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Annals of Oncology Advance Access published online on February 13, 2009
Annals of Oncology, doi:10.1093/annonc/mdn766
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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

Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer: a multi-institutional phase II study

L. Celio1, C. N. Sternberg2, R. Labianca3, I. La Torre4, V. Amoroso5, C. Barone6, G. Pinotti7, S. Cascinu8, F. Di Costanzo9, G. L. Cetto10 and E. Bajetta1,*

1 Medical Oncology Unit 2, Foundation IRCCS National Tumour Institute, Milan
2 Department of Medical Oncology, San Camillo Forlanini Hospital, Rome
3 Department of Medical Oncology, Reunited Hospitals, Bergamo
4 Medical Department, Eli Lilly Italy, Sesto Fiorentino
5 Department of Medical Oncology, Civil Hospitals, Brescia
6 Department of Medical Oncology, Catholic University of the Sacred Heart
7 Department of Oncology, Circle's Hospital, Varese
8 Department of Medical Oncology, University Hospital, Ancona
9 Department of Medical Oncology, Careggi Hospital, Florence
10 Department of Medical Oncology, Borgo Trento Hospital, Verona

* Correspondence to: Dr E. Bajetta, Medical Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian 1, 20133 Milan, Italy. Tel: +39-02-23902500; Fax: +39-02-23902149; E-mail: emilio.bajetta{at}istitutotumori.mi.it

Background: This clinical trial assessed the efficacy of pemetrexed combined with oxaliplatin (PEMOX) in patients with advanced gastric cancer (AGC).

Patients and methods: Forty-four patients with untreated AGC were enrolled to evaluate response rate (RR). Patients received pemetrexed (500 mg/m2) with vitamin supplementation and oxaliplatin (120 mg/m2) every 21 days for six cycles or until disease progression occurred.

Results: Median age was 62 years (range 26–76). The majority of patients (93%) had metastatic disease. Sixteen of the 44 patients achieved confirmed response [RR 36%; 95% confidence interval (CI) 22% to 52%]; four complete responses and 12 partial responses (complete and partial responses according to the RECIST guidelines are the confirmed-responses observed in the study population). Median time to tumor progression (TTP) was 6.2 months (95% CI 4.3–7.5) and median survival was 10.8 months (95% CI 7.7–17.2). A total of 220 cycles were administered, with a median of six cycles. Most common grade 3/4 toxic effects were neutropenia in 41% of patients (19% of cycles) and thrombocytopenia in 11% of patients (4% of cycles). Treatment delays or dose reductions for toxicity occurred in 10% and 5% of cycles, respectively.

Conclusions: PEMOX is active and well tolerated in AGC. RR, TTP, and survival were comparable to those achieved in studies using different 5-fluorouracil (5-FU)–oxaliplatin combinations, without the inconvenience of prolonged 5-FU schedules.

advanced gastric cancer, chemotherapy, oxaliplatin, pemetrexed, phase II trial

Received for publication November 4, 2008. Revision received November 14, 2008. Accepted for publication November 25, 2008.


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