TY - JOUR
T1 - Treatment of patients with MYC rearrangement positive large B-cell lymphoma with R-CHOP plus phaselenalidomide: II HOVON trial results of a multicenter
T2 - II HOVON trial results of a multicenter
AU - Chamuleau, Martine E. D.
AU - Burggraaff, Coreline N.
AU - Nijland, Marcel
AU - Bakunina, Katerina
AU - Mous, Rogier
AU - Lugtenburg, Pieternella J.
AU - Dierickx, Daan
AU - van Imhoff, Gustaaf W.
AU - Vermaat, Joost S. P.
AU - Marijt, Eric A. F.
AU - Visser, Otto
AU - Mandigers, Caroline
AU - Bilgin, Yavuz M.
AU - Beeker, Aart
AU - Durian, Mark F.
AU - van Rees, Bas P.
AU - Bohmer, Lara H.
AU - Tick, Lidwine W.
AU - Boersma, Rinske S.
AU - Snijders, Tjeerd J. F.
AU - Schouten, Harry C.
AU - Koene, Harry R.
AU - de Jongh, Eva
AU - Hijmering, Nathalie
AU - Diepstra, Arjan
AU - van de Berg, Anke
AU - Arens, Anne I. J.
AU - Huijbregts, Julia
AU - Hoekstra, Otto
AU - Zijlstra, Josee M.
AU - de Jong, Daphne
AU - Kersten, Marie José
PY - 2020/12/1
Y1 - 2020/12/1
N2 - atients 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) 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 MYCFISH 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 six cycles of R2CHOP. At end of treatment, 67% (95% Confidence interval [CI]: 58-75) of the patients reached CMR. With a median follow-up of 25.4 months, 2-year estimates for OS, DFS, EFS were 73% (95% CI: 62-82), 75% (95% CI: 63-84) and 63% change to: (95% CI: 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 - atients 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) 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 MYCFISH 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 six cycles of R2CHOP. At end of treatment, 67% (95% Confidence interval [CI]: 58-75) of the patients reached CMR. With a median follow-up of 25.4 months, 2-year estimates for OS, DFS, EFS were 73% (95% CI: 62-82), 75% (95% CI: 63-84) and 63% change to: (95% CI: 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 - http://www.scopus.com/inward/record.url?scp=85085230833&partnerID=8YFLogxK
U2 - https://doi.org/10.3324/haematol.2019.238162
DO - https://doi.org/10.3324/haematol.2019.238162
M3 - Article
C2 - 31857360
SN - 0390-6078
VL - 105
SP - 2805
EP - 2812
JO - Haematologica
JF - Haematologica
IS - 12
ER -