IngentaConnect A 2-month cisplatin-epirubicin-paclitaxel (PET) weekly combinatio...

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

Source: Annals of Oncology, Volume 16, Number 8, August 2005 , pp. 1268-1275(8)

Publisher: Oxford University Press

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

g/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

Document Type: Research article

DOI: 10.1093/annonc/mdi256

Affiliations: 1: 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@libero.it

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