Clinical Research Papers:
Efficacy, safety and proper dose analysis of PEGylated granulocyte colony-stimulating factor as support for dose-dense adjuvant chemotherapy in node positive Chinese breast cancer patients
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Fan Zhang1,*, RuiXia LingHu1,*, XingYang Zhan1,*, Ruisheng Li2,*, Fan Feng3, Xudong Gao4, Lei Zhao1,5 and Junlan Yang1
1Department of Oncology, PLA General Hospital Cancer Center, Institute of Geriatric, PLA General Hospital and Beijing Key Laboratory of Cell Engineering & Antibody, Beijing, China
2Research Center for Clinical and Translational Medicine, PLA 302 Hospital, Beijing, China
3Department of Pharmacy, General Hospital of Shenyang Military Command, Shenyang, China
4Department of Gastroenterology, PLA 302 Hospital, Beijing, China
5National Clinical Research Center for Normal Aging and Geriatric & The Key Laboratory of Normal Aging and Geriatric, PLA General Hospital and Second Military Medical University, Shanghai, China
*These authors have contributed equally to this work
Lei Zhao, email: [email protected]
Junlan Yang, email: [email protected]
Keywords: breast cancer, adjuvant dose-dense chemotherapy, neutropenia, PEGylated-recombinant human granulocyte colony stimulating factors
Received: August 20, 2016 Accepted: April 29, 2017 Published: May 24, 2017
For high-risk breast cancer patients with positive axillary lymph nodes, dose-dense every-two-week epirubicin/cyclophosphamide-paclitaxel (ddEC-P) regimen is the optimal postoperative adjuvant therapy. However, this regimen is limited by the grade 3/4 neutropenia and febrile neutropenia (FN). There is an urgent need to explore the efficacy, safety and proper dosage of PEGylated granulocyte colony-stimulating factor (PEG-G-CSF) as support for ddEC-P in Chinese breast cancer patients with positive axillary lymph nodes. Prospectively, 40 women with stage IIIA to IIIC breast cancer received ddEC-P ± trastuzumab as adjuvant treatment. PEG-G-CSF was injected subcutaneously in a dose of 6 mg or 3 mg on the 2th day of each treatment cycle. With administration of PEG-G-CSF, all of the 40 patients completed 8 cycles of ddEC-P ± trastuzumab regimen without dose reductions or treatment delays. Moreover, no FN cases were observed. Further analysis showed that the proper dosage of PEG-G-CSF was 6 mg for ddEC treatment, and 3 mg for ddP treatment. PEG-G-CSF exhibits advantages compared with G-CSF in convenient of administration and tolerance for high risk Chinese breast cancer patients. More importantly, the proper dose of PEG-G-CSF for high risk Chinese breast cancer patients during ddEC-P chemotherapy may be 6 mg for ddEC treatment and 3 mg for ddP treatment.
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