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

L. Celio, C. N. Sternberg, R. Labianca, I. La Torre, V. Amoroso, C. Barone, G. Pinotti, S. Cascinu, F. Di Costanzo, G. L. Cetto, Emilio Bajetta

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Abstract

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.

Original languageEnglish
Pages (from-to)1062-1067
Number of pages6
JournalAnnals of Oncology
Volume20
Issue number6
DOIs
Publication statusPublished - 2009

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Keywords

  • Advanced gastric cancer
  • Chemotherapy
  • Oxaliplatin
  • Pemetrexed
  • Phase II trial

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Celio, L., Sternberg, C. N., Labianca, R., La Torre, I., Amoroso, V., Barone, C., Pinotti, G., Cascinu, S., Di Costanzo, F., Cetto, G. L., & Bajetta, E. (2009). Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer: A multi-institutional phase II study. Annals of Oncology, 20(6), 1062-1067. https://doi.org/10.1093/annonc/mdn766