Effectiveness, safety and quality of life of trifluridine/tipiracil in pretreated patients with metastatic colorectal cancer: Real-world data from the noninterventional TACTIC study in Germany.
Humans
Quality of Life
Uracil
/ adverse effects
Colorectal Neoplasms
/ pathology
Prospective Studies
Trifluridine
/ adverse effects
Frontotemporal Dementia
/ chemically induced
Pyrrolidines
/ adverse effects
Colonic Neoplasms
/ drug therapy
Rectal Neoplasms
/ drug therapy
Drug Combinations
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
metastatic colorectal cancer
real-world data
trifluridine/tipiracil
Journal
International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124
Informations de publication
Date de publication:
15 09 2023
15 09 2023
Historique:
revised:
03
03
2023
received:
25
11
2022
accepted:
10
03
2023
medline:
21
7
2023
pubmed:
1
6
2023
entrez:
1
6
2023
Statut:
ppublish
Résumé
The prospective, multicenter, noninterventional TACTIC study assessed effectiveness and safety of trifluridine/tipiracil (FTD/TPI) in patients with metastatic colorectal cancer (mCRC) in a real-world setting in Germany, thus evaluating the external validity of the findings from the pivotal RECOURSE trial. Primary endpoint was overall survival (OS). Secondary objectives included progression-free survival (PFS), safety, and quality of life (QoL). Subgroups comprised patients with good (<3 metastatic sites at inclusion, ≥18 months from diagnosis of first metastasis to inclusion) or poor (remaining patients) prognostic characteristics (GPC/PPC). GPC without liver metastases was considered best prognostic characteristics (BPC). In total, 307 eligible patients (pretreated or not suitable for other available therapies) were treated with FTD/TPI. Overall, median [95%-CI] OS was 7.4 months [6.4-8.6], median PFS was 2.9 months [2.8-3.3]. In BPC (n = 65) and GPC (n = 176) compared to PPC (n = 124) subgroup, median OS (13.3 [9.1-17.6] vs 8.9 [7.6-9.8] vs 5.1 [4.4-7.0] months) and median PFS (4.0 [3.3-5.3] vs 3.4 [3.0-3.7] vs 2.6 [2.4-2.8] months) were longer. Patient-reported QoL, assessed by validated questionnaires (EQ-5D-5L, PRO-CTCAE), was stable throughout FTD/TPI treatment. Predominant FTD/TPI-related adverse events of grades 3 or 4 were neutropenia (13.0%), leukopenia (7.5%), and anemia (5.2%). Altogether, palliative FTD/TPI therapy in patients with pretreated mCRC was associated with prolonged survival, delayed progression, maintained health-related QoL, and manageable toxicity. Low metastatic burden and indolent disease were favorable prognostic factors for survival. TACTIC confirms the effectiveness and safety of FTD/TPI, highlighting its value in routine clinical practice.
Substances chimiques
tipiracil
NGO10K751P
Uracil
56HH86ZVCT
Trifluridine
RMW9V5RW38
Pyrrolidines
0
Drug Combinations
0
Banques de données
ClinicalTrials.gov
['NCT03665506']
Types de publication
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1227-1240Informations de copyright
© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.
Références
Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71:209-249.
Cervantes A, Adam R, Roselló S, et al. Metastatic colorectal cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2022;34:10-32.
Martini G, Troiani T, Cardone C, et al. Present and future of metastatic colorectal cancer treatment: a review of new candidate targets. World J Gastroenterol. 2017;23:4675-4688.
Vogel A, Hofheinz RD, Kubicka S, Arnold D. Treatment decisions in metastatic colorectal cancer-beyond first and second line combination therapies. Cancer Treat Rev. 2017;59:54-60.
Lonsurf-epar-product-information_en.pdf [Internet]. Accessed February 4, 2022. https://www.ema.europa.eu/en/documents/product-information/lonsurf-epar-product-information_en.pdf
Arnold D, Prager GW, Quintela A, et al. Beyond second-line therapy in patients with metastatic colorectal cancer: a systematic review. Ann Oncol. 2018;29:835-856.
Yoshino T, Mizunuma N, Yamazaki K, et al. TAS-102 monotherapy for pretreated metastatic colorectal cancer: a double-blind, randomised, placebo-controlled phase 2 trial. Lancet Oncol. 2012;13:993-1001.
Xu J, Kim TW, Shen L, et al. Results of a randomized, double-blind, placebo-controlled, phase III trial of trifluridine/tipiracil (TAS-102) monotherapy in Asian patients with previously treated metastatic colorectal cancer: the TERRA study. JCO. 2018;36:350-358.
Van Cutsem E, Mayer RJ, Laurent S, et al. The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer. Eur J Cancer. 2018;90:63-72.
Mayer RJ, Van Cutsem E, Falcone A, et al. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372:1909-1919.
Tabernero J, Argiles G, Sobrero AF, et al. Effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors at baseline: an exploratory analysis. ESMO Open. 2020;5:e000752.
Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727-1736.
Hagelstein V, Ortland I, Wilmer A, Mitchell SA, Jaehde U. Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™). Ann Oncol. 2016;27:2294-2299.
Multicenter study to evaluate the impact of eHealth monitoring on overall survival in patients with metastatic non-squamous NSCLC or extensive-stage SCLC or advanced TNBC under first-line treatment with atezolizumab in combination with chemotherapy (CHAPLIN) [Internet]. Accessed November 2022. https://www.pei.de/SharedDocs/Downloads/DE/awb/nis-0401-0500/0475-abschlussb.pdf?__blob=publicationFile&v=1
EuroQol Group. EQ-5D-5L User Guide.
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Internet]. Accessed February 7, 2022. https://healthcaredelivery.cancer.gov/pro-ctcae/
Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and reliability of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). JAMA Oncol. 2015;1:1051-1059.
Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
Chen P, Lin K-C, Liing R-J, Wu C-Y, Chen C-L, Chang K-C. Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation. Qual Life Res. 2016;25:1585-1596.
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Published November 27, 2017. U.S. Department of Health and Human Services. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
Kotani D, Kuboki Y, Horasawa S, et al. Retrospective cohort study of trifluridine/tipiracil (TAS-102) plus bevacizumab versus trifluridine/tipiracil monotherapy for metastatic colorectal cancer. BMC Cancer. 2019;19:1253.
Fernandez Montes A, Vazquez Rivera F, Martinez Lago N, et al. Efficacy and safety of trifluridine/tipiracil in third-line and beyond for the treatment of patients with metastatic colorectal cancer in routine clinical practice: patterns of use and prognostic nomogram. Clin Transl Oncol. 2020;22:351-359.
Andersen SE, Andersen IB, Jensen BV, Pfeiffer P, Ota T, Larsen JS. A systematic review of observational studies of trifluridine/tipiracil (TAS-102) for metastatic colorectal cancer. Acta Oncol. 2019;58:1149-1157.
Tabernero J, Taieb J, Prager GW, et al. Trifluridine/tipiracil plus bevacizumab for third-line management of metastatic colorectal cancer: SUNLIGHT study design. Future Oncol. 2021;17:1977-1985.
Prager GW, Taieb J, Fakih M, et al. Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer. N Engl J Med. 2023;388:1657-1667.
García-Alfonso P, Muñoz A, Jiménez-Castro J, et al. Early clinical experience with trifluridine/tipiracil for refractory metastatic colorectal cancer: the ROS study. Cancers (Basel). 2021;13:4514.
Fernández Montes A, Carmona-Bayonas A, Jimenez-Fonseca P, et al. Prediction of survival in patients with advanced, refractory colorectal cancer in treatment with trifluridine/tipiracil: real-world vs clinical trial data. Sci Rep. 2021;11:14321.
Weiss L, Karthaus M, Riera-Knorrenschild J, et al. Efficacy, safety and quality-of-life data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: results of the TALLISUR trial. ESMO Open. 2022;7:100391.
Bachet J-B, Wyrwicz L, Price T, et al. Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study. ESMO Open. 2020;5:e000698.
Cheung WY, Kavan P, Dolley A. Quality of life in a real-world study of patients with metastatic colorectal cancer treated with trifluridine/tipiracil. Curr Oncol. 2020;27:e451-e458.