Annals of Oncology Advance Access originally published online on February 13, 2009
Annals of Oncology 2009 20(7):1185-1192; doi:10.1093/annonc/mdn748
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breast cancer |
Preoperative weekly cisplatin–epirubicin–paclitaxel with G-CSF support in triple-negative large operable breast cancer
1 Department of Senology, National Cancer Institute of Naples, Naples
2 Department of Medical Oncology, National Cancer Institute of Naples, Naples
3 Department of Pathology, National Cancer Institute of Naples, Naples
4 Department of Radiology, National Cancer Institute of Naples, Naples
5 Department of Surgery, Faculty of Medicine, University of "Magna Grecia", Catanzaro, Italy
* Correspondence to: Dr G. Frasci, Department of Senology, Unit of Preoperative Treatments, National Cancer Institute, via Mariano Semmola 80131, Naples, Italy. Tel: +39-081-5903347; Fax: +39-81-5903802; E-mail: giuseppe.frasci{at}libero.it
Background: Findings from our previously published phase II study showed a high pathologic complete remission (pCR) rate in patients with triple-negative large operable breast cancer after the administration of eight cisplatin–epirubicin–paclitaxel (PET) weekly cycles. The safety and efficacy data of the initial population were updated, with inclusion of additional experience with the same therapy.
Methods: Patients with triple-negative large operable breast cancer (T2–T3 N0–1; T > 3 cm) received eight preoperative weekly cycles of cisplatin 30 mg/m2, epirubicin 50 mg/m2, paclitaxel (Taxol) 120 mg/m2, with granulocyte colony-stimulating factor (5 µg/kg days 3–5) support.
Results: Overall 74 consecutive patients (T2/T3 = 35/39; N0/N+ = 26/48) were treated, from May 1999 to May 2008. At pathological assessment, 46 women (62%; 95% confidence interval 50–73) showed pCR in both breast and axilla. At a 41-month median follow-up (range 3–119), 13 events (nine distant metastases) had occurred, 5-year projected disease-free survival (DFS) and distant disease-free survival being 76% and 84%, respectively. Five-year DFS was 90% and 56% in pCRs and non-pCRs, respectively. Severe neutropenia and anemia occurred in 23 (31%) and eight (10.8%) patients, respectively. Severe non-hematological toxicity was recorded in <20% of patients. Peripheral neuropathy was quite frequent but never severe.
Conclusions: Eight weekly PET cycles are a highly effective primary treatment in women with triple-negative large operable breast cancer. This approach results in a very promising long-term DFS in this poor prognosis population. This triplet regimen is worthy of evaluation in phase III trials.
Key words: cisplatin, epirubicin, operable breast cancer, paclitaxel, triple negative, weekly administration
Received for publication November 3, 2008. Accepted for publication November 18, 2008.
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