A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer
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| Názov: | A randomized, multi-center, open-label, phase III study of once-per-cycle DA-3031, a pegylated G-CSF, in comparison with daily filgrastim in patients receiving TAC chemotherapy for breast cancer |
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| Autori: | I. H. Park, Yang Soo Kim, S. Park, S.I. Lee, Soohyeon Lee, Jae Hong Seo, Ho Young Kim, Kyong Hwa Park, Young-Hyuck Im, Kyung Hae Jung, Yeon Hee Park, Jae Hoo Park, H. J. Lee, Seok Yun Kang |
| Prispievatelia: | K H Park, S Lee, J H Park, S Y Kang, H Y Kim, I H Park, Y H Park, Y H Im, H J Lee, S Park, S I Lee, K H Jung, Y S Kim, Jae Hong Seo |
| Zdroj: | Supportive Care in Cancer. 25:505-511 |
| Informácie o vydavateľovi: | Springer Science and Business Media LLC, 2016. |
| Rok vydania: | 2016 |
| Predmety: | Adult, Neutropenia, Breast Neoplasms / drug therapy, Filgrastim / administration & dosage, Filgrastim, Injections, Subcutaneous, Breast Neoplasms, Filgrastim / adverse effects, Docetaxel, Cyclophosphamide / administration & dosage, Drug Administration Schedule, Injections, Polyethylene Glycols, 03 medical and health sciences, Breast cancer, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols / adverse effects, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, Polyethylene Glycols / adverse effects, Humans, Chemotherapy-Induced Febrile Neutropenia / etiology, Granulocyte Colony-Stimulating Factor / adverse effects, Polyethylene Glycols / administration & dosage, Chemotherapy-Induced Febrile Neutropenia, Cyclophosphamide, Taxoids / administration & dosage, Aged, Subcutaneous, TAC chemotherapy, Chemotherapy-Induced Febrile Neutropenia / drug therapy, Doxorubicin / administration & dosage, Antineoplastic Combined Chemotherapy Protocols / administration & dosage, Middle Aged, 3. Good health, Doxorubicin, Granulocyte Colony-Stimulating Factor / administration & dosage, Female, Taxoids, Chemotherapy-Induced Febrile Neutropenia / prevention & control, Pegylated G-CSF |
| Popis: | This multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN).Seventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 μg/m2/day for up to 10 days or a single subcutaneous injection of DA-3031 at fixed doses of 6 mg on day 2 of each chemotherapy cycle.The mean duration of grade 4 (G4) neutropenia in cycle 1 was 2.08 ± 0.85 days for the filgrastim group and 2.28 ± 1.14 days for the DA-3031 group. The difference between groups was 0.2 ± 1.10 days (95 % confidence interval (CI) = -0.26, 0.66), which supported non-inferiority. No statistically significant differences were observed in nadir absolute neutrophil count (ANC) (154.34/mm3 and 161.75/mm3 for the filgrastim and DA-3031 groups, respectively; P = 0.8414) or in time to ANC recovery (10.03 ± 0.75 and 9.83 ± 1.56 days in the filgrastim and DA-3031 groups, respectively; P = 0.0611) during cycle 1. Serious AEs occurred in six (15.8 %) patients receiving filgrastim and in ten (27.8 %) patients receiving DA-3031; however, none was determined to be related to the study drug.DA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy. |
| Druh dokumentu: | Article |
| Jazyk: | English |
| ISSN: | 1433-7339 0941-4355 |
| DOI: | 10.1007/s00520-016-3429-2 |
| Prístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/27709313 |
| Rights: | Springer TDM CC BY NC ND |
| Prístupové číslo: | edsair.doi.dedup.....13fc2cf1cc9b93cb48167c6eefb516b5 |
| Databáza: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | This multi-center, randomized, phase III study was conducted to demonstrate the non-inferiority of DA-3031 compared with daily filgrastim in patients during the first cycle of chemotherapy for breast cancer in terms of the duration of severe neutropenia (DSN).Seventy-four patients with breast cancer who were receiving combination chemotherapy with docetaxel, doxorubicin, and cyclophosphamide (TAC) were enrolled. All participants were randomized to receive either daily subcutaneous injections of filgrastim 100 μg/m2/day for up to 10 days or a single subcutaneous injection of DA-3031 at fixed doses of 6 mg on day 2 of each chemotherapy cycle.The mean duration of grade 4 (G4) neutropenia in cycle 1 was 2.08 ± 0.85 days for the filgrastim group and 2.28 ± 1.14 days for the DA-3031 group. The difference between groups was 0.2 ± 1.10 days (95 % confidence interval (CI) = -0.26, 0.66), which supported non-inferiority. No statistically significant differences were observed in nadir absolute neutrophil count (ANC) (154.34/mm3 and 161.75/mm3 for the filgrastim and DA-3031 groups, respectively; P = 0.8414) or in time to ANC recovery (10.03 ± 0.75 and 9.83 ± 1.56 days in the filgrastim and DA-3031 groups, respectively; P = 0.0611) during cycle 1. Serious AEs occurred in six (15.8 %) patients receiving filgrastim and in ten (27.8 %) patients receiving DA-3031; however, none was determined to be related to the study drug.DA-3031 and daily filgrastim are similar in regard to DSN and safety in breast cancer patients receiving TAC chemotherapy. |
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| ISSN: | 14337339 09414355 |
| DOI: | 10.1007/s00520-016-3429-2 |