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Investigational New Drugs

, Volume 30, Issue 4, pp 1671–1675 | Cite as

Pilot study of adjuvant chemotherapy with 3-week combination of S-1 and cisplatin for patients with stage II-IV (M0) gastric cancer

  • Byung Woog Kang
  • Jong Gwang KimEmail author
  • Yee Soo Chae
  • Yoo Jin Lee
  • Soo Jung Lee
  • Joon Ho Moon
  • Sang Kyun Sohn
  • Min Kyu Jung
  • Seong Woo Jeon
  • Yun-Jin Jang
  • Jongduk Seo
  • Yong Hyun Lee
  • Ohkyung Kwon
  • Ho Young Chung
  • Wansik YuEmail author
PHASE II STUDIES

Summary

Purpose The feasibility of a 3-week combination of S-1 and cisplatin as an adjuvant chemotherapy for patients with curatively resected gastric cancer was investigated. Experimental design Korean patients with stage II-IV (M0) gastric adenocarcinoma who underwent a gastrectomy with D2 lymph node resection were enrolled. The S-1 was administered orally at 80 mg/m2 divided into two daily doses for 14 days, while the cisplatin was administered at 60 mg/m2 intravenously over 2 h every 21 days. The patients received a maximum of six cycles. Results From January 2006 to July 2010, 74 patients were included in this study. The median patient age was 56 years (range, 22–71), and 51.4% (38/74) of the patients had a performance status of 0. The median number of chemotherapy cycles administered was 6 (range, 1–6). The median relative dose intensity was 86.4% for S-1 and 80.0% for cisplatin. With a median follow-up duration of 13.9 months, the median relapse-free survival (RFS) and overall survival (OS) have not yet been reached. Fifteen relapses (20.3%) were documented. Plus, the estimated RFS rate was 60.5% at 3 years. The treatments were generally well tolerated. The most frequently observed grade 3–4 hematological toxicity was neutropenia (35.1%), and only 1 cycle of neutropenic fever occurred. The most frequently observed grade 3–4 non-hematological toxicities were nausea (4.1%) and asthenia (4.1%), and all the other grade 3–4 non-hematological toxicities were observed in less than 3% of the patients. Conclusions Postoperative adjuvant S-1 plus cisplatin for 18 weeks was found to be feasible for patients with stage II-IV (M0) gastric adenocarcinoma following complete surgical resection.

Keywords

Gastric cancer S-1 Cisplatin Adjuvant chemotherapy Feasibility 

Notes

Acknowledgments

All the authors collected the data, interpreted the data, and contributed to the manuscript in collaboration. The authors also reported no potential conflicts of interest.

References

  1. 1.
    Oba K (2009) Efficacy of adjuvant chemotherapy using tegafur-based regimen for curatively resected gastric cancer: update of a meta-analysis. Int J Clin Oncol 14:85–89CrossRefPubMedGoogle Scholar
  2. 2.
    Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA (2001) Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med 345:725–730CrossRefPubMedGoogle Scholar
  3. 3.
    Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants (2006) Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med 355:11–20Google Scholar
  4. 4.
    Kubota T (2008) The role of S-1 in the treatment of gastric cancer. Br J Canc 98:1301–1304CrossRefGoogle Scholar
  5. 5.
    Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K (2007) Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 357:1810–1820Google Scholar
  6. 6.
    Koizumi W, Narahara H, Hara TT, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M (2008) S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 9:215–221Google Scholar
  7. 7.
    Kodera Y, Ishiyama A, Yoshikawa T, Kinoshita T, Ito S, Yokoyama H, Mochizuki Y, Ito H, Tsuburaya A, Sakamoto J, Nakao A (2010) A feasibility study of postoperative chemotherapy with S-1 and cisplatin (CDDP) for gastric carcinoma (CCOG0703). Gastric Canc 13:197–203Google Scholar
  8. 8.
    Lee JL, Kang HJ, Kang YK, Ryu MH, Chang HM, Kim TW, Sohn HJ, Kim H, Lee JS (2008) Phase I/II study of 3-week combination of S-1 and cisplatin chemotherapy for metastatic or recurrent gastric cancer. Canc Chemother Pharmacol 61:837–845CrossRefGoogle Scholar
  9. 9.
    Takahari D, Hamaguchi T, Yoshimura K, Katai H, Ito S, Fuse N, Kinoshita T, Yasui H, Terashima M, Goto M, Tanigawa N, Shirao K, Sano T, Sasako M (2010) Feasibility study of adjuvant chemotherapy with S-1 plus cisplatin for gastric cancer. Canc Chemother PharmacolGoogle Scholar
  10. 10.
    Greene FL (2003) TNM staging for malignancies of the digestive tract: 2003 changes and beyond. Semin Surg Oncol 21:23–29CrossRefPubMedGoogle Scholar
  11. 11.
    Saif MW, Syrigos KN, Katirtzoglou NA (2009) S-1: a promising new oral fluoropyrimidine derivative. Expet Opin Investig Drugs 18:335–348CrossRefGoogle Scholar
  12. 12.
    Hejna M, Wohrer S, Schmidinger M, Raderer M (2006) Postoperative chemotherapy for gastric cancer. Oncologist 11:136–145CrossRefPubMedGoogle Scholar
  13. 13.
    Shirasaka T, Shimamoto Y, Ohshimo H, Saito H, Fukushima M (1993) Metabolic basis of the synergistic antitumor activities of 5-fluorouracil and cisplatin in rodent tumor models in vivo. Canc Chemother Pharmacol 32:167–172CrossRefGoogle Scholar
  14. 14.
    De Vita F, Giuliani F, Galizia G, Belli C, Aurilio G, Santabarbara G, Ciardiello F, Catalano G, Orditura M (2007) Neo-adjuvant and adjuvant chemotherapy of gastric cancer. Ann Oncol 18 Suppl 6:vi120–vi123CrossRefPubMedGoogle Scholar
  15. 15.
    De Vita F, Vecchione L, Galizia G, Di Martino N, Fabozzi T, Catalano G, Ciardiello F, Orditura M (2009) Perspectives in adjuvant therapy of gastric cancer. Oncology 77 Suppl 1:38–42CrossRefPubMedGoogle Scholar
  16. 16.
    Lee SS, Jeung HC, Chung HC, Noh SH, Hyung WJ, Ahn JY, Rha SY (2010) A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer. Investig New DrugsGoogle Scholar
  17. 17.
    Koizumi W, Tanabe S, Saigenji K, Ohtsu A, Boku N, Nagashima F, Shirao K, Matsumura Y, Gotoh M (2003) Phase I/II study of S-1 combined with cisplatin in patients with advanced gastric cancer. Br J Canc 89:2207–2212CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Byung Woog Kang
    • 1
  • Jong Gwang Kim
    • 1
    Email author
  • Yee Soo Chae
    • 1
  • Yoo Jin Lee
    • 1
  • Soo Jung Lee
    • 1
  • Joon Ho Moon
    • 1
  • Sang Kyun Sohn
    • 1
  • Min Kyu Jung
    • 2
  • Seong Woo Jeon
    • 2
  • Yun-Jin Jang
    • 3
  • Jongduk Seo
    • 4
  • Yong Hyun Lee
    • 4
  • Ohkyung Kwon
    • 4
  • Ho Young Chung
    • 4
  • Wansik Yu
    • 4
    Email author
  1. 1.Department of Hematology/OncologyKyungpook National University Hospital, Kyungpook National University School of MedicineDaeguKorea
  2. 2.Department of GastroenterologyKyungpook National University Hospital, Kyungpook National University School of MedicineDaeguSouth Korea
  3. 3.Department of RadiologyKyungpook National University Hospital, Kyungpook National University School of MedicineDaeguSouth Korea
  4. 4.Department of SurgeryKyungpook National University Hospital, Kyungpook National University School of MedicineDaeguKorea

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