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Annals of Oncology Advance Access originally published online on January 19, 2009
Annals of Oncology 2009 20(4):666-673; doi:10.1093/annonc/mdn717
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial

Y.-K. Kang1,*, W.-K. Kang2, D.-B. Shin3, J. Chen4, J. Xiong5, J. Wang6, M. Lichinitser7, Z. Guan8, R. Khasanov9, L. Zheng10, M. Philco-Salas11, T. Suarez12, J. Santamaria13, G. Forster14 and P. I. McCloud15

1 Division of Oncology, Department of Internal Medicine, Asan Medical Center
2 Department of Medicine, Samsung Medical Centre, Seoul
3 Department of Internal Medicine, Gil Medical Center, Incheon, Republic of Korea
4 Department of Oncology, Jiangsu Cancer Hospital, Jiangsu
5 Department of Oncology, First Affiliated Hospital of Jiangxi Medical College, Jiangxi
6 Department of Oncology, Shanghai Changzheng Hospital, Shanghai, China
7 Department of Oncology, Russian Cancer Research Center, Moscow, Russian Federation
8 Department of Oncology, Sun Yat-Sen University of Medical Science, Guangzhou, China
9 Department of Oncology, Republic Oncology Hospital, Kazan, Russian Federation
10 Department of Oncology, Shanghai Xinhua Hospital, Shanghai, China
11 Department of Oncology, Hospital Sabogal, Lima, Peru
12 Department of Oncology, Centro Medico Pensiones, Yucatan, Mexico
13 Department of Oncology, Instituto Oncologico Nacional, Ancon, Panama
14 Department of Oncology, Roche Pharmaceuticals, Taipei, China
15 Department of Oncology, Roche Products Pty Ltd, Sydney, Australia

* Correspondence to: Dr Y.-K. Kang, Division of Oncology, Department of Internal Medicine, Asan Medical Center, 388-1 Poonagnap-dong, Songpa-gu, Seoul 138-736, Republic of Korea. Tel: +822-3010-3230; Fax: +822-3010-6961; E-mail: ykkang{at}amc.seoul.kr

Background: To compare capecitabine/cisplatin with 5-fluorouracil/cisplatin as first-line treatment for advanced gastric cancer (AGC).

Patients and methods: In this randomised, open-label, phase III study, patients received cisplatin (80 mg/m2 i.v. day 1) plus oral capecitabine (1000 mg/m2 b.i.d., days 1–14) (XP) or 5-FU (800 mg/m2/day by continuous infusion, days 1–5) (FP) every 3 weeks. The primary end point was to confirm noninferiority of XP versus FP for progression-free survival (PFS).

Results: A total of 316 patients were randomised to XP (n = 160) or FP (n = 156). In the per-protocol population, median PFS for XP (n = 139) versus FP (n = 137) was 5.6 versus 5.0 months. The primary end point was met with an unadjusted hazard ratio (HR) of 0.81 [95% confidence interval (CI) 0.63–1.04, P < 0.001 versus noninferiority margin of 1.25]. Median overall survival was 10.5 versus 9.3 months for XP versus FP (unadjusted HR = 0.85, 95% CI 0.64–1.13, P = 0.008 versus noninferiority margin of 1.25). The most common treatment-related grade 3/4 adverse events in XP versus FP patients were as follows: neutropenia (16% versus 19%), vomiting (7% versus 8%), and stomatitis (2% versus 6%).

Conclusions: XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC. XP can be considered an effective alternative to FP.

Key words: 5-fluorouracil, advanced gastric cancer, capecitabine, cisplatin, phase III

Received for publication June 26, 2008. Revision received October 22, 2008. Accepted for publication October 24, 2008.


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