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Treatment of advanced gastric cancer with the combination fluorouracil, leucovorin, etoposide, and cisplatin: a phase II study of the ONCOPAZ cooperative group

  • Clinical Trial Report
  • Gastric Cancer, Chemotherapy, Toxicity
  • Published:
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Abstract

A phase II study was performed to assess the efficacy and toxicity of the combination of 5-fluorouracil (5-FU), leucovorin (LV), etoposide, and cisplatin (FLEP) in patients with advanced gastric carcinoma. A total of 46 consecutive, previously untreated patients with unresectable, measurable gastric carcinoma were treated with 300 mg/m2 LV, 100 mg/m2 etoposide, 500 mg/m2 5-FU, and 30 mg/m2 cisplatin on days 1–3 every 28 days. All courses were given on an outpatient basis. A total of 169 courses of treatment were given. In all, 18 of the 46 patients (39%) had an objective response [95% confidence interval (CI), 25%–54%] and 2 (4%) patients experienced a clinical complete response. The median duration of response was 5 months. The main side effects were hematological and gastrointestinal. Grade 3–4 toxicity was encountered as follows: leukopenia, in 9.5% of the courses; anemia, in 3%; thrombocytopenia, in 3%; nausea/vomiting, in 4%; and diarrhea, in 5%. Hospitalization due to fever and granulocytopenia was required in 5 patients, 3 of whom died of sepsis. In conclusion, FLEP shows moderate activity in patients with advanced gastric carcinoma, albeit at the cost of a high degree of toxicity. For this reason we do not recommend its use.

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Authors and Affiliations

  1. Servicio de Oncología Médica, Hospital La Paz, Paseo de la Castellana 261, E-28046, Madrid, Spain

    M. González-Barón, J. Feliu, E. Espinosa & A. Ordóñez

  2. Servicio de Oncología Médica, Hospital General Yagüe, Burgos, Spain

    C. García-Girón

  3. Servicio de Oncología Médica, Hospital Virgen de la Salud, Toledo, Spain

    I. Chacón

  4. Servicio de Oncología Médica, Hospital Ramóng Cajal, Madrid, Spain

    P. Garrido & P. Zamora

  5. Servicio de Oncología Médica, Hospital Militar del Aire, Madrid, Spain

    A. Colmenarejo

Authors
  1. M. González-Barón
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  2. J. Feliu
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  3. E. Espinosa
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  4. C. García-Girón
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  5. I. Chacón
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  6. P. Garrido
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  7. A. Colmenarejo
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  8. A. Ordóñez
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  9. P. Zamora
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González-Barón, M., Feliu, J., Espinosa, E. et al. Treatment of advanced gastric cancer with the combination fluorouracil, leucovorin, etoposide, and cisplatin: a phase II study of the ONCOPAZ cooperative group. Cancer Chemother. Pharmacol. 36, 255–258 (1995). https://doi.org/10.1007/BF00685856

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  • DOI: https://doi.org/10.1007/BF00685856

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