A phase II trial of pre-operative paclitaxel and paraplatin in women with newly diagnosed operable breast cancer

Abstract

794 Background: Combination therapy with paclitaxel and paraplatin are known to have produced significant response rates in the setting of metastatic breast cancer when used as a solo regimen or when combined with Herceptin. The efficacy of this combination is not known in the setting of neoadjuvant treatment of breast cancer. We have initiated an open label Phase II study of neoadjuvant combination therapy with paclitaxel and paraplatin in patients with newly diagnosed stage II carcinoma of the breast. Objectives of the trial include the clinical response and pathologic complete response (pCR) to a maximum of 4 cycles of neoadjuvant therapy, and assessment of tolerability of this regimen in a chemotherapy naïve population. Methods: Patients with newly diagnosed biopsy proven breast cancer were recruited from the UAB Interdisciplinary Breast. Patients were assessed for the type of surgery that would be performed at the time of diagnosis, with axillary nodal status determined clinically or by sentinel lymph node (SLN) biopsy. Patients were asked to undergo an extra tumor biopsy, which was snap frozen to be used for correlative studies including markers of response. Treatment consisted of concomitant paclitaxel (200 mg/m2) and paraplatin (AUC = 6) every 21 days for a total of 4 cycles. A target population of 30 patients has been reached for this study. Results: Since 10/02 30 patients have enrolled on the study, of which 26 have completed therapy. Approximately half of the patients have agreed to an additional biopsy. In patients who completed the treatment phase and have undergone surgery (n = 22) the pCR is 18%. Toxicities have included 1 case of Gr 2 neuropathy and 1 case of Taxol hypersensitivity. Conclusion: The results of this study thus far suggest a response rate that appears to be similar or slightly higher then that achieved with a comparable number of adriamycin based treatments. Toxicity has been minimal and largely self-limited to myalgias and transient myelosuppression. No correlation was seen with ER/PR status. The study is still ongoing, and an update of this data will be provided. Results: Conclusions: No significant financial relationships to disclose.