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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 4/2013

01-04-2013 | Original Article

Phase I/II study of albumin-bound nab-paclitaxel plus gemcitabine administered to Chinese patients with advanced pancreatic cancer

Authors: Dong-sheng Zhang, De-shen Wang, Zhi-qiang Wang, Feng-hua Wang, Hui-yan Luo, Miao-zhen Qiu, Feng Wang, Yu-hong Li, Rui-hua Xu

Published in: Cancer Chemotherapy and Pharmacology | Issue 4/2013

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Abstract

Purpose

The primary objective of this study was to evaluate the dose-limiting toxicities (DLTs) and identify the maximum-tolerated dose (MTD) and recommended dose of nab-paclitaxel plus gemcitabine as a first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).

Methods

Patients with previously untreated advanced PDA were treated with nab-paclitaxel followed by gemcitabine (1,000 mg/m2) administered intravenously for 30 min on days 1 and 8 and repeated every 21 days.

Results

Patients received nab-paclitaxel at the following dose levels: 80 mg/m2 (n = 3), 100 mg/m2 (n = 6), and 120 mg/m2 (n = 12). The DLTs evaluated were elevated alanine aminotransferase and febrile neutropenia. However, there had no two out of three to six patients experienced DLTs, the MTD was not met. A total of 93 cycles were administered. The most common grade 3/4 toxicities were neutropenia (9.52 %), thrombocytopenia (4.76 %), and sensory neuropathy (4.76 %). For 12 patients receiving 120 mg/m2, the overall response rate and disease control rate were 41.67 and 83.33 %, respectively, and the median progression-free survival and overall survival were 5.23 and 12.17 months, respectively.

Conclusions

Treatment with albumin-bound nab-paclitaxel (120 mg/m2) plus gemcitabine has a favorable safety profile with an encouraging antitumor effect in Chinese patients.
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Metadata
Title
Phase I/II study of albumin-bound nab-paclitaxel plus gemcitabine administered to Chinese patients with advanced pancreatic cancer
Authors
Dong-sheng Zhang
De-shen Wang
Zhi-qiang Wang
Feng-hua Wang
Hui-yan Luo
Miao-zhen Qiu
Feng Wang
Yu-hong Li
Rui-hua Xu
Publication date
01-04-2013
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 4/2013
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-013-2102-4

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