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Background  This phase I/II study aimed to determine the maximum tolerated dose (MTD) of nanoparticle albumin-bound paclitaxel ( nab  ® -paclitaxel) plus cisplatin as treatment for metastatic nasopharyngeal carcinoma (NPC).    Methods  Patients were enrolled into 1 of 3 dose cohorts, each with 21-day treatment cycles: 1) intravenous (IV)  nab -paclitaxel 260 mg/m 2  on day 1; 2) IV  nab -paclitaxel 140 mg/m 2  on days 1 and 8; 3) IV  nab -paclitaxel 100 mg/m 2  on days 1, 8, and 15. All patients received IV cisplatin 75 mg/m 2  on day 1. Treatment continued for 4–6 cycles, or until progression or unacceptable toxicity. If more than one-third of the patients in a cohort experienced a dose-limiting toxicity (DLT), the dose used in the previous cohort would be designated the MTD. Secreted protein acidic and rich in cysteine (SPARC) expression was detected by immunohistochemistry staining.    Results  Sixty-nine patients were enrolled, of whom 64 and 67 were eligible for efficacy and safety analysis, respectively. Two DLTs occurred in cohort 1 (grade 4 febrile neutropenia, grade 3 myalgia), none occurred in cohort 2, and 2 occurred in cohort 3 (both grade 3 fatigue). The MTD was not reached. Partial responses were achieved by 42 patients, 15 had stable disease, and 7 had progressive disease, giving an overall response rate of 66 %. Median progression-free survival was 9 months (95 % CI, 6–12 months). Grade ≥ 3 adverse events were mainly hematologic. There was no significant difference between the 3 cohorts with respect to efficacy or safety. Biomarker analyses indicated that stromal, rather than tumoral, SPARC may predict the response to nab-paclitaxel in NPC.    Conclusions  Our findings suggest that  nab -paclitaxel plus cisplatin is a highly active regimen with moderate toxicity for the treatment of metastatic NPC, which warrants further investigation in a phase III study.    Trial registrations  ClinicalTrials.gov ID:  NCT01735409 . The trial was registered on November 20th, 2012.    Electronic supplementary material  The online version of this article (doi:10.1186/s12885-016-2517-5) contains supplementary material, which is available to authorized users.

bmc cancer

Phase I/II dose-finding study of nanoparticle albumin-bound paclitaxel (nab®-Paclitaxel) plus Cisplatin as Treatment for Metastatic Nasopharyngeal Carcinoma