A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-Dense Doxorubicin/Cyclophosphamide / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment
;
: 812-818, 2019.
Article
in English
| WPRIM
| ID: wpr-763115
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 meta-analysis 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 ANDMETHODS:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Appointments and Schedules
/
Breast
/
Breast Neoplasms
/
Anorexia
/
Doxorubicin
/
Abdominal Pain
/
Incidence
/
Disease-Free Survival
/
Muscle Weakness
/
Cyclophosphamide
Type of study:
Controlled clinical trial
/
Incidence study
/
Prognostic study
/
Systematic reviews
Limits:
Humans
Language:
English
Journal:
Cancer Research and Treatment
Year:
2019
Type:
Article
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