nach oben

Erschienen in:

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)

verfasst von: 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

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 2/2012

Einloggen, um Zugang zu erhalten

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.

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

Munoz N, Franceschi S (1997) Epidemiology of gastric cancer and perspectives for prevention. Salud Publica Mex 39(4):318–330PubMed

Ministry of Health Law. Vital Statistics of Japan (2009)

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

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

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

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

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

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.

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.

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.

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.

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.

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

Titel: A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601)
verfasst von: 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
Publikationsdatum: 01.02.2012
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 2/2012
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-011-1701-1

Springer Medizin

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