Efficacy and safety of extimia® (empegfilgrastim): results of a double-blind controlled phase iii study in patients with diagnosis «breast cancer» receiving myelosuppressive chemotherapy


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Abstract

Objectives: to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2). Methods. 135 patients with breast cancer were randomly assigned at a ratio of 1:1:1 to receive either single s.c. injection of empegfilgrastim at doses of 6 mg or 7.5 mg, or daily s.c. injections of filgrastim at a dose of 5 mcg/kg (until ANC≥10×109/L), 24 h after chemotherapy. The primary efficacy endpoint was the duration of grade 4 neutropenia (ANC<0.5×109/L) during the first chemotherapy cycle.Results. Mean duration of grade 4 neutropenia was significantly shorter in both groups of empegfilgrastim compared to filgrastim group: 0.905 d (6 mg), 0.791 d (7,5 mg) and 1,725 d, correspondingly. Mean difference in duration of grade 4 neutropenia between filgrastim and empegfilgrastim 7.5 mg groups was -0.934 d (95% CI -1.504 to -0.364 days); p<0.05. During the next 3 cycles of chemotherapy mean duration of grade 4 neutropenia was also significantly shorter in both groups of empegfilgrastim. A statistically significant difference when comparing the rate of severe neutropenia during the study between both groups of empegfilgrastim (6 mg - 95.24%, 7.5 mg - 79.07%) and filgrastim (100.0%) was not observed (p>0.05). Febrile neutropenia was reported in 2.38% (6 mg), 6.98% (7.5 mg) and 5.00% (filgrastim) of patients. Results of this study indicate non-inferior efficacy of empegfilgrastim compared to filgrastim, efficacy parameters were preferable in the group of 7.5 mg empegfilgrastim.

About the authors

P V Krivorotko

N.N.Petrov Research Institute of Oncology of the Ministry of Health of the Russian Federation

д-р мед. наук, глав. науч. сотр., зав. клин. отд-нием опухолей молочной железы ФГБУ НИИ онкологии им. Н.Н.Петрова 197758, Russian Federation, Saint Petersburg, pos. Pesochnyi, ul. Leningradskaia, d. 68

O N Burdaeva

Arkhangelsk Clinical Oncology Dispensary

зав. химиотерапевтическим отд-нием ГБУ АО АКОД 163045, Russian Federation, Arkhangelsk, pr. Obvodnyi kanal, d. 145, korp. 1

M N Nechaeva

Arkhangelsk Clinical Oncology Dispensary

врач отд-ния химиотерапии ГБУ АО АКОД 163045, Russian Federation, Arkhangelsk, pr. Obvodnyi kanal, d. 145, korp. 1

M A Frolova

N.N.Blokhin Russian Cancer Research Center

канд. мед. наук, ст. науч. сотр. ФГБНУ РОНЦ им. Н.Н.Блохина 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23

M V Kopp

Samara Regional Clinical Oncology Center

д-р мед. наук, проф., руководитель отделения химиотерапии №1 Самарского областного клинического онкологического диспансера 443031, Russian Federation, Samara, ul. Solnechnaia, d. 50

A A Abrosimova

CJSC "Biocad"

мед. эксперт II категории ЗАО «Биокад» 198515, Russian Federation, Saint Petersburg, ul. Sviazi, 34a

R A Ivanov

CJSC "Biocad"

Email: ivanov@biocad.ru
зам. ген. дир. по биомедицинским исследованиям и развитию ЗАО «Биокад» 198515, Russian Federation, Saint Petersburg, ul. Sviazi, 34a

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