Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group (GHSG) phase‐I trial
Summary About 30% of all Hodgkin lymphoma (HL) patients are ≥60 years old. As lenalidomide has promising single agent activity in multiple relapsed HL, we replaced bleomycin in ABVD with lenalidomide in this phase‐I trial. Patients aged ≥60 years with early‐unfavourable‐ or advanced‐stage HL (Easter...
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| Veröffentlicht in: | British journal of haematology 2019-04, Vol.185 (1), p.42-52 |
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| creator | Böll, Boris Plütschow, Annette Bürkle, Carolin Atta, Johannes Pfreundschuh, Michael Feuring‐Buske, Michaela Vogelhuber, Martin Sökler, Martin Eichenauer, Dennis A. Thielen, Indra Tresckow, Bastian Fuchs, Michael Engert, Andreas Borchmann, Peter |
| description | Summary
About 30% of all Hodgkin lymphoma (HL) patients are ≥60 years old. As lenalidomide has promising single agent activity in multiple relapsed HL, we replaced bleomycin in ABVD with lenalidomide in this phase‐I trial. Patients aged ≥60 years with early‐unfavourable‐ or advanced‐stage HL (Eastern Cooperative Oncology Group performance status ≤2, Cumulative Illness Rating Scale for Geriatrics score 0–7) received 4–8 cycles of AVD (doxorubicin, vinblastine, dacarbazine) and lenalidomide in escalation with overdose control. Dose‐limiting toxicities (DLTs) included thromboembolism ≥grade 2, severe haematological toxicity, neutropenic fever and prolonged therapy delay. Twenty‐five patients with a median age of 68 years were included, 68% had advanced‐stage HL. A pre‐defined stopping criterion for dose escalation after DLT evaluation of 20/24 patients suggested a recommended phase II dose (RPTD) of 20 mg. DLTs occurred in 10/24 evaluable patients, all treated with ≥20 mg, however, median relative dose intensity was 97% (interquartile range 49–104%). Grade 3 or higher toxicities occurred in all 22 patients at ≥20 mg lenalidomide but no treatment‐related deaths occurred. Overall response rate was 80% for all patients (20/25) and 86% (19/22) at ≥20 mg lenalidomide. Three‐year estimates for progression‐free survival and OS were 69·7% (95% CI: 50·3–89·1%) and 83·8% (95%‐CI: 69·3–98·4%), respectively. In conclusion, AVD with lenalidomide 20 mg is feasible and highly effective in older HL patients. |
| doi_str_mv | 10.1111/bjh.15741 |
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About 30% of all Hodgkin lymphoma (HL) patients are ≥60 years old. As lenalidomide has promising single agent activity in multiple relapsed HL, we replaced bleomycin in ABVD with lenalidomide in this phase‐I trial. Patients aged ≥60 years with early‐unfavourable‐ or advanced‐stage HL (Eastern Cooperative Oncology Group performance status ≤2, Cumulative Illness Rating Scale for Geriatrics score 0–7) received 4–8 cycles of AVD (doxorubicin, vinblastine, dacarbazine) and lenalidomide in escalation with overdose control. Dose‐limiting toxicities (DLTs) included thromboembolism ≥grade 2, severe haematological toxicity, neutropenic fever and prolonged therapy delay. Twenty‐five patients with a median age of 68 years were included, 68% had advanced‐stage HL. A pre‐defined stopping criterion for dose escalation after DLT evaluation of 20/24 patients suggested a recommended phase II dose (RPTD) of 20 mg. DLTs occurred in 10/24 evaluable patients, all treated with ≥20 mg, however, median relative dose intensity was 97% (interquartile range 49–104%). Grade 3 or higher toxicities occurred in all 22 patients at ≥20 mg lenalidomide but no treatment‐related deaths occurred. Overall response rate was 80% for all patients (20/25) and 86% (19/22) at ≥20 mg lenalidomide. Three‐year estimates for progression‐free survival and OS were 69·7% (95% CI: 50·3–89·1%) and 83·8% (95%‐CI: 69·3–98·4%), respectively. In conclusion, AVD with lenalidomide 20 mg is feasible and highly effective in older HL patients.</description><identifier>ISSN: 0007-1048</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/bjh.15741</identifier><identifier>PMID: 30592027</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>ABVD ; Age Factors ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bleomycin ; Dacarbazine ; Dacarbazine - administration & dosage ; Doxorubicin ; Doxorubicin - administration & dosage ; Female ; Fever ; Geriatrics ; Hematology ; Hodgkin Disease - diagnosis ; Hodgkin Disease - drug therapy ; Hodgkin Disease - mortality ; Hodgkin lymphoma ; Hodgkin's lymphoma ; Humans ; IMID ; Immunotherapy ; lenalidomide ; Lenalidomide - administration & dosage ; Lymphoma ; Male ; Middle Aged ; Neoplasm Staging ; Neutropenia ; older ; Oncology ; Overdose ; Patients ; Prognosis ; Targeted cancer therapy ; Thromboembolism ; Toxicity ; Treatment Outcome ; Vinblastine ; Vinblastine - administration & dosage</subject><ispartof>British journal of haematology, 2019-04, Vol.185 (1), p.42-52</ispartof><rights>2018 British Society for Haematology and John Wiley & Sons Ltd</rights><rights>2018 British Society for Haematology and John Wiley & Sons Ltd.</rights><rights>Copyright © 2019 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3531-c490a866da4e1754661a3155f6773b28b591e1c9fdb6ece03eb84a6f474e4fc33</citedby><cites>FETCH-LOGICAL-c3531-c490a866da4e1754661a3155f6773b28b591e1c9fdb6ece03eb84a6f474e4fc33</cites><orcidid>0000-0002-6432-0981 ; 0000-0003-1410-4487</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjh.15741$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjh.15741$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30592027$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Böll, Boris</creatorcontrib><creatorcontrib>Plütschow, Annette</creatorcontrib><creatorcontrib>Bürkle, Carolin</creatorcontrib><creatorcontrib>Atta, Johannes</creatorcontrib><creatorcontrib>Pfreundschuh, Michael</creatorcontrib><creatorcontrib>Feuring‐Buske, Michaela</creatorcontrib><creatorcontrib>Vogelhuber, Martin</creatorcontrib><creatorcontrib>Sökler, Martin</creatorcontrib><creatorcontrib>Eichenauer, Dennis A.</creatorcontrib><creatorcontrib>Thielen, Indra</creatorcontrib><creatorcontrib>Tresckow, Bastian</creatorcontrib><creatorcontrib>Fuchs, Michael</creatorcontrib><creatorcontrib>Engert, Andreas</creatorcontrib><creatorcontrib>Borchmann, Peter</creatorcontrib><creatorcontrib>German Hodgkin Study Group (GHSG)</creatorcontrib><creatorcontrib>the German Hodgkin Study Group (GHSG)</creatorcontrib><title>Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group (GHSG) phase‐I trial</title><title>British journal of haematology</title><addtitle>Br J Haematol</addtitle><description>Summary
About 30% of all Hodgkin lymphoma (HL) patients are ≥60 years old. As lenalidomide has promising single agent activity in multiple relapsed HL, we replaced bleomycin in ABVD with lenalidomide in this phase‐I trial. Patients aged ≥60 years with early‐unfavourable‐ or advanced‐stage HL (Eastern Cooperative Oncology Group performance status ≤2, Cumulative Illness Rating Scale for Geriatrics score 0–7) received 4–8 cycles of AVD (doxorubicin, vinblastine, dacarbazine) and lenalidomide in escalation with overdose control. Dose‐limiting toxicities (DLTs) included thromboembolism ≥grade 2, severe haematological toxicity, neutropenic fever and prolonged therapy delay. Twenty‐five patients with a median age of 68 years were included, 68% had advanced‐stage HL. A pre‐defined stopping criterion for dose escalation after DLT evaluation of 20/24 patients suggested a recommended phase II dose (RPTD) of 20 mg. DLTs occurred in 10/24 evaluable patients, all treated with ≥20 mg, however, median relative dose intensity was 97% (interquartile range 49–104%). Grade 3 or higher toxicities occurred in all 22 patients at ≥20 mg lenalidomide but no treatment‐related deaths occurred. Overall response rate was 80% for all patients (20/25) and 86% (19/22) at ≥20 mg lenalidomide. Three‐year estimates for progression‐free survival and OS were 69·7% (95% CI: 50·3–89·1%) and 83·8% (95%‐CI: 69·3–98·4%), respectively. In conclusion, AVD with lenalidomide 20 mg is feasible and highly effective in older HL patients.</description><subject>ABVD</subject><subject>Age Factors</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bleomycin</subject><subject>Dacarbazine</subject><subject>Dacarbazine - administration & dosage</subject><subject>Doxorubicin</subject><subject>Doxorubicin - administration & dosage</subject><subject>Female</subject><subject>Fever</subject><subject>Geriatrics</subject><subject>Hematology</subject><subject>Hodgkin Disease - diagnosis</subject><subject>Hodgkin Disease - drug therapy</subject><subject>Hodgkin Disease - mortality</subject><subject>Hodgkin lymphoma</subject><subject>Hodgkin's lymphoma</subject><subject>Humans</subject><subject>IMID</subject><subject>Immunotherapy</subject><subject>lenalidomide</subject><subject>Lenalidomide - administration & dosage</subject><subject>Lymphoma</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Neutropenia</subject><subject>older</subject><subject>Oncology</subject><subject>Overdose</subject><subject>Patients</subject><subject>Prognosis</subject><subject>Targeted cancer therapy</subject><subject>Thromboembolism</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><subject>Vinblastine</subject><subject>Vinblastine - administration & dosage</subject><issn>0007-1048</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kU1uFDEQhS0EIkNgwQVQSWyIlE7stvuPHQToCYrEIrBu2e0y48Hd7tjdCcOKI3AEzsZJMEzIjto8lfS9p1I9Qp4yesLSnKrt5oQVlWD3yIrxsshyJth9sqKUVhmjoj4gj2LcUso4LdhDcpCkyWlercjPN_6rD4uyvR2P4dqOysk42xGPQcteBiW_pQXkqMHhKJ3VfrAawfgA3mkMsPb68xc7gtsN08YPEiY5Wxzn-BKMTQ4IGBc3R_AGJLQYBjnemS7nRe-gDX6Z4EW7vmyPYNrIiL--_ziHOVjpHpMHRrqIT271kHx69_bj2Tq7-NCen726yHpecJb1oqGyLkstBbKqEGXJJGdFYcqq4iqvVdEwZH1jtCqxR8pR1UKWRlQChek5PyTP97lT8FcLxrnb-iWk-2OXs6aidc2bKlFHe6oPPsaAppuCHWTYdYx2f7roUhfd3y4S--w2cVED6jvy3_MTcLoHbqzD3f-Tutfv1_vI33MZlRI</recordid><startdate>201904</startdate><enddate>201904</enddate><creator>Böll, Boris</creator><creator>Plütschow, Annette</creator><creator>Bürkle, Carolin</creator><creator>Atta, Johannes</creator><creator>Pfreundschuh, Michael</creator><creator>Feuring‐Buske, Michaela</creator><creator>Vogelhuber, Martin</creator><creator>Sökler, Martin</creator><creator>Eichenauer, Dennis A.</creator><creator>Thielen, Indra</creator><creator>Tresckow, Bastian</creator><creator>Fuchs, Michael</creator><creator>Engert, Andreas</creator><creator>Borchmann, Peter</creator><general>Blackwell Publishing Ltd</general><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>7T5</scope><scope>H94</scope><orcidid>https://orcid.org/0000-0002-6432-0981</orcidid><orcidid>https://orcid.org/0000-0003-1410-4487</orcidid></search><sort><creationdate>201904</creationdate><title>Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group (GHSG) phase‐I trial</title><author>Böll, Boris ; Plütschow, Annette ; Bürkle, Carolin ; Atta, Johannes ; Pfreundschuh, Michael ; Feuring‐Buske, Michaela ; Vogelhuber, Martin ; Sökler, Martin ; Eichenauer, Dennis A. ; Thielen, Indra ; Tresckow, Bastian ; Fuchs, Michael ; Engert, Andreas ; Borchmann, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3531-c490a866da4e1754661a3155f6773b28b591e1c9fdb6ece03eb84a6f474e4fc33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>ABVD</topic><topic>Age Factors</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Bleomycin</topic><topic>Dacarbazine</topic><topic>Dacarbazine - administration & dosage</topic><topic>Doxorubicin</topic><topic>Doxorubicin - administration & dosage</topic><topic>Female</topic><topic>Fever</topic><topic>Geriatrics</topic><topic>Hematology</topic><topic>Hodgkin Disease - diagnosis</topic><topic>Hodgkin Disease - drug therapy</topic><topic>Hodgkin Disease - mortality</topic><topic>Hodgkin lymphoma</topic><topic>Hodgkin's lymphoma</topic><topic>Humans</topic><topic>IMID</topic><topic>Immunotherapy</topic><topic>lenalidomide</topic><topic>Lenalidomide - administration & dosage</topic><topic>Lymphoma</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Neutropenia</topic><topic>older</topic><topic>Oncology</topic><topic>Overdose</topic><topic>Patients</topic><topic>Prognosis</topic><topic>Targeted cancer therapy</topic><topic>Thromboembolism</topic><topic>Toxicity</topic><topic>Treatment Outcome</topic><topic>Vinblastine</topic><topic>Vinblastine - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Böll, Boris</creatorcontrib><creatorcontrib>Plütschow, Annette</creatorcontrib><creatorcontrib>Bürkle, Carolin</creatorcontrib><creatorcontrib>Atta, Johannes</creatorcontrib><creatorcontrib>Pfreundschuh, Michael</creatorcontrib><creatorcontrib>Feuring‐Buske, Michaela</creatorcontrib><creatorcontrib>Vogelhuber, Martin</creatorcontrib><creatorcontrib>Sökler, Martin</creatorcontrib><creatorcontrib>Eichenauer, Dennis A.</creatorcontrib><creatorcontrib>Thielen, Indra</creatorcontrib><creatorcontrib>Tresckow, Bastian</creatorcontrib><creatorcontrib>Fuchs, Michael</creatorcontrib><creatorcontrib>Engert, Andreas</creatorcontrib><creatorcontrib>Borchmann, Peter</creatorcontrib><creatorcontrib>German Hodgkin Study Group (GHSG)</creatorcontrib><creatorcontrib>the German Hodgkin Study Group (GHSG)</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>British journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Böll, Boris</au><au>Plütschow, Annette</au><au>Bürkle, Carolin</au><au>Atta, Johannes</au><au>Pfreundschuh, Michael</au><au>Feuring‐Buske, Michaela</au><au>Vogelhuber, Martin</au><au>Sökler, Martin</au><au>Eichenauer, Dennis A.</au><au>Thielen, Indra</au><au>Tresckow, Bastian</au><au>Fuchs, Michael</au><au>Engert, Andreas</au><au>Borchmann, Peter</au><aucorp>German Hodgkin Study Group (GHSG)</aucorp><aucorp>the German Hodgkin Study Group (GHSG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group (GHSG) phase‐I trial</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2019-04</date><risdate>2019</risdate><volume>185</volume><issue>1</issue><spage>42</spage><epage>52</epage><pages>42-52</pages><issn>0007-1048</issn><eissn>1365-2141</eissn><abstract>Summary
About 30% of all Hodgkin lymphoma (HL) patients are ≥60 years old. As lenalidomide has promising single agent activity in multiple relapsed HL, we replaced bleomycin in ABVD with lenalidomide in this phase‐I trial. Patients aged ≥60 years with early‐unfavourable‐ or advanced‐stage HL (Eastern Cooperative Oncology Group performance status ≤2, Cumulative Illness Rating Scale for Geriatrics score 0–7) received 4–8 cycles of AVD (doxorubicin, vinblastine, dacarbazine) and lenalidomide in escalation with overdose control. Dose‐limiting toxicities (DLTs) included thromboembolism ≥grade 2, severe haematological toxicity, neutropenic fever and prolonged therapy delay. Twenty‐five patients with a median age of 68 years were included, 68% had advanced‐stage HL. A pre‐defined stopping criterion for dose escalation after DLT evaluation of 20/24 patients suggested a recommended phase II dose (RPTD) of 20 mg. DLTs occurred in 10/24 evaluable patients, all treated with ≥20 mg, however, median relative dose intensity was 97% (interquartile range 49–104%). Grade 3 or higher toxicities occurred in all 22 patients at ≥20 mg lenalidomide but no treatment‐related deaths occurred. Overall response rate was 80% for all patients (20/25) and 86% (19/22) at ≥20 mg lenalidomide. Three‐year estimates for progression‐free survival and OS were 69·7% (95% CI: 50·3–89·1%) and 83·8% (95%‐CI: 69·3–98·4%), respectively. In conclusion, AVD with lenalidomide 20 mg is feasible and highly effective in older HL patients.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>30592027</pmid><doi>10.1111/bjh.15741</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-6432-0981</orcidid><orcidid>https://orcid.org/0000-0003-1410-4487</orcidid></addata></record> |
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| subjects | ABVD Age Factors Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bleomycin Dacarbazine Dacarbazine - administration & dosage Doxorubicin Doxorubicin - administration & dosage Female Fever Geriatrics Hematology Hodgkin Disease - diagnosis Hodgkin Disease - drug therapy Hodgkin Disease - mortality Hodgkin lymphoma Hodgkin's lymphoma Humans IMID Immunotherapy lenalidomide Lenalidomide - administration & dosage Lymphoma Male Middle Aged Neoplasm Staging Neutropenia older Oncology Overdose Patients Prognosis Targeted cancer therapy Thromboembolism Toxicity Treatment Outcome Vinblastine Vinblastine - administration & dosage |
| title | Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group (GHSG) phase‐I trial |
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