Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial
Capecitabine plus oxaliplatin (XELOX) has shown modest activity and tolerable toxicity in a phase II trial for biliary tract cancers (BTCs). Meanwhile, gemcitabine plus oxaliplatin (GEMOX) has been the reference arm in recent phase II and III trials for BTCs. We aimed to investigate the efficacy of...
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| Veröffentlicht in: | Annals of oncology 2019-05, Vol.30 (5), p.788-795 |
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| creator | Kim, S.T. Kang, J.H. Lee, J. Lee, H.W. Oh, S.Y. Jang, J.S. Lee, M.A. Sohn, B.S. Yoon, S.Y. Choi, H.J. Hong, J.H. Kim, M.-J. Kim, S. Park, Y.S. Park, J.O. Lim, H.Y. |
| description | Capecitabine plus oxaliplatin (XELOX) has shown modest activity and tolerable toxicity in a phase II trial for biliary tract cancers (BTCs). Meanwhile, gemcitabine plus oxaliplatin (GEMOX) has been the reference arm in recent phase II and III trials for BTCs. We aimed to investigate the efficacy of XELOX versus GEMOX as first-line therapy for advanced BCTs.
In this open-label, randomized, phase III, noninferiority trial, we randomly selected patients with metastatic BCTs to receive GEMOX (gemcitabine 1000mg/m2 on days 1 and 8, and oxaliplatin 100mg/m2 on day 1) or XELOX (capecitabine 1000mg/m2, twice daily, on days 1–14 and oxaliplatin 130mg/m2 on day 1) as first-line treatment, given every 3weeks, totaling eight cycles. The primary end point was to prove the noninferiority of XELOX to GEMOX in terms of 6-month progression-free survival (PFS) rate.
In total, 114 patients randomly received GEMOX and 108 randomly received XELOX. The median PFS was 5.3months for the GEMOX group and 5.8months for the XELOX group. The 6-month PFS rate was 44.5% for the GEMOX group and 46.7% for the XELOX group. The 95% confidence interval of the 6-month PFS rate difference between both groups was −12% to 16%, meeting the criteria for noninferiority of XELOX to GEMOX. There was no difference in objective response (P=0.171) and median overall survival (P=0.131) between both groups. The most common grade three to four adverse events were neutropenia and thrombocytopenia. No patient died of treatment-related causes. The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P |
| doi_str_mv | 10.1093/annonc/mdz058 |
| format | Article |
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In this open-label, randomized, phase III, noninferiority trial, we randomly selected patients with metastatic BCTs to receive GEMOX (gemcitabine 1000mg/m2 on days 1 and 8, and oxaliplatin 100mg/m2 on day 1) or XELOX (capecitabine 1000mg/m2, twice daily, on days 1–14 and oxaliplatin 130mg/m2 on day 1) as first-line treatment, given every 3weeks, totaling eight cycles. The primary end point was to prove the noninferiority of XELOX to GEMOX in terms of 6-month progression-free survival (PFS) rate.
In total, 114 patients randomly received GEMOX and 108 randomly received XELOX. The median PFS was 5.3months for the GEMOX group and 5.8months for the XELOX group. The 6-month PFS rate was 44.5% for the GEMOX group and 46.7% for the XELOX group. The 95% confidence interval of the 6-month PFS rate difference between both groups was −12% to 16%, meeting the criteria for noninferiority of XELOX to GEMOX. There was no difference in objective response (P=0.171) and median overall survival (P=0.131) between both groups. The most common grade three to four adverse events were neutropenia and thrombocytopenia. No patient died of treatment-related causes. The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001).
XELOX showed significant noninferiority to GEMOX in terms of 6-month PFS rate. Thus, XELOX could be an alternative first-line treatment of BCTs.
This study was registered in ClinicalTrials.gov (number NCT01470443).</description><identifier>ISSN: 0923-7534</identifier><identifier>EISSN: 1569-8041</identifier><identifier>DOI: 10.1093/annonc/mdz058</identifier><identifier>PMID: 30785198</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; biliary tract cancer ; Biliary Tract Neoplasms - drug therapy ; Biliary Tract Neoplasms - pathology ; capecitabine ; Capecitabine - administration & dosage ; Capecitabine - adverse effects ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Female ; Gemcitabine ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - pathology ; Neoplasm Staging ; oxaliplatin ; Oxaliplatin - administration & dosage ; Oxaliplatin - adverse effects ; Progression-Free Survival ; Survival Rate</subject><ispartof>Annals of oncology, 2019-05, Vol.30 (5), p.788-795</ispartof><rights>2019 THE AUTHORS</rights><rights>The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com. 2019</rights><rights>The Author(s) 2019. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c479t-a3be992b8de3d087f7a2221d5a8afe269bc5eccc1228eec158c27a8f914df2e03</citedby><cites>FETCH-LOGICAL-c479t-a3be992b8de3d087f7a2221d5a8afe269bc5eccc1228eec158c27a8f914df2e03</cites><orcidid>0000-0001-6502-2612</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30785198$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, S.T.</creatorcontrib><creatorcontrib>Kang, J.H.</creatorcontrib><creatorcontrib>Lee, J.</creatorcontrib><creatorcontrib>Lee, H.W.</creatorcontrib><creatorcontrib>Oh, S.Y.</creatorcontrib><creatorcontrib>Jang, J.S.</creatorcontrib><creatorcontrib>Lee, M.A.</creatorcontrib><creatorcontrib>Sohn, B.S.</creatorcontrib><creatorcontrib>Yoon, S.Y.</creatorcontrib><creatorcontrib>Choi, H.J.</creatorcontrib><creatorcontrib>Hong, J.H.</creatorcontrib><creatorcontrib>Kim, M.-J.</creatorcontrib><creatorcontrib>Kim, S.</creatorcontrib><creatorcontrib>Park, Y.S.</creatorcontrib><creatorcontrib>Park, J.O.</creatorcontrib><creatorcontrib>Lim, H.Y.</creatorcontrib><title>Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial</title><title>Annals of oncology</title><addtitle>Ann Oncol</addtitle><description>Capecitabine plus oxaliplatin (XELOX) has shown modest activity and tolerable toxicity in a phase II trial for biliary tract cancers (BTCs). Meanwhile, gemcitabine plus oxaliplatin (GEMOX) has been the reference arm in recent phase II and III trials for BTCs. We aimed to investigate the efficacy of XELOX versus GEMOX as first-line therapy for advanced BCTs.
In this open-label, randomized, phase III, noninferiority trial, we randomly selected patients with metastatic BCTs to receive GEMOX (gemcitabine 1000mg/m2 on days 1 and 8, and oxaliplatin 100mg/m2 on day 1) or XELOX (capecitabine 1000mg/m2, twice daily, on days 1–14 and oxaliplatin 130mg/m2 on day 1) as first-line treatment, given every 3weeks, totaling eight cycles. The primary end point was to prove the noninferiority of XELOX to GEMOX in terms of 6-month progression-free survival (PFS) rate.
In total, 114 patients randomly received GEMOX and 108 randomly received XELOX. The median PFS was 5.3months for the GEMOX group and 5.8months for the XELOX group. The 6-month PFS rate was 44.5% for the GEMOX group and 46.7% for the XELOX group. The 95% confidence interval of the 6-month PFS rate difference between both groups was −12% to 16%, meeting the criteria for noninferiority of XELOX to GEMOX. There was no difference in objective response (P=0.171) and median overall survival (P=0.131) between both groups. The most common grade three to four adverse events were neutropenia and thrombocytopenia. No patient died of treatment-related causes. The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001).
XELOX showed significant noninferiority to GEMOX in terms of 6-month PFS rate. Thus, XELOX could be an alternative first-line treatment of BCTs.
This study was registered in ClinicalTrials.gov (number NCT01470443).</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>biliary tract cancer</subject><subject>Biliary Tract Neoplasms - drug therapy</subject><subject>Biliary Tract Neoplasms - pathology</subject><subject>capecitabine</subject><subject>Capecitabine - administration & dosage</subject><subject>Capecitabine - adverse effects</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Female</subject><subject>Gemcitabine</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis</subject><subject>Neoplasm Recurrence, Local - drug therapy</subject><subject>Neoplasm Recurrence, Local - pathology</subject><subject>Neoplasm Staging</subject><subject>oxaliplatin</subject><subject>Oxaliplatin - administration & dosage</subject><subject>Oxaliplatin - adverse effects</subject><subject>Progression-Free Survival</subject><subject>Survival Rate</subject><issn>0923-7534</issn><issn>1569-8041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUFv1DAQhS0EotvCkSvykcOG2s5mY3NDK6ArVeIC52hij6mRY1u2d0X78_hlTRTgVnEaaeabJ733CHnD2XvOVHsNIcSgryfzwDr5jGx4t1eNZDv-nGyYEm3Td-3uglyW8pMxtldCvSQXLetlx5XckN8HSKhdhdEFpMmfCo2_wLvkobpAz5jLvPqB09MMFGpdLrXxy7neYYZ0T23MFMwZgkZDR-cd5HtaM-hK9bLM5QMFOp18dRpDxbylMWFoPIzotzRDMHFyD2i2NN1BQXo8Hrd09uqCxexidnXRc-BfkRcWfMHXf-YV-f7507fDTXP79cvx8PG20bte1QbaEZUSozTYGiZ724MQgpsOJFgUezXqDrXWXAiJqHkntehBWsV3xgpk7RVpVl2dYykZ7ZCym2ZbA2fD0sWwdjGsXcz825VPp3FC84_-G_4MvFuBeEr_1epXFGeDZ4d5KNrhkq3LqOtgonvi8xH1Q6_M</recordid><startdate>201905</startdate><enddate>201905</enddate><creator>Kim, S.T.</creator><creator>Kang, J.H.</creator><creator>Lee, J.</creator><creator>Lee, H.W.</creator><creator>Oh, S.Y.</creator><creator>Jang, J.S.</creator><creator>Lee, M.A.</creator><creator>Sohn, B.S.</creator><creator>Yoon, S.Y.</creator><creator>Choi, H.J.</creator><creator>Hong, J.H.</creator><creator>Kim, M.-J.</creator><creator>Kim, S.</creator><creator>Park, Y.S.</creator><creator>Park, J.O.</creator><creator>Lim, H.Y.</creator><general>Elsevier Ltd</general><general>Oxford University Press</general><scope>6I.</scope><scope>AAFTH</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><orcidid>https://orcid.org/0000-0001-6502-2612</orcidid></search><sort><creationdate>201905</creationdate><title>Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial</title><author>Kim, S.T. ; Kang, J.H. ; Lee, J. ; Lee, H.W. ; Oh, S.Y. ; Jang, J.S. ; Lee, M.A. ; Sohn, B.S. ; Yoon, S.Y. ; Choi, H.J. ; Hong, J.H. ; Kim, M.-J. ; Kim, S. ; Park, Y.S. ; Park, J.O. ; Lim, H.Y.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c479t-a3be992b8de3d087f7a2221d5a8afe269bc5eccc1228eec158c27a8f914df2e03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>biliary tract cancer</topic><topic>Biliary Tract Neoplasms - drug therapy</topic><topic>Biliary Tract Neoplasms - pathology</topic><topic>capecitabine</topic><topic>Capecitabine - administration & dosage</topic><topic>Capecitabine - adverse effects</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Female</topic><topic>Gemcitabine</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis</topic><topic>Neoplasm Recurrence, Local - drug therapy</topic><topic>Neoplasm Recurrence, Local - pathology</topic><topic>Neoplasm Staging</topic><topic>oxaliplatin</topic><topic>Oxaliplatin - administration & dosage</topic><topic>Oxaliplatin - adverse effects</topic><topic>Progression-Free Survival</topic><topic>Survival Rate</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, S.T.</creatorcontrib><creatorcontrib>Kang, J.H.</creatorcontrib><creatorcontrib>Lee, J.</creatorcontrib><creatorcontrib>Lee, H.W.</creatorcontrib><creatorcontrib>Oh, S.Y.</creatorcontrib><creatorcontrib>Jang, J.S.</creatorcontrib><creatorcontrib>Lee, M.A.</creatorcontrib><creatorcontrib>Sohn, B.S.</creatorcontrib><creatorcontrib>Yoon, S.Y.</creatorcontrib><creatorcontrib>Choi, H.J.</creatorcontrib><creatorcontrib>Hong, J.H.</creatorcontrib><creatorcontrib>Kim, M.-J.</creatorcontrib><creatorcontrib>Kim, S.</creatorcontrib><creatorcontrib>Park, Y.S.</creatorcontrib><creatorcontrib>Park, J.O.</creatorcontrib><creatorcontrib>Lim, H.Y.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Annals of oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, S.T.</au><au>Kang, J.H.</au><au>Lee, J.</au><au>Lee, H.W.</au><au>Oh, S.Y.</au><au>Jang, J.S.</au><au>Lee, M.A.</au><au>Sohn, B.S.</au><au>Yoon, S.Y.</au><au>Choi, H.J.</au><au>Hong, J.H.</au><au>Kim, M.-J.</au><au>Kim, S.</au><au>Park, Y.S.</au><au>Park, J.O.</au><au>Lim, H.Y.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial</atitle><jtitle>Annals of oncology</jtitle><addtitle>Ann Oncol</addtitle><date>2019-05</date><risdate>2019</risdate><volume>30</volume><issue>5</issue><spage>788</spage><epage>795</epage><pages>788-795</pages><issn>0923-7534</issn><eissn>1569-8041</eissn><abstract>Capecitabine plus oxaliplatin (XELOX) has shown modest activity and tolerable toxicity in a phase II trial for biliary tract cancers (BTCs). Meanwhile, gemcitabine plus oxaliplatin (GEMOX) has been the reference arm in recent phase II and III trials for BTCs. We aimed to investigate the efficacy of XELOX versus GEMOX as first-line therapy for advanced BCTs.
In this open-label, randomized, phase III, noninferiority trial, we randomly selected patients with metastatic BCTs to receive GEMOX (gemcitabine 1000mg/m2 on days 1 and 8, and oxaliplatin 100mg/m2 on day 1) or XELOX (capecitabine 1000mg/m2, twice daily, on days 1–14 and oxaliplatin 130mg/m2 on day 1) as first-line treatment, given every 3weeks, totaling eight cycles. The primary end point was to prove the noninferiority of XELOX to GEMOX in terms of 6-month progression-free survival (PFS) rate.
In total, 114 patients randomly received GEMOX and 108 randomly received XELOX. The median PFS was 5.3months for the GEMOX group and 5.8months for the XELOX group. The 6-month PFS rate was 44.5% for the GEMOX group and 46.7% for the XELOX group. The 95% confidence interval of the 6-month PFS rate difference between both groups was −12% to 16%, meeting the criteria for noninferiority of XELOX to GEMOX. There was no difference in objective response (P=0.171) and median overall survival (P=0.131) between both groups. The most common grade three to four adverse events were neutropenia and thrombocytopenia. No patient died of treatment-related causes. The XELOX group had significantly lower frequencies of hospital visits than the GEMOX group (P<0.001).
XELOX showed significant noninferiority to GEMOX in terms of 6-month PFS rate. Thus, XELOX could be an alternative first-line treatment of BCTs.
This study was registered in ClinicalTrials.gov (number NCT01470443).</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30785198</pmid><doi>10.1093/annonc/mdz058</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-6502-2612</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use biliary tract cancer Biliary Tract Neoplasms - drug therapy Biliary Tract Neoplasms - pathology capecitabine Capecitabine - administration & dosage Capecitabine - adverse effects Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Female Gemcitabine Humans Male Middle Aged Neoplasm Metastasis Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - pathology Neoplasm Staging oxaliplatin Oxaliplatin - administration & dosage Oxaliplatin - adverse effects Progression-Free Survival Survival Rate |
| title | Capecitabine plus oxaliplatin versus gemcitabine plus oxaliplatin as first-line therapy for advanced biliary tract cancers: a multicenter, open-label, randomized, phase III, noninferiority trial |
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