Multicenter Phase II Study of a New Effective S-1 and Irinotecan Combination Schedule in Patients with Unresectable Metastatic or Recurrent Colorectal Cancer

Clinical Medicine Insights: Oncology

Volumn 7, Issue , 2013, Pages

  Ogata, Yutaka ^a,b   Tanaka, Takaho ^c   Akagi, Yoshito ^b   Ishibashi, Nobuya ^a   Tsuji, Yoshiaki ^d   Matono, Keiko ^d   Isobe, Makoto ^e   Sueyoshi, Susumu ^f   Kaibara, Atsushi ^c   Shirouzu, Kazuo ^b  

^a KURUME UNIVERSITY MEDICAL CENTER   (Japan)

^b KURUME UNIVERSITY HOSPITAL   (Japan)

^c Social Insurance Tagawa Hospital   (Japan)

^d Asakura Medical Association Hospital   (Japan)

^e Social Insurance Kurume Daiichi Hospital   (Japan)

^f Omuta City General Hospital   (Japan)

Author keywords

advanced colorectal carcinoma; first line chemotherapy; irinotecan; metronomic chemotherapy; multicenter phase II study; S 1

Indexed keywords

EID: 84901192680     PISSN: None     EISSN: 11795549     Source Type: Journal    
DOI: 10.4137/CMO.S10769     Document Type: Article

References (39)

1. Shimada Y., Yoshino M., Wakui A. et al. Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. CPT-11 Gastrointestinal Cancer Study Group. J Clin Oncol. 1993; 11: 909–13.
2. Rothenberg M.L., Cox J.V., DeVore R.F. et al. A multicenter, phase II trial of weekly irinotecan (CPT-11) in patients with previously treated colorectal carcinoma. Cancer. 1999; 85: 786–95.
3. Saltz L.B., Cox J.V., Blanke C. et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000; 343: 905–14.
4. Douillard J.Y., Cunningham D., Roth A.D. et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000; 355: 1041–7.
5. de Gramont A., Figer A., Seymour M. et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2000; 18: 2938–47.
6. Shirasaka T., Nakano K., Takechi T. et al. Antitumor activity of 1 M tegafur-0.4 M 5-chloro-2,4-dihydroxypyridine-1 M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res. 1996; 56: 2602–6.
7. Takechi T., Nakano K., Uchida J. et al. Antitumor activity and low intestinal toxicity of S-1, a new formulation of oral tegafur, in experimental tumor models in rats. Cancer Chemother Pharmacol. 1997; 39: 205–11.
8. Kato T., Shimamoto Y., Uchida J. et al. Possible regulation of 5-fluorouracil-induced neuro- and oral toxicities by two biochemical modulators consisting of S-1, a new oral formulation of 5-fluorouracil. Anticancer Res. 2001; 21: 1705–12.
9. Robben N.C., Pippas A.W., Moore J.O. The syndrome of 5-fluorouracil cardiotoxicity. An elusive cardiopathy. Cancer. 1993; 71: 493–509.
10. Shirasaka T., Shimamoto Y., Fukushima M. Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res. 1993; 53: 4004–9.
11. Takechi T., Fujioka A., Matsushima E. et al. Enhancement of the antitumour activity of 5-fluorouracil (5-FU) by inhibiting dihydropyrimidine dehydrogenase activity (DPD) using 5-chloro-2,4-dihydroxypyridine (CDHP) in human tumour cells. Eur J Cancer. 2002; 38: 1271–7.
12. Ohtsu A., Baba H., Sakata Y. et al. Phase II study of S-1, a novel oral fluorophyrimidine derivative, in patients with metastatic colorectal carcinoma. S-1 Cooperative Colorectal Carcinoma Study Group. Br J Cancer. 2000; 83: 141–5.
13. Shirao K., Ohtsu A., Takada H. et al. Phase II study of oral S-1 for treatment of metastatic colorectal carcinoma. Cancer. 2004; 100: 2355–61.
14. Van den Brande J., Schöffski P., Schellens J.H. et al. EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer. Br J Cancer. 2003; 88: 648–53.
15. Goto A., Yamada Y., Yasui H. et al. Phase II study of combination therapy with S-1 and irinotecan in patients with advanced colorectal cancer. Ann Oncol. 2006; 17: 968–73.
16. Tsunoda A., Yasuda N., Nakao K. et al. Phase II study of S-1 combined with irinotecan (CPT-11) in patients with advanced colorectal cancer. Oncology. 2009; 77: 192–6.
17. Yoshioka T., Kato S., Gamoh M. et al. Phase I/II study of sequential therapy with irinotecan and S-1 for metastatic colorectal cancer. Br J Cancer. 2009; 101: 1972–7.
18. Iwasa S., Yamada Y., Kato K. et al. Long-term results of a phase II study of S-1 plus irinotecan in metastatic colorectal cancer. Anticancer Res. 2012; 32: 4157–61.
19. Komatsu Y., Yuki S., Sogabe S. et al. Phase II study of combined treatment with irinotecan and S-1 (IRIS) in patients with inoperable or recurrent advanced colorectal cancer (HGCSG0302). Oncology. 2011; 80: 70–5.
20. Muro K., Boku N., Shimada Y. et al. Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 non-inferiority study (FIRIS study). Lancet Oncol. 2010; 11: 853–60.
21. Miller K.D., Sweeney C.J., Sledge G.W. Jr. Redefining the target: hemotherapeutics as antiangiogenics. J Clin Oncol. 2001; 19: 1195–206.
22. Kerbel R.S., Kamen B.A. The anti-angiogenic basis of metronomic chemotherapy. Nat Rev Cancer. 2004; 4: 423–36.
23. Ogata Y., Sasatomi T., Akagi Y., Ishibashi N., Mori S., Shirouzu K. Dosage escalation study of S-1 and irinotecan in metronomic chemotherapy against advanced colorectal cancer. Kurume Med J. 2009; 56: 1–7.
24. Therasse P., Arbuck S.G., Eisenhauer E.A. et al.; European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada: New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000; 92: 205–16.
25. Punt C.J. New options and old dilemmas in the treatment of patients with advanced colorectal cancer. Ann Oncol. 2004; 15: 1453–9.
26. Tournigand C., André T., Achille E. et al. FOLFIRI followed by FOLFOX 6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol. 2004; 22: 229–37.
27. Colucci G., Gebbia V., Paoletti G. et al. Phase III randomized controlled trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the groppo oncologico dell'italia meridionale. J Clin Oncol. 2005; 23: 4866–75.
28. Köhne C.H., van Cutsem E., Wils J. et al.; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organization for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol. 2005; 23: 4856–65.
29. Murakami H., Ogata Y., Akagi Y., Ishibashi N., Shirouzu K. Circulating endothelial progenitor cells in metronomic chemotherapy using irinotecan and/or bevacizumab for colon carcinoma: Study of their clinical significance. Exp Ther Med. 2011; 2: 595–600.
30. Munoz R., Man S., Shaked Y. et al. Highly efficacious nontoxic preclinical treatment for advanced metastatic breast cancer using combination oral UFT-cyclophosphamide metronomic chemotherapy. Cancer Res. 2006; 66: 3386–91.
31. Duda D.G., Cohen K.S., di Tomaso E. et al. Differential CD146 expression on circulating versus tissue endothelial cells in rectal cancer patients: implications for circulating endothelial and progenitor cells as biomarkers for antiangiogenic therapy. J Clin Oncol. 2006; 24: 1449–53.
32. Whyte S., Pandor A., Stevenson M., Rees A. Bevacizumab in combination with fuoropyrimidine-based chemotherapy for the first-line treatment of metastatic colorectal cancer. Health Technol Assess. 2010; 14(Suppl 2): 47–53.
33. Guichard S., Hennebelle I., Bugat R., Canal P. Cellular interactions of 5-fluorouracil and the camptothecin analogue CPT-11 (irinotecan) in a human colorectal carcinoma cell line. Biochem Pharmacol. 1998; 55: 667–76.
34. Torigoe S., Ogata Y., Matono K., Shirouzu K. Molecular mechanisms of sequence-dependent antitumor effects of SN-38 and 5-fluorouracil combination therapy against colon cancer cells. Anticancer Res. 2009; 29: 2083–9.
35. Tsunoda A., Yasuda N., Nakao K. et al. Phase I study of S-1 combined with irinotecan (CPT-11) in patients with advanced colorectal cancer. Oncology. 2007; 72: 58–63.
36. Bajetta E., Di Bartolomeo M., Mariani L. et al.; Italian Trials in Medical Oncology (I.T.M.O.) Group. Randomized multicenter phase II trial of two different schedules of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma. Cancer. 2004; 100: 279–87.
37. Patt Y.Z., Liebmann J., Diamandidis D. et al. Capecitabine (X) plus irinotecan (XELIRI) as first-line treatment for metastatic colorectal cancer (MCRC): Final safety findings from a phase II trial. [Abstract]. J Clin Oncol. 2004; 22(14S): 271.
38. Rea D.W., Nortier J.W., Ten Bokkel Huinink W.W. et al. A phase I/II and pharmacokinetics study of irinotecan in combination with capecitabine as first-line therapy for advanced colorectal cancer. Ann Oncol. 2005; 16: 1123–32.
39. Yamada Y., Yasui H., Goto A. et al. Phase I study of irinotecan and S-1 combination therapy in patients with metastatic gastric cancer. Int J Clin Oncol. 2003; 8: 374–80.