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

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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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Acknowledgments

We gratefully thank the staff members in the department of medical oncology at Sun Yat-sen University Cancer Center for their suggestion and assistance. This work was supported by the National Natural Science Foundation of China Grant [30672408].

Conflict of interest

The author(s) declare that they have no competing interests.

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Authors and Affiliations

  1. State Key Laboratory of Oncology in South China, Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dong Feng Road East, Guangzhou, 510060, China

    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

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  1. Dong-sheng Zhang
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  2. De-shen Wang
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  3. Zhi-qiang Wang
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  4. Feng-hua Wang
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  5. Hui-yan Luo
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  6. Miao-zhen Qiu
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  7. Feng Wang
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  8. Yu-hong Li
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  9. Rui-hua Xu
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Corresponding authors

Correspondence to Yu-hong Li or Rui-hua Xu.

Additional information

D. Zhang, D. Wang, and Z. Wang contributed equally to this work.

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Zhang, Ds., Wang, Ds., Wang, Zq. et al. Phase I/II study of albumin-bound nab-paclitaxel plus gemcitabine administered to Chinese patients with advanced pancreatic cancer. Cancer Chemother Pharmacol 71, 1065–1072 (2013). https://doi.org/10.1007/s00280-013-2102-4

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  • DOI: https://doi.org/10.1007/s00280-013-2102-4

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