TY - JOUR
T1 - Feasibility and effectiveness of trifluridine/tipiracil in metastatic colorectal cancer
T2 - real-life data from The Netherlands
AU - Kwakman, Johannes J M
AU - Vink, G.R.
AU - Vestjens, J.H.M.J.
AU - Beerepoot, Laurens V.
AU - de Groot, J. W.
AU - Jansen, R. L.
AU - Opdam, F.L.
AU - Boot, H.
AU - Creemers, G.J.
AU - van Rooijen, J.J.M.
AU - Los, M.
AU - Vulink, A. J.E.
AU - Schut, Menno H.
AU - van Meerten, Esther
AU - Baars, A.
AU - Hamberg, Paul
AU - Kapiteijn, Ellen
AU - Sommeijer, D W
AU - Punt, C. J A
AU - Koopman, M.
N1 - Funding Information:
Conflict of interest C.J.A.P. has acted in an advisory role for Servier and Nordic Pharma. J.J.M.K. has received an unrestricted research grant from Servier. All other authors have declared no conflicts of interest.
Publisher Copyright:
© 2017, The Author(s).
PY - 2018/6
Y1 - 2018/6
N2 - Background: The RECOURSE trial showed clinical efficacy for trifluridine/tipiracil for refractory metastatic colorectal cancer patients. We assessed the feasibility and effectiveness of trifluridine/tipiracil in daily clinical practice in The Netherlands. Methods: Medical records of patients from 17 centers treated in the trifluridine/tipiracil compassionate use program were reviewed and checked for RECOURSE eligibility criteria. Baseline characteristics, safety, and survival times were compared, and prespecified baseline characteristics were tested in multivariate analyses for prognostic significance on overall survival (OS). Results: A total of 136 patients with a median age of 62 years were analyzed. Forty-three patients (32%) did not meet the RECOURSE eligibility criteria for not having received all prior standard treatments (n = 35, 26%) and/or ECOG performance status (PS) 2 (n = 12, 9%). The most common grade ≥3 toxicities were neutropenia (n = 44, 32%), leukopenia (n = 8, 6%), anemia (n = 7, 5%), and fatigue (n = 7, 5%). Median progression-free survival (PFS) and median OS were 2.1 (95% CI, 1.8–2.3) and 5.4 months (95% CI, 4.0–6.9), respectively. Patients with ECOG PS 2 had a worse median OS (3.2 months) compared to patients with ECOG PS 0–1 (5.9 months). ECOG PS, KRAS-mutation status, white blood cell count, serum lactate dehydrogenase, and alkaline phosphatase were prognostic factors for OS. Conclusions: Our data show that treatment with trifluridine/tipiracil in daily clinical practice is feasible and safe. Differences in patient characteristics between our population and the RECOURSE study population should be taken into account in the interpretation of survival data. Our results argue against the use of trifluridine/tipiracil in patients with ECOG PS 2. Funding: Johannes J.M. Kwakman received an unrestricted research grant from Servier.
AB - Background: The RECOURSE trial showed clinical efficacy for trifluridine/tipiracil for refractory metastatic colorectal cancer patients. We assessed the feasibility and effectiveness of trifluridine/tipiracil in daily clinical practice in The Netherlands. Methods: Medical records of patients from 17 centers treated in the trifluridine/tipiracil compassionate use program were reviewed and checked for RECOURSE eligibility criteria. Baseline characteristics, safety, and survival times were compared, and prespecified baseline characteristics were tested in multivariate analyses for prognostic significance on overall survival (OS). Results: A total of 136 patients with a median age of 62 years were analyzed. Forty-three patients (32%) did not meet the RECOURSE eligibility criteria for not having received all prior standard treatments (n = 35, 26%) and/or ECOG performance status (PS) 2 (n = 12, 9%). The most common grade ≥3 toxicities were neutropenia (n = 44, 32%), leukopenia (n = 8, 6%), anemia (n = 7, 5%), and fatigue (n = 7, 5%). Median progression-free survival (PFS) and median OS were 2.1 (95% CI, 1.8–2.3) and 5.4 months (95% CI, 4.0–6.9), respectively. Patients with ECOG PS 2 had a worse median OS (3.2 months) compared to patients with ECOG PS 0–1 (5.9 months). ECOG PS, KRAS-mutation status, white blood cell count, serum lactate dehydrogenase, and alkaline phosphatase were prognostic factors for OS. Conclusions: Our data show that treatment with trifluridine/tipiracil in daily clinical practice is feasible and safe. Differences in patient characteristics between our population and the RECOURSE study population should be taken into account in the interpretation of survival data. Our results argue against the use of trifluridine/tipiracil in patients with ECOG PS 2. Funding: Johannes J.M. Kwakman received an unrestricted research grant from Servier.
KW - Compassionate use
KW - Feasibility
KW - Metastatic colorectal cancer
KW - TAS-102
KW - Trifluridine/tipiracil
KW - Prognosis
KW - Humans
KW - Middle Aged
KW - Male
KW - Treatment Outcome
KW - Uracil/adverse effects
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Trifluridine/adverse effects
KW - Colorectal Neoplasms/drug therapy
KW - Neutropenia/chemically induced
KW - Leukopenia/chemically induced
KW - Disease-Free Survival
KW - Netherlands
KW - Aged, 80 and over
KW - Adult
KW - Female
KW - Aged
KW - Drug Combinations
UR - http://www.scopus.com/inward/record.url?scp=85036543483&partnerID=8YFLogxK
U2 - 10.1007/s10147-017-1220-0
DO - 10.1007/s10147-017-1220-0
M3 - Article
C2 - 29204933
AN - SCOPUS:85036543483
SN - 1341-9625
VL - 23
SP - 482
EP - 489
JO - International Journal of Clinical Oncology
JF - International Journal of Clinical Oncology
IS - 3
ER -