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A pilot study of S-1-based concurrent chemoradiotherapy in patients with biliary tract cancer

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Abstract

Purpose

S-1 chemotherapy is effective against advanced biliary tract cancer. The purpose was to evaluate the efficacy and safety of S-1-based concurrent chemoradiotherapy in patients with advanced biliary tract cancer.

Methods

Patients with pathologically-proven advanced biliary tract cancer were eligible. S-1 was orally administered at a dose of 40 mg/m2, twice daily from day 1 to 14 and from day 22 to 35; concurrent radiotherapy of 180–200 cGy per fraction was delivered in 25–28 fractions. After treatment completion, tumor response was evaluated by computed tomography. In the first stage of the optimal two-stage phase II design, 18 patients were required.

Results

Twenty patients were enrolled between August 2006 and February 2009. The median age was 62.5 years (range 45–77 years). The median follow-up time was 11.6 months (range 1.9–49.1 months). Fifteen patients (75 %) had extrahepatic cholangiocarcinoma, two patients (10 %) had intrahepatic cholangiocarcinoma, and three patients (15 %) had gallbladder cancer. After treatment, a partial response was achieved in three patients (15 %), and stable disease was achieved in 14 patients (70 %). The overall response rate was 15 %, and the disease stabilization rate was 85 %. There was no grade 4 toxicity or treatment-related death. The common grade 3 toxicities were thrombocytopenia (15 %), neutropenia (10 %), and nausea (10 %). The median progression-free survival and median overall survival were 5.9 months (range 2.2–9.5 months) and 10.8 months (range 1.1–20.4 months), respectively.

Conclusions

This study shows that S-1-based concurrent chemoradiotherapy is feasible and tolerable in patients with advanced biliary tract cancer. It will be further confirmed in a following large-scale phase II study.

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References

  1. Valle J, Wasan H, Palmer DH, Cunningham D, Anthoney A, Maraveyas A, Madhusudan S, Iveson T, Hughes S, Pereira SP, Roughton M, Bridgewater J, Investigators ABCT (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362:1273–1281. doi:10.1056/NEJMoa0908721

    Article  PubMed  CAS  Google Scholar 

  2. Yi SW, Kang DR, Kim KS, Park MS, Seong J, Park JY, Bang SM, Song SY, Chung JB, Park SW (2014) Efficacy of concurrent chemoradiotherapy with 5-fluorouracil or gemcitabine in locally advanced biliary tract cancer. Cancer Chemother Pharmacol 73:191–198. doi:10.1007/s00280-013-2340-5

    Article  PubMed  CAS  Google Scholar 

  3. Ghafoori AP, Nelson JW, Willett CG, Chino J, Tyler DS, Hurwitz HI, Uronis HE, Morse MA, Clough RW, Czito BG (2011) Radiotherapy in the treatment of patients with unresectable extrahepatic cholangiocarcinoma. Int J Radiat Oncol Biol Phys 81:654–659. doi:10.1016/j.ijrobp.2010.06.018

    Article  PubMed  PubMed Central  Google Scholar 

  4. Ueno H, Okusaka T, Ikeda M, Takezako Y, Morizane C (2004) Phase II study of S-1 in patients with advanced biliary tract cancer. Br J Cancer 91:1769–1774. doi:10.1038/sj.bjc.6602208

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  5. Sasaki T, Isayama H, Yashima Y, Yagioka H, Kogure H, Arizumi T, Togawa O, Matsubara S, Ito Y, Nakai Y, Sasahira N, Hirano K, Tsujino T, Tada M, Kawabe T, Omata M (2009) S-1 monotherapy in patients with advanced biliary tract cancer. Oncology 77:71–74. doi:10.1159/000226214

    Article  PubMed  CAS  Google Scholar 

  6. Furuse J, Okusaka T, Boku N, Ohkawa S, Sawaki A, Masumoto T, Funakoshi A (2008) S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer: a multicenter phase II study. Cancer Chemother Pharmacol 62:849–855. doi:10.1007/s00280-007-0673-7

    Article  PubMed  CAS  Google Scholar 

  7. Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, Fukushima M (1996) 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 7:548–557

    Article  PubMed  CAS  Google Scholar 

  8. Saif MW, Syrigos KN, Katirtzoglou NA (2009) S-1: a promising new oral fluoropyrimidine derivative. Expert Opin Investig Drugs 18:335–348. doi:10.1517/13543780902729412

    Article  PubMed  CAS  Google Scholar 

  9. Shirasaka T (2009) Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol 39:2–15. doi:10.1093/jjco/hyn127

    Article  PubMed  PubMed Central  Google Scholar 

  10. Ikeda M, Ioka T, Ito Y, Yonemoto N, Nagase M, Yamao K, Miyakawa H, Ishii H, Furuse J, Sato K, Sato T, Okusaka T (2013) A multicenter phase II trial of S-1 with concurrent radiation therapy for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys 85:163–169. doi:10.1016/j.ijrobp.2012.03.059

    Article  PubMed  Google Scholar 

  11. Kim HM, Bang S, Park JY, Seong J, Song SY, Chung JB, Park SW (2009) Phase II trial of S-1 and concurrent radiotherapy in patients with locally advanced pancreatic cancer. Cancer Chemother Pharmacol 63:535–541. doi:10.1007/s00280-008-0836-1

    Article  PubMed  CAS  Google Scholar 

  12. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205–216

    Article  PubMed  CAS  Google Scholar 

  13. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1–10

    Article  PubMed  CAS  Google Scholar 

  14. Leong E, Chen WW, Ng E, Van Hazel G, Mitchell A, Spry N (2012) Outcomes from combined chemoradiotherapy in unresectable and locally advanced resected cholangiocarcinoma. J Gastrointest Cancer 43:50–55. doi:10.1007/s12029-010-9213-5

    Article  PubMed  CAS  Google Scholar 

  15. Deodato F, Clemente G, Mattiucci GC, Macchia G, Costamagna G, Giuliante F, Smaniotto D, Luzi S, Valentini V, Mutignani M, Nuzzo G, Cellini N, Morganti AG (2006) Chemoradiation and brachytherapy in biliary tract carcinoma: long-term results. Int J Radiat Oncol Biol Phys 64:483–488. doi:10.1016/j.ijrobp.2005.07.977

    Article  PubMed  Google Scholar 

  16. Czito BG, Anscher MS, Willett CG (2006) Radiation therapy in the treatment of cholangiocarcinoma. Oncology (Williston Park) 20:873–884 (discussion 886-878, 893-875)

    Google Scholar 

  17. Das P, Wolff RA, Abbruzzese JL, Varadhachary GR, Evans DB, Vauthey JN, Baschnagel A, Delclos ME, Krishnan S, Janjan NA, Crane CH (2006) Concurrent capecitabine and upper abdominal radiation therapy is well tolerated. Radiat Oncol 1:41. doi:10.1186/1748-717X-1-41

    Article  PubMed  PubMed Central  Google Scholar 

  18. Macdonald OK, Crane CH (2002) Palliative and postoperative radiotherapy in biliary tract cancer. Surg Oncol Clin N Am 11:941–954

    Article  PubMed  Google Scholar 

  19. Pretz JL, Wo JY, Mamon HJ, Kachnic LA, Hong TS (2013) Chemoradiation therapy: localized esophageal, gastric, and pancreatic cancer. Surg Oncol Clin N Am 22:511–524. doi:10.1016/j.soc.2013.02.005

    Article  PubMed  Google Scholar 

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The authors have no financial conflicts of interest.

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Correspondence to Seung Woo Park.

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H. M. Kim and K. J. Lee equally contributed to this work.

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Kim, H.M., Lee, K.J., Cha, J. et al. A pilot study of S-1-based concurrent chemoradiotherapy in patients with biliary tract cancer. Cancer Chemother Pharmacol 74, 861–865 (2014). https://doi.org/10.1007/s00280-014-2565-y

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  • DOI: https://doi.org/10.1007/s00280-014-2565-y

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