Weekly cisplatin, epirubicin, and paclitaxel with granulocyte colony-stimulating factor support vs triweekly epirubicin and paclitaxel in locally advanced breast cancer: Final analysis of a SICOG phase III study

Giuseppe Frasci, G. D'Aiuto, P. Comella, R. Thomas, G. Botti, M. Di Bonito, V. De Rosa, G. Iodice, M. R. Rubulotta, G. Comella

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Abstract

The present study aimed at evaluating whether a weekly cisplatin, epirubicin, and paclitaxel (PET) regimen could increase the pathological complete response (pCR) rate in comparison with a tri-weekly epirubicin and paclitaxel administration in locally advanced breast cancer (LABC) patients. Patients with stage IIIB disease were randomised to receive either 12 weekly cycles of cisplatin 30mg m -2, epirubicin 50mg m -2, and paclitaxel 120mg m -2 (PET) plus granulocyte-colony stimulating factor support, or four cycles of epirubicin 90mg m -2+paclitaxel 175mg m -2 (ET) every 3 weeks. Overall, 200 patients (PET/ET=100/100) were included in this study. A pCR in both breast and axilla occurred in 16 (16%) PET patients and in six (6%) ET patients (P=0.02). The higher activity of PET was evident only in ER negative (27.5 vs 5.4%; P=0.026), and in HER/neu positive (31 vs 5%; P=0.037) tumours. The two arms yielded similar pCR rate in ER positive (PET/ET=7.5/7.1%) and HER/neu negative (PET/ET=10/6%) patients. At a 39 months median follow-up, 70 patients showed a progression or relapses (PET, 32 vs ET, 38). Anaemia, mucositis, peripheral neuropathy, and gastrointestinal toxicity were substantially more frequent in the PET arm. The PET weekly regimen is superior to ET in terms of pCR rate in LABC patients with ER negative and/or HER2 positive tumours Mature data in terms of disease-free and overall survival are needed to ascertain whether this approach could improve the prognosis of these subsets of LABC patients.

Original languageEnglish
Pages (from-to)1005-1012
Number of pages8
JournalBritish Journal of Cancer
Volume95
Issue number8
DOIs
Publication statusPublished - Oct 23 2006

Fingerprint

Epirubicin
Granulocyte Colony-Stimulating Factor
Paclitaxel
Breast Neoplasms
Arm
TP protocol
Mucositis
Axilla
Peripheral Nervous System Diseases
Cisplatin
Disease-Free Survival
Anemia
Neoplasms
Breast
Recurrence

Keywords

  • Cisplatin
  • Epirubicin
  • LABC
  • Paclitaxel
  • Randomised trial
  • Weekly administration

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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title = "Weekly cisplatin, epirubicin, and paclitaxel with granulocyte colony-stimulating factor support vs triweekly epirubicin and paclitaxel in locally advanced breast cancer: Final analysis of a SICOG phase III study",
abstract = "The present study aimed at evaluating whether a weekly cisplatin, epirubicin, and paclitaxel (PET) regimen could increase the pathological complete response (pCR) rate in comparison with a tri-weekly epirubicin and paclitaxel administration in locally advanced breast cancer (LABC) patients. Patients with stage IIIB disease were randomised to receive either 12 weekly cycles of cisplatin 30mg m -2, epirubicin 50mg m -2, and paclitaxel 120mg m -2 (PET) plus granulocyte-colony stimulating factor support, or four cycles of epirubicin 90mg m -2+paclitaxel 175mg m -2 (ET) every 3 weeks. Overall, 200 patients (PET/ET=100/100) were included in this study. A pCR in both breast and axilla occurred in 16 (16{\%}) PET patients and in six (6{\%}) ET patients (P=0.02). The higher activity of PET was evident only in ER negative (27.5 vs 5.4{\%}; P=0.026), and in HER/neu positive (31 vs 5{\%}; P=0.037) tumours. The two arms yielded similar pCR rate in ER positive (PET/ET=7.5/7.1{\%}) and HER/neu negative (PET/ET=10/6{\%}) patients. At a 39 months median follow-up, 70 patients showed a progression or relapses (PET, 32 vs ET, 38). Anaemia, mucositis, peripheral neuropathy, and gastrointestinal toxicity were substantially more frequent in the PET arm. The PET weekly regimen is superior to ET in terms of pCR rate in LABC patients with ER negative and/or HER2 positive tumours Mature data in terms of disease-free and overall survival are needed to ascertain whether this approach could improve the prognosis of these subsets of LABC patients.",
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author = "Giuseppe Frasci and G. D'Aiuto and P. Comella and R. Thomas and G. Botti and {Di Bonito}, M. and {De Rosa}, V. and G. Iodice and Rubulotta, {M. R.} and G. Comella",
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T1 - Weekly cisplatin, epirubicin, and paclitaxel with granulocyte colony-stimulating factor support vs triweekly epirubicin and paclitaxel in locally advanced breast cancer

T2 - Final analysis of a SICOG phase III study

AU - Frasci, Giuseppe

AU - D'Aiuto, G.

AU - Comella, P.

AU - Thomas, R.

AU - Botti, G.

AU - Di Bonito, M.

AU - De Rosa, V.

AU - Iodice, G.

AU - Rubulotta, M. R.

AU - Comella, G.

PY - 2006/10/23

Y1 - 2006/10/23

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