S-1 for the treatment of gastrointestinal cancer

Bibliography

• Heidelberger C, Chaudhari NK, Danenberg P, Fluorinated pyrimidines: a new class of tumor inhibitory compounds. Nature 1957;179:663–6
   PubMed Web of Science ®Google Scholar
• Lokich JJ, Ahlgren JD, Gullo JJ, A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: a Mid-Atlantic Oncology Program study. J Clin Oncol 1989;7:425–32
   PubMed Web of Science ®Google Scholar
• Meta-Analysis Group in Cancer. Efficacy of intravenous continuous infusion of fluorouracil compared with bolus administration in advanced colorectal cancer. J Clin Oncol 1998;16:301–8
   PubMed Web of Science ®Google Scholar
• Mansfield PF, Hohn DC, Fornage BD, Complications and Failures of Subclavian-Vein Catheterization. N Engl J Med 1994;331:1735–8
   PubMed Web of Science ®Google Scholar
• Agnelli G, Verso M. Therapy insight: venous-catheter-related thrombosis in cancer patients. Nat Clin Pract Oncol 2006;3:214–22
   PubMedGoogle Scholar
• Dimick JB, Pelz RK, Consunji R, Increased resource use associated with catheter-related bloodstream infection in the surgical intensive care unit. Arch Surg 2001;136:229–34
   PubMedGoogle Scholar
• Warren DK, Quadir WW, Hollenbeak CS, Attributable cost of catheter associated bloodstream infections among intensive care patients in a nonteaching hospital. Crit Care Med 2006;34:2084–9
   PubMed Web of Science ®Google Scholar
• Blot SI, Depuydt P, Annemans L, Clinical and economic outcomes in critically ill patients with nosocomial catheter-related bloodstream infections. Clin Infect Dis 2005;41:1591–8
   PubMed Web of Science ®Google Scholar
• Renaud B, Brun-Buisson C. Outcomes of primary and catheter-related bacteremia. A cohort and case control study in critically ill patients. Am J Respir Crit Care Med 2001;163:1584–90
   PubMed Web of Science ®Google Scholar
• Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc 2006;81:1159–71
   PubMed Web of Science ®Google Scholar
• Maroun J, Asche C, Romeyer F, A cost comparison of oral tegafur plus uracil/folinic acid and parenteral Xuorouracil for colorectal cancer in Canada. Pharmacoeconomics 2003;21:1039–51
   PubMed Web of Science ®Google Scholar
• Ward S, Kaltenthaler E, Cowan J, Clinical and cost-effectiveness of capecitabine and tegafur with uracil for the treatment of metastatic colorectal cancer: systematic review and economic evaluation. Health Technol Assess 2003;7(32):1–93
   PubMedGoogle Scholar
• Liu G, Franssen E, Fitch M, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110–15
   PubMed Web of Science ®Google Scholar
• Borner MM, Schöffski P, de Wit R, Patient preference and pharmacokinetics of oral modulated UFT versus intravenous fluorouracil and leucovorin: a randomized crossover trial in advanced colorectal cancer. Eur J Cancer 2002;38:349–58
   PubMed Web of Science ®Google Scholar
• Hahn RG, Moertel CG, Schutt AJ, Bruckner HW. A double-blind comparison of intensive course 5-fluorouracil by oral vs. intravenous route in the treatment of colorectal carcinoma. Cancer 1975;35(4):1031–5
   PubMedGoogle Scholar
• Giller SA, Zhuk RA, Lidak MI. Analogs of pyrimidine nucleosides. I. N1-(alpha-furanidyl) derivatives of natural pyrimidine bases and their antimetabolities. Dokl Akad Nauk SSSR 1967;176(2):332–5; (in Russian with English abstract)
   PubMedGoogle Scholar
• Fujii S, Ikenaka K, Fukushima M, Shirasaka T. Effect of Uracil and Its Derivatives on Tumor Activity of 5- Fluorouracil and 1-(2-Tetrahydrofuryl)-5-Fluorouracil. Gann 1978;69:763–72
   PubMedGoogle Scholar
• Fujii S, Kitano S, Ikenaka K, Effect of coadministration of uracil or cytosine on the anti-tumor activity of clinical doses of 1-(2-tetrahydrofuryl)-5-fluorouracil and level of 5-fluorouracil in rodents. Gann 1979;70:209–14
   PubMedGoogle Scholar
• Tatsumi K, Fukushima M, Shirasaka T, Fujii S. Inhibitory effects of pyrimidine, barbituric acid and pyridine derivatives on 5-fluorouracil degradation in rat liver extracts. Jpn J Cancer Res 1987;78(7):748–55
   PubMedGoogle Scholar
• 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(17):4004–9
   PubMedGoogle Scholar
• Shirasaka T, Shimamato Y, Ohshimo H, Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs 1996;7(5):548–57
   PubMed Web of Science ®Google Scholar
• Hirata K, Horikoshi N, Aiba K, Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 1999;5(8):2000–5
   PubMed Web of Science ®Google Scholar
• Tegafur, Gimeracil and Oteracil Potassium Capsule and Granule [Package insert]. Revised: July 2010 (25th version). Available from: www.info.pmda.go.jp/downfiles/ph/PDF/400107_4229101D1025_1_03.pdf
   Google Scholar
• Summary of the European Public Assessment Report (EPAR) for Teysuno. European Medicines Agency. Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001242/human_med_001422.jsp&mid=WC0b01ac058001d124
   Google Scholar
• Saif MW, Syrigos KN, Katirtzoglou NA. S-1: a promising new oral fluoropyrimidine derivative. Expert Opin Investig Drugs 2009;18(3):335–48
   PubMed Web of Science ®Google Scholar
• Kobayashi Y, Kumadaki I, Taguchi S. Organic fluorine compounds. VI. Preparations and reactions of bis (trifluoromethyl) quinoline N-oxide.Chem Pharm Bull 1969;17:2335–9
   Google Scholar
• Buroker T, Miller A, Baker L, Phase II clinical trial of ftorafur in 5-fluorouracil-refractory colorectal cancer. Cancer Treat Rep 1977;61:1579–80
   PubMedGoogle Scholar
• Shimada T, Yamazaki H, Guengerich FP. Ethnic-related differences in coumarin 7-hydroxylation activities catalyzed by cytochrome P4502A6 in liver microsomes of Japanese and Caucasian populations. Xenobiotica 1996;26:395–403
   PubMed Web of Science ®Google Scholar
• Muggia FM, Peters GJ, Landolph JR Jr. XIII International Charles Heidelberger Symposium and 50 Years of Fluoropyrimidines in Cancer Therapy, September 6–8, 2007, New York University Cancer Institute, Smilow Conference Center. Mol Cancer Ther 2009;8:992–9
   PubMedGoogle Scholar
• Spears CP, Shahinian AH, Moran RG, In vivo kinetics of thymidylate synthetase inhibition of 5-fluorouracil-sensitive and -resistant murine colon adenocarcinomas. Cancer Res 1982;42:450–6
   PubMed Web of Science ®Google Scholar
• Hartmann KU, Heidelberger C. Studies on fluorinated pyrimidines. XIII. Inhibition of thymidylate synthetase. J Biol Chem 1961;236:3006–13
   PubMed Web of Science ®Google Scholar
• Danneberg PB, Montag BJ, Heidelberger C. Studies on fluorinated pyrimidines. IV. Effects on nucleic acid metabolism in vivo. Cancer Res 1958;18:329–34
   PubMed Web of Science ®Google Scholar
• Chaudhuri NK, Mukherjee KL, Heidelberger C. Studies on fluorinated pyrimidines. VII: the degradative pathway. Biochem Pharmacol 1958;1:328–41
   Web of Science ®Google Scholar
• Peters GJ, Noordhuis P, Van Kuilenburg AB, Pharmacokinetics of S-1, an oral formulation of ftorafur, oxonic acid and 5-chloro-2,4-dihydroxypyridine (molar ratio 1:0.4:1) in patients with solid tumors. Cancer Chemother Pharmacol 2003;52:1–12
   PubMed Web of Science ®Google Scholar
• Miwa M, Ura M, Nishida M, Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998;34:1274–81
   PubMed Web of Science ®Google Scholar
• XELODA [package insert]. Genentech USA, Inc; South San Francisco, CA 2011
   Google Scholar
• Schüller J, Cassidy J, Dumont E, Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol 2000;45:291–7
   PubMed Web of Science ®Google Scholar
• Yen-Revollo JL, Goldberg RM, McLeod HL. Can inhibiting dihydropyrimidine dehydrogenase limit hand-foot syndrome caused by fluoropyrimidines? Clin Cancer Res 2008;14(1):8–13
   PubMedGoogle Scholar
• Taguchi T, Gan-to-Kagakuryoho (Jpn J Cancer Chemother). 1997;24(15):2253
   Google Scholar
• Hoff PM, Wenske CA, Medgyesy DC, Phase I and pharmacokinetic (PK) study of a novel oral fluoropyrimidine, S-1 [abstract]. Proc Am Soc Clin Oncol 1999;18:665
   Google Scholar
• Hoff PM, Saad ED, Ajani JA, Phase I study with pharmacokinetics of S-1 on an oral daily schedule for 28 days in patients with solid tumors. Clin Cancer Res 2003;9:134–42
   PubMed Web of Science ®Google Scholar
• van Groeningen CJ, Peters GJ, Schornagel JH, Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol 2000;18:2772–9
   PubMed Web of Science ®Google Scholar
• Meropol NJ, Leichman CG, Yeslow G, Phase I and pharmacokinetic study of single daily oral administration of S-1 [abstract]. Proc Am Soc Clin Oncol 2001;20:361
   Google Scholar
• Cohen SJ, Leichman CG, Yeslow G, Phase I and pharmacokinetic study of once daily oral administration of S-1 in patients with advanced cancer. Clin Cancer Res 2002;8:2116–22
   PubMed Web of Science ®Google Scholar
• Chuah B, Goh BC, Lee SC, Comparison of the pharmacokinetics and pharmacodynamics of S-1 between Caucasian and East Asian patients. Cancer Sci 2011;102:478–83
   PubMed Web of Science ®Google Scholar
• Haller DG, Cassidy J, Clarke SJ, Potential regional differences for the tolerability profiles of fluoropyrimidines. J Clin Oncol 2008;26(13):2118–23
   PubMed Web of Science ®Google Scholar
• Sakata Y, Ohtsu A, Horikoshi N, Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715–20
   PubMed Web of Science ®Google Scholar
• Koizumi W, Kurihara M, Nakano S, Hasegawa K. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology 2000;58:191–7
   PubMed Web of Science ®Google Scholar
• Koizumi W, Tanabe S, Saigenji K, Phase I/II study of S-1 combined with cisplatin in patients with advanced gastric cancer. Br J Cancer 2003;89:2207–12
   PubMed Web of Science ®Google Scholar
• Boku N, Yamamoto S, Fukuda H, Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol 2009;10:1063–9
   PubMed Web of Science ®Google Scholar
• Koizumi W, Narahara H, Hara T, S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a Phase III trial. Lancet Oncol 2008;9:215–21
   PubMed Web of Science ®Google Scholar
• Jin M, Lu H, Li J, Randomized 3-armed phase III study of S-1 monotherapy versus S-1/CDDP (SP) versus 5-FU/CDDP (FP) in patients (pts) with advanced gastric cancer (AGC): SC-101 study [abstract]. J Clin Oncol 2008;26(Suppl):4533
   Google Scholar
• ClinicalTrials.gov. Trial of 3-weekly Versus 5-weekly Schedule of S-1 Plus Cisplatin in Gastric Cancer (SOS). Available from: http://clinicaltrials.gov/ct2/show/NCT00915382
   Google Scholar
• Chollet P, Schöffski P, Weigang-Köhler K, Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG). Eur J Cancer 2003;39:1264–70
   PubMed Web of Science ®Google Scholar
• Ajani JA, Lee F-C, Singh DA, Multicenter phase II trial of S-1 plus cisplatin in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol 2006;24:663–7
   PubMed Web of Science ®Google Scholar
• Ajani JA, Rodriguez W, Bodoky G, Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. J Clin Oncol 2010;28:1547–53
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov. Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial (DIGEST). Available from: http://clinicaltrials.gov/ct2/show/NCT01285557
   Google Scholar
• Narahara H, Ishii H, Imamura H, Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002). Gastric Cancer 2011;14:72–80
   PubMed Web of Science ®Google Scholar
• Kim YH, Koizumi W, Lee KH, Randomized phase III study of S-1 alone versus S-1 plus docetaxel (DOC) in the treatment for advanced gastric cancer (AGC): the START trial [abstract]. J Clin Oncol 2011;29(Suppl 4):7
   PubMedGoogle Scholar
• Japan Pharmaceutical Information Center Clinical Trials Information. Randomized phase III study of S-1 plus oxaliplatin compared with S-1 plus cisplatin as first-line therapy for advanced or recurrent gastric cancer. (JapicCTI-101021). Available from: http://www.clinicaltrials.jp/user/cteDetail.jsp
   Google Scholar
• Koizumi W, Takiuchi H, Yamada Y, Phase II study of oxaliplatin plus S-1 as first-line treatment for advanced gastric cancer (G-SOX study). Ann Oncol 2010;21:1001–5
   PubMed Web of Science ®Google Scholar
• University Hospital Medical Information Network (UMIN). Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis. UMIN000005930. Available from: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000007012&language=J
   Google Scholar
• Sato Y, Takayama T, Sagawa T, Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Cancer Chemother Pharmacol 2010;66:721–8
   PubMedGoogle Scholar
• Koizumi W, Nakayama N, Tanabe S, A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601). Cancer Chemother Pharmacol 2012;69:407–13
   PubMed Web of Science ®Google Scholar
• Iwase H, Shimada M, Tsuzuki T, A phase II multi-center study of triple therapy with paclitaxel, S-1 and cisplatin in patients with advanced gastric cancer. Oncology 2011;80:76–83
   PubMedGoogle Scholar
• Kim JY, Do YR, Park KU, Multicenter phase II trial of S-1, paclitaxel and cisplatin triplet combination chemotherapy in patients with advanced gastric cancer. Cancer Chemother Pharmacol 2011;67:527–32
   PubMedGoogle Scholar
• Park SR, Kong SY, Rhee J, Phase II study of a triplet regimen of S-1 combined with irinotecan and oxaliplatin in patients with metastatic gastric cancer: clinical and pharmacogenetic results. Ann Oncol 2011;22:890–6
   PubMedGoogle Scholar
• University Hospital Medical Information Network (UMIN). Phase III study of cisplatin plus S-1 (CS) compared with docetaxel and cisplatin plus S-1 (DCS) as first-line therapy for advanced gastric cancer (JCOG1013, GC_CS/DCS_P3 ADOPT). UMIN000007652. Available from: http://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000008795&language=E
   Google Scholar
• Choo SP, Tham CK, Lim KH, A phase 2 study of trustuzumab with S-1 and cisplatin in HER2-Positive advanced gastric cancer. The 84th Annual Meeting of JGCA 400:IS8-6
   Google Scholar
• University Hospital Medical Information Network (UMIN). Phase II trial of TS-1 + CDDP + Trastuzumab(SPT)-3 weekly schedule in HER2-positive advanced gastric cancer. Available from: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000006758&type=summary&language=E
   Google Scholar
• Sakuramoto S, Sasako M, Yamaguchi T, Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 2007;357:1810–20
   PubMed Web of Science ®Google Scholar
• Sasako M, Sakuramoto S, Katai H, Five-Year Outcomes of a Randomized Phase III Trial Comparing Adjuvant Chemotherapy With S-1 Versus Surgery Alone in Stage II or III Gastric Cancer. J Clin Oncol 2011;29:4387–93
   PubMed Web of Science ®Google Scholar
• Terashima M, Ochiai A, Kitada K, Impact of human epidermal growth factor receptor (EGFR) and ERBB2 (HER2) expressions on survival in patients with stage II/III gastric cancer, enrolled in the ACTS-GC study [abstract]. J Clin Oncol 2011;29(Suppl):4013
   Google Scholar
• Sasako M, Terashima M, Ichikawa W, Impact of the gene expressions of thymidylate synthase and dihydropyrimidine dehydrogenase on survival in patients enrolled in the ACTS-GC study [abstract]. J Clin Oncol 2012;30(Suppl 4):52
   Google Scholar
• Kitada K, Ochiai A, Ichikawa W, Interaction between intratumoral ERCC1 expression and adjuvant treatment with S-1 on the survival of patients enrolled in the ACTS-GC study [abstract]. J Clin Oncol 2012;30(Suppl 4):53
   PubMedGoogle Scholar
• Takahari D. Tetsuya Hamaguchi, Kenichi Yoshimura, et al. Survival analysis of adjuvant chemotherapy with S-1 plus cisplatin for stage III gastric cancer. J Clin Oncol 2012;30(Suppl 4):abstract 107
   Google Scholar
• Matsuyama J, Tamura S, Fujitani K, Phase II feasibility study of adjuvant S-1 plus docetaxel for stage III gastric cancer patients after curative D2 gastrectomy (OGSG 0604). J Clin Oncol 2012;30(Suppl 4):abstract 108
   Google Scholar
• Kochi M, Fujii M, Kanamori N, Neoadjuvant chemotherapy with S-1 and CDDP in advanced gastric cancer. J Cancer Res Clin Oncol 2006;132:781–5
   PubMed Web of Science ®Google Scholar
• Satoh S, Hasegawa S, Ozaki N, Retrospective analysis of 45 consecutive patients with advanced gastric cancer treated with neoadjuvant chemotherapy using an S-1/CDDP combination. Gastric Cancer 2006;9:129–35
   PubMedGoogle Scholar
• Kinoshita T, Konishi M, Nakagohri T, Neoadjuvant chemotherapy with S-1 for scirrhous gastric cancer: a pilot study. Gastric Cancer 2003;6(Suppl 1):40–4
   PubMedGoogle Scholar
• Kinoshita T, Sasako M, Sano T, Phase II trial of S-1 for neoadjuvant chemotherapy against scirrhous gastric cancer (JCOG 0002). Gastric Cancer 2009;12:37–42
   PubMed Web of Science ®Google Scholar
• Fujitani K, Sasako M, Iwasaki Y, A Phase II study of preoperative chemotherapy (CX) with S-1 and cisplatin followed by gastrectomy for clinically resectable type 4 and large type 3 gastric cancer: JCOG 0210. J Clin Oncol 2007;25(Suppl 18):4609
   Google Scholar
• University Hospital Medical Information Network (UMIN). Randomized phase III trial of surgery plus neoadjuvant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501). UMIN000000279. Available from: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000000356&language=J
   Google Scholar
• Yoshikawa T, Nakamura K, Tusuburaya A, A Phase II study of preoperative chemotherapy with S-1 (S) and cisplatin (P) followed by D3 gastrectomy for gastric cancer (GC) with extensive lymph node metastasis (ELM): survival results of JCOG0405 [abstract]. J Clin Oncol 2011;29(Suppl 4):70
   Google Scholar
• Li T, Chen L. Efficacy and safety of SOX regimen as neoadjuvant chemotherapy for advanced gastric cancer. Zhonghua Wei Chang Wai Ke Za Zhi 2011;14:104–6
   PubMedGoogle Scholar
• Yoshikawa T, Tsuburaya A, Morita S, A Comparison of Multimodality Treatment: two or Four Courses of Paclitaxel plus Cisplatin or S-1 plus Cisplatin Followed by Surgery for Locally Advanced Gastric Cancer, a Randomized Phase II Trial (COMPASS). Jpn J Clin Oncol 2010;40(4):369–72
   PubMedGoogle Scholar
• ClinicalTrials.gov. Phase III Study to Compare Perioperative Chemotherapy of Oxaliplatin Combined With S-1(SOX) Versus SOX or Oxaliplatin With Capecitabine (XELOX) as Post-operative Chemotherapy in Locally Advanced Gastric Adenocarcinoma With D2 Dissection. NCT01534546. Available from: http://clinicaltrials.gov/ct2/show/NCT01534546
   Google Scholar
• University Hospital Medical Information Network (UMIN). A phase II study of systemic chemotherapy with Docetaxel, CDDP, and S-1 followed by surgery in advanced gastric cancer with extensive lymph node metastasis (JCOG1002, BulkyGC Pre-DCS Phase II). UMIN000006069. Available from: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000007004&type=summary&language=E
   Google Scholar
• Yoshikawa T, Taguri M, Sakuramoto S, A Comparison of Multimodality Treatment: Two and Four Courses of Neoadjuvant Chemotherapy Using S-1/CDDP or S-1/CDDP/Docetaxel Followed by Surgery and S-1 Adjuvant Chemotherapy for Macroscopically Resectable Serosa-positive Gastric Cancer: A Randomized Phase II Trial (COMPASS-D Trial). Jpn J Clin Oncol 2012;42(1):74–7
   PubMedGoogle Scholar
• ClinicalTrials.gov. Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer (PRODIGY). NCT01515748. Available from: http://clinicaltrials.gov/ct2/show/NCT01515748
   Google Scholar
• Shirao K, Ohtsu A, Takada H, Phase II Study of Oral S-1 for Treatment of Metastatic Colorectal Carcinoma. Cancer 2004;100(11):2355–61
   PubMedGoogle Scholar
• Goto A, Yamada Y, Yasui H, Phase II study of combination therapy with S-1 and irinotecan in patients with advanced colorectal cancer. Ann Oncol 2006;17:968–73
   PubMed Web of Science ®Google Scholar
• Nakafusa Y, Tanaka M, Ohtsuka T, Phase I/II study of combination therapy with S-1 and CPT-11 for metastatic colorectal cancer. Mol Med Rep 2008;1:925–30
   PubMedGoogle Scholar
• Tsunoda A, Yasuda N, Nakao K, Phase II study of S-1 combined with irinotecan (CPT-11) in patients with advanced colorectal cancer. Oncology 2009;77:192–6
   PubMedGoogle Scholar
• Yoshioka T, Kato S, Gamoh M, Phase I/II study of sequential therapy with irinotecan and S-1 for metastatic colorectal cancer. Br J Cancer 2009;102:1972–7
   Google Scholar
• Shiozawa M, Akaike M, Sugano N, A phase II study of combination therapy with irinotecan and S-1 (IRIS) in patients with advanced colorectal cancer. Cancer Chemother Pharmacol 2010;66:987–92
   PubMed Web of Science ®Google Scholar
• Kusaba H, Esaki T, Futami K, Phase I/II study of a 3-week cycle of irinotecan and S-1 in patients with advanced colorectal cancer. Cancer Sci 2010;101:2591–5
   PubMedGoogle Scholar
• Komatsu Y, Yuki S, Sogabe S, 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
   PubMed Web of Science ®Google Scholar
• Muro K, Boku N, Shimada Y, 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 noninferiority study (FIRIS study). Lancet Oncol 2010;11:853–60
   PubMed Web of Science ®Google Scholar
• Baba H, Muro K, Yasui H, Updated results of the FIRIS study: a phase II/III trial of 5-FU/l-leucovorin/irinotecan (FOLFIRI) versus irinotecan/S-1 (IRIS) as second-line chemotherapy for metastatic colorectal cancer (mCRC) [abstract]. J Clin Oncol 2011;29(Suppl):3562
   Google Scholar
• Baba H, Watanabe M, Okabe H, Changes in expression levels of excision repair cross-complementing group 1 (ERCC1) and dihydropyrimidine dehydrogenase (DPD) during first-line oxaliplatin-based treatment of advanced metastatic colorectal cancer (mCRC) [abstract]. J Clin Oncol 2012;30(Suppl 4):520
   Google Scholar
• Yuki S, Komatsu Y, Miyagishima T, Phase II trial of combined chemotherapy with irinotecan, S-1, and bevacizumab (IRIS/Bev) in patients with metastatic colorectal cancer: Update analysis—Hokkaido Gastrointestinal Cancer Study Group (HGCSG) trial. J Clin Oncol 2012;30(Suppl):abstract 3593
   Google Scholar
• Yamada Y, Yamaguchi T, Matsumoto H, Phase II study of oral S-1 with irinotecan and bevacizumab (SIRB) as first-line therapy for patients with metastatic colorectal cancer. Invest New Drugs 2011. [Epub ahead of print]
   PubMedGoogle Scholar
• Yamada Y, Tahara M, Miya T, Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer. Br J Cancer 2008;98:1034–8
   PubMed Web of Science ®Google Scholar
• Zang DY, Lee BH, Park H-C, Phase II study with oxaliplatin and S-1 for patients with metastatic colorectal cancer. Ann Oncol 2009;20:892–6
   PubMed Web of Science ®Google Scholar
• Park YS, Lim HY, LEE J, A randomized phase III study of Sox (S-1/oxaliplatin) versus COX (capecitabine/oxaliplatin) in patients with advanced colorectal cancer [abstract]. J Clin Oncol 2011;29(Suppl 15):3524
   Google Scholar
• Japan Pharmaceutical Information Center Clinical Trials Information. A Randomized Phase III Trial of S-1/Oxaliplatin (SOX) plus Bevacizumab versus 5-FU/l-LV/Oxaliplatin (FOLFOX) plus Bevacizumab in Treating Patients with Metastatic Colorectal Cancer. JapicCTI-101021. Available from: http://www.clinicaltrials.jp/user/cteDetail.jsp?clinicalTrialId=1963&language=ja
   Google Scholar
• Koizumi W, Boku N, Yamaguchi K, Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer. Ann Oncol 2010;21(4):766–71
   PubMedGoogle Scholar
• Otsuji T, Yamazaki K, Ojima H, Updated survival results of the randomized phase II study of S-1, oral leucovorin, and oxaliplatin combination therapy (SOL) versus mFOLFOX6 in patients with untreated metastatic colorectal cancer (mCRC) [abstract]. J Clin Oncol 2012;30(Suppl 4):586
   Google Scholar
• Kato T, Nishina T, Yamazaki K, Phase II study of S-1, oral leucovorin, oxaliplatin, and bevacizumab combination therapy (SOL+BV; SOLA) in patients with unresectable metastatic colorectal cancer (mCRC) [abstract]. J Clin Oncol 2012;30(Suppl 4):611
   Google Scholar
• Takahari D, Takiuchi H, Muro K, Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC). EJC 2011;47(Suppl 1);428
   Google Scholar
• Watanabe T, Itabashi M, Shimada Y, Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2010 for the treatment of colorectal cancer. Int J Clin Oncol 2012;17(1):1–29
   PubMed Web of Science ®Google Scholar
• Mochizuki I, Takiuchi H, Ikejiri K, Safety of UFT/LV and S-1 as adjuvant therapy for stage III colon cancer in phase III trial: ACTS-CC trial. Br J Cancer 2012;106(7):1268–73
   PubMed Web of Science ®Google Scholar
• Shimada Y, Hamaguchi T, Moriya Y, Randomized phase III study of adjuvant chemotherapy with oral uracil and tegafur plus leucovorin versus intravenous fluorouracil and levofolinate in patients (pts) with stage III colon cancer (CC): Final results of Japan Clinical Oncology Group study (JCOG0205). J Clin Oncol 2012;30(Suppl):abstract 3524
   Google Scholar
• JAPIC Clinical Trials Information. Randomized phase III study of S-1/Oxaliplatin comparing Tegafur-Uracil/Leucovorin in the adjuvant chemotherapy of Stage IIIb colorectal cancer. JapicCTI-101073
   Google Scholar
• University Hospital Medical Information Network (UMIN). Randomized phase III trial comparing adjuvant S-1 to capecitabine in stage III colorectal cancer (JCOG0910, CRC Adj-CAPS). UMIN000003272
   Google Scholar
• University Hospital Medical Information Network (UMIN). A randomized controlled study comparing S-1 with UFT as postoperative adjuvant chemotherapy in rectal cancer. C000000385
   Google Scholar
• Ueno H, Okusaka T, Ikeda M, An early phase II study of S-1 in patients with metastatic pancreatic cancer. Oncology 2005;68:171–8
   PubMed Web of Science ®Google Scholar
• Okusaka T, Funakoshi A, Furuse J, A late phase II study of S-1 for metastatic pancreatic cancer. Cancer Chemother Pharmacol 2008;61:615–21
   PubMed Web of Science ®Google Scholar
• Morizane C, Okusaka T, Furuse J, A phase II study of S-1 in gemcitabine-refractory metastatic pancreatic cancer. Cancer Chemother Pharmacol 2009;63:313–19
   PubMed Web of Science ®Google Scholar
• Sudo K, Yamaguchi T, Nakamura K, Phase II study of S-1 in patients with gemcitabine-resistant advanced pancreatic cancer. Cancer Chemother Pharmacol 2011;67:249–54
   PubMed Web of Science ®Google Scholar
• Ueno H, Okusaka T, Furuse J, Multicenter Phase II Study of Gemcitabine and S-1 Combination Therapy (GS) in Patients With Metastatic Pan*creatic Cancer. Jpn J Clin Oncol 2011;41(8):953–8
   PubMed Web of Science ®Google Scholar
• Nakamura K, Yamaguchi T, Ishihara T, Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer. Br J Cancer 2006;94(11):1575–9
   PubMed Web of Science ®Google Scholar
• Ioka T, Ikeda M, Ohkawa S, Randomized phase III study of gemcitabine plus S-1 (GS) versus S-1 versus gemcitabine (GEM) in unresectable advanced pancreatic cancer (PC) in Japan and Taiwan: GEST study [abstract]. J Clin Oncol 2011;29(Suppl 15):4007
   PubMedGoogle Scholar
• Ozaka M, Matsumura Y, Ishii H, Randomized phase II study of gemcitabine and S-1 combination versus gemcitabine alone in the treatment of unresectable advanced pancreatic cancer (Japan Clinical Cancer Research Organization PC-01 study). Cancer Chemother Pharmacol 2012;69(5):1197–204
   PubMed Web of Science ®Google Scholar
• Nakai Y, Isayama H, Sasaki T, A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study. Br J Cancer Adv 2012 online publication 3 May 2012; doi: 10.1038/bjc.2012.183
   Google Scholar
• Yuyat Ku GY, Haaland B, Ioka T, Meta-analysis of randomized phase II and phase III trials of gemcitabine with/without S-1 in Asian patients with advanced pancreatic cancer [abstract]. J Clin Oncol 2012;30(Suppl 4):311
   Google Scholar
• Ueno H, Okusaka T, Ikeda M, Phase II study of S-1 in patients with advanced biliary tract cancer. Br J Cancer 2004;91(10):1769–74
   PubMed Web of Science ®Google Scholar
• Furuse J, Okusaka T, Boku N, S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer: a multicenter phase II study. Cancer Chemother Pharmacol 2008;62(5):849–55
   PubMed Web of Science ®Google Scholar
• Morizane C, Okusaka T, Mizusawa J, Randomized phase II trial of gemcitabine plus S-1 combination therapy versus S-1 in advanced biliary tract cancer: results of the Japan Clinical Oncology Group study (JCOG0805) [abstract]. J Clin Oncol 2012;30(Suppl 4):255
   Google Scholar