Epirubicin, taxotere and fluorouracil modulated by folinic acid in the treatment of advanced gastric cancer

A phase II study of the Gruppo Oncologico dell' Italia Meridionale (GOIM)

F. Giuliani, S. Romito, E. Maiello, A. Capobianco, F. Carrozza, I. Nugnes, A. Misino, M. R. Valerio, L. Manzione, G. Colucci

Research output: Contribution to journalArticle

Abstract

Introduction: Despite the large number of drugs active in AGC, no combination can be considered as the gold standard treatment. Modest increase have been obtained in overall survival with the most widely employed regimens such as CF or ECF, often obtained at expense of increased toxicity. So there is a strong need to develop new active drugs to improve the clinical outcome. Taxotere showed to be effective in preclinical studies and some phase II trials confirmed its clinical efficacy. Recently, the addition of TXT to CDDP + FU (TCF regimen), obtained, in a large randomised phase III trial, better survival than CF alone. However the toxicity of this combination was relevant and mainly due to the association with CDDP. Considering these data the GOIM started a phase II study aiming to evaluate efficacy and safety of a three drugs combination, employing EPI instead of CDDP. Materials and methods: Forty-one histologically proven untreated gastric cancer patients, with advanced measurable disease, age between 18 and 75 years, performance status ≥ 70 (Kfsky scale) and available to sign written informed consent, were enrolled. They received the following treatment: Epirubicin at 60 mg/m2 on day 1, Taxotere at 50 mg/m2 on day 1, Folinic Acid at 100 mg/m2 on days 1-2, Fluorouracil bolus at 400 mg/m2 on days 1-2 and Fluorouracil 22 h continuous infusion on days 1-2 every three weeks. Results: Amongst the 38 evaluable patients we observed 5 CR (13%), 9 PR (24%), 9 SD (24%) and 15 PD (39%) for an ORR of 37% (95% CI: 22-52) and a tumor growth control rate of 61%. The median time to progression was 4 months and the median survival was 9 months. The treatment was well tolerated. The main grade III-IV haematologic toxicities were leucopenia 7%, neutropenia 5% and anemia 5% while non-haematologics were diarrhoea 2%, alopecia 2% and cardiac 2%. Conclusion: The three drugs combination of Taxotere, Epirubicin and Fluorouracil is active and well tolerated first-line treatment in advanced gastric cancer patients.

Original languageEnglish
Pages (from-to)107-112
Number of pages6
JournalEuropean Journal of Cancer, Supplement
Volume6
Issue number14
DOIs
Publication statusPublished - Oct 2008

Fingerprint

docetaxel
Epirubicin
Leucovorin
Fluorouracil
Stomach Neoplasms
Drug Combinations
Survival
Alopecia
Leukopenia
Therapeutics
Neutropenia
Informed Consent
Pharmaceutical Preparations
Anemia
Diarrhea
Safety
Growth

Keywords

  • Epirubicin
  • Gastric cancer
  • Taxotere

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Epirubicin, taxotere and fluorouracil modulated by folinic acid in the treatment of advanced gastric cancer : A phase II study of the Gruppo Oncologico dell' Italia Meridionale (GOIM). / Giuliani, F.; Romito, S.; Maiello, E.; Capobianco, A.; Carrozza, F.; Nugnes, I.; Misino, A.; Valerio, M. R.; Manzione, L.; Colucci, G.

In: European Journal of Cancer, Supplement, Vol. 6, No. 14, 10.2008, p. 107-112.

Research output: Contribution to journalArticle

@article{5760d522a30244c6b42c379a132b2a54,
title = "Epirubicin, taxotere and fluorouracil modulated by folinic acid in the treatment of advanced gastric cancer: A phase II study of the Gruppo Oncologico dell' Italia Meridionale (GOIM)",
abstract = "Introduction: Despite the large number of drugs active in AGC, no combination can be considered as the gold standard treatment. Modest increase have been obtained in overall survival with the most widely employed regimens such as CF or ECF, often obtained at expense of increased toxicity. So there is a strong need to develop new active drugs to improve the clinical outcome. Taxotere showed to be effective in preclinical studies and some phase II trials confirmed its clinical efficacy. Recently, the addition of TXT to CDDP + FU (TCF regimen), obtained, in a large randomised phase III trial, better survival than CF alone. However the toxicity of this combination was relevant and mainly due to the association with CDDP. Considering these data the GOIM started a phase II study aiming to evaluate efficacy and safety of a three drugs combination, employing EPI instead of CDDP. Materials and methods: Forty-one histologically proven untreated gastric cancer patients, with advanced measurable disease, age between 18 and 75 years, performance status ≥ 70 (Kfsky scale) and available to sign written informed consent, were enrolled. They received the following treatment: Epirubicin at 60 mg/m2 on day 1, Taxotere at 50 mg/m2 on day 1, Folinic Acid at 100 mg/m2 on days 1-2, Fluorouracil bolus at 400 mg/m2 on days 1-2 and Fluorouracil 22 h continuous infusion on days 1-2 every three weeks. Results: Amongst the 38 evaluable patients we observed 5 CR (13{\%}), 9 PR (24{\%}), 9 SD (24{\%}) and 15 PD (39{\%}) for an ORR of 37{\%} (95{\%} CI: 22-52) and a tumor growth control rate of 61{\%}. The median time to progression was 4 months and the median survival was 9 months. The treatment was well tolerated. The main grade III-IV haematologic toxicities were leucopenia 7{\%}, neutropenia 5{\%} and anemia 5{\%} while non-haematologics were diarrhoea 2{\%}, alopecia 2{\%} and cardiac 2{\%}. Conclusion: The three drugs combination of Taxotere, Epirubicin and Fluorouracil is active and well tolerated first-line treatment in advanced gastric cancer patients.",
keywords = "Epirubicin, Gastric cancer, Taxotere",
author = "F. Giuliani and S. Romito and E. Maiello and A. Capobianco and F. Carrozza and I. Nugnes and A. Misino and Valerio, {M. R.} and L. Manzione and G. Colucci",
year = "2008",
month = "10",
doi = "10.1016/j.ejcsup.2008.06.017",
language = "English",
volume = "6",
pages = "107--112",
journal = "European Journal of Cancer, Supplement",
issn = "1359-6349",
publisher = "Elsevier Limited",
number = "14",

}

TY - JOUR

T1 - Epirubicin, taxotere and fluorouracil modulated by folinic acid in the treatment of advanced gastric cancer

T2 - A phase II study of the Gruppo Oncologico dell' Italia Meridionale (GOIM)

AU - Giuliani, F.

AU - Romito, S.

AU - Maiello, E.

AU - Capobianco, A.

AU - Carrozza, F.

AU - Nugnes, I.

AU - Misino, A.

AU - Valerio, M. R.

AU - Manzione, L.

AU - Colucci, G.

PY - 2008/10

Y1 - 2008/10

N2 - Introduction: Despite the large number of drugs active in AGC, no combination can be considered as the gold standard treatment. Modest increase have been obtained in overall survival with the most widely employed regimens such as CF or ECF, often obtained at expense of increased toxicity. So there is a strong need to develop new active drugs to improve the clinical outcome. Taxotere showed to be effective in preclinical studies and some phase II trials confirmed its clinical efficacy. Recently, the addition of TXT to CDDP + FU (TCF regimen), obtained, in a large randomised phase III trial, better survival than CF alone. However the toxicity of this combination was relevant and mainly due to the association with CDDP. Considering these data the GOIM started a phase II study aiming to evaluate efficacy and safety of a three drugs combination, employing EPI instead of CDDP. Materials and methods: Forty-one histologically proven untreated gastric cancer patients, with advanced measurable disease, age between 18 and 75 years, performance status ≥ 70 (Kfsky scale) and available to sign written informed consent, were enrolled. They received the following treatment: Epirubicin at 60 mg/m2 on day 1, Taxotere at 50 mg/m2 on day 1, Folinic Acid at 100 mg/m2 on days 1-2, Fluorouracil bolus at 400 mg/m2 on days 1-2 and Fluorouracil 22 h continuous infusion on days 1-2 every three weeks. Results: Amongst the 38 evaluable patients we observed 5 CR (13%), 9 PR (24%), 9 SD (24%) and 15 PD (39%) for an ORR of 37% (95% CI: 22-52) and a tumor growth control rate of 61%. The median time to progression was 4 months and the median survival was 9 months. The treatment was well tolerated. The main grade III-IV haematologic toxicities were leucopenia 7%, neutropenia 5% and anemia 5% while non-haematologics were diarrhoea 2%, alopecia 2% and cardiac 2%. Conclusion: The three drugs combination of Taxotere, Epirubicin and Fluorouracil is active and well tolerated first-line treatment in advanced gastric cancer patients.

AB - Introduction: Despite the large number of drugs active in AGC, no combination can be considered as the gold standard treatment. Modest increase have been obtained in overall survival with the most widely employed regimens such as CF or ECF, often obtained at expense of increased toxicity. So there is a strong need to develop new active drugs to improve the clinical outcome. Taxotere showed to be effective in preclinical studies and some phase II trials confirmed its clinical efficacy. Recently, the addition of TXT to CDDP + FU (TCF regimen), obtained, in a large randomised phase III trial, better survival than CF alone. However the toxicity of this combination was relevant and mainly due to the association with CDDP. Considering these data the GOIM started a phase II study aiming to evaluate efficacy and safety of a three drugs combination, employing EPI instead of CDDP. Materials and methods: Forty-one histologically proven untreated gastric cancer patients, with advanced measurable disease, age between 18 and 75 years, performance status ≥ 70 (Kfsky scale) and available to sign written informed consent, were enrolled. They received the following treatment: Epirubicin at 60 mg/m2 on day 1, Taxotere at 50 mg/m2 on day 1, Folinic Acid at 100 mg/m2 on days 1-2, Fluorouracil bolus at 400 mg/m2 on days 1-2 and Fluorouracil 22 h continuous infusion on days 1-2 every three weeks. Results: Amongst the 38 evaluable patients we observed 5 CR (13%), 9 PR (24%), 9 SD (24%) and 15 PD (39%) for an ORR of 37% (95% CI: 22-52) and a tumor growth control rate of 61%. The median time to progression was 4 months and the median survival was 9 months. The treatment was well tolerated. The main grade III-IV haematologic toxicities were leucopenia 7%, neutropenia 5% and anemia 5% while non-haematologics were diarrhoea 2%, alopecia 2% and cardiac 2%. Conclusion: The three drugs combination of Taxotere, Epirubicin and Fluorouracil is active and well tolerated first-line treatment in advanced gastric cancer patients.

KW - Epirubicin

KW - Gastric cancer

KW - Taxotere

UR - http://www.scopus.com/inward/record.url?scp=55749091134&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=55749091134&partnerID=8YFLogxK

U2 - 10.1016/j.ejcsup.2008.06.017

DO - 10.1016/j.ejcsup.2008.06.017

M3 - Article

VL - 6

SP - 107

EP - 112

JO - European Journal of Cancer, Supplement

JF - European Journal of Cancer, Supplement

SN - 1359-6349

IS - 14

ER -