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Doxorubicin, vinblastine, dacarbazine and lenalidomide for older Hodgkin lymphoma patients: final results of a German Hodgkin Study Group ( GHSG ) phase‐I trial
Author(s) -
Böll Boris,
Plütschow Annette,
Bürkle Carolin,
Atta Johannes,
Pfreundschuh Michael,
FeuringBuske Michaela,
Vogelhuber Martin,
Sökler Martin,
Eichenauer Dennis A.,
Thielen Indra,
Tresckow Bastian,
Fuchs Michael,
Engert Andreas,
Borchmann Peter
Publication year - 2019
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.15741
Subject(s) - lenalidomide , medicine , dacarbazine , vinblastine , abvd , hodgkin's lymphoma , gastroenterology , surgery , oncology , vincristine , chemotherapy , multiple myeloma , cyclophosphamide
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 ( DLT 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 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. DLT 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 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.