Phase II study of pemetrexed disodium (Alimta®) administered with oral folic acid in patients with advanced gastric cancer

Emilio Bajetta, L. Celio, R. Buzzoni, L. Ferrari, A. Marchianò, A. Martinetti, R. Longarini, C. Becerra, C. Ilardi, W. John

Research output: Contribution to journalArticle

Abstract

Background: The aim of this study was to assess the activity of pemetrexed in patients with advanced gastric cancer. Patients and methods: Thirty-eight eligible patients (median age 60 years) received pemetrexed 500 mg/m2 every 3 weeks. Since toxicity was considerable in the first six patients, the protocol was amended to supplement subsequent patients with oral folic acid (5 mg/day on days -2 to +2 of every cycle). Results: Among 36 stage IV patients evaluable for efficacy (six non-supplemented\30 supplemented), there were two complete and six partial responses. The response rate was 21% (95% confidence interval 8% to 32%) according to intention-to-treat analysis. All responding patients were in the supplemented group. The median duration of response was 4.6 months and the median survival was 7.8 months. Five of six non-supplemented patients (83%) developed grade 3/4 neutropenia; two (33%) unsupplemented patients discontinued; two (33%) patients died due to toxicity. In the supplemented group, 12 of 32 patients (37%) had grade 3/4 neutropenia. None of the supplemented patients discontinued treatment due to hematological toxicity. Severe non-hematological toxicities were infrequent. Conclusions: The activity of pemetrexed is promising in light of the tumor burden in these patients (all patients were stage IV and 39% had three or more organs involved). Toxicities were remarkably decreased with folic acid supplementation. Combination studies are warranted.

Original languageEnglish
Pages (from-to)1543-1548
Number of pages6
JournalAnnals of Oncology
Volume14
Issue number10
DOIs
Publication statusPublished - Oct 2003

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Pemetrexed
Folic Acid
Stomach Neoplasms
Neutropenia

Keywords

  • Folic acid
  • Gastric cancer
  • Pemetrexed
  • Phase II trial

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Phase II study of pemetrexed disodium (Alimta®) administered with oral folic acid in patients with advanced gastric cancer. / Bajetta, Emilio; Celio, L.; Buzzoni, R.; Ferrari, L.; Marchianò, A.; Martinetti, A.; Longarini, R.; Becerra, C.; Ilardi, C.; John, W.

In: Annals of Oncology, Vol. 14, No. 10, 10.2003, p. 1543-1548.

Research output: Contribution to journalArticle

Bajetta, Emilio ; Celio, L. ; Buzzoni, R. ; Ferrari, L. ; Marchianò, A. ; Martinetti, A. ; Longarini, R. ; Becerra, C. ; Ilardi, C. ; John, W. / Phase II study of pemetrexed disodium (Alimta®) administered with oral folic acid in patients with advanced gastric cancer. In: Annals of Oncology. 2003 ; Vol. 14, No. 10. pp. 1543-1548.
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AU - Celio, L.

AU - Buzzoni, R.

AU - Ferrari, L.

AU - Marchianò, A.

AU - Martinetti, A.

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AU - Becerra, C.

AU - Ilardi, C.

AU - John, W.

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N2 - Background: The aim of this study was to assess the activity of pemetrexed in patients with advanced gastric cancer. Patients and methods: Thirty-eight eligible patients (median age 60 years) received pemetrexed 500 mg/m2 every 3 weeks. Since toxicity was considerable in the first six patients, the protocol was amended to supplement subsequent patients with oral folic acid (5 mg/day on days -2 to +2 of every cycle). Results: Among 36 stage IV patients evaluable for efficacy (six non-supplemented\30 supplemented), there were two complete and six partial responses. The response rate was 21% (95% confidence interval 8% to 32%) according to intention-to-treat analysis. All responding patients were in the supplemented group. The median duration of response was 4.6 months and the median survival was 7.8 months. Five of six non-supplemented patients (83%) developed grade 3/4 neutropenia; two (33%) unsupplemented patients discontinued; two (33%) patients died due to toxicity. In the supplemented group, 12 of 32 patients (37%) had grade 3/4 neutropenia. None of the supplemented patients discontinued treatment due to hematological toxicity. Severe non-hematological toxicities were infrequent. Conclusions: The activity of pemetrexed is promising in light of the tumor burden in these patients (all patients were stage IV and 39% had three or more organs involved). Toxicities were remarkably decreased with folic acid supplementation. Combination studies are warranted.

AB - Background: The aim of this study was to assess the activity of pemetrexed in patients with advanced gastric cancer. Patients and methods: Thirty-eight eligible patients (median age 60 years) received pemetrexed 500 mg/m2 every 3 weeks. Since toxicity was considerable in the first six patients, the protocol was amended to supplement subsequent patients with oral folic acid (5 mg/day on days -2 to +2 of every cycle). Results: Among 36 stage IV patients evaluable for efficacy (six non-supplemented\30 supplemented), there were two complete and six partial responses. The response rate was 21% (95% confidence interval 8% to 32%) according to intention-to-treat analysis. All responding patients were in the supplemented group. The median duration of response was 4.6 months and the median survival was 7.8 months. Five of six non-supplemented patients (83%) developed grade 3/4 neutropenia; two (33%) unsupplemented patients discontinued; two (33%) patients died due to toxicity. In the supplemented group, 12 of 32 patients (37%) had grade 3/4 neutropenia. None of the supplemented patients discontinued treatment due to hematological toxicity. Severe non-hematological toxicities were infrequent. Conclusions: The activity of pemetrexed is promising in light of the tumor burden in these patients (all patients were stage IV and 39% had three or more organs involved). Toxicities were remarkably decreased with folic acid supplementation. Combination studies are warranted.

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