Zarzio®, biosimilar of filgrastim, in prophylaxis of chemotherapy-induced neutropenia in routine practice: a French prospective multicentric study.
OBJECTIVE
Chemotherapy-induced neutropenia is a serious and potentially life-threatening consequence of cancer treatment. Prophylactic treatment with granulocyte-colony stimulating factor (G-CSF) decreases the incidence of febrile neutropenia, the rate of hospitalization, and the use of antibiotics in patients at risk. The aim of this study was to assess efficacy, safety, and use of Zarzio(®)-biosimilar of Neupogen(®) (G-CSF; filgrastim)-in prophylaxis of chemotherapy-induced neutropenia in current practice in cancer patients.


METHODS
We conducted an observational, prospective, longitudinal, and multicentric study in France. The incidence of neutropenia was evaluated at each cycle of chemotherapy.


RESULTS
One hundred eighty-four patients (women, 64.7 %; mean age, 61.7 years) with solid tumor (89.7 %; breast cancer, 50.5 %) or non-Hodgkin lymphoma (10.3 %) were included. The risk of febrile neutropenia based on chemotherapy regimen was >20 % for 32.1 % of patients. No case of febrile neutropenia was reported. Neutropenia was the cause of hospitalization and/or antibiotic therapy in 10 patients. The most frequent adverse events related to Zarzio(®) were pain, in particular bone pain. No serious adverse event related to Zarzio(®) was reported.


CONCLUSIONS
The results obtained in real-life conditions confirm that Zarzio(®) is efficient and well tolerated in cancer patients.
Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France.
Sophie
S
Nahon
Centre d'Hémato-Cancérologie Praz-Coutant, Passy, France.
Mansour
M
Rastkhah
Centre Paul Strauss, Strasbourg, France.
Meher
M
Ben Abdelghani
Sandoz Biopharmaceuticals, 49, Avenue Georges Pompidou, 92593, Levallois-Perret, Cedex, France.
Ravaka-Fatoma
RF
Soumoudronga
Sandoz Biopharmaceuticals, 49, Avenue Georges Pompidou, 92593, Levallois-Perret, Cedex, France. isabelle.gasnereau@sandoz.com.
Isabelle
I
Gasnereau
Centre Hospitalier, Carcassonne, France.
Jean-Luc
JL
Labourey
D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage / Q000009:adverse effects; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage / Q000009:adverse effects; D005602:France / Q000453:epidemiology; D006401:Hematologic Agents / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D059352:Musculoskeletal Pain / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D006401:Hematologic Agents; D000069585:Filgrastim
Biosimilar; Chemotherapy-induced neutropenia; Filgrastim; Observational study; Zarzio®