Annals of Oncology Advance Access originally published online on June 3, 2005
Annals of Oncology 2005 16(8):1268-1275; doi:10.1093/annonc/mdi256
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© 2005 European Society for Medical Oncology
A 2-month cisplatin–epirubicin–paclitaxel (PET) weekly combination as primary systemic therapy for large operable breast cancer: a phase II study
Divisions of Medical Oncology A, Surgical, Oncology, Pathology, Radiology, National Tumor Institute, Naples, Italy
* Correspondence to: Dr G. Frasci, Division of Medical Oncology A, National Tumor Institute, via Mariano Semmola 80131, Naples, Italy. Telephone: +39-081-5903225; Fax: +39-81-5903821; Email: giuseppe.frasci{at}libero.it
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.
Key words: cisplatin, epirubicin, operable breast cancer, paclitaxel, primary chemotherapy, weekly administration
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