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

Cancer Research and Treatment : Official Journal of Korean Cancer Association
Gun Min KimJoohyuk Sohn

Abstract

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. 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. 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 A...Continue Reading

References

Dec 8, 2005·Journal of the National Cancer Institute·Marco VenturiniPaolo Bruzzi
May 28, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·David R GandaraPhilip C Mack
Aug 16, 2011·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Yoshikazu HasegawaMinoru Takada
Feb 20, 2014·British Journal of Cancer·Y WangD Y C Heng
Apr 29, 2015·Breast Cancer Research and Treatment·Fausto PetrelliSandro Barni
Nov 9, 2016·JAMA : the Journal of the American Medical Association·Theodoros FoukakisUNKNOWN Swedish Breast Cancer Group (SweBCG), the German Breast Group (GBG), and the Austrian Breast & Colorectal Cancer Study Group
Oct 27, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·V MöbusUNKNOWN AGO Breast Study Group (AGO-B)
Nov 7, 2017·Biologicals : Journal of the International Association of Biological Standardization·Jeungwoon HongChan-Wha Kim

❮ Previous
Next ❯

Citations

Jun 12, 2021·Expert Review of Anticancer Therapy·Michelle ShayneGary H Lyman

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT03575520

Related Concepts

Related Feeds

Anorexia Nervosa

Anorexia nervosa (AN) is a psychiatric condition characterized by severe weight loss and secondary problems associated with malnutrition. Here is the latest research on AN.