Integrative analysis of a phase 2 trial combining lenalidomide with CHOP in angioimmunoblastic T-cell lymphoma
Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, h...
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| Published in | Blood advances Vol. 5; no. 2; pp. 539 - 548 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
26.01.2021
The American Society of Hematology American Society of Hematology |
| Subjects | |
| Online Access | Get full text |
| ISSN | 2473-9529 2473-9537 2473-9537 |
| DOI | 10.1182/bloodadvances.2020003081 |
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| Abstract | Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, has shown efficacy as a single agent in AITL treatment. We performed a multicentric phase 2 trial combining 25 mg lenalidomide daily for 14 days per cycle with 8 cycles of CHOP21 in previously untreated AITL patients aged 60 to 80 years. The primary objective was the complete metabolic response (CMR) rate at the end of treatment. Seventy-eight of the 80 patients enrolled were included in the efficacy and safety analysis. CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. The 2-year progression-free survival (PFS) was 42.1% (95% CI, 30.9%-52.8%), and the 2-year overall survival was 59.2% (95% CI, 47.3%-69.3%). The most common toxicities were hematologic and led to treatment discontinuation in 15% of patients. This large prospective and uniform series of AITL treatment data was used to perform an integrative analysis of clinical, pathologic, biologic, and molecular data. TET2, RHOA, DNMT3A, and IDH2 mutations were present in 78%, 54%, 32%, and 22% of patients, respectively. IDH2 mutations were associated with distinct pathologic and clinical features and DNMT3A was associated with shorter PFS. In conclusion, the combination of lenalidomide and CHOP did not improve the CMR in AITL patients. This trial clarified the clinical impact of recurrent mutations in AITL. This trial was registered at www.clincialtrials.gov as #NCT01553786.
•Lenalidomide CHOP did not improve the complete metabolic response rate compared with historical controls in previously untreated AITL patients aged 60 to 80 years.•DNMT3A mutations were present in 32% of patients and appeared to confer shorter PFS.
[Display omitted] |
|---|---|
| AbstractList | Lenalidomide CHOP did not improve the complete metabolic response rate compared with historical controls in previously untreated AITL patients aged 60 to 80 years.
DNMT3A
mutations were present in 32% of patients and appeared to confer shorter PFS.
Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, has shown efficacy as a single agent in AITL treatment. We performed a multicentric phase 2 trial combining 25 mg lenalidomide daily for 14 days per cycle with 8 cycles of CHOP21 in previously untreated AITL patients aged 60 to 80 years. The primary objective was the complete metabolic response (CMR) rate at the end of treatment. Seventy-eight of the 80 patients enrolled were included in the efficacy and safety analysis. CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. The 2-year progression-free survival (PFS) was 42.1% (95% CI, 30.9%-52.8%), and the 2-year overall survival was 59.2% (95% CI, 47.3%-69.3%). The most common toxicities were hematologic and led to treatment discontinuation in 15% of patients. This large prospective and uniform series of AITL treatment data was used to perform an integrative analysis of clinical, pathologic, biologic, and molecular data.
TET2
,
RHOA
,
DNMT3A
, and
IDH2
mutations were present in 78%, 54%, 32%, and 22% of patients, respectively.
IDH2
mutations were associated with distinct pathologic and clinical features and
DNMT3A
was associated with shorter PFS. In conclusion, the combination of lenalidomide and CHOP did not improve the CMR in AITL patients. This trial clarified the clinical impact of recurrent mutations in AITL. This trial was registered at
www.clincialtrials.gov
as #NCT01553786. Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, has shown efficacy as a single agent in AITL treatment. We performed a multicentric phase 2 trial combining 25 mg lenalidomide daily for 14 days per cycle with 8 cycles of CHOP21 in previously untreated AITL patients aged 60 to 80 years. The primary objective was the complete metabolic response (CMR) rate at the end of treatment. Seventy-eight of the 80 patients enrolled were included in the efficacy and safety analysis. CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. The 2-year progression-free survival (PFS) was 42.1% (95% CI, 30.9%-52.8%), and the 2-year overall survival was 59.2% (95% CI, 47.3%-69.3%). The most common toxicities were hematologic and led to treatment discontinuation in 15% of patients. This large prospective and uniform series of AITL treatment data was used to perform an integrative analysis of clinical, pathologic, biologic, and molecular data. TET2, RHOA, DNMT3A, and IDH2 mutations were present in 78%, 54%, 32%, and 22% of patients, respectively. IDH2 mutations were associated with distinct pathologic and clinical features and DNMT3A was associated with shorter PFS. In conclusion, the combination of lenalidomide and CHOP did not improve the CMR in AITL patients. This trial clarified the clinical impact of recurrent mutations in AITL. This trial was registered at www.clincialtrials.gov as #NCT01553786. Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, has shown efficacy as a single agent in AITL treatment. We performed a multicentric phase 2 trial combining 25 mg lenalidomide daily for 14 days per cycle with 8 cycles of CHOP21 in previously untreated AITL patients aged 60 to 80 years. The primary objective was the complete metabolic response (CMR) rate at the end of treatment. Seventy-eight of the 80 patients enrolled were included in the efficacy and safety analysis. CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. The 2-year progression-free survival (PFS) was 42.1% (95% CI, 30.9%-52.8%), and the 2-year overall survival was 59.2% (95% CI, 47.3%-69.3%). The most common toxicities were hematologic and led to treatment discontinuation in 15% of patients. This large prospective and uniform series of AITL treatment data was used to perform an integrative analysis of clinical, pathologic, biologic, and molecular data. TET2, RHOA, DNMT3A, and IDH2 mutations were present in 78%, 54%, 32%, and 22% of patients, respectively. IDH2 mutations were associated with distinct pathologic and clinical features and DNMT3A was associated with shorter PFS. In conclusion, the combination of lenalidomide and CHOP did not improve the CMR in AITL patients. This trial clarified the clinical impact of recurrent mutations in AITL. This trial was registered at www.clincialtrials.gov as #NCT01553786. Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, has shown efficacy as a single agent in AITL treatment. We performed a multicentric phase 2 trial combining 25 mg lenalidomide daily for 14 days per cycle with 8 cycles of CHOP21 in previously untreated AITL patients aged 60 to 80 years. The primary objective was the complete metabolic response (CMR) rate at the end of treatment. Seventy-eight of the 80 patients enrolled were included in the efficacy and safety analysis. CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. The 2-year progression-free survival (PFS) was 42.1% (95% CI, 30.9%-52.8%), and the 2-year overall survival was 59.2% (95% CI, 47.3%-69.3%). The most common toxicities were hematologic and led to treatment discontinuation in 15% of patients. This large prospective and uniform series of AITL treatment data was used to perform an integrative analysis of clinical, pathologic, biologic, and molecular data. TET2, RHOA, DNMT3A, and IDH2 mutations were present in 78%, 54%, 32%, and 22% of patients, respectively. IDH2 mutations were associated with distinct pathologic and clinical features and DNMT3A was associated with shorter PFS. In conclusion, the combination of lenalidomide and CHOP did not improve the CMR in AITL patients. This trial clarified the clinical impact of recurrent mutations in AITL. This trial was registered at www.clincialtrials.gov as #NCT01553786. •Lenalidomide CHOP did not improve the complete metabolic response rate compared with historical controls in previously untreated AITL patients aged 60 to 80 years.•DNMT3A mutations were present in 32% of patients and appeared to confer shorter PFS. [Display omitted] Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, has shown efficacy as a single agent in AITL treatment. We performed a multicentric phase 2 trial combining 25 mg lenalidomide daily for 14 days per cycle with 8 cycles of CHOP21 in previously untreated AITL patients aged 60 to 80 years. The primary objective was the complete metabolic response (CMR) rate at the end of treatment. Seventy-eight of the 80 patients enrolled were included in the efficacy and safety analysis. CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. The 2-year progression-free survival (PFS) was 42.1% (95% CI, 30.9%-52.8%), and the 2-year overall survival was 59.2% (95% CI, 47.3%-69.3%). The most common toxicities were hematologic and led to treatment discontinuation in 15% of patients. This large prospective and uniform series of AITL treatment data was used to perform an integrative analysis of clinical, pathologic, biologic, and molecular data. TET2, RHOA, DNMT3A, and IDH2 mutations were present in 78%, 54%, 32%, and 22% of patients, respectively. IDH2 mutations were associated with distinct pathologic and clinical features and DNMT3A was associated with shorter PFS. In conclusion, the combination of lenalidomide and CHOP did not improve the CMR in AITL patients. This trial clarified the clinical impact of recurrent mutations in AITL. This trial was registered at www.clincialtrials.gov as #NCT01553786.Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy. Lenalidomide, which has been safely combined with CHOP to treat B-cell lymphoma, has shown efficacy as a single agent in AITL treatment. We performed a multicentric phase 2 trial combining 25 mg lenalidomide daily for 14 days per cycle with 8 cycles of CHOP21 in previously untreated AITL patients aged 60 to 80 years. The primary objective was the complete metabolic response (CMR) rate at the end of treatment. Seventy-eight of the 80 patients enrolled were included in the efficacy and safety analysis. CMR was achieved in 32 (41%; 95% confidence interval [CI], 30%-52.7%) patients, which was below the prespecified CMR rate of 55% defined as success in the study. The 2-year progression-free survival (PFS) was 42.1% (95% CI, 30.9%-52.8%), and the 2-year overall survival was 59.2% (95% CI, 47.3%-69.3%). The most common toxicities were hematologic and led to treatment discontinuation in 15% of patients. This large prospective and uniform series of AITL treatment data was used to perform an integrative analysis of clinical, pathologic, biologic, and molecular data. TET2, RHOA, DNMT3A, and IDH2 mutations were present in 78%, 54%, 32%, and 22% of patients, respectively. IDH2 mutations were associated with distinct pathologic and clinical features and DNMT3A was associated with shorter PFS. In conclusion, the combination of lenalidomide and CHOP did not improve the CMR in AITL patients. This trial clarified the clinical impact of recurrent mutations in AITL. This trial was registered at www.clincialtrials.gov as #NCT01553786. |
| Author | Camus, Vincent Robe, Cyrielle Moles-Moreau, Marie-Pierre Parrens, Marie Bossard, Céline Bachy, Emmanuel de Leval, Laurence Beldi-Ferchiou, Asma Meignan, Michel Cartron, Guillaume Pelletier, Laura Letourneau, Audrey Haioun, Corinne Cottereau, Anne-Ségolène Fourati, Slim Gaulard, Philippe Casasnovas, Olivier Lemonnier, François Becker, Stéphanie Missiaglia, Edoardo Delmer, Alain Régny, Caroline Delfau-Larue, Marie-Hélène Bouabdallah, Reda Voillat, Laurent Cacheux, Victoria Safar, Violaine Fataccioli, Virginie |
| Author_xml | – sequence: 1 givenname: François orcidid: 0000-0001-6205-5419 surname: Lemonnier fullname: Lemonnier, François organization: Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, Unité Hémopathies Lymphoïdes, Créteil, France – sequence: 2 givenname: Violaine surname: Safar fullname: Safar, Violaine organization: Service d'Hématologie Clinique, Hospices Civils de Lyon, Pierre-Bénite, and Université Lyon 1, Lyon, France – sequence: 3 givenname: Asma orcidid: 0000-0002-7806-9687 surname: Beldi-Ferchiou fullname: Beldi-Ferchiou, Asma organization: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France – sequence: 4 givenname: Anne-Ségolène surname: Cottereau fullname: Cottereau, Anne-Ségolène organization: Département de Médecine Nucléaire, Hôpital Cochin, AP-HP, Université Paris Descartes, Paris, France – sequence: 5 givenname: Emmanuel surname: Bachy fullname: Bachy, Emmanuel organization: Service d'Hématologie Clinique, Hospices Civils de Lyon, Pierre-Bénite, and Université Lyon 1, Lyon, France – sequence: 6 givenname: Guillaume orcidid: 0000-0003-0659-9635 surname: Cartron fullname: Cartron, Guillaume organization: Département d'Hématologie Clinique, Centre Hospitalo-Universitaire de Montpellier, Unité Mixte de Recherche–Centre National de Recherche Scientifique 5535, Université de Montpellier, Montpellier, France – sequence: 7 givenname: Virginie surname: Fataccioli fullname: Fataccioli, Virginie organization: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France – sequence: 8 givenname: Laura surname: Pelletier fullname: Pelletier, Laura organization: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France – sequence: 9 givenname: Cyrielle surname: Robe fullname: Robe, Cyrielle organization: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France – sequence: 10 givenname: Audrey surname: Letourneau fullname: Letourneau, Audrey organization: Institut de Pathologie, Centre Hospitalier Universitaire Vaudois et Université de Lausanne, Lausanne, Switzerland – sequence: 11 givenname: Edoardo orcidid: 0000-0001-9221-0117 surname: Missiaglia fullname: Missiaglia, Edoardo organization: Institut de Pathologie, Centre Hospitalier Universitaire Vaudois et Université de Lausanne, Lausanne, Switzerland – sequence: 12 givenname: Slim surname: Fourati fullname: Fourati, Slim organization: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France – sequence: 13 givenname: Marie-Pierre surname: Moles-Moreau fullname: Moles-Moreau, Marie-Pierre organization: Service d'Hématologie, Centre Hospitalier Universitaire, Angers, France – sequence: 14 givenname: Alain orcidid: 0000-0002-1430-2574 surname: Delmer fullname: Delmer, Alain organization: Service d'Hématologie, Centre Hospitalier Universitaire, Reims, France – sequence: 15 givenname: Reda surname: Bouabdallah fullname: Bouabdallah, Reda organization: Service d'Hématologie, Institut Paoli-Calmette, Marseille, France – sequence: 16 givenname: Laurent surname: Voillat fullname: Voillat, Laurent organization: Service d'Hématologie, Centre Hospitalier, Chalon, France – sequence: 17 givenname: Stéphanie surname: Becker fullname: Becker, Stéphanie organization: Service de Médecine Nucléaire, Centre de Lutte Contre le Cancer Becquerel, Rouen, France – sequence: 18 givenname: Céline surname: Bossard fullname: Bossard, Céline organization: Université de Nantes, Center Hospitalier Universitaire Nantes, Département de Pathologie, INSERM Centre de Recherche en Cancérologie et Immunologie Nantes Angers, Nantes, France – sequence: 19 givenname: Marie surname: Parrens fullname: Parrens, Marie organization: Département de Pathologie, Hôpital Haut-Lévêque, Pessac, INSERM U1053, Université de Bordeaux, Bordeaux, France – sequence: 20 givenname: Olivier surname: Casasnovas fullname: Casasnovas, Olivier organization: Service d'Hématologie, Centre Hospitalier Universitaire, Dijon, France – sequence: 21 givenname: Victoria surname: Cacheux fullname: Cacheux, Victoria organization: Service d'Hématologie, Centre Hospitalier Universitaire, Clermont Ferrand, France – sequence: 22 givenname: Caroline surname: Régny fullname: Régny, Caroline organization: Service d'Hématologie, Centre Hospitalier Universitaire, Grenoble, France – sequence: 23 givenname: Vincent surname: Camus fullname: Camus, Vincent organization: Département d'Hématologie, Centre Henri Becquerel, Rouen, France; and – sequence: 24 givenname: Marie-Hélène orcidid: 0000-0002-8010-2343 surname: Delfau-Larue fullname: Delfau-Larue, Marie-Hélène organization: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France – sequence: 25 givenname: Michel surname: Meignan fullname: Meignan, Michel organization: LYSA Image, Hôpitaux Universitaires Henri Mondor, Créteil, France – sequence: 26 givenname: Laurence surname: de Leval fullname: de Leval, Laurence organization: Institut de Pathologie, Centre Hospitalier Universitaire Vaudois et Université de Lausanne, Lausanne, Switzerland – sequence: 27 givenname: Philippe surname: Gaulard fullname: Gaulard, Philippe organization: Université Paris Est Créteil, INSERM, Institut Médical de Recherche Biomédicale, Créteil, France – sequence: 28 givenname: Corinne orcidid: 0000-0003-0095-5379 surname: Haioun fullname: Haioun, Corinne email: corinne.haioun@aphp.fr organization: Assistance Publique–Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, Unité Hémopathies Lymphoïdes, Créteil, France |
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| Snippet | Angioimmunoblastic T-cell lymphoma (AITL) is a frequent T-cell lymphoma in the elderly population that has a poor prognosis when treated with cyclophosphamide,... Lenalidomide CHOP did not improve the complete metabolic response rate compared with historical controls in previously untreated AITL patients aged 60 to 80... |
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| SubjectTerms | Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - adverse effects Cancer Hematology Human health and pathology Humans Lenalidomide Life Sciences Lymphoid Neoplasia Lymphoma, T-Cell Middle Aged Pharmaceutical sciences Pharmacology Prospective Studies Rituximab Santé publique et épidémiologie |
| Title | Integrative analysis of a phase 2 trial combining lenalidomide with CHOP in angioimmunoblastic T-cell lymphoma |
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