Safa Najafi1, Maryam Ansari1, Vahid Kaveh2, Shahpar Haghighat3. 1. Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. 2. Department of Hematology and Medical Oncology, Firoozgar Hospital, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran. 3. Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. sha_haghighat@yahoo.com.
Abstract
BACKGROUND: The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. METHODS: In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. RESULTS:Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. CONCLUSION: It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. TRIAL REGISTRATION: IRCT20190504043465N1 , May 2019.
RCT Entities:
BACKGROUND: The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancerpatients in a non-inferiority clinical trial. METHODS: In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. RESULTS: Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. CONCLUSION: It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. TRIAL REGISTRATION: IRCT20190504043465N1 , May 2019.
Entities:
Keywords:
Breast cancer; Chemotherapy; Filgrastim; Iran; Pegfilgrastim
Authors: M D Green; H Koelbl; J Baselga; A Galid; V Guillem; P Gascon; S Siena; R I Lalisang; H Samonigg; M R Clemens; V Zani; B C Liang; J Renwick; M J Piccart Journal: Ann Oncol Date: 2003-01 Impact factor: 32.976
Authors: M A Bonilla; D Dale; C Zeidler; L Last; A Reiter; M Ruggeiro; M Davis; B Koci; W Hammond; A Gillio; Karl Welte Journal: Br J Haematol Date: 1994-12 Impact factor: 6.998