Abstract 2357
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
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) |
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.
Resources from the same session
2728 - MicroRNA expression and DNA methylation profiles do not distinguish between primary and recurrent well-differentiated liposarcoma
Presenter: Melissa Vos
Session: Poster Display session 1
Resources:
Abstract
3197 - Genomic Alterations, Tumor Mutation Burden and Prognosis of Chinese Cardiac Sarcoma Patients
Presenter: Na Zhu
Session: Poster Display session 1
Resources:
Abstract
4214 - Evaluation of a peptide-conjugated alkylator melflufen in osteosarcoma preclinical models
Presenter: Konstantin Byrgazov
Session: Poster Display session 1
Resources:
Abstract
2654 - Expression analysis of NHEJ and HR genes in Ewing sarcomas: indications of DSB repair dysfunction
Presenter: Anastasios Kyriazoglou
Session: Poster Display session 1
Resources:
Abstract
4383 - Epidemiology of Synovial Sarcoma in EU28 countries
Presenter: Nedra Joseph
Session: Poster Display session 1
Resources:
Abstract
1937 - Resection Of High-Grade Large Soft Tissue Sarcoma With Adequate Wide Margin Can Lead To Good Local Control Without Adjuvant Radiotherapy
Presenter: Toshiyuki Kunisada
Session: Poster Display session 1
Resources:
Abstract
3757 - Influence of eribulin on proliferation, migration and invasion properties of leiomyosarcoma cell line models
Presenter: Marta Mendiola
Session: Poster Display session 1
Resources:
Abstract
1040 - EREMISS: Efficacy of regorafenib (REG) as maintenance therapy in non-adipocytic soft tissue sarcomas (STS) having received 1st-line doxorubicin-based chemotherapy (Doxo-CT)
Presenter: Nicolas Penel
Session: Poster Display session 1
Resources:
Abstract
1048 - A Phase 2 biomarker-driven study evaluating the clinical efficacy of an MDM2 inhibitor, milademetan, in patients with intimal sarcoma, a disease with a high unmet need
Presenter: Kan Yonemori
Session: Poster Display session 1
Resources:
Abstract
1511 - A pilot study of oral paclitaxel (ORAXOL) in subjects with cutaneous angiosarcomas (KX-ORAX-010)
Presenter: Herbert Loong
Session: Poster Display session 1
Resources:
Abstract