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Annals of Oncology Advance Access originally published online on June 16, 2008
Annals of Oncology 2008 19(8):1450-1457; doi:10.1093/annonc/mdn166
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© The Author 2008. 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

Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction

M. Dank1, J. Zaluski2, C. Barone3, V. Valvere4, S. Yalcin5, C. Peschel6, M. Wenczl7, E. Goker8, L. Cisar9, K. Wang9 and R. Bugat10,*

1 Semmelweis University, Budapest, Hungary
2 Wielkopolskie Centrum Onkologii Poznan, Poznan, Poland
3 Catholic University of Sacred Heart, Rome, Italy
4 Estonian Oncology Center, Tallinn, Estonia
5 Hacettepe University Medical Faculty Institute of Oncology, Sihhiye, Ankara, Turkey
6 III Med. Klinik, Munich, Germany
7 Markusovszky County Hospital, Szombathely, Markusovszky, Hungary
8 Ege University Medical School, Izmir, Turkey
9 Pfizer, New York, NY, USA
10 Institut Claudius Regaud, Toulouse, France

* Correspondence to: Dr Roland Bugat, Département de Médecine, Institut Claudius Regaud, 20 rue du Pont St Pierre, 31052 Toulouse Cedex 3, France. Tel: +33-5-61-42-41-19; Fax: +33-5-61-42-46-20; E-mail: bugat{at}icr.fnclcc.fr

Background: We aimed to establish the superiority (or noninferiority if superiority was not achieved) in terms of time to progression (TTP) of irinotecan/5-fluorouracil (IF) over cisplatin/5-fluorouracil (CF) in chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction.

Patients and methods: Patients received either IF: i.v. irinotecan 80 mg/m2 30 min, folinic acid 500 mg/m2 2 h, 5-fluorouracil (5-FU) 2000 mg/m2 22 h, for 6/7 weeks or CF: cisplatin 100 mg/m2 1–3 h, with 5-FU 1000 mg/m2/day 24 h, days 1–5, every 4 weeks.

Results: In all, 333 patients were randomized and treated (IF 170, CF 163). Patient characteristics were balanced except more IF patients had Karnofsky performance status 100%. TTP for IF was 5.0 months [95% confidence interval (CI) 3.8–5.8] and 4.2 months (95% CI 3.7–5.5) for CF (P = 0.088). Overall survival (OS) was 9.0 versus 8.7 months, response rate 31.8% versus 25.8%, time to treatment failure (TTF) 4.0 versus 3.4 months for IF and CF, respectively. The difference in TTF was statistically significant (P = 0.018). IF was better in terms of toxic deaths (0.6% versus 3%), discontinuation for toxicity (10.0% versus 21.5%), severe neutropenia, thrombocytopenia and stomatitis, but not diarrhea.

Conclusion: IF did not yield a significant TTP or OS superiority over CF, and the results of noninferiority of IF were borderline. However, IF may provide a viable, platinum-free front-line treatment alternative for metastatic gastric cancer.

Key words: cisplatin, 5-fluorouracil, gastric, irinotecan, phase III

Received for publication November 21, 2006. Revision received November 30, 2007. Revision received January 18, 2008. Accepted for publication March 20, 2008.


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