Details der Publikation - Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)

Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)

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

Erscheinungsjahr:	2023
Erschienen:	2023

Enthalten in:	Zur Gesamtaufnahme - volume:149
Enthalten in:	Journal of cancer research and clinical oncology - 149(2023), 11 vom: 22. Mai, Seite 9361-9374

Sprache:	Englisch

Beteiligte Personen:	Shitara, Kohei [VerfasserIn] George, Ben [VerfasserIn] Taieb, Julien [VerfasserIn] Sundar, Raghav [VerfasserIn] Fakih, Marwan G. [VerfasserIn] Makris, Lukas [VerfasserIn] Benhadji, Karim A. [VerfasserIn] Ghidini, Michele [VerfasserIn]

Links:	Volltext [kostenfrei]

BKL:	44.81$jOnkologie
Themen:	Antineoplastic protocols Gastric cancer Gastroesophageal junction cancer Third- or later-line therapy Trifluridine tipiracil

RVK:	RVK Klassifikation ELIB24

Anmerkungen:	© The Author(s) 2023

doi:	10.1007/s00432-023-04813-z

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	OLC2144704848

Internformat


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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. 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.
650		4	\|a Gastric cancer
650		4	\|a Gastroesophageal junction cancer
650		4	\|a Trifluridine tipiracil
650		4	\|a Antineoplastic protocols
650		4	\|a Third- or later-line therapy
700	1		\|a George, Ben \|4 aut
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700	1		\|a Sundar, Raghav \|4 aut
700	1		\|a Fakih, Marwan G. \|4 aut
700	1		\|a Makris, Lukas \|4 aut
700	1		\|a Benhadji, Karim A. \|4 aut
700	1		\|a Ghidini, Michele \|4 aut
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Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)

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