2357 - Modalities of biosimilar filgrastim use in clinical practice in >1000 patients receiving chemotherapy regimens with a rest period of ≤14 days: the TOPAZE study

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.Table:

1812P Modalities of use of biosimilar filgrastim in patients receiving chemotherapy for curative intent

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:

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.

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.

Clinical trial identification

Editorial acknowledgement

Caroline McGown of Spirit Medical Communications Ltd, supported by Sandoz.

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.