Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma
AbstractBackgroundErdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdaf...
Gespeichert in:
| Veröffentlicht in: | The New England journal of medicine 2023-11, Vol.389 (21), p.1961-1971 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 1971 |
|---|---|
| container_issue | 21 |
| container_start_page | 1961 |
| container_title | The New England journal of medicine |
| container_volume | 389 |
| creator | Loriot, Yohann Matsubara, Nobuaki Park, Se Hoon Huddart, Robert A. Burgess, Earle F. Houede, Nadine Banek, Severine Guadalupi, Valentina Ku, Ja Hyeon Valderrama, Begoña P. Tran, Ben Triantos, Spyros Kean, Yin Akapame, Sydney Deprince, Kris Mukhopadhyay, Sutapa Stone, Nicole L. Siefker-Radtke, Arlene O. |
| description | AbstractBackgroundErdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti–programmed cell death protein 1 [PD-1] or anti–programmed death ligand 1 [PD-L1] agents) are unclear.MethodsWe conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti–PD-1 or anti–PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator’s choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.ResultsA total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P=0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P |
| doi_str_mv | 10.1056/NEJMoa2308849 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_hal_p</sourceid><recordid>TN_cdi_hal_primary_oai_HAL_hal_04501602v1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2892696870</sourcerecordid><originalsourceid>FETCH-LOGICAL-c332t-9630f5b2822e05a5d5d10540435ab62a8f15bb99237f97af2bb5384b83a48c43</originalsourceid><addsrcrecordid>eNpd0UtLw0AQAOBFFKyPo_eAFz1E95nsHkuo1tLqpZ6X2WRDtyTZupsW-u9NqAg6l4GZj2GGQeiO4CeCRfb8PlusPFCGpeTqDE2IYCzlHGfnaIIxlSnPFbtEVzFu8RCEqwlazEIFtetd50ziQ1JsbOv7jQ2wOyauS6bVAbrSVmNvZXuIPfSuTD7DiBoHTVJAKF3nW7hBFzU00d7-5Gu0fpmti3m6_Hh9K6bLtGSM9qnKGK6FoZJSiwWISlTD9hxzJsBkFGRNhDFKUZbXKoeaGiOY5EYy4LLk7Bo9nsZuoNG74FoIR-3B6fl0qcca5gKTDNMDGezDye6C_9rb2OvWxdI2DXTW76OmUhLKc0HlQO__0a3fh244ZFCKZiqTOR5UelJl8DEGW_9uQLAen6D_PIF9A0I6d7s</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2892696870</pqid></control><display><type>article</type><title>Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma</title><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>New England Journal of Medicine</source><creator>Loriot, Yohann ; Matsubara, Nobuaki ; Park, Se Hoon ; Huddart, Robert A. ; Burgess, Earle F. ; Houede, Nadine ; Banek, Severine ; Guadalupi, Valentina ; Ku, Ja Hyeon ; Valderrama, Begoña P. ; Tran, Ben ; Triantos, Spyros ; Kean, Yin ; Akapame, Sydney ; Deprince, Kris ; Mukhopadhyay, Sutapa ; Stone, Nicole L. ; Siefker-Radtke, Arlene O.</creator><creatorcontrib>Loriot, Yohann ; Matsubara, Nobuaki ; Park, Se Hoon ; Huddart, Robert A. ; Burgess, Earle F. ; Houede, Nadine ; Banek, Severine ; Guadalupi, Valentina ; Ku, Ja Hyeon ; Valderrama, Begoña P. ; Tran, Ben ; Triantos, Spyros ; Kean, Yin ; Akapame, Sydney ; Deprince, Kris ; Mukhopadhyay, Sutapa ; Stone, Nicole L. ; Siefker-Radtke, Arlene O.</creatorcontrib><description>AbstractBackgroundErdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti–programmed cell death protein 1 [PD-1] or anti–programmed death ligand 1 [PD-L1] agents) are unclear.MethodsWe conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti–PD-1 or anti–PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator’s choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.ResultsA total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P=0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).ConclusionsErdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti–PD-1 or anti–PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.)</description><identifier>ISSN: 0028-4793</identifier><identifier>EISSN: 1533-4406</identifier><identifier>DOI: 10.1056/NEJMoa2308849</identifier><language>eng</language><publisher>Boston: Massachusetts Medical Society</publisher><subject>Apoptosis ; Cancer therapies ; Cell death ; Chemotherapy ; Confidence intervals ; Fibroblast growth factor receptors ; Immune checkpoint inhibitors ; Kinases ; Life Sciences ; Metastases ; Metastasis ; Mutation ; Patients ; PD-1 protein ; PD-L1 protein ; Tumors ; Urological cancer ; Urothelial carcinoma</subject><ispartof>The New England journal of medicine, 2023-11, Vol.389 (21), p.1961-1971</ispartof><rights>Copyright © 2023 Massachusetts Medical Society. All rights reserved.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c332t-9630f5b2822e05a5d5d10540435ab62a8f15bb99237f97af2bb5384b83a48c43</citedby><cites>FETCH-LOGICAL-c332t-9630f5b2822e05a5d5d10540435ab62a8f15bb99237f97af2bb5384b83a48c43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,2746,27901,27902</link.rule.ids><backlink>$$Uhttps://hal.science/hal-04501602$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Loriot, Yohann</creatorcontrib><creatorcontrib>Matsubara, Nobuaki</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Huddart, Robert A.</creatorcontrib><creatorcontrib>Burgess, Earle F.</creatorcontrib><creatorcontrib>Houede, Nadine</creatorcontrib><creatorcontrib>Banek, Severine</creatorcontrib><creatorcontrib>Guadalupi, Valentina</creatorcontrib><creatorcontrib>Ku, Ja Hyeon</creatorcontrib><creatorcontrib>Valderrama, Begoña P.</creatorcontrib><creatorcontrib>Tran, Ben</creatorcontrib><creatorcontrib>Triantos, Spyros</creatorcontrib><creatorcontrib>Kean, Yin</creatorcontrib><creatorcontrib>Akapame, Sydney</creatorcontrib><creatorcontrib>Deprince, Kris</creatorcontrib><creatorcontrib>Mukhopadhyay, Sutapa</creatorcontrib><creatorcontrib>Stone, Nicole L.</creatorcontrib><creatorcontrib>Siefker-Radtke, Arlene O.</creatorcontrib><title>Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma</title><title>The New England journal of medicine</title><description>AbstractBackgroundErdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti–programmed cell death protein 1 [PD-1] or anti–programmed death ligand 1 [PD-L1] agents) are unclear.MethodsWe conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti–PD-1 or anti–PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator’s choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.ResultsA total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P=0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).ConclusionsErdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti–PD-1 or anti–PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.)</description><subject>Apoptosis</subject><subject>Cancer therapies</subject><subject>Cell death</subject><subject>Chemotherapy</subject><subject>Confidence intervals</subject><subject>Fibroblast growth factor receptors</subject><subject>Immune checkpoint inhibitors</subject><subject>Kinases</subject><subject>Life Sciences</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Mutation</subject><subject>Patients</subject><subject>PD-1 protein</subject><subject>PD-L1 protein</subject><subject>Tumors</subject><subject>Urological cancer</subject><subject>Urothelial carcinoma</subject><issn>0028-4793</issn><issn>1533-4406</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>BEC</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNpd0UtLw0AQAOBFFKyPo_eAFz1E95nsHkuo1tLqpZ6X2WRDtyTZupsW-u9NqAg6l4GZj2GGQeiO4CeCRfb8PlusPFCGpeTqDE2IYCzlHGfnaIIxlSnPFbtEVzFu8RCEqwlazEIFtetd50ziQ1JsbOv7jQ2wOyauS6bVAbrSVmNvZXuIPfSuTD7DiBoHTVJAKF3nW7hBFzU00d7-5Gu0fpmti3m6_Hh9K6bLtGSM9qnKGK6FoZJSiwWISlTD9hxzJsBkFGRNhDFKUZbXKoeaGiOY5EYy4LLk7Bo9nsZuoNG74FoIR-3B6fl0qcca5gKTDNMDGezDye6C_9rb2OvWxdI2DXTW76OmUhLKc0HlQO__0a3fh244ZFCKZiqTOR5UelJl8DEGW_9uQLAen6D_PIF9A0I6d7s</recordid><startdate>20231123</startdate><enddate>20231123</enddate><creator>Loriot, Yohann</creator><creator>Matsubara, Nobuaki</creator><creator>Park, Se Hoon</creator><creator>Huddart, Robert A.</creator><creator>Burgess, Earle F.</creator><creator>Houede, Nadine</creator><creator>Banek, Severine</creator><creator>Guadalupi, Valentina</creator><creator>Ku, Ja Hyeon</creator><creator>Valderrama, Begoña P.</creator><creator>Tran, Ben</creator><creator>Triantos, Spyros</creator><creator>Kean, Yin</creator><creator>Akapame, Sydney</creator><creator>Deprince, Kris</creator><creator>Mukhopadhyay, Sutapa</creator><creator>Stone, Nicole L.</creator><creator>Siefker-Radtke, Arlene O.</creator><general>Massachusetts Medical Society</general><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BEC</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K0Y</scope><scope>LK8</scope><scope>M0R</scope><scope>M0T</scope><scope>M1P</scope><scope>M2M</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQGLB</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>1XC</scope></search><sort><creationdate>20231123</creationdate><title>Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma</title><author>Loriot, Yohann ; Matsubara, Nobuaki ; Park, Se Hoon ; Huddart, Robert A. ; Burgess, Earle F. ; Houede, Nadine ; Banek, Severine ; Guadalupi, Valentina ; Ku, Ja Hyeon ; Valderrama, Begoña P. ; Tran, Ben ; Triantos, Spyros ; Kean, Yin ; Akapame, Sydney ; Deprince, Kris ; Mukhopadhyay, Sutapa ; Stone, Nicole L. ; Siefker-Radtke, Arlene O.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c332t-9630f5b2822e05a5d5d10540435ab62a8f15bb99237f97af2bb5384b83a48c43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Apoptosis</topic><topic>Cancer therapies</topic><topic>Cell death</topic><topic>Chemotherapy</topic><topic>Confidence intervals</topic><topic>Fibroblast growth factor receptors</topic><topic>Immune checkpoint inhibitors</topic><topic>Kinases</topic><topic>Life Sciences</topic><topic>Metastases</topic><topic>Metastasis</topic><topic>Mutation</topic><topic>Patients</topic><topic>PD-1 protein</topic><topic>PD-L1 protein</topic><topic>Tumors</topic><topic>Urological cancer</topic><topic>Urothelial carcinoma</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Loriot, Yohann</creatorcontrib><creatorcontrib>Matsubara, Nobuaki</creatorcontrib><creatorcontrib>Park, Se Hoon</creatorcontrib><creatorcontrib>Huddart, Robert A.</creatorcontrib><creatorcontrib>Burgess, Earle F.</creatorcontrib><creatorcontrib>Houede, Nadine</creatorcontrib><creatorcontrib>Banek, Severine</creatorcontrib><creatorcontrib>Guadalupi, Valentina</creatorcontrib><creatorcontrib>Ku, Ja Hyeon</creatorcontrib><creatorcontrib>Valderrama, Begoña P.</creatorcontrib><creatorcontrib>Tran, Ben</creatorcontrib><creatorcontrib>Triantos, Spyros</creatorcontrib><creatorcontrib>Kean, Yin</creatorcontrib><creatorcontrib>Akapame, Sydney</creatorcontrib><creatorcontrib>Deprince, Kris</creatorcontrib><creatorcontrib>Mukhopadhyay, Sutapa</creatorcontrib><creatorcontrib>Stone, Nicole L.</creatorcontrib><creatorcontrib>Siefker-Radtke, Arlene O.</creatorcontrib><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>eLibrary</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</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>SciTech Premium Collection</collection><collection>New England Journal of Medicine</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</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 Applied & Life Sciences</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>The New England journal of medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Loriot, Yohann</au><au>Matsubara, Nobuaki</au><au>Park, Se Hoon</au><au>Huddart, Robert A.</au><au>Burgess, Earle F.</au><au>Houede, Nadine</au><au>Banek, Severine</au><au>Guadalupi, Valentina</au><au>Ku, Ja Hyeon</au><au>Valderrama, Begoña P.</au><au>Tran, Ben</au><au>Triantos, Spyros</au><au>Kean, Yin</au><au>Akapame, Sydney</au><au>Deprince, Kris</au><au>Mukhopadhyay, Sutapa</au><au>Stone, Nicole L.</au><au>Siefker-Radtke, Arlene O.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma</atitle><jtitle>The New England journal of medicine</jtitle><date>2023-11-23</date><risdate>2023</risdate><volume>389</volume><issue>21</issue><spage>1961</spage><epage>1971</epage><pages>1961-1971</pages><issn>0028-4793</issn><eissn>1533-4406</eissn><abstract>AbstractBackgroundErdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti–programmed cell death protein 1 [PD-1] or anti–programmed death ligand 1 [PD-L1] agents) are unclear.MethodsWe conducted a global phase 3 trial of erdafitinib as compared with chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included an anti–PD-1 or anti–PD-L1. Patients were randomly assigned in a 1:1 ratio to receive erdafitinib or the investigator’s choice of chemotherapy (docetaxel or vinflunine). The primary end point was overall survival.ResultsA total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P=0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P<0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).ConclusionsErdafitinib therapy resulted in significantly longer overall survival than chemotherapy among patients with metastatic urothelial carcinoma and FGFR alterations after previous anti–PD-1 or anti–PD-L1 treatment. (Funded by Janssen Research and Development; THOR ClinicalTrials.gov number, NCT03390504.)</abstract><cop>Boston</cop><pub>Massachusetts Medical Society</pub><doi>10.1056/NEJMoa2308849</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0028-4793 |
| ispartof | The New England journal of medicine, 2023-11, Vol.389 (21), p.1961-1971 |
| issn | 0028-4793 1533-4406 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_04501602v1 |
| source | Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine |
| subjects | Apoptosis Cancer therapies Cell death Chemotherapy Confidence intervals Fibroblast growth factor receptors Immune checkpoint inhibitors Kinases Life Sciences Metastases Metastasis Mutation Patients PD-1 protein PD-L1 protein Tumors Urological cancer Urothelial carcinoma |
| title | Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-19T07%3A15%3A47IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_hal_p&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Erdafitinib%20or%20Chemotherapy%20in%20Advanced%20or%20Metastatic%20Urothelial%20Carcinoma&rft.jtitle=The%20New%20England%20journal%20of%20medicine&rft.au=Loriot,%20Yohann&rft.date=2023-11-23&rft.volume=389&rft.issue=21&rft.spage=1961&rft.epage=1971&rft.pages=1961-1971&rft.issn=0028-4793&rft.eissn=1533-4406&rft_id=info:doi/10.1056/NEJMoa2308849&rft_dat=%3Cproquest_hal_p%3E2892696870%3C/proquest_hal_p%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2892696870&rft_id=info:pmid/&rfr_iscdi=true |