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dc.contributor.authorVan Cutsem, E
dc.contributor.authorDanielewicz, I
dc.contributor.authorSaunders, Mark P
dc.contributor.authorPfeiffer, P
dc.contributor.authorArgiles, G
dc.contributor.authorBorg, C
dc.contributor.authorGlynne-Jones, R
dc.contributor.authorPunt, CJA
dc.contributor.authorVan de Wouw, AJ
dc.contributor.authorFedyanin, M
dc.contributor.authorStroyakovskiy, D
dc.contributor.authorKroening, H
dc.contributor.authorGarcia-Alfonso, P
dc.contributor.authorWasan, H
dc.contributor.authorFalcone, A
dc.contributor.authorKanehisa, A
dc.contributor.authorEgorov, A
dc.contributor.authorAubel, P
dc.contributor.authorAmellal, N
dc.contributor.authorMoiseenko, V
dc.date.accessioned2020-08-10T08:09:16Z
dc.date.available2020-08-10T08:09:16Z
dc.date.issued2020en
dc.identifier.citationVan Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argiles G, Borg C, et al. Trifluridine/Tipiracil plus Bevacizumab in Patients with Untreated Metastatic Colorectal Cancer Ineligible for Intensive Therapy: the Randomized TASCO1 Study. Ann Oncol. 2020.en
dc.identifier.pmid32497736en
dc.identifier.doi10.1016/j.annonc.2020.05.024en
dc.identifier.urihttp://hdl.handle.net/10541/623069
dc.description.abstractPurpose: We designed an open-label, non-comparative phase II study to assess the safety and efficacy of first-line treatment with trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B) in untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies. Patients and methods: From 29 April 2016 to 29 March 2017, 153 patients were randomly assigned (1:1) to either TT-B (n=77) or C-B (n=76). The primary endpoint was progression-free survival (PFS). The primary PFS analysis was performed after 100 events (radiological progression or death) were observed. Secondary endpoints included overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires) and safety. Results: Median duration of treatment was 7.8 [6.0;9.7] months and 6.2 [4.1;9.1] months in the TT-B and C-B groups, respectively. Median PFS was 9.2 [7.6;11.6] and 7.8 [5.5;10.1] months, respectively. Median OS was 18 [15.2;NA] and 16.2 [12.5;NA] months, respectively. QoL questionnaires showed no relevant changes over time for either treatment. Therapies were well tolerated. Patients receiving TT-B had more grade ?3 neutropenia (47% vs. 5% with C-B). Patients receiving C-B had more grade ?3 hand-foot syndrome (12% vs. 0% with TT-B) and grade ?3 diarrhea (8% vs. 1% with TT-B), consistent with the known safety profiles of these agents. Conclusion: TT-B treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL. Keywords: TASCO1 study; Trifluridine/tipiracil; bevacizumab; capecitabine; intensive therapy; metastatic colorectal cancer.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2020.05.024en
dc.titleTrifluridine/Tipiracil plus Bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 studyen
dc.typeArticleen
dc.contributor.departmentUniversity Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.en
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2020-08-12T09:43:15Z


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