Phase 1 study of oral TAS-102 in patients with refractory metastatic colorectal cancer

Cancer Chemotherapy and Pharmacology

Volumn 76, Issue 5, 2015, Pages 925-932

  Bendell, Johanna C ^a   Rosen, Lee S ^b   Mayer, Robert J ^c   Goldman, Jonathan W ^b   Infante, Jeffrey R ^a   Benedetti, Fabio ^d   Lin, Donghu ^e   Mizuguchi, Hirokazu ^d   Zergebel, Christopher ^d   Patel, Manish R ^f  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c DANA FARBER CANCER INSTITUTE   (United States)

^d TAIHO   (United States)

^e Taiho Pharmaceutical of Beijing Co Ltd   (China)

^f SARAH CANNON RESEARCH INSTITUTE   (United States)

Author keywords

Antimetabolite; Metastatic colorectal cancer; Phase 1 study; Recommended dose; Safety; TAS 102

Indexed keywords

ALKALINE PHOSPHATASE; BEVACIZUMAB; CETUXIMAB; FLUOROPYRIMIDINE; IRINOTECAN; OXALIPLATIN; PANITUMUMAB; REGORAFENIB; TIPIRACIL PLUS TRIFLURIDINE; ANTINEOPLASTIC ANTIMETABOLITE; DRUG COMBINATION; TRIFLURIDINE; URACIL;

ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ARTICLE; CANCER CENTER; CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER PROGNOSIS; CANCER SURVIVAL; CHOLESTASIS; CLINICAL ARTICLE; CLINICAL EVALUATION; COHORT ANALYSIS; CONSTIPATION; DECREASED APPETITE; DIARRHEA; DOSE LIMITING TOXICITY; DOSE RESPONSE; DRUG DOSE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; EVIDENCE BASED PRACTICE; FATIGUE; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; HYPONATREMIA; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; METASTATIC COLORECTAL CANCER; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TOXICOLOGICAL PARAMETERS; TREATMENT RESPONSE; UNITED STATES; VOMITING; ADENOCARCINOMA; ANALOGS AND DERIVATIVES; CHEMICALLY INDUCED; CLINICAL TRIAL; COLORECTAL NEOPLASMS; DISEASE FREE SURVIVAL; DRUG COMBINATION; GASTROINTESTINAL DISEASE; KAPLAN MEIER METHOD; MIDDLE AGED; ORAL DRUG ADMINISTRATION; PATHOLOGY; SALVAGE THERAPY; SECONDARY; TREATMENT OUTCOME; VERY ELDERLY;

ADENOCARCINOMA; ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; SALVAGE THERAPY; TREATMENT OUTCOME; TRIFLURIDINE; URACIL;

EID: 84945453824     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-015-2850-4     Document Type: Article

References (28)

1. Siegel R, Ma J, Zou Z, Jemal A (2014) Cancer statistics, 2014. CA Cancer J Clin 64:9-29
2. Siegel R, Desantis C, Jemal A (2014) Colorectal cancer statistics, 2014. CA Cancer J Clin 64:104-117
3. National Comprehensive Cancer Network (2014). NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Colon cancer, version 3. http://www.nccn.org. Accessed 26 March 2014
4. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355:1041-1047
5. Tournigand C, André T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22:229-237
6. Falcone A, Ricci S, Brunetti I et al (2007) Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol 25:1670-1676
7. Grothey A, Sargent D, Goldberg RM, Schmoll HJ (2004) Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 22:1209-1214
8. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F (2004) Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342
9. Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P (2009) Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 360:1408-1417
10. Peeters M, Price TJ, Cervantes A, Sobrero AF, Ducreux M, Hotko Y, André T, Chan E, Lordick F, Punt CJ, Strickland AH, Wilson G, Ciuleanu TE, Roman L, Van Cutsem E, Tzekova V, Collins S, Oliner KS, Rong A, Gansert J (2010) Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer. J Clin Oncol 28:4706-4713
11. Grothey A, Van Cutsem E, Sobrero A et al (2013) Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicenter, randomised, placebo-controlled phase 3 trial. Lancet 381:303-312
12. Emura T, Suzuki N, Yamaguchi M, Ohshimo H, Fukushima M (2004) A novel combination antimetabolite, TAS-102, exhibits antitumor activity in FU-resistant human cancer cells through a mechanism involving FTD incorporation in DNA. Int J Oncol 25:571-578
13. Suzuki N, Nakagawa F, Nukatsuka M, Fukushima M (2011) Trifluorothymidine exhibits potent antitumor activity via the induction of DNA double-strand breaks. Exp Ther Med 2:393-397
14. Fukushima M, Suzuki N, Emura T, Yano S, Kazuno H, Tada Y, Yamada Y, Asao T (2000) Structure and activity of specific inhibitors of thymidine phosphorylase to potentiate the function of antitumor 2′deoxyribonucleosides. Biochem Pharmacol 59:1227-1236
15. Longley DB, Harkin DP, Johnston PG (2003) 5-fluorouracil: mechanisms of action and clinical strategies. Nat Rev Cancer 3:330-338
16. Murakami Y, Kazuno H, Emura T, Tsujimoto H, Suzuki N, Fukushima M (2000) Different mechanisms of acquired resistance to fluorinated pyrimidines in human colorectal cancer cells. Int J Oncol 17:277-283
17. Emura T, Murakami Y, Nakagawa F, Fukushima M, Kitazato K (2004) A novel antimetabolite, TAS-102 retains its effects on FU-related resistant cancer cells. Int J Mol Med 13:545-549
18. Bijnsdorp IV, Peters GJ, Temmink OH, Fukushima M, Kruyt FA (2010) Differential activation of cell death and autophagy results in an increased cytotoxic potential for trifluorothymidine compared with 5-fluorouracil in colon cancer cells. Int J Cancer 126:2457-2468
19. Hong DS, Abbruzzese JL, Bogaard K, Lassere Y, Fukushima M, Mita A, Kuwata K, Hoff PM (2006) Phase I study to determine the safety and pharmacokinetics of oral administration of TAS-102 in patients with solid tumors. Cancer 107:1383-1390
20. Overman MJ, Varadhachary G, Kopetz S, Thomas MB, Fukushima M, Kuwata K, Mita A, Wolff RA, Hoff P, Xiong H, Abbruzzese JL (2008) Phase 1 study of TAS-102 administered once daily on a 5-day-per-week schedule in patients with solid tumors. Invest New Drugs 26:445-454
21. Overman MJ, Kopetz S, Varadhachary G, Fukushima M, Kuwata K, Mita A, Wolff RA, Hoff P, Xiong H, Abbruzzese JL (2008) Phase I clinical study of three times a day oral administration of TAS-102 in patients with solid tumors. Cancer Invest 26:794-799
22. Doi T, Ohtsu A, Yoshino T, Boku N, Onozawa Y, Fukutomi A, Hironaka S, Koizumi W, Sasaki T (2012) Phase I study of TAS-102 treatment in Japanese patients with advanced solid tumors. Br J Cancer 107:429-434
23. Green MC, Pusztai L, Theriault RL, Adinin RB, Hofweber M, Fukushima M, Mita A, Bindra N, Hortobagyi GN (2006) Phase I study to determine the safety of oral administration of TAS-102 on a twice daily (BID) schedule for five days a week (wk) followed by two days rest for two wks, every (Q) four wks in patients (pts) with metastatic breast cancer (MBC). J Clin Oncol 24(18S):10576
24. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247
25. Brookmeyer R, Crowley J (1982) A confidence interval for the median survival time. Biometrics 38:29-41
26. Smith TJ, Khatcheressian J, Lyman GH et al (2006) 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 24:3187-3205
27. Yoshino T, Mizunuma N, Yamazaki K, Nishina T, Komatsu Y, Baba H, Tsuji A, Yamaguchi K, Muro K, Sugimoto N, Tsuji Y, Moriwaki T, Esaki T, Hamada C, Tanase T, Ohtsu A (2012) TAS-102 monotherapy for pretreated metastatic colorectal cancer: a double-blind, randomised, placebo-controlled phase 2 study. Lancet Oncol 13:993-1001
28. Mayer RJ, Van Cutsem E, Falcone A et al (2015) Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med 372:1909-1919