Cancer Res Treat.  2019 Apr;51(2):812-818. 10.4143/crt.2018.383.

A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-Dense Doxorubicin/Cyclophosphamide

Affiliations
  • 1Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. oncosohn@yuhs.ac
  • 2Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.

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 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.

Keyword

Breast neoplasms; Dose-dense chemotherapy; Pegfilgrastim

MeSH Terms

Abdominal Pain
Alopecia
Anorexia
Appointments and Schedules
Breast Neoplasms*
Breast*
Cyclophosphamide
Diarrhea
Disease-Free Survival
Doxorubicin
Drug Therapy
Drug-Related Side Effects and Adverse Reactions
Dyspepsia
Febrile Neutropenia
Headache
Humans
Incidence
Mucositis
Muscle Weakness
Myalgia
Nausea
Cyclophosphamide
Doxorubicin
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