Sustained Clinical Response to Ivosidenib in Previously Treated Patients with Advanced Intrahepatic Cholangiocarcinoma Harboring an IDH1 R132 Mutation: Two Case Reports
Abstract Introduction: Patients with progressing intrahepatic cholangiocarcinoma (iCCA) harboring an isocitrate dehydrogenase 1 (IDH1) mutation who received ivosidenib showed a median progression-free survival (PFS) benefit of 1.3 months compared to placebo in the phase 3 ClarIDHy trial. Case Presen...
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| Veröffentlicht in: | Case reports in oncology 2024-01, Vol.17 (1), p.753-762 |
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| creator | Müller, Christian Franke, Sabine Reisländer, Timo Keitel, Verena Venerito, Marino |
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Introduction: Patients with progressing intrahepatic cholangiocarcinoma (iCCA) harboring an isocitrate dehydrogenase 1 (IDH1) mutation who received ivosidenib showed a median progression-free survival (PFS) benefit of 1.3 months compared to placebo in the phase 3 ClarIDHy trial. Case Presentations: We describe 2 consecutive patients with previously treated unresectable and metastatic iCCA harboring an IDH1 R132 mutation who achieved durable clinical responses with ivosidenib 500 mg once daily for >12 months until disease progression. In one case with a mixed response, a single progressive liver metastasis was additionally treated locally with interstitial brachytherapy, while ivosidenib was continued until further progression. Ivosidenib therapy resulted in long-term disease control with PFS of 20 and 13 months and duration of treatment of 26 and 13 months, respectively, with no relevant side effects. Conclusion: Patients with unresectable or metastatic IDH1-mutated iCCA can achieve sustained clinical responses for >12 months with ivosidenib. No new safety signals were observed during long-term treatment with ivosidenib. |
| doi_str_mv | 10.1159/000539665 |
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Introduction: Patients with progressing intrahepatic cholangiocarcinoma (iCCA) harboring an isocitrate dehydrogenase 1 (IDH1) mutation who received ivosidenib showed a median progression-free survival (PFS) benefit of 1.3 months compared to placebo in the phase 3 ClarIDHy trial. Case Presentations: We describe 2 consecutive patients with previously treated unresectable and metastatic iCCA harboring an IDH1 R132 mutation who achieved durable clinical responses with ivosidenib 500 mg once daily for >12 months until disease progression. In one case with a mixed response, a single progressive liver metastasis was additionally treated locally with interstitial brachytherapy, while ivosidenib was continued until further progression. Ivosidenib therapy resulted in long-term disease control with PFS of 20 and 13 months and duration of treatment of 26 and 13 months, respectively, with no relevant side effects. Conclusion: Patients with unresectable or metastatic IDH1-mutated iCCA can achieve sustained clinical responses for >12 months with ivosidenib. No new safety signals were observed during long-term treatment with ivosidenib.</description><identifier>ISSN: 1662-6575</identifier><identifier>EISSN: 1662-6575</identifier><identifier>DOI: 10.1159/000539665</identifier><identifier>PMID: 39015644</identifier><language>eng</language><publisher>Basel, Switzerland: S. Karger AG</publisher><subject>Ablation ; Biomarkers ; Case Report ; Case reports ; Chemotherapy ; Cholangiocarcinoma ; Gallbladder ; Genes ; idh1 ; intrahepatic cholangiocarcinoma ; ivosidenib ; Liver ; Metastasis ; Mutation ; Patients ; Radiation therapy ; Reimbursement ; Remission (Medicine) ; sustained clinical response</subject><ispartof>Case reports in oncology, 2024-01, Vol.17 (1), p.753-762</ispartof><rights>2024 The Author(s). Published by S. Karger AG, Basel</rights><rights>2024 The Author(s). Published by S. Karger AG, Basel.</rights><rights>2024 The Author(s). Published by S. Karger AG, Basel. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the associated terms available at: https://uk.sagepub.com/en-gb/eur/reusing-open-access-and-sage-choice-content</rights><rights>2024 The Author(s). Published by S. Karger AG, Basel 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0001-8581-0974</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250517/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250517/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2100,27634,27923,27924,53790,53792</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39015644$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Müller, Christian</creatorcontrib><creatorcontrib>Franke, Sabine</creatorcontrib><creatorcontrib>Reisländer, Timo</creatorcontrib><creatorcontrib>Keitel, Verena</creatorcontrib><creatorcontrib>Venerito, Marino</creatorcontrib><title>Sustained Clinical Response to Ivosidenib in Previously Treated Patients with Advanced Intrahepatic Cholangiocarcinoma Harboring an IDH1 R132 Mutation: Two Case Reports</title><title>Case reports in oncology</title><addtitle>Case Rep Oncol</addtitle><description>Abstract
Introduction: Patients with progressing intrahepatic cholangiocarcinoma (iCCA) harboring an isocitrate dehydrogenase 1 (IDH1) mutation who received ivosidenib showed a median progression-free survival (PFS) benefit of 1.3 months compared to placebo in the phase 3 ClarIDHy trial. Case Presentations: We describe 2 consecutive patients with previously treated unresectable and metastatic iCCA harboring an IDH1 R132 mutation who achieved durable clinical responses with ivosidenib 500 mg once daily for >12 months until disease progression. In one case with a mixed response, a single progressive liver metastasis was additionally treated locally with interstitial brachytherapy, while ivosidenib was continued until further progression. Ivosidenib therapy resulted in long-term disease control with PFS of 20 and 13 months and duration of treatment of 26 and 13 months, respectively, with no relevant side effects. Conclusion: Patients with unresectable or metastatic IDH1-mutated iCCA can achieve sustained clinical responses for >12 months with ivosidenib. No new safety signals were observed during long-term treatment with ivosidenib.</description><subject>Ablation</subject><subject>Biomarkers</subject><subject>Case Report</subject><subject>Case reports</subject><subject>Chemotherapy</subject><subject>Cholangiocarcinoma</subject><subject>Gallbladder</subject><subject>Genes</subject><subject>idh1</subject><subject>intrahepatic cholangiocarcinoma</subject><subject>ivosidenib</subject><subject>Liver</subject><subject>Metastasis</subject><subject>Mutation</subject><subject>Patients</subject><subject>Radiation therapy</subject><subject>Reimbursement</subject><subject>Remission (Medicine)</subject><subject>sustained clinical response</subject><issn>1662-6575</issn><issn>1662-6575</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>M--</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DOA</sourceid><recordid>eNpdUk1v1DAQjRCIlsKBO0KWuHBZsOPYjrmgKnzsSkWtluVsTRxv1kvWDrazVf8RPxPTLaXtyaOZN2_ePE9RvCT4HSFMvscYMyo5Z4-KY8J5OeNMsMd34qPiWYxbjLlknD0tjqjEhPGqOi5-f59iAutMh5rBOqthQEsTR--iQcmjxd5H2xlnW2Qdughmb_0Uhyu0CgZS7rqAZI1LEV3atEGn3R6czumFSwE2ZsxVjZqNH8D11msI2jq_AzSH0PpgXY_AocWnOUFLQkv0bUq5w7sPaHXpUQNZxNKMPqT4vHiyhiGaFzfvSfHjy-dVM5-dnX9dNKdns44KlmacMpCEEqKFBkIM05JhJknd8lKKqjWtIGwNIGsOosI10RVeV5JTrBklXNOTYnHg7Txs1RjsDsKV8mDVdcKHXkHISw1GcVPTkrbdmmFZlSWTPI-tQAjZcg2cZK6PB65xanem0-avKcM90vsVZzeq93tFSJlVE5EZ3t4wBP9rMjGpnY3aDNlOk_9B0byBEDUVZYa-eQDd-im47JWi2ZBS1uU14eu7km61_LuIDHh1APyE0JtwCzgc2P8pD8rN8vyAUGO3pn8AeG7MbQ</recordid><startdate>20240101</startdate><enddate>20240101</enddate><creator>Müller, Christian</creator><creator>Franke, Sabine</creator><creator>Reisländer, Timo</creator><creator>Keitel, Verena</creator><creator>Venerito, Marino</creator><general>S. 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Introduction: Patients with progressing intrahepatic cholangiocarcinoma (iCCA) harboring an isocitrate dehydrogenase 1 (IDH1) mutation who received ivosidenib showed a median progression-free survival (PFS) benefit of 1.3 months compared to placebo in the phase 3 ClarIDHy trial. Case Presentations: We describe 2 consecutive patients with previously treated unresectable and metastatic iCCA harboring an IDH1 R132 mutation who achieved durable clinical responses with ivosidenib 500 mg once daily for >12 months until disease progression. In one case with a mixed response, a single progressive liver metastasis was additionally treated locally with interstitial brachytherapy, while ivosidenib was continued until further progression. Ivosidenib therapy resulted in long-term disease control with PFS of 20 and 13 months and duration of treatment of 26 and 13 months, respectively, with no relevant side effects. Conclusion: Patients with unresectable or metastatic IDH1-mutated iCCA can achieve sustained clinical responses for >12 months with ivosidenib. No new safety signals were observed during long-term treatment with ivosidenib.</abstract><cop>Basel, Switzerland</cop><pub>S. Karger AG</pub><pmid>39015644</pmid><doi>10.1159/000539665</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-8581-0974</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Ablation Biomarkers Case Report Case reports Chemotherapy Cholangiocarcinoma Gallbladder Genes idh1 intrahepatic cholangiocarcinoma ivosidenib Liver Metastasis Mutation Patients Radiation therapy Reimbursement Remission (Medicine) sustained clinical response |
| title | Sustained Clinical Response to Ivosidenib in Previously Treated Patients with Advanced Intrahepatic Cholangiocarcinoma Harboring an IDH1 R132 Mutation: Two Case Reports |
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