Efficacy Of Biosimilar Filgrastim Research Articles

Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study.

IntroductionFebrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study (ClinicalTrials.gov identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy.MethodsThis was a prospective, multicenter, non-interventional, longitudinal study. Consenting adult patients with solid tumors or hematologic malignancies for whom cytotoxic chemotherapy and treatment with biosimilar filgrastim was planned were enrolled.ResultsAmong the enrolled patients (N = 386), 81% were female, with a median age (range) of 61 (22–92) years, with 39% >65 years old. Most patients (n = 338; 88%) had solid tumors and the remainder (n = 49; 13%) had hematological malignancies. The majority of the patients (64%) received biosimilar filgrastim as primary prophylaxis and 36% as secondary prophylaxis. At the follow-up visits, for the majority of patients (95.6%) there had been no change in chemotherapy dose due to FN. For two patients (0.5%) the chemotherapy was discontinued due to FN and for four patients (1.0%) the chemotherapy dose was reduced due to FN. For the majority of patients (96.9%) the chemotherapy cycle following the first biosimilar filgrastim treatment was not delayed due to FN. For 3 patients (0.8%), the chemotherapy was delayed following the first biosimilar filgrastim treatment. Less than one-third (29.8%) of the patients experienced ≥1 adverse event that was at least potentially related to biosimilar filgrastim treatment.ConclusionsBiosimilar filgrastim was effective and well-tolerated in both the primary and secondary prophylactic setting in patients undergoing chemotherapy for solid tumors and hematological malignancies.Trial RegistrationClinicalTrials.gov identifier, NCT01627990.FundingHospira Inc, A Pfizer Company, Lake Forest, IL, USA.

Abstract P1-10-03: Biosimilar filgrastim in the treatment of patients with breast cancer undergoing neutropenia-inducing chemotherapy: A subanalysis of the NEXT study

Abstract Introduction Febrile neutropenia (FN) is a frequent and serious complication in breast cancer patients undergoing chemotherapy. In addition to being a major risk factor for infection-related morbidity/mortality and disease progression, FN can lead to dose delays and reduction. Nivestim™ (Hospira Inc), a biosimilar filgrastim, is a granulocyte colony-stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The NEXT (Nivestim safety profile in patiEnts treated with cytotoXic CT in real-life clinical pracTice) study was a prospective real-world trial assessing the safety of curative or prophylactic biosimilar filgrastim in the treatment of patients undergoing chemotherapy. The large size of this study enabled a subanalysis to be performed in breast cancer patients; the results are presented herein. Methods NEXT was a prospective, noninterventional, longitudinal, multicenter French study (NCT01574235). Patients with a solid tumor or a malignant hemopathy (excepting chronic myeloproliferative and myelodysplastic syndromes) undergoing or starting neutropenia-inducing chemotherapy were enrolled. Objectives were to evaluate safety and incidence of FN and infection. Patients received biosimilar filgrastim (Hospira) and were monitored for 1–6 chemotherapy cycles, with 3 visits at inclusion, during, and following treatment. Results A total of 2114 patients were enrolled in this study; of these, 463 patients had breast cancer and were included in this analysis. Mean age was 58.4 years, 97% were female, 95.8% had an ECOG PS of 0–1, and 19.4% had metastatic disease. The majority of patients (n = 454; 98.1%) received biosimilar filgrastim as prophylaxis (primary, 94.1%; secondary, 5.9%); 9 (1.9%) patients received curative biosimilar filgrastim. Median time to initiation of biosimilar filgrastim was 7.5 days for curative patients and 4 days for prophylactic patients. Mean treatment duration was: 6.0±1.7 days (curative) and 5.6±2.6 days (prophylactic). Biosimilar filgrastim-related adverse events (AEs) were reported in 119 patients (curative, n = 1; primary prophylaxis, n = 111; secondary prophylaxis, n = 7). The rate of AEs was higher in breast cancer patients (26.1%) compared with the entire NEXT study population with solid tumors (21.1%); similar rates of FN were reported but breast cancer patients had higher rates of AEs and bone and muscle pain compared with the total study population. Considering the prophylactic group only, 4.7% experienced FN and 1.6% reported an infection. The incidence of FN and/or infection resulted in hospitalization in 4.7% of patients (mean duration: 4.6±2.5 days), chemotherapy dose reduction in 2.7% of patients, and a delay of chemotherapy in 5.2% of patients. Conclusion These data demonstrate the safety and efficacy of biosimilar filgrastim in a real-world setting. The subanalysis illustrated that biosimilar filgrastim was effective and well tolerated in breast cancer patients in the curative and prophylactic setting. These results mirror those of the parent NEXT study, and show that biosimilar filgrastim is a valid alternative therapeutic option for chemotherapy-induced neutropenia in breast cancer patients. Citation Format: Albrand H, Kamioner D, Leprêtre S. Biosimilar filgrastim in the treatment of patients with breast cancer undergoing neutropenia-inducing chemotherapy: A subanalysis of the NEXT study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-10-03.

1611 Safety and efficacy of biosimilar filgrastim in patients with colorectal cancer undergoing neutropenia-inducing chemotherapy: A sub-analysis of the NEXT study

1611 Safety and efficacy of biosimilar filgrastim in patients with colorectal cancer undergoing neutropenia-inducing chemotherapy: A sub-analysis of the NEXT study

1501 Safety and efficacy of biosimilar filgrastim in patients with lung cancer undergoing neutropenia-inducing chemotherapy:A sub-analysis of the NEXT study

1501 Safety and efficacy of biosimilar filgrastim in patients with lung cancer undergoing neutropenia-inducing chemotherapy:A sub-analysis of the NEXT study