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Annals of Oncology Advance Access published online on June 3, 2005

Annals of Oncology, doi:10.1093/annonc/mdi256
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© 2005 European Society for Medical Oncology
Received February 1, 2005
Revised April 4, 2005
Accepted April 7, 2005

Original article

A 2-month cisplatin-epirubicin-paclitaxel (PET) weekly combination as primary systemic therapy for large operable breast cancer: a phase II study

G. Frasci 1*, G. D'Aiuto 1, P. Comella 1, R. Thomas 1, G. Botti 1, M. Di Bonito 1, M. D'Aiuto 1, G. Romano 1, M. R. Rubulotta 1, G. Comella 1, and On behalf of the Southern Italy Cooperative Oncology Group (SICOG), Italy

1 Divisions of Medical Oncology A, Surgical, Oncology, Pathology, Radiology, National Tumor Institute, Naples, Italy

* To whom correspondence should be addressed.
G. Frasci, E-mail: Giuseppe.frasci{at}libero.it


   Abstract

Purpose: The present study aimed to define the antitumor activity of eight cisplatin-epirubicin-paclitaxel (PET) weekly cycles with granulocyte colony-stimulating factor (G-CSF) support in patients with large operable breast cancer.

Methods: Operable breast cancer (T2-3 N0-1; T >3 cm) patients received eight preoperative weekly cycles of cisplatin 30 mg/m2, epirubicin 50 mg/m2 and paclitaxel 120 mg/m2, with G-CSF (5 µg/kg, days 3-5) support.

Results: Sixty-three patients (T2/T3=30/33; N0/N+=8/55) were enrolled. Thirty-one clinical complete (49%) and 30 partial (48%) responses were recorded, giving a 97% response rate (95% confidence interval 89% to 100%). Breast-sparing surgery was performed in 32/63 (51%) patients. At pathological assessment, 28 patients (45%) showed absence of invasive residual disease in breast and 34 (55%) had negative axilla. In 20 women (32%) both breast and axilla were found to be disease-free. At a 23-month median follow-up (range 4-63), only eight relapses and two deaths had occurred, with the 4-year projected relapse-free and overall survival being 59% and 95%, respectively. Grade 3-4 neutropenia and anemia occurred in 24% and 5% of patients, respectively. Emesis, diarrhea and mucositis were the main non-hematological toxicities; however, only nine (14%) patients experienced one or more episodes of severe non-hematological toxicity. Peripheral neuropathy was frequent, but never severe.

Conclusions: A 2-month weekly treatment with PET represents a well tolerated and highly effective approach in large operable breast cancer patients. In spite of the short duration of chemotherapy, one-third of patients achieved a complete eradication of the tumor in both breast and axilla.

Keywords: cisplatin; epirubicin; operable breast cancer; paclitaxel; primary chemotherapy; weekly administration.
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