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Annals of Oncology Advance Access originally published online on December 12, 2006
Annals of Oncology 2007 18(3):510-517; doi:10.1093/annonc/mdl459
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© 2006 European Society for Medical Oncology

gastrointestinal tumors

Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study)

C Pinto1,*, F Di Fabio1, S Siena2, S Cascinu3, FL Rojas Llimpe1, C Ceccarelli4, V Mutri1, L Giannetta2, S Giaquinta1, C Funaioli1, R Berardi3, C Longobardi1, E Piana1 and AA Martoni1

1 Medical Oncology, S. Orsola-Malpighi Hospital, Bologna
2 Medical Oncology, Falck Division, Niguarda Cà Granda Hospital, Milan
3 Medical Oncology, University of Marche, Umberto I Hospital, Ancona
4 Pathology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy

* Correspondence to: Dr C. Pinto, Medical Oncology Unit, S. Orsola-Malpighi Hospital, Via Albertoni 15, 40138 Bologna, Italy; E-mail: cpinto{at}aosp.bo.it

Background: The purpose of this phase II study was to evaluate the efficacy and safety of cetuximab combined with FOLFIRI as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Patients and methods: Untreated patients with confirmed advanced gastric or gastroesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg/m2 intravenously (i.v.) followed by weekly doses of 250 mg/m2, CPT 11 180 mg/m2 i.v. on day 1, LFA 100 mg/m2 i.v. followed by 5-FU 400 mg/m2 i.v. bolus, and 600 mg/m2 i.v. 22-h continuous infusion on days 1 and 2 (FOLFIRI) every 2 weeks, for a maximum of 24 weeks, then cetuximab alone was allowed in patients with a complete response, partial response, or stable disease. Antitumor activity was assessed by computed tomography (CT) and positron emission tomography (PET) at baseline and after 6 weeks, and further by CT alone or CT and PET every 6 weeks.

Results: Thirty-eight patients were enrolled (median age 63.5 years, range 39–83; median Karnofsky performance status 90, range 70–100; stomach 89.5% and GEJ 10.5%; locally advanced disease 13.2% and metastatic disease 86.8%). All 38 patients were assessed for safety and survival, and 34 patients were assessed for overall response rates (ORR). The ORR was 44.1% [95% confidence interval (CI) 27.5% to 60.9%]. The median time-to-progression was 8 months (95% CI 7–9). At the median follow-up time of 11 months, 55.3% of patients were alive, with a median expected survival time of 16 months (95% CI 9–23). Grade 3–4 toxicity included neutropenia (42.1%), acne-like rash (21.1%), diarrhea (7.9%), asthenia (5.3%), stomatitis (5.3%), and hypertransaminasemia (5.3%). There was one (2.6%) treatment-related death.

Conclusions: The combination of cetuximab and FOLFIRI is active in gastric and GEJ adenocarcinoma. The higher toxicity appears to be limited to neutropenia.

Key words: advanced gastric cancer, Cetuximab, FOLFIRI regimen

Received for publication August 28, 2006. Revision received October 30, 2006. Accepted for publication November 2, 2006.


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