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
3317 - Circulating tumor DNA (ctDNA) analysis in patients (pts) with non-small cell lung cancer (NSCLC) treated with telisotuzumab vedotin (teliso-v), an antibody-drug conjugate targeting c-Met
Presenter: Rebecca Heist
Session: Poster Display session 1
Resources:
Abstract
3887 - First Real Life Data on Durvalumab after definitive concomitant ChemoRadiotherapy (cCRT) in unresectable Stage (St) III Non-Small Cell Lung Cancer (NSCLC) in France: Analysis of 591 patients (pts) enrolled in the French cohort (c) Temporary Authorization of Use (ATU)
Presenter: Virginie Avrillon
Session: Poster Display session 1
Resources:
Abstract
682 - EGFR Inhibitor Versus Chemotherapy as Adjuvant Treatment for Locally-advanced EGFR-mutant Non-Small Cell Lung Cancer
Presenter: Peng Xie
Session: Poster Display session 1
Resources:
Abstract
2509 - Afatinib in EGFR TKI-naïve patients with EGFR mutation-positive (EGFRm+) NSCLC: interim analysis of a Phase IIIb, multi-national, open-label study
Presenter: Filippo de Marinis
Session: Poster Display session 1
Resources:
Abstract
3300 - First-line ceritinib versus chemotherapy in patients (pts) with advanced ALK rearranged (ALK+) non-small cell lung cancer (NSCLC): ASCEND-4 Asian subgroup analysis
Presenter: Daniel SW Tan
Session: Poster Display session 1
Resources:
Abstract
2653 - A combined analysis of two Phase IIIb studies of afatinib in EGFR TKI-naïve patients (pts) with EGFR mutation-positive (EGFRm+) NSCLC
Presenter: Filippo de Marinis
Session: Poster Display session 1
Resources:
Abstract
3663 - Impact of plasma EGFR mutation fractions on response to first generation tyrosine-kinase inhibitor in treatment of naïve non-small cell lung cancer patients
Presenter: Xiaohong Wang
Session: Poster Display session 1
Resources:
Abstract
5921 - Definition of an afatinib trough concentration threshold in the treatment of NSCLC
Presenter: Stephane Bouchet
Session: Poster Display session 1
Resources:
Abstract
2852 - A Phase Ib Trial of Neoadjuvant Chemoradiotherapy and Durvalumab(MEDI4736) for Potentially Resectable stage III Non-Small Cell Lung Cancer (NSCLC)
Presenter: Beung chul AHN
Session: Poster Display session 1
Resources:
Abstract
3273 - Low expression of Notch1 and combined Notch1/HES1 are associated with adverse survival factor for limited stage small cell lung cancer
Presenter: Jinsoo Lee
Session: Poster Display session 1
Resources:
Abstract