Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: a multicenter study
Aim To compare survival outcomes, response rates, and adverse events (AEs) in proton pump inhibitor (PPI) user and non-user patients with metastatic colorectal cancer (mCRC) treated with regorafenib. Methods We included 272 patients with mCRC treated with regorafenib in this study. Patients were div...
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Veröffentlicht in: | European journal of clinical pharmacology 2022-12, Vol.78 (12), p.1973-1979 |
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container_end_page | 1979 |
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container_issue | 12 |
container_start_page | 1973 |
container_title | European journal of clinical pharmacology |
container_volume | 78 |
creator | Yekedüz, Emre Özbay, Mehmet Fatih Çağlayan, Dilek Yıldırım, Atila Erol, Cihan Yıldırım, Hasan Çağrı Tunç, Sezai Özyurt, Neslihan Özdemir, Feyyaz Şendur, Mehmet Ali Nahit Işıkdoğan, Abdurrahman Kılıçkap, Saadettin Ürün, Yüksel Yalçın, Şuayib Artaç, Mehmet Coşkun, Hasan Şenol Utkan, Güngör |
description | Aim
To compare survival outcomes, response rates, and adverse events (AEs) in proton pump inhibitor (PPI) user and non-user patients with metastatic colorectal cancer (mCRC) treated with regorafenib.
Methods
We included 272 patients with mCRC treated with regorafenib in this study. Patients were divided into two categories according to their status of PPI use. The primary endpoint was overall survival (OS). The secondary endpoints were time to treatment failure (TTF), response rates, and safety. To exclude immortal time bias in survival analyses, we compared PPI non-user patients and all patients.
Results
There were 141 and 131 patients in the PPI non-user and user groups. Baseline characteristics were similar in each group. Pantoprazole was the most used PPI. At the median 35.2 (95% confidence interval (CI): 32.6–37.9) months follow-up, the median OS was similar in PPI non-user and all patients (6.9 months (95% CI: 5.3–8.5) and 7.7 months (95% CI:6.6–8.8),
p
= 0.913). TTF was also similar in PPI non-user and all patients (3.3 months (95% CI: 2.7–3.9) and 3.5 months (95% CI: 3.0–4.0),
p
= 0.661). In multivariable analysis, no statistically significant difference was observed between PPI user and non-user groups in OS and TTF (hazard ratio (HR), 0.99; 95% CI, 0.77–1.28;
p
= 0.963 for OS; HR, 0.93; 0.77–1.20,
p
= 0.598 for TTF). The objective response rates (ORR) were similar in the PPI non-user and user groups (19.8% and 16.8%,
p
= 0.455). The rates of any grade AEs were also similar in each group.
Conclusion
This study found no worse outcome in the combined use of PPI and regorafenib among patients with mCRC. |
doi_str_mv | 10.1007/s00228-022-03403-1 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2727643628</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2727643628</sourcerecordid><originalsourceid>FETCH-LOGICAL-c352t-7427e51447908ceb2f52be071be8e006c3f08e9185be58bc684f3ce65691f52c3</originalsourceid><addsrcrecordid>eNp9kc1q3TAQhUVJIDdJXyArQTfZOB392JazC5cmLQS6addCVsaJgi25kkzJY_SNO-kNFLroZiRmvnM04jB2IeBKAPQfC4CUpqHSgNKgGvGO7YRWshGgxRHbASjRdEMPJ-y0lGcA0Q6gduzXfg4xeDfztFWfFiw8TdynSPdQXax8K_jaWnOqKfJ1W1Ye4lMYQ025cBcfeMbHlN2EMYw04qurAWMt_GeoT3zB6kqllifXOWX0lR7zLnrM19zxZZtpRjxmXur28HLOjic3F3z_dp6x77efvu0_N_df777sb-4br1pZm17LHluhdT-A8TjKqZUjQi9GNAjQeTWBwUGYdsTWjL4zelIeu7YbBKFenbHLgy_97MeGpdolFI_z7CKmrVjZy77TqpOG0A__oM9py5G2I0ppQwtBS5Q8UD6nUjJOds1hcfnFCrCvKdlDSpaK_ZOSFSRSB1EhOD5i_mv9H9VvR-mXag</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2734835205</pqid></control><display><type>article</type><title>Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: a multicenter study</title><source>SpringerLink Journals - AutoHoldings</source><creator>Yekedüz, Emre ; Özbay, Mehmet Fatih ; Çağlayan, Dilek ; Yıldırım, Atila ; Erol, Cihan ; Yıldırım, Hasan Çağrı ; Tunç, Sezai ; Özyurt, Neslihan ; Özdemir, Feyyaz ; Şendur, Mehmet Ali Nahit ; Işıkdoğan, Abdurrahman ; Kılıçkap, Saadettin ; Ürün, Yüksel ; Yalçın, Şuayib ; Artaç, Mehmet ; Coşkun, Hasan Şenol ; Utkan, Güngör</creator><creatorcontrib>Yekedüz, Emre ; Özbay, Mehmet Fatih ; Çağlayan, Dilek ; Yıldırım, Atila ; Erol, Cihan ; Yıldırım, Hasan Çağrı ; Tunç, Sezai ; Özyurt, Neslihan ; Özdemir, Feyyaz ; Şendur, Mehmet Ali Nahit ; Işıkdoğan, Abdurrahman ; Kılıçkap, Saadettin ; Ürün, Yüksel ; Yalçın, Şuayib ; Artaç, Mehmet ; Coşkun, Hasan Şenol ; Utkan, Güngör</creatorcontrib><description>Aim
To compare survival outcomes, response rates, and adverse events (AEs) in proton pump inhibitor (PPI) user and non-user patients with metastatic colorectal cancer (mCRC) treated with regorafenib.
Methods
We included 272 patients with mCRC treated with regorafenib in this study. Patients were divided into two categories according to their status of PPI use. The primary endpoint was overall survival (OS). The secondary endpoints were time to treatment failure (TTF), response rates, and safety. To exclude immortal time bias in survival analyses, we compared PPI non-user patients and all patients.
Results
There were 141 and 131 patients in the PPI non-user and user groups. Baseline characteristics were similar in each group. Pantoprazole was the most used PPI. At the median 35.2 (95% confidence interval (CI): 32.6–37.9) months follow-up, the median OS was similar in PPI non-user and all patients (6.9 months (95% CI: 5.3–8.5) and 7.7 months (95% CI:6.6–8.8),
p
= 0.913). TTF was also similar in PPI non-user and all patients (3.3 months (95% CI: 2.7–3.9) and 3.5 months (95% CI: 3.0–4.0),
p
= 0.661). In multivariable analysis, no statistically significant difference was observed between PPI user and non-user groups in OS and TTF (hazard ratio (HR), 0.99; 95% CI, 0.77–1.28;
p
= 0.963 for OS; HR, 0.93; 0.77–1.20,
p
= 0.598 for TTF). The objective response rates (ORR) were similar in the PPI non-user and user groups (19.8% and 16.8%,
p
= 0.455). The rates of any grade AEs were also similar in each group.
Conclusion
This study found no worse outcome in the combined use of PPI and regorafenib among patients with mCRC.</description><identifier>ISSN: 0031-6970</identifier><identifier>EISSN: 1432-1041</identifier><identifier>DOI: 10.1007/s00228-022-03403-1</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Biomedical and Life Sciences ; Biomedicine ; Clinical outcomes ; Colorectal cancer ; Colorectal carcinoma ; Inhibitor drugs ; Metastases ; Metastasis ; Patients ; Pharmacology/Toxicology ; Proton pump inhibitors ; Response rates ; Statistical analysis ; Survival ; Targeted cancer therapy ; User groups</subject><ispartof>European journal of clinical pharmacology, 2022-12, Vol.78 (12), p.1973-1979</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2022. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c352t-7427e51447908ceb2f52be071be8e006c3f08e9185be58bc684f3ce65691f52c3</citedby><cites>FETCH-LOGICAL-c352t-7427e51447908ceb2f52be071be8e006c3f08e9185be58bc684f3ce65691f52c3</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/s00228-022-03403-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00228-022-03403-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids></links><search><creatorcontrib>Yekedüz, Emre</creatorcontrib><creatorcontrib>Özbay, Mehmet Fatih</creatorcontrib><creatorcontrib>Çağlayan, Dilek</creatorcontrib><creatorcontrib>Yıldırım, Atila</creatorcontrib><creatorcontrib>Erol, Cihan</creatorcontrib><creatorcontrib>Yıldırım, Hasan Çağrı</creatorcontrib><creatorcontrib>Tunç, Sezai</creatorcontrib><creatorcontrib>Özyurt, Neslihan</creatorcontrib><creatorcontrib>Özdemir, Feyyaz</creatorcontrib><creatorcontrib>Şendur, Mehmet Ali Nahit</creatorcontrib><creatorcontrib>Işıkdoğan, Abdurrahman</creatorcontrib><creatorcontrib>Kılıçkap, Saadettin</creatorcontrib><creatorcontrib>Ürün, Yüksel</creatorcontrib><creatorcontrib>Yalçın, Şuayib</creatorcontrib><creatorcontrib>Artaç, Mehmet</creatorcontrib><creatorcontrib>Coşkun, Hasan Şenol</creatorcontrib><creatorcontrib>Utkan, Güngör</creatorcontrib><title>Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: a multicenter study</title><title>European journal of clinical pharmacology</title><addtitle>Eur J Clin Pharmacol</addtitle><description>Aim
To compare survival outcomes, response rates, and adverse events (AEs) in proton pump inhibitor (PPI) user and non-user patients with metastatic colorectal cancer (mCRC) treated with regorafenib.
Methods
We included 272 patients with mCRC treated with regorafenib in this study. Patients were divided into two categories according to their status of PPI use. The primary endpoint was overall survival (OS). The secondary endpoints were time to treatment failure (TTF), response rates, and safety. To exclude immortal time bias in survival analyses, we compared PPI non-user patients and all patients.
Results
There were 141 and 131 patients in the PPI non-user and user groups. Baseline characteristics were similar in each group. Pantoprazole was the most used PPI. At the median 35.2 (95% confidence interval (CI): 32.6–37.9) months follow-up, the median OS was similar in PPI non-user and all patients (6.9 months (95% CI: 5.3–8.5) and 7.7 months (95% CI:6.6–8.8),
p
= 0.913). TTF was also similar in PPI non-user and all patients (3.3 months (95% CI: 2.7–3.9) and 3.5 months (95% CI: 3.0–4.0),
p
= 0.661). In multivariable analysis, no statistically significant difference was observed between PPI user and non-user groups in OS and TTF (hazard ratio (HR), 0.99; 95% CI, 0.77–1.28;
p
= 0.963 for OS; HR, 0.93; 0.77–1.20,
p
= 0.598 for TTF). The objective response rates (ORR) were similar in the PPI non-user and user groups (19.8% and 16.8%,
p
= 0.455). The rates of any grade AEs were also similar in each group.
Conclusion
This study found no worse outcome in the combined use of PPI and regorafenib among patients with mCRC.</description><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Clinical outcomes</subject><subject>Colorectal cancer</subject><subject>Colorectal carcinoma</subject><subject>Inhibitor drugs</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Proton pump inhibitors</subject><subject>Response rates</subject><subject>Statistical analysis</subject><subject>Survival</subject><subject>Targeted cancer therapy</subject><subject>User groups</subject><issn>0031-6970</issn><issn>1432-1041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp9kc1q3TAQhUVJIDdJXyArQTfZOB392JazC5cmLQS6addCVsaJgi25kkzJY_SNO-kNFLroZiRmvnM04jB2IeBKAPQfC4CUpqHSgNKgGvGO7YRWshGgxRHbASjRdEMPJ-y0lGcA0Q6gduzXfg4xeDfztFWfFiw8TdynSPdQXax8K_jaWnOqKfJ1W1Ye4lMYQ025cBcfeMbHlN2EMYw04qurAWMt_GeoT3zB6kqllifXOWX0lR7zLnrM19zxZZtpRjxmXur28HLOjic3F3z_dp6x77efvu0_N_df777sb-4br1pZm17LHluhdT-A8TjKqZUjQi9GNAjQeTWBwUGYdsTWjL4zelIeu7YbBKFenbHLgy_97MeGpdolFI_z7CKmrVjZy77TqpOG0A__oM9py5G2I0ppQwtBS5Q8UD6nUjJOds1hcfnFCrCvKdlDSpaK_ZOSFSRSB1EhOD5i_mv9H9VvR-mXag</recordid><startdate>20221201</startdate><enddate>20221201</enddate><creator>Yekedüz, Emre</creator><creator>Özbay, Mehmet Fatih</creator><creator>Çağlayan, Dilek</creator><creator>Yıldırım, Atila</creator><creator>Erol, Cihan</creator><creator>Yıldırım, Hasan Çağrı</creator><creator>Tunç, Sezai</creator><creator>Özyurt, Neslihan</creator><creator>Özdemir, Feyyaz</creator><creator>Şendur, Mehmet Ali Nahit</creator><creator>Işıkdoğan, Abdurrahman</creator><creator>Kılıçkap, Saadettin</creator><creator>Ürün, Yüksel</creator><creator>Yalçın, Şuayib</creator><creator>Artaç, Mehmet</creator><creator>Coşkun, Hasan Şenol</creator><creator>Utkan, Güngör</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20221201</creationdate><title>Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: a multicenter study</title><author>Yekedüz, Emre ; Özbay, Mehmet Fatih ; Çağlayan, Dilek ; Yıldırım, Atila ; Erol, Cihan ; Yıldırım, Hasan Çağrı ; Tunç, Sezai ; Özyurt, Neslihan ; Özdemir, Feyyaz ; Şendur, Mehmet Ali Nahit ; Işıkdoğan, Abdurrahman ; Kılıçkap, Saadettin ; Ürün, Yüksel ; Yalçın, Şuayib ; Artaç, Mehmet ; Coşkun, Hasan Şenol ; Utkan, Güngör</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c352t-7427e51447908ceb2f52be071be8e006c3f08e9185be58bc684f3ce65691f52c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Clinical outcomes</topic><topic>Colorectal cancer</topic><topic>Colorectal carcinoma</topic><topic>Inhibitor drugs</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Patients</topic><topic>Pharmacology/Toxicology</topic><topic>Proton pump inhibitors</topic><topic>Response rates</topic><topic>Statistical analysis</topic><topic>Survival</topic><topic>Targeted cancer therapy</topic><topic>User groups</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yekedüz, Emre</creatorcontrib><creatorcontrib>Özbay, Mehmet Fatih</creatorcontrib><creatorcontrib>Çağlayan, Dilek</creatorcontrib><creatorcontrib>Yıldırım, Atila</creatorcontrib><creatorcontrib>Erol, Cihan</creatorcontrib><creatorcontrib>Yıldırım, Hasan Çağrı</creatorcontrib><creatorcontrib>Tunç, Sezai</creatorcontrib><creatorcontrib>Özyurt, Neslihan</creatorcontrib><creatorcontrib>Özdemir, Feyyaz</creatorcontrib><creatorcontrib>Şendur, Mehmet Ali Nahit</creatorcontrib><creatorcontrib>Işıkdoğan, Abdurrahman</creatorcontrib><creatorcontrib>Kılıçkap, Saadettin</creatorcontrib><creatorcontrib>Ürün, Yüksel</creatorcontrib><creatorcontrib>Yalçın, Şuayib</creatorcontrib><creatorcontrib>Artaç, Mehmet</creatorcontrib><creatorcontrib>Coşkun, Hasan Şenol</creatorcontrib><creatorcontrib>Utkan, Güngör</creatorcontrib><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS 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>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</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>MEDLINE - Academic</collection><jtitle>European journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yekedüz, Emre</au><au>Özbay, Mehmet Fatih</au><au>Çağlayan, Dilek</au><au>Yıldırım, Atila</au><au>Erol, Cihan</au><au>Yıldırım, Hasan Çağrı</au><au>Tunç, Sezai</au><au>Özyurt, Neslihan</au><au>Özdemir, Feyyaz</au><au>Şendur, Mehmet Ali Nahit</au><au>Işıkdoğan, Abdurrahman</au><au>Kılıçkap, Saadettin</au><au>Ürün, Yüksel</au><au>Yalçın, Şuayib</au><au>Artaç, Mehmet</au><au>Coşkun, Hasan Şenol</au><au>Utkan, Güngör</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: a multicenter study</atitle><jtitle>European journal of clinical pharmacology</jtitle><stitle>Eur J Clin Pharmacol</stitle><date>2022-12-01</date><risdate>2022</risdate><volume>78</volume><issue>12</issue><spage>1973</spage><epage>1979</epage><pages>1973-1979</pages><issn>0031-6970</issn><eissn>1432-1041</eissn><abstract>Aim
To compare survival outcomes, response rates, and adverse events (AEs) in proton pump inhibitor (PPI) user and non-user patients with metastatic colorectal cancer (mCRC) treated with regorafenib.
Methods
We included 272 patients with mCRC treated with regorafenib in this study. Patients were divided into two categories according to their status of PPI use. The primary endpoint was overall survival (OS). The secondary endpoints were time to treatment failure (TTF), response rates, and safety. To exclude immortal time bias in survival analyses, we compared PPI non-user patients and all patients.
Results
There were 141 and 131 patients in the PPI non-user and user groups. Baseline characteristics were similar in each group. Pantoprazole was the most used PPI. At the median 35.2 (95% confidence interval (CI): 32.6–37.9) months follow-up, the median OS was similar in PPI non-user and all patients (6.9 months (95% CI: 5.3–8.5) and 7.7 months (95% CI:6.6–8.8),
p
= 0.913). TTF was also similar in PPI non-user and all patients (3.3 months (95% CI: 2.7–3.9) and 3.5 months (95% CI: 3.0–4.0),
p
= 0.661). In multivariable analysis, no statistically significant difference was observed between PPI user and non-user groups in OS and TTF (hazard ratio (HR), 0.99; 95% CI, 0.77–1.28;
p
= 0.963 for OS; HR, 0.93; 0.77–1.20,
p
= 0.598 for TTF). The objective response rates (ORR) were similar in the PPI non-user and user groups (19.8% and 16.8%,
p
= 0.455). The rates of any grade AEs were also similar in each group.
Conclusion
This study found no worse outcome in the combined use of PPI and regorafenib among patients with mCRC.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><doi>10.1007/s00228-022-03403-1</doi><tpages>7</tpages></addata></record> |
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subjects | Biomedical and Life Sciences Biomedicine Clinical outcomes Colorectal cancer Colorectal carcinoma Inhibitor drugs Metastases Metastasis Patients Pharmacology/Toxicology Proton pump inhibitors Response rates Statistical analysis Survival Targeted cancer therapy User groups |
title | Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: a multicenter study |
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