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1. Lomustine is beneficial to older AML with ELN2017 adverse risk profile and intermediate karyotype: a FILO study

Author

Largeaud, Laetitia, Cornillet-Lefebvre, Pascale, Hamel, Jean-François, Dumas, Pierre-Yves, Prade, Naïs, Dufrechou, Stéphanie, Plenecassagnes, Julien, Luquet, Isabelle, Blanchet, Odile, Banos, Anne, Béné, Marie, Bernard, Marc, Bertoli, Sarah, Bonmati, Caroline, Fornecker, Luc Matthieu, Guièze, Romain, Haddaoui, Lamya, Hunault, Mathilde, Ianotto, Jean Christophe, Jourdan, Eric, Ojeda, Mario, Peterlin, Pierre, Vey, Norbert, Zerazhi, Hacene, Yosr, Hicheri, Mineur, Ariane, Cahn, Jean-Yves, Ifrah, Norbert, Récher, Christian, Pigneux, Arnaud, Delabesse, Eric, Marolleau, J.-P., Aleme, A., Orsini-Piocelle, F., Cadoux, N., Marie, C., Al Jijakli, A., Lepeu, G., Beyrne, M., Labarrere, S., Deconinck, E., Peria, M., El Yamani, A., Kadiri, O., Choufi, B., Brument, M., Leguay, T., Berthou, C., Guillerm, G., Drugmanne, G., Tournilhac, O., Roy, G., Audhuy, B., Camara, S., Caillot, D., Grandjean, M., Bulabois, C.-E., Fief, B., Ladraa, C., Dorvaux, V., Hagopian, M., Fegueux, N., Fenoll, C., Sabadash, V., Haby, C., Witz, F., Lhuire, M., Delaunay, J., Airiau, L., Mannone, L., Touitou, I., Umuhire, D., Alexis, M., Michel, O., Dreyfus, F., Bouscary, D., Cheung, A., Sanhes, L., Touhami, F., Ribas, E., Puyade, M., Gallego-Hernanz, M.-P., Hugon, N., Himberlin, C., Maggi, L., Lamy, T., Testu, A., Tavernier, E., Marchand, S., Lioure, B., Kravanja, C., Benboubker, L., Nollet, D., Attal, M., Sarry, A., Lhermitte, A., Yrica, G., Schwartz, D., Le Montagner, N., Auvray, L., Delepine, R., Fayault, A., Centre de Recherches en Cancérologie de Toulouse (CRCT), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service d'Hématologie Biologique [Hôpital Robert Debré, Paris], AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Bordeaux, Service d'Hématologie Clinique et Thérapie Cellulaire, F-33000 Bordeaux, France., Biothérapies des maladies génétiques et cancers, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier de la Côte Basque (CHCB), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Département d'Oncologie et Hématologie [Strasbourg], Les Hôpitaux Universitaires de Strasbourg (HUS), Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), Université Clermont Auvergne (UCA), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département d'Hématologie Clinique (BREST - Hémato Clinique), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Université de Montpellier (UM), Service d’Hématologie [Institut Paoli Calmettes, Marseille], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Innate Immunity and Immunotherapy (CRCINA-ÉQUIPE 7), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), and Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)

Subjects
0301 basic medicine, Oncology, Male, Cancer Research, medicine.medical_specialty, NPM1, Karyotype, [SDV.CAN]Life Sciences [q-bio]/Cancer, Risk profile, law.invention, 03 medical and health sciences, Cytogenetics, 0302 clinical medicine, Randomized controlled trial, law, Lomustine, Internal medicine, medicine, Biomarkers, Tumor, Idarubicin, Humans, Antineoplastic Agents, Alkylating, ComputingMilieux_MISCELLANEOUS, Chromosome Aberrations, business.industry, Cytarabine, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, Middle Aged, Prognosis, 3. Good health, Leukemia, Myeloid, Acute, 030104 developmental biology, 030220 oncology & carcinogenesis, Karyotyping, Mutation, Female, business, Nucleophosmin, medicine.drug
Abstract

International audience; We previously reported the benefit of lomustine addition to conventional chemotherapy in older acute myeloid leukemias with nonadverse chromosomal aberrations in the LAM-SA 2007 randomized clinical trial (NCT00590837). A molecular analysis of 52 genes performed in 330 patients included in this trial, 163 patients being treated with lomustine in combination with idarubicin and cytarabine and 167 without lomustine, identified 1088 mutations with an average of 3.3 mutations per patient. NPM1, FLT3, and DNMT3A were the most frequently mutated genes. A putative therapeutic target was identified in 178 patients (54%). Among five molecular classifications analyzed, the ELN2017 risk classification has the stronger association with the clinical evolution. Patients not treated with lomustine have an expected survival prognosis in agreement with this classification regarding the overall and event-free survivals. In strong contrast, lomustine erased the ELN2017 classification prognosis. The benefit of lomustine in nonadverse chromosomal aberrations was restricted to patients with RUNX1, ASXL1, TP53, and FLT3-ITDhigh/NPM1WT mutations in contrast to the intermediate and favorable ELN2017 patients. This post-hoc analysis identified a subgroup of fit elderly AML patients with intermediate cytogenetics and molecular markers who may benefit from lomustine addition to intensive chemotherapy.

Published
2021
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4. Test fonctionnel de la p53 et corrélation avec la délétion 17p et/ou les mutations de TP53 dans la leucémie lymphoïde chronique. Résultats du protocole ICLL001 BOMP sous l’égide du groupe FILO

Author

Le Garff-Tavernier, M., Quiney, C., Véronèse, Lauren, Nguyen-Khac, F., Robbe, P., Combes, P., Dihuydy, M.S., Feugier, P., Mahé, B., Sanhes, L., Delmer, A., Ysebaert, Loic, Truchan-Graczyk, M., Dreyfus, B., Choquet, S., Aurran, T., Ferrant, E., Dartigeas, C., Lepretre, S., Pica, G.M., Davi, F., Pereira, Bruno, Delepine, R., Schuh, A., Guiéze, Romain, Bay, Jacques‐Olivier, Leblond, V., Merle-Béral, H., De Guibert, S., Tournilhac, Olivier, Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Clermont-Ferrand, Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), and Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
[SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology
Abstract

04-19; International audience

Published
2019

5. PF393 A RANDOMISED JOINT AUSTRALASIAN (ALLG) AND FRENCH (FILO) STUDY OF LENALIDOMIDE CONSOLIDATION IN PATIENTS WITH RESIDUAL CLL AFTER FRONT-LINE TREATMENT WITH FC/FCR (THE CLL6 TRIAL)

Author

Gottlieb, D., primary, Aurran-Schleinitz, T., additional, Mulligan, S., additional, Letestu, R., additional, Sartor, M., additional, Bene, M., additional, Kuss, B., additional, Delepine, R., additional, Nguyen, U., additional, Butcher, B., additional, Dreyfus, F., additional, Tam, C., additional, and Cymbalista, F., additional

Published
2019
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12. Prognostic value of high-sensitivity measurable residual disease assessment after front-line chemoimmunotherapy in chronic lymphocytic leukemia.

Author

Letestu R, Dahmani A, Boubaya M, Baseggio L, Campos L, Chatelain B, Debliquis A, Drénou B, Jacob MC, Legac E, Le Garff-Tavernier M, Lhoumeau AC, Quiney C, Robillard N, Ticchioni M, Aanei C, Katsahian S, Delepine R, Vaudaux S, Rouillé V, Béné MC, Dartigeas C, Van Den Neste E, Leprêtre S, Feugier P, Cartron G, Leblond V, Lévy V, and Cymbalista F

Subjects
Aged, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Cyclophosphamide administration & dosage, Female, Follow-Up Studies, Humans, Leukemia, Lymphocytic, Chronic, B-Cell immunology, Leukemia, Lymphocytic, Chronic, B-Cell therapy, Male, Prognosis, Retrospective Studies, Rituximab administration & dosage, Survival Rate, Vidarabine administration & dosage, Vidarabine analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bone Marrow pathology, Immunotherapy mortality, Leukemia, Lymphocytic, Chronic, B-Cell pathology, Neoplasm, Residual pathology
Abstract

Measurable residual disease (MRD) status is widely adopted in clinical trials in patients with chronic lymphocytic leukemia (CLL). Findings from FILO group trials (CLL2007FMP, CLL2007SA, CLL2010FMP) enabled investigation of the prognostic value of high-sensitivity (0.7 × 10 -5 ) MRD assessment using flow cytometry, in blood (N = 401) and bone marrow (N = 339), after fludarabine, cyclophosphamide, and rituximab (FCR)-based chemoimmunotherapy in a homogeneous population with long follow-up (median 49.5 months). Addition of low-level positive MRD < 0.01% to MRD ≥ 0.01% increased the proportion of cases with positive MRD in blood by 39% and in bone marrow by 27%. Compared to low-level positive MRD < 0.01%, undetectable MRD was associated with significantly longer progression-free survival (PFS) when using blood (72.2 versus 42.7 months; hazard ratio 0.40, p = 0.0003), but not when using bone marrow. Upon further stratification, positive blood MRD at any level, compared to undetectable blood MRD, was associated with shorter PFS irrespective of clinical complete or partial remission, and a lower 5-year PFS rate irrespective of IGHV-mutated or -unmutated status (all p < 0.05). In conclusion, high-sensitivity (0.0007%) MRD assessment in blood yielded additional prognostic information beyond the current standard sensitivity (0.01%). Our approach provides a model for future determination of the optimal MRD investigative strategy for any regimen.

Published
2021
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13. Improved Survival by Adding Lomustine to Conventional Chemotherapy for Elderly Patients With AML Without Unfavorable Cytogenetics: Results of the LAM-SA 2007 FILO Trial.

Author

Pigneux A, Béné MC, Salmi LR, Dumas PY, Delaunay J, Bonmati C, Guièze R, Luquet I, Cornillet-Lefebvre P, Delabesse E, Ianotto JC, Ojeda-Uribe M, Hunault M, Banos A, Fornecker LM, Bernard M, Jourdan E, Vey N, Zerazhi H, Hishri Y, Mineur A, Asselineau J, Delepine R, Cahn JY, Ifrah N, and Récher C

Abstract

Purpose: Acute myeloid leukemia (AML) in elderly patients has a poor prognosis. In an attempt to improve outcome for these patients, the prospective open-label phase III LAM-SA 2007 (Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old) trial randomly assigned patients to a standard induction regimen with lomustine added or to a consolidation regimen with cytarabine and idarubicin., Patients and Methods: Adults age 60 years or older with previously untreated AML who were fit to receive intensive chemotherapy and who were without unfavorable cytogenetics received standard chemotherapy with lomustine (idarubicin, cytarabine, and lomustine [ICL]) or without (idarubicin and cytarabine [IC]). The primary objective of the study was overall survival (OS); secondary objectives were response rate, cumulative incidence of relapse (CIR), event-free survival (EFS), and safety., Results: From February 2008 to December 2011, 459 patients were enrolled. Comparing patients in the IC and ICL arms, complete response or complete response with incomplete recovery was achieved in 74.9% versus 84.7% ( P = .01). The proportional hazards assumption was rejected for OS ( P = .02), which led us to consider two separate time intervals: during and after induction. There was no significant difference between the two arms during induction, although induction deaths were 3.7% versus 7.7%, respectively ( P = .11). However, significantly better results were observed after induction with an improved 2-year OS of 56% in the ICL arm versus 48% in the IC arm ( P = .02). At 2 years, EFS was improved at 41% in the ICL arm versus 26% in the IC arm ( P = .01). The CIR at 2 years was 41.2% in the ICL arm versus 60.9% in the IC arm ( P = .003). Grade 3 and 4 toxicities, mostly hematologic, were significantly higher in the ICL arm ( P = .04), and fewer patients required a second treatment after ICL., Conclusion: Adding lomustine to standard chemotherapy significantly improved the outcome of elderly patients with AML.

Published
2018
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14. Evaluating abbreviated induction with fludarabine, cyclophosphamide, and dose-dense rituximab in elderly patients with chronic lymphocytic leukemia.

Author

Dartigeas C, Van Den Neste E, Berthou C, Maisonneuve H, Leprêtre S, Dilhuydy MS, Béné MC, Nguyen-Khac F, Letestu R, Cymbalista F, De Guibert S, Aurran T, Laribi K, Vilque JP, Tournilhac O, Delmer A, Feugier P, Cazin B, Michallet AS, Lévy V, Troussard X, Delepine R, Tavernier E, Colombat P, and Leblond V

Abstract

Elderly patients with chronic lymphocytic leukemia (CLL) are underrepresented in trials evaluating fludarabine, cyclophosphamide, and rituximab (FCR). We assessed four cycles of FCR with two additional rituximab doses on day 14 of cycles 1 and 2 in 194 untreated CLL patients > 65 years (median age 71.2) without del17p. Four FCR cycles were administered to 90.7% (176/194), with (n = 74) or without (n = 102) dose-delay and/or dose-reduction. A total of 50% grade 3/4 neutropenia occurred after each cycle. Only 6.2% cycles were associated with severe infection. Complete remission (CR) was achieved in 19.7%, and partial remission (PR) in 73.9% of patients. Minimal residual disease (MRD) was negative in 36.7%. Overall survival at 36 months was estimated at 87.4%. Oral FC and dose-dense rituximab is feasible and active in fit elderly CLL patients. However, myelosuppression is significant and frequent dose adaptations are required implying that these results cannot be generalized to unfit or frail elderly CLL.

Published
2016
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15. High-dose therapy followed by autologous purged stem-cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by GOELAMS.

Author

Deconinck E, Foussard C, Milpied N, Bertrand P, Michenet P, Cornillet-LeFebvre P, Escoffre-Barbe M, Maisonneuve H, Delwail V, Gressin R, Legouffe E, Vilque JP, Desablens B, Jaubert J, Ramee JF, Jenabian A, Thyss A, Le Pourhiet-Le Mevel A, Travade P, Delepine R, and Colombat P

Subjects
Adult, Disease Progression, Doxorubicin adverse effects, Feasibility Studies, Female, Follow-Up Studies, France, Humans, Lymphoma, Follicular drug therapy, Lymphoma, Follicular surgery, Male, Middle Aged, Neoplasm Staging, Recurrence, Survival Rate, Transplantation, Autologous, Doxorubicin therapeutic use, Lymphoma, Follicular pathology, Lymphoma, Follicular therapy, Stem Cell Transplantation
Abstract

Doxorubicin-based immunochemotherapy, with interferon, has been shown to improve survival in patients with advanced follicular lymphoma. High-dose chemotherapy with stem-cell support is effective in follicular lymphoma in relapse but remains controversial as a first-line therapy. In a randomized study using a purged autologous stem-cell support, we compared these 2 approaches in patients with advanced follicular lymphoma. Newly diagnosed advanced follicular lymphoma patients (172 patients) were randomly assigned either to an immunochemotherapy regimen (cyclophosphamide, doxorubicin, teniposide, prednisone, and interferon) or to a high-dose therapy followed by purged autologous stem-cell transplantation. Compared with the patients who received chemotherapy and interferon, patients treated with high-dose therapy had a higher response rate (69% vs 81%, P = .045) and a longer median event-free survival (not reached vs 45 months). This did not translate into a better survival rate due to an excess of secondary malignancies after transplantation. The Follicular Lymphoma Prognostic Index identified a subgroup of patients with a significantly higher event-free survival rate after high-dose therapy. Autologous stem-cell transplantation cannot be considered as the standard first-line treatment of follicular lymphoma for patients younger than 60 years old with a high tumor burden.

Published
2005
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