Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)
© 2023. The Author(s)..
BACKGROUND: In the phase III TAGS trial, trifluridine/tipiracil showed survival benefit versus placebo in patients with metastatic gastric/gastroesophageal junction cancer and ≥ 2 prior chemotherapies. This post hoc exploratory analysis assessed the impact of prior therapy type on outcomes.
METHODS: Based on prior treatment, patients in TAGS (N = 507) were categorized into overlapping subgroups: ramucirumab ± other agents (n = 169), no ramucirumab (n = 338), paclitaxel but no ramucirumab (n = 136), ramucirumab + paclitaxel sequentially or in combination (n = 154), neither paclitaxel nor ramucirumab (n = 202), irinotecan (n = 281), and no irinotecan (n = 226). Overall and progression-free survival, time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2, and safety were assessed.
RESULTS: Baseline characteristics and prior therapy patterns were generally well balanced between trifluridine/tipiracil and placebo arms across subgroups. Trifluridine/tipiracil was associated with survival benefits versus placebo regardless of prior treatment: across subgroups, median overall survival was 4.6-6.1 versus 3.0-3.8 months (hazard ratios, 0.47-0.88), median progression-free survival was 1.9-2.3 versus 1.7-1.8 months (hazard ratios, 0.49-0.67), and median time to ECOG PS ≥ 2 was 4.0-4.7 versus 1.9-2.5 months (hazard ratios, 0.56-0.88). Among trifluridine/tipiracil-randomized patients, median overall and progression-free survival trended longer in those who had not received ramucirumab, paclitaxel and ramucirumab, or irinotecan (6.0-6.1 and 2.1-2.3 months, respectively) than in those who previously received these agents (4.6-5.7 and 1.9 months). The trifluridine/tipiracil safety profile was consistent across subgroups, with similar overall incidences of grade ≥ 3 adverse events. Minor variations in hematologic toxicities were noted.
CONCLUSIONS: In TAGS, third- or later-line trifluridine/tipiracil treatment demonstrated overall and progression-free survival and functioning benefits versus placebo and a consistent safety profile in patients with metastatic gastric/gastroesophageal junction cancer, regardless of prior treatment type.
CLINICAL TRIALS REGISTRATION: clinicaltrials.gov NCT02500043.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:149 |
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| Enthalten in: |
Journal of cancer research and clinical oncology - 149(2023), 11 vom: 22. Sept., Seite 9361-9374 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Shitara, Kohei [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 01.08.2023 Date Revised 01.08.2023 published: Print-Electronic ClinicalTrials.gov: NCT02500043 Citation Status MEDLINE |
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| doi: |
10.1007/s00432-023-04813-z |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM357155068 |
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| 100 | 1 | |a Shitara, Kohei |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS) |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 01.08.2023 | ||
| 500 | |a Date Revised 01.08.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02500043 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a BACKGROUND: In the phase III TAGS trial, trifluridine/tipiracil showed survival benefit versus placebo in patients with metastatic gastric/gastroesophageal junction cancer and ≥ 2 prior chemotherapies. This post hoc exploratory analysis assessed the impact of prior therapy type on outcomes | ||
| 520 | |a METHODS: Based on prior treatment, patients in TAGS (N = 507) were categorized into overlapping subgroups: ramucirumab ± other agents (n = 169), no ramucirumab (n = 338), paclitaxel but no ramucirumab (n = 136), ramucirumab + paclitaxel sequentially or in combination (n = 154), neither paclitaxel nor ramucirumab (n = 202), irinotecan (n = 281), and no irinotecan (n = 226). Overall and progression-free survival, time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2, and safety were assessed | ||
| 520 | |a RESULTS: Baseline characteristics and prior therapy patterns were generally well balanced between trifluridine/tipiracil and placebo arms across subgroups. Trifluridine/tipiracil was associated with survival benefits versus placebo regardless of prior treatment: across subgroups, median overall survival was 4.6-6.1 versus 3.0-3.8 months (hazard ratios, 0.47-0.88), median progression-free survival was 1.9-2.3 versus 1.7-1.8 months (hazard ratios, 0.49-0.67), and median time to ECOG PS ≥ 2 was 4.0-4.7 versus 1.9-2.5 months (hazard ratios, 0.56-0.88). Among trifluridine/tipiracil-randomized patients, median overall and progression-free survival trended longer in those who had not received ramucirumab, paclitaxel and ramucirumab, or irinotecan (6.0-6.1 and 2.1-2.3 months, respectively) than in those who previously received these agents (4.6-5.7 and 1.9 months). The trifluridine/tipiracil safety profile was consistent across subgroups, with similar overall incidences of grade ≥ 3 adverse events. Minor variations in hematologic toxicities were noted | ||
| 520 | |a CONCLUSIONS: In TAGS, third- or later-line trifluridine/tipiracil treatment demonstrated overall and progression-free survival and functioning benefits versus placebo and a consistent safety profile in patients with metastatic gastric/gastroesophageal junction cancer, regardless of prior treatment type | ||
| 520 | |a CLINICAL TRIALS REGISTRATION: clinicaltrials.gov NCT02500043 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Antineoplastic protocols | |
| 650 | 4 | |a Gastric cancer | |
| 650 | 4 | |a Gastroesophageal junction cancer | |
| 650 | 4 | |a Third- or later-line therapy | |
| 650 | 4 | |a Trifluridine tipiracil | |
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| 650 | 7 | |a Irinotecan |2 NLM | |
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| 650 | 7 | |a Paclitaxel |2 NLM | |
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| 650 | 7 | |a tipiracil |2 NLM | |
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| 650 | 7 | |a Trifluridine |2 NLM | |
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| 700 | 1 | |a George, Ben |e verfasserin |4 aut | |
| 700 | 1 | |a Taieb, Julien |e verfasserin |4 aut | |
| 700 | 1 | |a Sundar, Raghav |e verfasserin |4 aut | |
| 700 | 1 | |a Fakih, Marwan G |e verfasserin |4 aut | |
| 700 | 1 | |a Makris, Lukas |e verfasserin |4 aut | |
| 700 | 1 | |a Benhadji, Karim A |e verfasserin |4 aut | |
| 700 | 1 | |a Ghidini, Michele |e verfasserin |4 aut | |
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