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Annals of Oncology Advance Access originally published online on January 17, 2007
Annals of Oncology 2007 18(4):745-751; doi:10.1093/annonc/mdl463
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© 2007 European Society for Medical Oncology

gastrointestinal tumors

Second-line chemotherapy with pemetrexed after gemcitabine failure in patients with advanced pancreatic cancer: a multicenter phase II trial

S Boeck1, K Weigang-Köhler2, M Fuchs3, E Kettner4, D Quietzsch5, J Trojan6, O Stötzer7, S Zeuzem8, F Lordick9, C-H Köhne10, H Kröning11, T Steinmetz12, H Depenbrock13 and V Heinemann1,*

1 Department of Internal Medicine III, University Hospital Grosshadern, Ludwigs-Maximilians University, Munich
2 Medical Department V, Hospital Nürnberg-Nord, Nürnberg
3 Medical Department II, Hospital Bogenhausen, Munich
4 Department of Hematology and Oncology, City Hospital Magdeburg, Magdeburg
5 Department of Internal Medicine II, Hospital Chemnitz, Chemnitz
6 Medical Department I, Johann Wolfgang Goethe University Hospital, Frankfurt am Main
7 Practice for Oncology, Munich
8 Department of Internal Medicine II, University Hospital Saarland, Homburg/Saar
9 Medical Department III, Klinikum rechts der Isar, Technical University, Munich
10 Medical Department I, University Hospital Dresden
11 Practice for Oncology, Magdeburg
12 Practice for Oncology, Cologne
13 Medical Department, Lilly Deutschland GmbH, Bad Homburg, Germany

* Correspondence to: Prof. Volker Heinemann, Department of Internal Medicine III, University Hospital Grosshadern, Marchioninistr. 15, D-81377 Munich, Germany. Tel: +49-89-7095 2208; Fax: +49-89-7095 5256; E-mail: volker.heinemann{at}med.uni-muenchen.de

Background: A standard second-line chemotherapy regimen has yet to be defined for patients with gemcitabine (Gem)-refractory advanced pancreatic cancer (PC).

Patients and methods: In this multicenter phase II trial, patients with unresectable or metastatic PC who had progressed on single-agent Gem or a Gem-containing regimen received pemetrexed 500 mg/m2 as a 10-min infusion every 3 weeks until disease progression or occurrence of unacceptable toxicity. The primary end point was the 3-month survival rate.

Results: A total of 192 treatment cycles were given to 52 patients. The overall response rate was 3.8% (two partial responses); 10 patients (19.2%) experienced stable disease, nine of them for >12 weeks. At least one CA 19-9 reduction ≥50% occurred in 12 patients (23.1%). The 3-month survival rate was 75% (95% confidence interval 63.2% to 86.8%), the median time to tumor progression was 7 weeks (range 1–62 weeks) and the median overall survival time was 20 weeks (range 1–84 weeks). Grade 3/4 hematological toxic effects included (percent of patients): neutropenia (17.3%), thrombocytopenia (5.8%) and anemia (3.8%). The most frequent non-hematological toxic effects were diarrhea, nausea and stomatitis/pharyngitis (23.1% each).

Conclusion: Pemetrexed is a safe treatment option with moderate activity in patients with advanced PC after failure of Gem.

Key words: gemcitabine, multitargeted antifolate, pancreatic cancer, pemetrexed, second-line therapy

Received for publication July 8, 2006. Revision received October 25, 2006. Accepted for publication November 13, 2006.


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