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

被引：12

作者：

Park, K. H. ^{[1
]}

Lee, S. ^{[2
]}

Park, J. H. ^{[3
]}

Kang, S. Y. ^{[4
]}

Kim, H. Y. ^{[5
]}

Park, I. H. ^{[6
,7
]}

Park, Y. H. ^{[8
]}

Im, Y. H. ^{[8
]}

Lee, H. J. ^{[9
]}

Park, S. ^{[10
]}

Lee, S. I. ^{[11
]}

Jung, K. H. ^{[12
]}

Kim, Y. S. ^{[13
]}

Seo, Jae Hong ^{[1
]}

机构：

[1] Korea Univ, Coll Med, Dept Internal Med, Div Oncol Hematol, 73 Inchonro, Seoul 02481, South Korea

[2] Yonsei Univ, Coll Med, Dept Internal Med, Div Oncol,Severance Hosp, Seoul, South Korea

[3] Univ Ulsan, Coll Med, Dept Internal Med, Div Oncol Hematol, Ulsan, South Korea

[4] Ajou Univ, Sch Med, Dept Hematol Oncol, Suwon, South Korea

[5] Hallym Univ, Sacred Heart Hosp, Dept Internal Med, Div Oncol Hematol, Anyang Si, Gyeonggi Do, South Korea

[6] Natl Canc Ctr, Ctr Breast Canc, Goyang Si, South Korea

[7] Natl Canc Ctr, Ctr Clin Trials, Goyang Si, South Korea

[8] Samsung Med Ctr, Dept Internal Med, Div Hematol Oncol, Seoul, South Korea

[9] Dong A ST, Prod Dev HQ, Seoul, South Korea

[10] Catholic Univ, Coll Med, Div Oncol, Dept Internal Med,Seoul St Marys Hosp, Seoul, South Korea

[11] Dong A Univ, Coll Med, Dept Internal Med, Div Oncol Hematol, Busan, South Korea

[12] Univ Ulsan, Coll Med, Dept Oncol, Asan Med Ctr, Seoul, South Korea

[13] Kosin Univ, Gospel Hosp, Div Oncol Hematol, Dept Internal Med, Busan, South Korea

来源：

SUPPORTIVE CARE IN CANCER | 2017年 / 25卷 / 02期

关键词：

Breast cancer; Pegylated G-CSF; TAC chemotherapy; Neutropenia; COLONY-STIMULATING FACTOR; ADJUVANT TREATMENT; FEBRILE NEUTROPENIA; DOSE INTENSITY; DOCETAXEL; PEGFILGRASTIM; UPDATE; TRIAL;

D O I：

10.1007/s00520-016-3429-2

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 mu g/m(2)/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/mm(3) and 161.75/mm(3) 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.

引用

页码：505 / 511

页数：7

共 26 条

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