Abstract P6-02-06: Safety and feasibility of neoadjuvant combined chemotherapy of breast cancer with paclitaxel carried in a lipid nanoemulsion (LDE) associated with adriamycin and cyclophosphamide

Abstract

Abstract Background The introduction of neoadjuvant chemotherapy considerably changed the natural history of breast cancer by permitting a big tumors to be operable, permitting less aggressive surgical procedures and when achieving complete pathological response prolonging the disease-free period. However, the chemotherapy schemes bear high toxicity rates and are even life-threatening. Neoadjuvant chemotherapy aims at reducing mortality and improving surgical options and offers an in vivo chemosensitivity testing at the same time. It is the ideal setting for clinical and translational research. Compared to the classical adjuvant treatment, it offers several advantages. Methods We performed a pilot study to evaluate the safety and feasibility of neoadjuvant combined chemotherapy of breast cancer with paclitaxel carried in a lipid nanoemulsion (LDE) associated with adriamycin and cyclophosphamide in comparison to the classical neoadjuvant chemotherapy paclitaxel, adriamicyn and cyclofosfamide (TAC). All the patients were women with recently diagnosed breast cancer who needed primary chemotherapy as the first treatment selected from Perola Byington Hospital in São Paulo - Brazil. Results From April 2006 to June 2008, 39 patients from a center for breast disorders (Pérola Byington Hospital) were included in the study. These patients were randomized to the standard chemotherapy scheme (control arm – n=16) or LDE-paclitaxel (LDE arm – N=17). Six patients were excluded from the study because they did not complete at least 5 cycles of chemotherapy. We also excluded three patients because of lack of follow up. The majority of patients had stage III (37% IIIA and 27% IIIB). There was no significant difference among the groups, considering the clinical variables, so the sample was considered homogeneous. The patients were grouped in four different groups regarding the expression of ER, PR and CerbB2: Luminal subtype, Triple Negative, Her2-positive and Hybrid Luminal. We observed 37,5% of complete response in the control arm and 23,5% in the LDE arm. The partial response were 43,7% in the control group and 58,8% in the LDE group. The toxicity particularly in grade 3 and 4 events were substantially lower in LDE group: Nausea 11% vs 2,2%; Vomiting 7,3% vs 0.7% and neutropenia 8,8% vs 2,2%. Conclusion LDE scheme was effective and had lower grad 3 and 4 events than the TAC regiment. More studies are necessary to evaluate this approach. Citation Format: Andre Mattar, Luciana B Ferreira, Luiz H Gebrim, Roberto Hegg, Raul C Maranhão. Safety and feasibility of neoadjuvant combined chemotherapy of breast cancer with paclitaxel carried in a lipid nanoemulsion (LDE) associated with adriamycin and cyclophosphamide [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P6-02-06.