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Unpublished analyses that various clinical parameters may be associated with the risk of neutropenia: age 65 years, female sex, level of leukocytes at baseline, and time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 Identifier | NCT04166604 |
| Sponsor | GERCOR - Multidisciplinary Oncology Cooperative Group |
| Last Modified on | 25 June 2022 |
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