1812PModalities of biosimilar filgrastim use in clinical practice in > 1000 patients receiving chemotherapy regimens with a rest period of ≤ 14 days: The TOPAZE study

Abstract Background International guidelines recommend the use of granulocyte colony stimulating factors (G-CSF), such as filgrastim, to prevent chemotherapy-induced febrile neutropenia (FN) and maintain chemotherapy dose to improve clinical outcomes. However, there are no clear recommendations for regimens with a rest period (duration between two cytotoxic administrations, within one cycle or between two different cycles) of ≤ 14 days. This study aimed to describe modalities of daily clinical use of biosimilar filgrastim in patients (pts) receiving chemotherapy regimens with a rest period of ≤ 14 days. Methods This multicentre, prospective, non‐interventional study was performed in France in pts receiving biosimilar filgrastim during cytotoxic chemotherapy with rest period of ≤ 14 days. Results A total of 1080 pts were enrolled, of which 953 were included in the full analysis set: 144 had lymphoma (DLBCL, N = 39; Hodgkin’s lymphoma, N = 105), and 809 had solid tumours (breast, N = 299; lung, N = 144; gastrointestinal [GI], N = 366 [colorectal, N = 203; pancreatic, N = 106; gastric N = 39; oesophageal, N = 18]). The Table shows modalities of filgrastim treatment for pts receiving chemotherapy for curative intent. Similar results were reported in pts receiving chemotherapy for palliative intent. Pts with solid tumours were planned to receive filgrastim on Day 2 of treatment for ≤5 days duration. Pts with lymphoma were planned to receive filgrastim on Day ≥3 for 4–8 days duration. Of the patients receiving chemotherapy for curative intent, FN was reported in 2 pts with GI cancer, 1 pt with lung cancer and 7 pts with lymphoma. Conclusions Biosimilar filgrastim treatment in pts receiving chemotherapy with a rest period of ≤ 14 days results in a low incidence of FN in real-world clinical practice. Editorial acknowledgement Caroline McGown of Spirit Medical Communications Ltd, supported by Sandoz. Table . 1812P Modalities of use of biosimilar filgrastim in patients receiving chemotherapy for curative intent Full group N (%) Lymphoma 144 (15.1) Solid tumours 809 (85) Subgroup (intent of chemotherapy) DLBCL (i) N = 35 HL (i) N = 100 Breast cancer (c) N = 139 GI cancers (c) N = 126 Lung cancer (c) N = 58 Regimen ‡ biw N = 23 m N = 12 biw N = 100 qw N = 91 biw N = 37 m N = 11 qw N = 1 biw N = 120 m N = 5 qw N = 1 m N = 57 Relative dose intensity with planned dose, % Mean (SD) 97.7 (4.4) - 109.5 (94.9) 100.9 (21.8) 97.2 (10.4) 95.2 (12.6) - 99.5 (24.0) 96.4 (8.0) - 95.1 (28.4) Patients with at least one episode of grade 4 neutropenia † Yes n (%) 3 (13.0) 1 (8.3) 11 (11.0) 0 2 (5.4) 0 0 1 (0.8) 0 0 2 (3.5) Number of patients with at least one episode of FN † Yes n (%) 1 (4.3) 1 (8.3) 5 (5.0) 0 0 0 0 2 (1.7) 0 0 1 (1.8) DLBCL: R-ACVBP; R-CHOP 14. HL: ABVD; increased-dose BEACOPP. Breast cancer: eribulin; paclitaxel weekly. Digestive cancers: simplified FolFOx4 (colorectal, gastric and oesophageal cancers); FolFlrinOx (pancreatic cancer). Lung cancer: carboplatin + paclitaxel (weekly); vinorelbine + platinum salt (carboplatin or cisplatin) 21-day cycle. biw, twice weekly regimen; c, curative; DLBCL, diffuse large B-cell lymphoma; FN, febrile neutropenia; GI, gastrointestinal; HL, Hodgkin’s lymphoma; i, induction; m, mixed regimen; N, number of patients in group; n, number of patients with event; qw, once weekly regimen; SD, standard deviation. † Note: percentages are calculated compared to completed data (i.e. not including missing data). ‡ The most frequently used chemotherapies in the overall study population were: Legal entity responsible for the study Sandoz. Funding Sandoz. Disclosure J.M. Phelip: Advisory / Consultancy: Roche; Advisory / Consultancy: Merck; Advisory / Consultancy: Amgen; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Bayer; Advisory / Consultancy: Servier; Advisory / Consultancy: Lilly; Advisory / Consultancy: MSD; Advisory / Consultancy: Pierre Favre; Research grant / Funding (institution): Merck Serono. P. Souquet: Honoraria (self), Speaker Bureau / Expert testimony, Non-remunerated activity/ies: Sandoz (a Novartis company). M. Declerck: Full / Part-time employment: Sandoz. E. Nabirotchkina: Full / Part-time employment: Sandoz. O. Tredan: Non-remunerated activity/ies: Sandoz; Honoraria (self): Roche; Honoraria (self): Novartis; Honoraria (self): Pfizer; Honoraria (self): Lilly; Honoraria (self): Astra-Zeneca; Honoraria (self): MSD-Merck; Honoraria (self): BMS. All other authors have declared no conflicts of interest.