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 B...
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| Veröffentlicht in: | Journal of cancer research and clinical oncology 2023-09, Vol.149 (11), p.9361-9374 |
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| creator | Shitara, Kohei George, Ben Taieb, Julien Sundar, Raghav Fakih, Marwan G. Makris, Lukas Benhadji, Karim A. Ghidini, Michele |
| description | 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. |
| doi_str_mv | 10.1007/s00432-023-04813-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10374776</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2817776635</sourcerecordid><originalsourceid>FETCH-LOGICAL-c508t-ccc8352ea9d09fe30cf5c267d2d381c68b6b0a3e50a28b4db4e039afd640cae53</originalsourceid><addsrcrecordid>eNqFkk1v1DAQhiMEokvhD3BAlri0h7Djj3zsCVVVW1aqxIFythxnsutVYgfbKWJ_FL8Rp7uUjwOcxh4_875je7LsNYV3FKBaBgDBWQ6M5yBqyvP9k2xB5xTlvHiaLYBWNC8YLU-yFyHsIO2Lij3PTnjFKAcOi-z7VdehjoG4jozeOE_iFr0aDaaUJW6K2g1p_dXELYnedP3kTWssLqMZjVfa9MRYMqpo0MYjN2BUIaaUJpu08EYvH6LD4Mat2qDqyW6yOppkoZXV6GcRRbyyrRvMHluSuIBkvV7Prok_u7u4-XT-MnvWqT7gq2M8zT5fX91dfshvP96sLy9uc11AHXOtdc0LhmrVwqpDDrorNCurlrW8prqsm7IBxbEAxepGtI1A4CvVtaUArbDgp9n7g-44NQO2Ot3Nq16mFxqU_yadMvLPE2u2cuPuJQVeiaoqk8LZUcG7LxOGKAcTNPa9suimIDkIEAKq9Hv_Q1lNqyRZ8rmvt3-hOzd5m54iUYKVK8FWIlHsQGnvQvDYPTZOQc6jIw-jI5O5fBgduU9Fb36_8mPJz1lJAD8AIR3ZDfpf3v-Q_QGWPdQS</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2842694294</pqid></control><display><type>article</type><title>Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Shitara, Kohei ; George, Ben ; Taieb, Julien ; Sundar, Raghav ; Fakih, Marwan G. ; Makris, Lukas ; Benhadji, Karim A. ; Ghidini, Michele</creator><creatorcontrib>Shitara, Kohei ; George, Ben ; Taieb, Julien ; Sundar, Raghav ; Fakih, Marwan G. ; Makris, Lukas ; Benhadji, Karim A. ; Ghidini, Michele</creatorcontrib><description>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.</description><identifier>ISSN: 0171-5216</identifier><identifier>ISSN: 1432-1335</identifier><identifier>EISSN: 1432-1335</identifier><identifier>DOI: 10.1007/s00432-023-04813-z</identifier><identifier>PMID: 37213030</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antiviral drugs ; Cancer ; Cancer Research ; Clinical trials ; Colorectal Neoplasms - pathology ; Drug Combinations ; Esophagogastric Junction - pathology ; Gastric cancer ; Hematology ; Humans ; Internal Medicine ; Irinotecan ; Irinotecan - therapeutic use ; Medicine ; Medicine & Public Health ; Metastases ; Metastasis ; Oncology ; Paclitaxel ; Paclitaxel - therapeutic use ; Patients ; Placebos ; Pyrrolidines ; Safety ; Stomach Neoplasms - drug therapy ; Survival ; therapeutics ; Trifluridine - therapeutic use</subject><ispartof>Journal of cancer research and clinical oncology, 2023-09, Vol.149 (11), p.9361-9374</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><rights>The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c508t-ccc8352ea9d09fe30cf5c267d2d381c68b6b0a3e50a28b4db4e039afd640cae53</citedby><cites>FETCH-LOGICAL-c508t-ccc8352ea9d09fe30cf5c267d2d381c68b6b0a3e50a28b4db4e039afd640cae53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00432-023-04813-z$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00432-023-04813-z$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37213030$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shitara, Kohei</creatorcontrib><creatorcontrib>George, Ben</creatorcontrib><creatorcontrib>Taieb, Julien</creatorcontrib><creatorcontrib>Sundar, Raghav</creatorcontrib><creatorcontrib>Fakih, Marwan G.</creatorcontrib><creatorcontrib>Makris, Lukas</creatorcontrib><creatorcontrib>Benhadji, Karim A.</creatorcontrib><creatorcontrib>Ghidini, Michele</creatorcontrib><title>Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)</title><title>Journal of cancer research and clinical oncology</title><addtitle>J Cancer Res Clin Oncol</addtitle><addtitle>J Cancer Res Clin Oncol</addtitle><description>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.</description><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antiviral drugs</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Clinical trials</subject><subject>Colorectal Neoplasms - pathology</subject><subject>Drug Combinations</subject><subject>Esophagogastric Junction - pathology</subject><subject>Gastric cancer</subject><subject>Hematology</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Irinotecan</subject><subject>Irinotecan - therapeutic use</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Oncology</subject><subject>Paclitaxel</subject><subject>Paclitaxel - therapeutic use</subject><subject>Patients</subject><subject>Placebos</subject><subject>Pyrrolidines</subject><subject>Safety</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Survival</subject><subject>therapeutics</subject><subject>Trifluridine - therapeutic use</subject><issn>0171-5216</issn><issn>1432-1335</issn><issn>1432-1335</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkk1v1DAQhiMEokvhD3BAlri0h7Djj3zsCVVVW1aqxIFythxnsutVYgfbKWJ_FL8Rp7uUjwOcxh4_875je7LsNYV3FKBaBgDBWQ6M5yBqyvP9k2xB5xTlvHiaLYBWNC8YLU-yFyHsIO2Lij3PTnjFKAcOi-z7VdehjoG4jozeOE_iFr0aDaaUJW6K2g1p_dXELYnedP3kTWssLqMZjVfa9MRYMqpo0MYjN2BUIaaUJpu08EYvH6LD4Mat2qDqyW6yOppkoZXV6GcRRbyyrRvMHluSuIBkvV7Prok_u7u4-XT-MnvWqT7gq2M8zT5fX91dfshvP96sLy9uc11AHXOtdc0LhmrVwqpDDrorNCurlrW8prqsm7IBxbEAxepGtI1A4CvVtaUArbDgp9n7g-44NQO2Ot3Nq16mFxqU_yadMvLPE2u2cuPuJQVeiaoqk8LZUcG7LxOGKAcTNPa9suimIDkIEAKq9Hv_Q1lNqyRZ8rmvt3-hOzd5m54iUYKVK8FWIlHsQGnvQvDYPTZOQc6jIw-jI5O5fBgduU9Fb36_8mPJz1lJAD8AIR3ZDfpf3v-Q_QGWPdQS</recordid><startdate>20230901</startdate><enddate>20230901</enddate><creator>Shitara, Kohei</creator><creator>George, Ben</creator><creator>Taieb, Julien</creator><creator>Sundar, Raghav</creator><creator>Fakih, Marwan G.</creator><creator>Makris, Lukas</creator><creator>Benhadji, Karim A.</creator><creator>Ghidini, Michele</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>7S9</scope><scope>L.6</scope><scope>5PM</scope></search><sort><creationdate>20230901</creationdate><title>Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)</title><author>Shitara, Kohei ; George, Ben ; Taieb, Julien ; Sundar, Raghav ; Fakih, Marwan G. ; Makris, Lukas ; Benhadji, Karim A. ; Ghidini, Michele</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c508t-ccc8352ea9d09fe30cf5c267d2d381c68b6b0a3e50a28b4db4e039afd640cae53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antiviral drugs</topic><topic>Cancer</topic><topic>Cancer Research</topic><topic>Clinical trials</topic><topic>Colorectal Neoplasms - pathology</topic><topic>Drug Combinations</topic><topic>Esophagogastric Junction - pathology</topic><topic>Gastric cancer</topic><topic>Hematology</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Irinotecan</topic><topic>Irinotecan - therapeutic use</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Oncology</topic><topic>Paclitaxel</topic><topic>Paclitaxel - therapeutic use</topic><topic>Patients</topic><topic>Placebos</topic><topic>Pyrrolidines</topic><topic>Safety</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Survival</topic><topic>therapeutics</topic><topic>Trifluridine - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shitara, Kohei</creatorcontrib><creatorcontrib>George, Ben</creatorcontrib><creatorcontrib>Taieb, Julien</creatorcontrib><creatorcontrib>Sundar, Raghav</creatorcontrib><creatorcontrib>Fakih, Marwan G.</creatorcontrib><creatorcontrib>Makris, Lukas</creatorcontrib><creatorcontrib>Benhadji, Karim A.</creatorcontrib><creatorcontrib>Ghidini, Michele</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>AGRICOLA</collection><collection>AGRICOLA - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of cancer research and clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shitara, Kohei</au><au>George, Ben</au><au>Taieb, Julien</au><au>Sundar, Raghav</au><au>Fakih, Marwan G.</au><au>Makris, Lukas</au><au>Benhadji, Karim A.</au><au>Ghidini, Michele</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS)</atitle><jtitle>Journal of cancer research and clinical oncology</jtitle><stitle>J Cancer Res Clin Oncol</stitle><addtitle>J Cancer Res Clin Oncol</addtitle><date>2023-09-01</date><risdate>2023</risdate><volume>149</volume><issue>11</issue><spage>9361</spage><epage>9374</epage><pages>9361-9374</pages><issn>0171-5216</issn><issn>1432-1335</issn><eissn>1432-1335</eissn><abstract>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.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>37213030</pmid><doi>10.1007/s00432-023-04813-z</doi><tpages>14</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0171-5216 |
| ispartof | Journal of cancer research and clinical oncology, 2023-09, Vol.149 (11), p.9361-9374 |
| issn | 0171-5216 1432-1335 1432-1335 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10374776 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Antineoplastic Combined Chemotherapy Protocols - adverse effects Antiviral drugs Cancer Cancer Research Clinical trials Colorectal Neoplasms - pathology Drug Combinations Esophagogastric Junction - pathology Gastric cancer Hematology Humans Internal Medicine Irinotecan Irinotecan - therapeutic use Medicine Medicine & Public Health Metastases Metastasis Oncology Paclitaxel Paclitaxel - therapeutic use Patients Placebos Pyrrolidines Safety Stomach Neoplasms - drug therapy Survival therapeutics Trifluridine - therapeutic use |
| title | Effects of prior therapies on outcomes with trifluridine/tipiracil in patients with metastatic gastric/gastroesophageal junction cancer in a randomized phase III trial (TAGS) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-21T20%3A43%3A23IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effects%20of%20prior%20therapies%20on%20outcomes%20with%20trifluridine/tipiracil%20in%20patients%20with%20metastatic%20gastric/gastroesophageal%20junction%20cancer%20in%20a%20randomized%20phase%20III%20trial%20(TAGS)&rft.jtitle=Journal%20of%20cancer%20research%20and%20clinical%20oncology&rft.au=Shitara,%20Kohei&rft.date=2023-09-01&rft.volume=149&rft.issue=11&rft.spage=9361&rft.epage=9374&rft.pages=9361-9374&rft.issn=0171-5216&rft.eissn=1432-1335&rft_id=info:doi/10.1007/s00432-023-04813-z&rft_dat=%3Cproquest_pubme%3E2817776635%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2842694294&rft_id=info:pmid/37213030&rfr_iscdi=true |