorectal cancer. Cancer Chemother Pharmacol. 2015;76(5):925–32. doi:10.1007/s00280-015-2850-4.
11. Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, et al. RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909–19. doi:10.1056/NEJMoa1414325.
12. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–47. doi:10.1016/j.ejca.2008.10.026.
13. Yoshino T, Komatsu Y, Yamada Y, Yamazaki K, Tsuji A, et al. Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations. Invest New Drugs. 2015;33(3):740–50. doi:10.1007/s10637-014-0154-x Epub 2014 Sep 12.
14. De Angelis R, Sant M, Coleman MP, Francisci S, Baili P, Pierannunzio D, EUROCARE Working Group, et al. Cancer survival in Europe 1999-2007 by country and age: results of EUROCARE–5-a population-based study. Lancet Oncol. 2014;15(1):23–34. doi:10.1016/S1470-2045(13)70546-1.
15. Ohtsu A, Yoshino T, Wabha MM, Benedetti FM, Mayer RJ, van Cutsem E, et al; RECOURSE Study Group. Phase 3 RECOURSE trial of TAS-102 versus placebo with best supportive care in patients with metastatic colorectal cancer: geographic subgroups. 2015 American Society of Clinical Oncology Annual Meeting; 29 May-2 June, 2015; Chicago, IL. Abstract no. 3564. http://meetinglibrary.asco.org/content/148025-156. Accessed 4 Feb 2016.
16. Fukuoka M, Yano S, Giaccone G, Tamura T, Nakagawa K, Douillard JY, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected]. J Clin Oncol. 2003;21(12):2237–46. doi:10.1200/JCO.2003.10.038.
17. Jang RW, Caraiscos VB, Swami N, et al. Simple prognostic model for patients with advanced cancer based on performance status. J Oncol Pract. 2014;10(5):e335–41.
18. Saguil A. Evaluation of the patient with muscle weakness. Am Fam Physician. 2005;71(7):1327–36.