Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer
Copyright © 2023 Massachusetts Medical Society..
BACKGROUND: In a previous phase 3 trial, treatment with trifluridine-tipiracil (FTD-TPI) prolonged overall survival among patients with metastatic colorectal cancer. Preliminary data from single-group and randomized phase 2 trials suggest that treatment with FTD-TPI in addition to bevacizumab has the potential to extend survival.
METHODS: We randomly assigned, in a 1:1 ratio, adult patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer to receive FTD-TPI plus bevacizumab (combination group) or FTD-TPI alone (FTD-TPI group). The primary end point was overall survival. Secondary end points were progression-free survival and safety, including the time to worsening of the Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 or 1 to 2 or more (on a scale from 0 to 5, with higher scores indicating greater disability).
RESULTS: A total of 246 patients were assigned to each group. The median overall survival was 10.8 months in the combination group and 7.5 months in the FTD-TPI group (hazard ratio for death, 0.61; 95% confidence interval [CI], 0.49 to 0.77; P<0.001). The median progression-free survival was 5.6 months in the combination group and 2.4 months in the FTD-TPI group (hazard ratio for disease progression or death, 0.44; 95% CI, 0.36 to 0.54; P<0.001). The most common adverse events in both groups were neutropenia, nausea, and anemia. No treatment-related deaths were reported. The median time to worsening of the ECOG performance-status score from 0 or 1 to 2 or more was 9.3 months in the combination group and 6.3 months in the FTD-TPI group (hazard ratio, 0.54; 95% CI, 0.43 to 0.67).
CONCLUSIONS: Among patients with refractory metastatic colorectal cancer, treatment with FTD-TPI plus bevacizumab resulted in longer overall survival than FTD-TPI alone. (Funded by Servier and Taiho Oncology; SUNLIGHT ClinicalTrials.gov number, NCT04737187; EudraCT number, 2020-001976-14.).
Errataetall: |
CommentIn: Nat Rev Clin Oncol. 2023 Aug;20(8):504. - PMID 37198414 |
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Medienart: |
E-Artikel |
Erscheinungsjahr: |
2023 |
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Erschienen: |
2023 |
Enthalten in: |
Zur Gesamtaufnahme - volume:388 |
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Enthalten in: |
The New England journal of medicine - 388(2023), 18 vom: 04. Mai, Seite 1657-1667 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Prager, Gerald W [VerfasserIn] |
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Links: |
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Themen: |
2S9ZZM9Q9V |
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Date Completed 08.05.2023 Date Revised 26.07.2023 published: Print ClinicalTrials.gov: NCT04737187 EudraCT: 2020-001976-14 CommentIn: Nat Rev Clin Oncol. 2023 Aug;20(8):504. - PMID 37198414 Citation Status MEDLINE |
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doi: |
10.1056/NEJMoa2214963 |
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funding: |
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PPN (Katalog-ID): |
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500 | |a CommentIn: Nat Rev Clin Oncol. 2023 Aug;20(8):504. - PMID 37198414 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a Copyright © 2023 Massachusetts Medical Society. | ||
520 | |a BACKGROUND: In a previous phase 3 trial, treatment with trifluridine-tipiracil (FTD-TPI) prolonged overall survival among patients with metastatic colorectal cancer. Preliminary data from single-group and randomized phase 2 trials suggest that treatment with FTD-TPI in addition to bevacizumab has the potential to extend survival | ||
520 | |a METHODS: We randomly assigned, in a 1:1 ratio, adult patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer to receive FTD-TPI plus bevacizumab (combination group) or FTD-TPI alone (FTD-TPI group). The primary end point was overall survival. Secondary end points were progression-free survival and safety, including the time to worsening of the Eastern Cooperative Oncology Group (ECOG) performance-status score from 0 or 1 to 2 or more (on a scale from 0 to 5, with higher scores indicating greater disability) | ||
520 | |a RESULTS: A total of 246 patients were assigned to each group. The median overall survival was 10.8 months in the combination group and 7.5 months in the FTD-TPI group (hazard ratio for death, 0.61; 95% confidence interval [CI], 0.49 to 0.77; P<0.001). The median progression-free survival was 5.6 months in the combination group and 2.4 months in the FTD-TPI group (hazard ratio for disease progression or death, 0.44; 95% CI, 0.36 to 0.54; P<0.001). The most common adverse events in both groups were neutropenia, nausea, and anemia. No treatment-related deaths were reported. The median time to worsening of the ECOG performance-status score from 0 or 1 to 2 or more was 9.3 months in the combination group and 6.3 months in the FTD-TPI group (hazard ratio, 0.54; 95% CI, 0.43 to 0.67) | ||
520 | |a CONCLUSIONS: Among patients with refractory metastatic colorectal cancer, treatment with FTD-TPI plus bevacizumab resulted in longer overall survival than FTD-TPI alone. (Funded by Servier and Taiho Oncology; SUNLIGHT ClinicalTrials.gov number, NCT04737187; EudraCT number, 2020-001976-14.) | ||
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700 | 1 | |a Gruenberger, Birgit |e investigator |4 oth | |
700 | 1 | |a Popper, Ulrich |e investigator |4 oth | |
700 | 1 | |a Prager, Gerald |e investigator |4 oth | |
700 | 1 | |a Winder, Thomas |e investigator |4 oth | |
700 | 1 | |a Hendrickx, Koen |e investigator |4 oth | |
700 | 1 | |a Houbiers, Ghislain |e investigator |4 oth | |
700 | 1 | |a Lybaert, Willem |e investigator |4 oth | |
700 | 1 | |a Peeters, Marc |e investigator |4 oth | |
700 | 1 | |a Van Custem, Eric |e investigator |4 oth | |
700 | 1 | |a Abdalla, Káthia Cristina |e investigator |4 oth | |
700 | 1 | |a Campos Bragagnoli, Arinilda |e investigator |4 oth | |
700 | 1 | |a Carmagani Pestana, Roberto |e investigator |4 oth | |
700 | 1 | |a Cruz, Felipe José Silva Melo |e investigator |4 oth | |
700 | 1 | |a Spina Donadio, Mauro Daniel |e investigator |4 oth | |
700 | 1 | |a Fernandes, Gustavo Dos Santos |e investigator |4 oth | |
700 | 1 | |a Moniz, Camila Motta Venchiarutti |e investigator |4 oth | |
700 | 1 | |a Liposits, Gabor Istvan |e investigator |4 oth | |
700 | 1 | |a Olesen, Rene |e investigator |4 oth | |
700 | 1 | |a Petersen, Lone Nørgård |e investigator |4 oth | |
700 | 1 | |a Pfeiffer, Per |e investigator |4 oth | |
700 | 1 | |a Borg, Christophe |e investigator |4 oth | |
700 | 1 | |a Boussion, Helene |e investigator |4 oth | |
700 | 1 | |a Galais, Marie-Pierre |e investigator |4 oth | |
700 | 1 | |a Poureau, Pierre-Guillaume |e investigator |4 oth | |
700 | 1 | |a Taieb, Julien |e investigator |4 oth | |
700 | 1 | |a Tougeron, David |e investigator |4 oth | |
700 | 1 | |a Heinemann, Volker |e investigator |4 oth | |
700 | 1 | |a Kisro, Jens |e investigator |4 oth | |
700 | 1 | |a Modest, Dominik Paul |e investigator |4 oth | |
700 | 1 | |a Schwaner, Ingo |e investigator |4 oth | |
700 | 1 | |a Arkosy, Péter |e investigator |4 oth | |
700 | 1 | |a Bodoky, György |e investigator |4 oth | |
700 | 1 | |a Csejtei, András |e investigator |4 oth | |
700 | 1 | |a Csöszi, Tibor |e investigator |4 oth | |
700 | 1 | |a Horvath, Zsolt |e investigator |4 oth | |
700 | 1 | |a Nagy, Zoltan |e investigator |4 oth | |
700 | 1 | |a Olah, Judith |e investigator |4 oth | |
700 | 1 | |a Pápai, Zsuzsanna |e investigator |4 oth | |
700 | 1 | |a Sipöcz, István |e investigator |4 oth | |
700 | 1 | |a Avallone, Antonio |e investigator |4 oth | |
700 | 1 | |a Banzi, Maria |e investigator |4 oth | |
700 | 1 | |a Bilancia, Domenico |e investigator |4 oth | |
700 | 1 | |a Ciardiello, Fortunato |e investigator |4 oth | |
700 | 1 | |a Cremolini, Chiara |e investigator |4 oth | |
700 | 1 | |a Lonardi, Sara |e investigator |4 oth | |
700 | 1 | |a Maiello, Evaristo |e investigator |4 oth | |
700 | 1 | |a Personeni, Nicola |e investigator |4 oth | |
700 | 1 | |a Scartozzi, Mario |e investigator |4 oth | |
700 | 1 | |a Duchnowska, Renata |e investigator |4 oth | |
700 | 1 | |a Itrych, Bartosz |e investigator |4 oth | |
700 | 1 | |a Karaszewska, Bogusława |e investigator |4 oth | |
700 | 1 | |a Radecka, Barbara |e investigator |4 oth | |
700 | 1 | |a Rogowski, Wojciech |e investigator |4 oth | |
700 | 1 | |a Wyrwicz, Lucjan |e investigator |4 oth | |
700 | 1 | |a Wysocki, Piotr |e investigator |4 oth | |
700 | 1 | |a Fedyanin, Mikhail |e investigator |4 oth | |
700 | 1 | |a Kirtbaya, Dmitry |e investigator |4 oth | |
700 | 1 | |a Kislov, Nikolay |e investigator |4 oth | |
700 | 1 | |a Kopp, Mikhail |e investigator |4 oth | |
700 | 1 | |a Lebedeva, Ludmila |e investigator |4 oth | |
700 | 1 | |a Ledin, Evgeny |e investigator |4 oth | |
700 | 1 | |a Makarova, Yulia |e investigator |4 oth | |
700 | 1 | |a Moiseenko, Fedor |e investigator |4 oth | |
700 | 1 | |a Orlova, Rashida |e investigator |4 oth | |
700 | 1 | |a Radyukova, Irina |e investigator |4 oth | |
700 | 1 | |a Semiglazova, Tatiana |e investigator |4 oth | |
700 | 1 | |a Stroyakovskyi, Daniil |e investigator |4 oth | |
700 | 1 | |a Tjulandin, Sergei A |e investigator |4 oth | |
700 | 1 | |a Élez, Elena |e investigator |4 oth | |
700 | 1 | |a Ferreiro-Monteagudo, Reyes |e investigator |4 oth | |
700 | 1 | |a Grávalos-Castro, Cristina |e investigator |4 oth | |
700 | 1 | |a Polo-Marqués, Eduardo |e investigator |4 oth | |
700 | 1 | |a Pachón Olmos, Vanessa |e investigator |4 oth | |
700 | 1 | |a Ortiz-Morales, María José |e investigator |4 oth | |
700 | 1 | |a Rivera, Fernando |e investigator |4 oth | |
700 | 1 | |a Safont, María José |e investigator |4 oth | |
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700 | 1 | |a Shparyk, Yaroslav |e investigator |4 oth | |
700 | 1 | |a Bekaii-Saab, Tanios S |e investigator |4 oth | |
700 | 1 | |a Birhiray, Ruemu E |e investigator |4 oth | |
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