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A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-Dense Doxorubicin/Cyclophosphamide
- Source :
- Cancer Research and Treatment : Official Journal of Korean Cancer Association
- Publication Year :
- 2018
- Publisher :
- Korean Cancer Association, 2018.
-
Abstract
- Purpose Dose-dense chemotherapy (DD-CT) is a preferred (neo)adjuvant regimen in early breast cancer (BC). Although the results of reported randomized trials are conflicting, a recent metaanalysis showed improved overall and disease-free survival with DD-CT compared to conventional schedules. However, no DD-CT safety data for Korean BC patients are available. This phase II study was conducted to evaluate the safety and efficacy of pegteograstim in Korean BC patients receiving DD-CT. Materials and methods Patients with operable (stage I-III), histologically confirmed BC received four cycles of intravenous doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) on day 1 every 2 weeks as neoadjuvant or adjuvant therapy. Pegteograstim (6.0 mg) was administered subcutaneously on day 2 of each cycle. The primary endpoint was the incidence of febrile neutropenia (FN). The secondary endpoints were safety and tolerability. Results Of 63 patients, one (1.6%) developed FN during all cycles of DD-CT. Dose delay was observed in four patients (6.3%) and dose reduction in two (3.2%) during DD-CT. Frequent adverse events (AEs) were nausea, alopecia, generalized muscle weakness, myalgia, mucositis, anorexia, dyspepsia, and diarrhea; most AEs were related to chemotherapy. Grade 3-4 AEs were reported in five of 63 patients (7.9%), and all grade 3 and 4 AEs were related to chemotherapy. Adverse drug reactions possibly linked to pegteograstim were abdominal pain, bone pain, myalgia, generalized muscle weakness, and headache in five of 63 patients (7.9%). Conclusion Dose-dense AC (doxorubicin/cyclophosphamide) chemotherapywith pegteograstim support is a tolerable and safe regimen in Korean early BC patients.
- Subjects :
- 0301 basic medicine
Adult
Cancer Research
medicine.medical_specialty
Dose-dense chemotherapy
Cyclophosphamide
medicine.medical_treatment
Breast Neoplasms
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Republic of Korea
medicine
Mucositis
Adjuvant therapy
Humans
Aged
Neoplasm Staging
Chemotherapy
business.industry
Middle Aged
medicine.disease
Pegfilgrastim
Neoadjuvant Therapy
Regimen
030104 developmental biology
Treatment Outcome
Oncology
Tolerability
Doxorubicin
030220 oncology & carcinogenesis
Original Article
Female
Neoplasm Grading
business
Febrile neutropenia
Biomarkers
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 20059256 and 15982998
- Volume :
- 51
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Cancer Research and Treatment : Official Journal of Korean Cancer Association
- Accession number :
- edsair.doi.dedup.....2a79995dfddf025c575b787423544908