Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 25, No 18S (June 20 Supplement), 2007: 4544
© 2007 American Society of Clinical Oncology

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Abstract

The impact of cetuximab on the gemcitabine/cisplatin combination in first-line treatment of EGFR-positive advanced pancreatic cancer (APC): A randomized phase II trial of GISCAD

Universita Politecnica delle Marche, Ancona, Italy; Azienda Ospedaliera Cà Granda, Milan, Italy; Ospedali Riuniti di Bergamo, Bergamo, Italy; Azienda USL 6, Livorno, Italy; Azienda Ospedaliera Carlo Poma, Mantova, Italy; Azienda Ospedaliera Treviglio, Treviglio, Italy; Azienda Ospedaliera Careggi, Firenze, Italy; Ospedale S.Gerardo, Monza (MI), Italy; Li. Ist. Univ. Campus Biomedico, Roma, Italy; Casa di Cura Poliambulanza, Brescia, Italy

4544

Background: Cetuximab, an EGFR antibody inhibitor, has been shown to increase the activity of gemcitabine (GEM) in APC. Based on data from randomised trials and meta-analyses suggesting that the combination of a GEM with a platinum analog significantly improves survival as compared to GEM alone, we assessed the activity and feasibility of a combination of GEM/cisplatin (CDDP) plus cetuximab. Methods: Multicenter, randomised two-arm phase II trial: GEM 1,000 mg/m² day 1,8 and CDDP 35 mg/m² day 1,8 every 21 days alone or in combination with cetuximab 250 mg/m² weekly after a loading dose of 400 mg/m². Treatment was limited to a maximum of 9 cycles. With 37 patients in each arm the power was 90% to select the truly better arm if the true between arm difference in response rate (RECIST) is at least 15%. The study was open for accrual until June 2005. Results: We present here the results of 74 patients including in the study. In all the patients, the first response rate are available (investigators’ assessment after 3 cycles) as well as toxicity data. Conclusions: Cetuximab does not seem to positively interact with GEM/CDDP combination in terms of activity especially concerning time to progression. Although toxicity was not increased by cetuximab, this combination should not be assessed in a phase III trial.The trial was supported in part by by Merck KGaA.

Abstract presentation from the 2007 ASCO Annual Meeting