LONsurf and G-CSF Use: Being On A Right Dose-intensity to Optimize Treatment Efficacy

  • participants needed
  • sponsor
    GERCOR - Multidisciplinary Oncology Cooperative Group
Updated on 11 August 2022
ct scan
growth factor
neutrophil count
liver metastasis
chemotherapy regimen
vascular endothelial growth factor
colorectal adenocarcinoma


Prospective cohort of patients treated with trifluridine/tipiracil, maximal sample size 250 patients. It is expected, that 89 patients will experience a grade 3-4 neutropenia and will be included in the phase II.


Trifluridine/tipiracil has demonstrated its efficacy in patients with metastatic colorectal cancer (mCRC) resistant to standard drugs (fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and panitumumab or cetuximab in case of RAS wild-type tumors). This treatment has a marketing authorization.

Neutropenia is a classic complication of cytotoxic treatments. Febrile neutropenia are associated with a mortality rate of 9.5% and a hospitalization of 6 days in median. Recent meta-analyses have reported that the use of granulocyte-colony stimulating factor (GCSF) allows to maintain the dose-intensity of cytotoxic treatment and was associated with a better overall survival (OS).

There is currently no clear recommendation for the use of G-CSF with trifluridine/tipiracil.

Unpublished analyses that various clinical parameters may be associated with the risk of neutropenia: age 65 years, female sex, level of leukocytes at baseline, and time of initial diagnostic to randomization 36 months.These data are too preliminary to allow proposing a G-CSF primary prophylaxis in a defined subgroup of patients. However, a secondary prophylaxis based on the administration of G-CSF seems efficient, with a prescription from day 14 to day 18.

The aim of this phase II study is to assess the efficacy of the secondary prophylaxis with G-CSF in case of first episode of grade 3-4 neutropenia in the aim to maintain the optimal dose intensity.

Condition Metastatic Colorectal Cancer
Treatment Trifluridine/Tipiracil
Clinical Study IdentifierNCT04166604
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last Modified on11 August 2022

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