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01.04.2013 | Original Article

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

verfasst von: 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

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 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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Titel: Phase I/II study of albumin-bound nab-paclitaxel plus gemcitabine administered to Chinese patients with advanced pancreatic cancer
verfasst von: 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
Publikationsdatum: 01.04.2013
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 4/2013
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-013-2102-4

Springer Medizin

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