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Annals of Oncology Advance Access originally published online on August 8, 2005
Annals of Oncology 2005 16(10):1639-1645; doi:10.1093/annonc/mdi309
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© 2005 European Society for Medical Oncology

A phase III trial of pemetrexed plus gemcitabine versus gemcitabine in patients with unresectable or metastatic pancreatic cancer

H. Oettle1,*, D. Richards2, R. K. Ramanathan3, J. L. van Laethem4, M. Peeters5, M. Fuchs6, A. Zimmermann7, W. John7, D. Von Hoff8, M. Arning7 and H. L. Kindler9

1 University of Berlin, Berlin, Germany; 2 Tyler Cancer Center, Tyler, TX; 3 University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 4 Erasme University Hospital, Brussels; 5 University Hospital Ghent, Ghent, Belgium; 6 Hospital Bogenhausen, Munich, Germany; 7 Eli Lilly and Company, Indianapolis, IN; 8 US Oncology, Houston, TX; 9 University of Chicago, Chicago, IL, USA

* Correspondence to: Dr H. Oettle, Universitätsklinikum Charité, Humboldt-Universität zu Berlin, Medizinische Klinik mit Schwerpunkt Hämatologie/Onkologie, Augustenburger Platz 1, Berlin, D-13353, Germany. Tel: +49-30-4505-53222, Fax: +49-30-4505-53959. E-mail: helmut.oettle{at}charite.de

Background: This randomized phase III study compared the overall survival (OS) of pemetrexed plus gemcitabine (PG) versus standard gemcitabine (G) in patients with advanced pancreatic cancer.

Patients and methods: Patients with unresectable locally advanced or metastatic pancreatic cancer and no prior systemic therapy (including 5-fluorouracil as a radiosensitizer) were randomized to receive either 1250 mg/m2 gemcitabine on days 1 and 8 plus pemetrexed 500 mg/m2 after gemcitabine on day 8 (PG arm) of each 21-day cycle, or gemcitabine 1000 mg/m2 on days 1, 8 and 15 of each 28-day cycle (G arm).

Results: Five hundred and sixty-five patients with well-balanced baseline characteristics were randomly assigned (283 PG, 282 G). OS was not improved on the PG arm (6.2 months) compared with the G arm (6.3 months) (P = 0.8477). Progression-free survival (3.9 versus 3.3 months; P = 0.1109) and time to treatment failure (3 versus 2.2 months; P = 0.2680) results were similar. Tumor response rate (14.8% versus 7.1%; P = 0.004) was significantly better on the PG arm. Grade 3 or 4 neutropenia (45.1% versus 12.8%), thrombocytopenia (17.9% versus 6.2%), anemia (13.9% versus 2.9%), febrile neutropenia (9.9% versus 0.4%; all P <0.001) and fatigue (15% versus 6.6%; P = 0.002) were significantly more common on the PG arm. Four treatment-related deaths occurred on the PG arm and none in the G arm.

Conclusions: Pemetrexed plus gemcitabine therapy did not improve OS. Single-agent gemcitabine remains the standard of care for advanced pancreatic cancer.

Key words: gemcitabine, pancreatic cancer, pemetrexed, phase III, survival


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