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Annals of Oncology Advance Access originally published online on May 20, 2009
Annals of Oncology 2009 20(8):1369-1374; doi:10.1093/annonc/mdp005
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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

Feasibility of radiotherapy with concomitant gemcitabine and oxaliplatin in locally advanced pancreatic cancer and distal cholangiocarcinoma: a prospective dose finding phase I–II study

S. Laurent1, E. Monsaert1, T. Boterberg2, A. Demols3, I. Borbath4, M. Polus5, A. Hendlisz6, B. de Hemptinne7, C. Mahin8, P. Scalliet9, J.-L. Van Laethem3 and M. Peeters1,*,{dagger}

1 Department of Gastroenterology
2 Department of Radiotherapy, Ghent University Hospital, Ghent
3 Department of Gastroenterology, Erasme University Hospital, Brussels
4 Department of Gastroenterology, Université catholique de Louvain, Cliniques universitaires Saint-Luc, Brussels
5 Department of Gastroenterology, CHU Sart-Tilman, Liège
6 Department of Gastroenterology, Institut Jules Bordet
7 Department of Surgery, Ghent University Hospital, Ghent
8 Department of Radiotherapy, Institut Jules Bordet, Brussels
9 Department of Radiotherapy, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Brussels, Belgium

* Correspondence to: Dr M. Peeters, Digestive Oncology Unit, Department of Gastroenterology, Ghent University Hospital, De Pintelaan 185, 9000 Gent, Belgium. Tel: +32-9-3322371; Fax: +32-9-3324984; E-mail: marc.peeters{at}ugent.be

Background: The prognosis of pancreaticobiliary tumors is poor. The aim was to assess the feasibility of radiotherapy (RT) and concomitant gemcitabine and oxaliplatin in locally advanced pancreatic cancer and distal cholangiocarcinoma.

Patients and methods: Twenty-two patients with locally advanced pancreatic (n = 17) or biliary tract cancer (n = 5) were included. They received two cycles of gemcitabine/oxaliplatin followed by 5 weeks of RT in combination with a weekly fixed dose gemcitabine and an escalating dose of oxaliplatin from 40 up to 70 mg/m2. National Cancer Institute—Common Toxicity Criteria 3.0 was used to score weekly the treatment-related toxicity.

Results: The patients treated at a dose of 40 mg/m2 of oxaliplatin had no dose-limiting toxicity. At 50 mg/m2, two patients developed grade 4 thrombocytopenia. Nine patients received 60 mg/m2, one developed grade 4 thrombocytopenia. Grade 4 thrombocytopenia in two patients and grade 3 diarrhea in one patient were observed with 70 mg/m2. Median time to progression was 8 months and median overall survival was 17 months.

Conclusions: RT in combination with gemcitabine and oxaliplatin is feasible in patients with locally advanced pancreaticobiliary cancer. The reported time to progression underlines the potential activity of this regimen. The dose of 60 mg/m2 of oxaliplatin can be considered as the recommended dose.

Key words: chemotherapy, cholangiocarcinoma, gemcitabine, oxaliplatin, pancreatic cancer, radiotherapy

{dagger} Senior Clinical Investigator of the fund for Scientific Research-Flanders (FWO).

Received for publication July 22, 2008. Revision received December 22, 2008. Accepted for publication December 23, 2008.


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