Albumin component of nab-paclitaxel and skin toxicities in Chinese breast cancer patients.

e11567 Background: This phase II study was to explore the efficacy and safety of weekly nab-paclitaxel and cisplatin combinationin Chinese advanced breast cancer (ABC) patients. While all other safety profiles were similar and expected based on published clinical trial results conducted in Western patients, the incidence of skin rash was unexpectedly higher. Methods: Nab-paclitaxel(125 mg/m2) was administered on days 1, 8, 15, followed by cisplatin (75 mg/m2) on day 1 every 28 day cycle until disease progression, intolerable toxicities or the maximum of 6 cycles. Patients who received at least one injection of the study drug were included in this analysis of the incidence of skin rash among Chinese patients. Toxicity was graded using the CTCAE4.0. The incidences of skin toxicity with conventional- and nab-paclitaxel were obtained from published trial results in both Chinese and Western patients. Results: 73 patients enrolled were qualified to be analyzed, and a total of 384 cycles were administered before the datalock on Oct 1st, 2011. Rash was presented in 27 patients (37.0%). The most common sites involved were face (14/27), neck (14/27), limbs (18/27) and frictional parts of the trunk (10/27). Macular and papular rash with pruritus commonly occurred 2 (1-7) days after the first day of chemotherapy. Only one patient developed Grade 3 skin toxicity with generalized erythroderma and disfigurement of the face requiring dose reduction. The rash gradually regressed 2 (1-10) days after antihistamines using and pigmentation remained in 13/27 cases. The incidence rate of skin toxicity was significantly higher in Chinese patients than Western counterparts (P<0.0001), while no difference was found with conventional paclitaxel. Conclusions: A higher rate of skin toxicity occurred in Chinese breast cancer patients treated with weekly nab-paclitaxel comparing to Western patients. The albumin component of nab-paclitaxel maybe the cause of the skin disorder. [Table: see text]