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Published in: Cancer Chemotherapy and Pharmacology 2/2012

01-02-2012 | Original Article

A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601)

Authors: Wasaburo Koizumi, Norisuke Nakayama, Satoshi Tanabe, Tohru Sasaki, Katsuhiko Higuchi, Ken Nishimura, Seiichi Takagi, Mizutomo Azuma, Takako Ae, Kenji Ishido, Kento Nakatani, Akira Naruke, Chikatoshi Katada

Published in: Cancer Chemotherapy and Pharmacology | Issue 2/2012

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Abstract

Purpose

We conducted a phase II study to evaluate the efficacy and safety of a triplet regimen of docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer.

Methods

Docetaxel (40 mg/m2) and cisplatin (70 or 60 mg/m2) were given on day 1 of a 28-day cycle. S-1 (40 mg/m2) was given twice daily on days 1–14. Treatment with this regimen was continued for a maximum of 6 cycles. Subsequently, patients with no disease progression received a combination of docetaxel and S-1.

Results

Fifty-nine patients were enrolled. The median number of administered cycles was 8 (range, 1–25). Because some patients had serious myelosuppression and renal dysfunction with 70 mg/m2 of cisplatin, dose of cisplatin was reduced to 60 mg/m2 after 19 patients had been treated. Common severe toxic effects of grade 3 or 4 were leukocytopenia (44%), neutropenia (72%), anemia (15%), and febrile neutropenia (14%). The overall response rate of this group was 81% (95% confidence interval (CI), 71–91%). The median overall survival and progression-free survival were 18.5 (95% CI, 15.6–21.5) and 8.7 (95% CI, 6.7–10.7) months, respectively.

Conclusions

Triplet of docetaxel, cisplatin, and S-1 is a well-tolerated and highly active regimen for advanced or recurrent gastric cancer. A 60 mg/m2 of cisplatin is as effective as 70 mg/m2 of cisplatin.
Literature
1.
go back to reference Kamangar F, Dores GM, Anderson WF (2006) Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 24(14):2137–2150PubMedCrossRef Kamangar F, Dores GM, Anderson WF (2006) Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 24(14):2137–2150PubMedCrossRef
2.
go back to reference Munoz N, Franceschi S (1997) Epidemiology of gastric cancer and perspectives for prevention. Salud Publica Mex 39(4):318–330PubMed Munoz N, Franceschi S (1997) Epidemiology of gastric cancer and perspectives for prevention. Salud Publica Mex 39(4):318–330PubMed
3.
go back to reference Ministry of Health Law. Vital Statistics of Japan (2009) Ministry of Health Law. Vital Statistics of Japan (2009)
4.
go back to reference Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K et al (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(5):548–557PubMedCrossRef Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K et al (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(5):548–557PubMedCrossRef
5.
go back to reference Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A et al (2009) Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol 10(11):1063–1069PubMedCrossRef Boku N, Yamamoto S, Fukuda H, Shirao K, Doi T, Sawaki A et al (2009) Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol 10(11):1063–1069PubMedCrossRef
6.
go back to reference Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M et al (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(3):215–221PubMedCrossRef Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M et al (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(3):215–221PubMedCrossRef
7.
go back to reference Ajani JA, Rodriguez W, Bodoky G, Moiseyenko V, Lichinitser M, Gorbunova V et al (2010) 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 28(9):1547–1553PubMedCrossRef Ajani JA, Rodriguez W, Bodoky G, Moiseyenko V, Lichinitser M, Gorbunova V et al (2010) 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 28(9):1547–1553PubMedCrossRef
8.
go back to reference Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C et al (2006) Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 study group. J Clin Oncol 24(31):4991–4997PubMedCrossRef Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C et al (2006) Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 study group. J Clin Oncol 24(31):4991–4997PubMedCrossRef
9.
go back to reference Nakayama N, Koizumi W, Sasaki T, Higuchi K, Tanabe S, Nishimura K et al (2008) A multicenter, phase I dose-escalating study of docetaxel, cisplatin and S-1 for advanced gastric cancer (KDOG0601). Oncology 75(1–2):1–7PubMedCrossRef Nakayama N, Koizumi W, Sasaki T, Higuchi K, Tanabe S, Nishimura K et al (2008) A multicenter, phase I dose-escalating study of docetaxel, cisplatin and S-1 for advanced gastric cancer (KDOG0601). Oncology 75(1–2):1–7PubMedCrossRef
10.
go back to reference Yoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y et al (2006) Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin Cancer Res 12:3402–3407PubMedCrossRef Yoshida K, Ninomiya M, Takakura N, Hirabayashi N, Takiyama W, Sato Y et al (2006) Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer. Clin Cancer Res 12:3402–3407PubMedCrossRef
11.
go back to reference Yamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H et al (2006) Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer 94(12):1803–1808PubMedCrossRef Yamaguchi K, Shimamura T, Hyodo I, Koizumi W, Doi T, Narahara H et al (2006) Phase I/II study of docetaxel and S-1 in patients with advanced gastric cancer. Br J Cancer 94(12):1803–1808PubMedCrossRef
12.
go back to reference Fujii M (2008) Chemotherapy for advanced gastric cancer: ongoing phase III study of S-1 alone versus S-1 and docetaxel combination (JACCRO GC03 study). Int J Clin Oncol 13(3):201–205PubMedCrossRef Fujii M (2008) Chemotherapy for advanced gastric cancer: ongoing phase III study of S-1 alone versus S-1 and docetaxel combination (JACCRO GC03 study). Int J Clin Oncol 13(3):201–205PubMedCrossRef
13.
go back to reference Sato Y, Takayama T, Sagawa T, Takahashi Y, Ohnuma H, Okubo S et al (2010) Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Cancer Chemother Pharmacol 66:721–728 Sato Y, Takayama T, Sagawa T, Takahashi Y, Ohnuma H, Okubo S et al (2010) Phase II study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Cancer Chemother Pharmacol 66:721–728
14.
go back to reference Al-Refaie WB, Tseng JF, Gay G, Patel-Parekh L, Mansfield PF, Pisters PWT, Yao JC, Feig BW (2008) The impact of ethnicity on the presentation and prognosis of patients with gastric adenocarcinoma. Cancer 113:461–469PubMedCrossRef Al-Refaie WB, Tseng JF, Gay G, Patel-Parekh L, Mansfield PF, Pisters PWT, Yao JC, Feig BW (2008) The impact of ethnicity on the presentation and prognosis of patients with gastric adenocarcinoma. Cancer 113:461–469PubMedCrossRef
Metadata
Title
A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601)
Authors
Wasaburo Koizumi
Norisuke Nakayama
Satoshi Tanabe
Tohru Sasaki
Katsuhiko Higuchi
Ken Nishimura
Seiichi Takagi
Mizutomo Azuma
Takako Ae
Kenji Ishido
Kento Nakatani
Akira Naruke
Chikatoshi Katada
Publication date
01-02-2012
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 2/2012
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-011-1701-1

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