Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group (GHSG) phase‐I trial

Media type: E-Article
Title: Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group (GHSG) phase‐I trial
Contributor: Böll, Boris; Plütschow, Annette; Bürkle, Carolin; Atta, Johannes; Pfreundschuh, Michael; Feuring‐Buske, Michaela; Vogelhuber, Martin; Sökler, Martin; Eichenauer, Dennis A.; Thielen, Indra; von Tresckow, Bastian; Fuchs, Michael; Engert, Andreas; Borchmann, Peter
imprint: Wiley, 2019
Published in: British Journal of Haematology
Language: English
DOI: 10.1111/bjh.15741
ISSN: 1365-2141; 0007-1048
Keywords: Hematology
Origination:
Footnote:
Description: <jats:title>Summary</jats:title><jats:p>About 30% of all Hodgkin lymphoma (<jats:styled-content style="fixed-case">HL</jats:styled-content>) patients are ≥60 years old. As lenalidomide has promising single agent activity in multiple relapsed <jats:styled-content style="fixed-case">HL</jats:styled-content>, we replaced bleomycin in <jats:styled-content style="fixed-case">ABVD</jats:styled-content> with lenalidomide in this phase‐I trial. Patients aged ≥60 years with early‐unfavourable‐ or advanced‐stage <jats:styled-content style="fixed-case">HL</jats:styled-content> (Eastern Cooperative Oncology Group performance status ≤2, Cumulative Illness Rating Scale for Geriatrics score 0–7) received 4–8 cycles of <jats:styled-content style="fixed-case">AVD</jats:styled-content> (doxorubicin, vinblastine, dacarbazine) and lenalidomide in escalation with overdose control. Dose‐limiting toxicities (<jats:styled-content style="fixed-case">DLT</jats:styled-content>s) 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 <jats:styled-content style="fixed-case">HL</jats:styled-content>. A pre‐defined stopping criterion for dose escalation after <jats:styled-content style="fixed-case">DLT</jats:styled-content> evaluation of 20/24 patients suggested a recommended phase <jats:styled-content style="fixed-case">II</jats:styled-content> dose (<jats:styled-content style="fixed-case">RPTD</jats:styled-content>) of 20 mg. <jats:styled-content style="fixed-case">DLT</jats:styled-content>s 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 <jats:styled-content style="fixed-case">OS</jats:styled-content> were 69·7% (95% <jats:styled-content style="fixed-case">CI</jats:styled-content>: 50·3–89·1%) and 83·8% (95%‐<jats:styled-content style="fixed-case">CI</jats:styled-content>: 69·3–98·4%), respectively. In conclusion, <jats:styled-content style="fixed-case">AVD</jats:styled-content> with lenalidomide 20 mg is feasible and highly effective in older <jats:styled-content style="fixed-case">HL</jats:styled-content> patients.</jats:p>

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