Biosimilar medicines in oncology: Single-center experience with biosimilar G-CSF.

Abstract

e19501 Background: A biosimilar medicine is one with proven similarity to a reference biological product for which the patent has expired and whose active ingredient is produced or derived from a living organism. Recombinant granulocyte colony-stimulating growth factors (G-CSF) are used for the prophylaxis of febrile neutropenia. Methods: In this observational study a total of 48 patients with solid tumours were treated with biosimilar Zarzio, a new biosimilar G-CSF for 4−14 days from the day following the end of chemotherapy. The primary prophylaxis group was composed of 10 patients with breast carcinoma receiving adjuvant chemotherapy (CEF: 5-fluorouracil 600 mg/m2, epirubicin 100 mg/m2 G1, cyclophosphamide 600 mg/m2 G1, q 21 for 4 cycles à docetaxel 100 mg/m2 G1, q 21); 17 patients with locally advanced or metastatic lung carcinoma (66% adenocarcinoma, 34% squamous) receiving 4–6 cycles of platinum-based chemotherapy; 6 patients with metastatic gastric adenocarcinoma treated with TCF (Taxotere 75 mg/m2, cisplatin 75 mg/m2, 5-fluorouracil 300 mg/m2 by continuous 24 hour infusion for 5 days, q 21) for 4–6 cycles; 4 patients with prostate adenocarcinoma treated with Docetaxel 75 mg/m2 G1, q 21 in 6 cycles. The secondary prophylaxis group was composed of 11 patients with colorectal adenocarcinoma (54.5% treated with adjuvant XELOX therapy: Xeloda 2000 mg/m2 G1à14, oxaliplatin 130 mg/m2 G1, q 21, and the remainder treated with first-line metastatic FOLFOXIRI therapy [CPT-11 165mg/m2 G1, 5-FU 3200 mg/m2 continuous infusion for 48 hours, oxaliplatin 85 mg/m2 G1, q 14]). Results: Three cases of febrile neutropenia were reported: two in patients with prostate adenocarcinoma and one case in a patient with pulmonary squamous cell carcinoma and multiple secondary skeletal lesions. These patients were treated with antibiotics with resolution of the clinical picture without hospitalization after 24 hours. Conclusions: Our experience indicates that the use of biosimilar G-CSF is safe and effective at reducing neutropenic complications in patients with mixed tumors and is associated with cost savings.