TY - JOUR
T1 - Treatment of patients with MYC rearrangement positive large B-cell lymphoma with R-CHOP plus lenalidomide: results of a multicenter HOVON phase II trial
T2 - results of a multicenter HOVON phase II trial
AU - Martine e D Chamuleau, null
AU - Coreline N Burggraaff, null
AU - Marcel Nijland, null
AU - Katerina Bakunina, null
AU - Rogier Mous, null
AU - Pieternella J Lugtenburg, null
AU - Daan Dierickx, null
AU - Gustaaf W van Imhoff, null
AU - Joost S P Vermaat, null
AU - Erik A F Marijt, null
AU - Otto Visser, null
AU - Caroline Mandigers, null
AU - Yavuz M Bilgin, null
AU - Aart Beeker, null
AU - Mark F Durian, null
AU - Bas van Rees, null
AU - Lara H Bohmer, null
AU - Lidwine W Tick, null
AU - Rinske S Boersma, null
AU - Tjeerd J F Snijders, null
AU - Harry C Schouten, null
AU - Harry R Koene, null
AU - Eva de Jongh, null
AU - Nathalie Hijmering, null
AU - Arjan Diepstra, null
AU - Anke van den Berg, null
AU - Anne I J Arens, null
AU - Julia Huijbregts, null
AU - Otto Hoekstra, null
AU - Josee M Zijlstra, null
AU - Daphne de Jong, null
AU - Marie José Kersten, null
N1 - Copyright © 2019, Ferrata Storti Foundation.
PY - 2019/12/19
Y1 - 2019/12/19
N2 - Patients with MYC-rearrangement positive large B-cell lymphoma (MYC+ LBCL) have an inferior prognosis following standard first-line therapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) as compared to patients without MYC rearrangement. Although intensive chemotherapy regimens yield higher remission rates, toxicity remains a concern. Lenalidomide is an oral immunomodulatory drug which downregulates MYC and its target genes thereby providing support using lenalidomide as additional therapeutic option for MYC+ LBCL. A phase II trial was conducted evaluating the efficacy of lenalidomide (15 mg day 1-14) in combination with R-CHOP (R2CHOP) in newly diagnosed MYC+ LBCL patients identified through a nationwide MYC-FISH screening program. The primary endpoint was complete metabolic response (CMR) on centrally reviewed 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)-computer tomography (CT)-scan at end-of-treatment. Secondary endpoints were overall survival (OS), disease-free survival (DFS) and event-free survival (EFS). Eighty-two patients with stage II-IV MYC+ LBCL were treated with 6 cycles of R2CHOP. At EOT, 67% (confidence interval (CI) 58-75%) of the patients reached CMR. With a median follow-up of 25.4 months, 2-year estimates (95% CI) for OS, DFS, EFS were 73% (62-82%), 75% (63-84%) and 63% (52-73%) respectively. In this prospective trial for newly diagnosed MYC+ LBCL patients, we found that administering R2CHOP was safe, and yields comparable CMR and survival rates as in studies applying more intensive chemotherapy regimens. Hence, these findings offer new prospects for MYC+ LBCL patients and warrant comparison in prospective randomized clinical trials. This trial was registered at www.clinicaltrialsregister.eu (#2014-002654-39).
AB - Patients with MYC-rearrangement positive large B-cell lymphoma (MYC+ LBCL) have an inferior prognosis following standard first-line therapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) as compared to patients without MYC rearrangement. Although intensive chemotherapy regimens yield higher remission rates, toxicity remains a concern. Lenalidomide is an oral immunomodulatory drug which downregulates MYC and its target genes thereby providing support using lenalidomide as additional therapeutic option for MYC+ LBCL. A phase II trial was conducted evaluating the efficacy of lenalidomide (15 mg day 1-14) in combination with R-CHOP (R2CHOP) in newly diagnosed MYC+ LBCL patients identified through a nationwide MYC-FISH screening program. The primary endpoint was complete metabolic response (CMR) on centrally reviewed 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)-computer tomography (CT)-scan at end-of-treatment. Secondary endpoints were overall survival (OS), disease-free survival (DFS) and event-free survival (EFS). Eighty-two patients with stage II-IV MYC+ LBCL were treated with 6 cycles of R2CHOP. At EOT, 67% (confidence interval (CI) 58-75%) of the patients reached CMR. With a median follow-up of 25.4 months, 2-year estimates (95% CI) for OS, DFS, EFS were 73% (62-82%), 75% (63-84%) and 63% (52-73%) respectively. In this prospective trial for newly diagnosed MYC+ LBCL patients, we found that administering R2CHOP was safe, and yields comparable CMR and survival rates as in studies applying more intensive chemotherapy regimens. Hence, these findings offer new prospects for MYC+ LBCL patients and warrant comparison in prospective randomized clinical trials. This trial was registered at www.clinicaltrialsregister.eu (#2014-002654-39).
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85085230833&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/33256379
U2 - https://doi.org/10.3324/haematol.2019.238162
DO - https://doi.org/10.3324/haematol.2019.238162
M3 - Article
C2 - 33256379
SN - 0390-6078
VL - 105
SP - 2805
EP - 2812
JO - Haematologica
JF - Haematologica
IS - 12
ER -