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

Research output: Contribution to journalArticle

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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oxaliplatin
Pemetrexed
Stomach Neoplasms
Confidence Intervals
Therapeutics
Fluorouracil
Survival
Poisons
Neutropenia

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

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

In: Annals of Oncology, Vol. 20, No. 6, 2009, p. 1062-1067.

Research output: Contribution to journalArticle

Celio, L, Sternberg, CN, Labianca, R, La Torre, I, Amoroso, V, Barone, C, Pinotti, G, Cascinu, S, Di Costanzo, F, Cetto, GL & 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, vol. 20, no. 6, pp. 1062-1067. https://doi.org/10.1093/annonc/mdn766
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, Emilio. / Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer : A multi-institutional phase II study. In: Annals of Oncology. 2009 ; Vol. 20, No. 6. pp. 1062-1067.
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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.",
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T1 - Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer

T2 - A multi-institutional phase II study

AU - Celio, L.

AU - Sternberg, C. N.

AU - Labianca, R.

AU - La Torre, I.

AU - Amoroso, V.

AU - Barone, C.

AU - Pinotti, G.

AU - Cascinu, S.

AU - Di Costanzo, F.

AU - Cetto, G. L.

AU - Bajetta, Emilio

PY - 2009

Y1 - 2009

N2 - 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.

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