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3. Utilizing risk factors to guide treatment decisions in chronic lymphocytic leukemia.

Author

Lopedote, Paolo, Kittai, Adam S., and Danilov, Alexey

Subjects
CHRONIC lymphocytic leukemia, PROGNOSIS, BRUTON tyrosine kinase, OVERALL survival, VENETOCLAX
Abstract

Introduction: In the era of chemo-immunotherapy, high-risk factors unequivocally predicted inferior outcomes for patients with CLL. The widespread adoption of BTK inhibitors has challenged the practical implications of such testing, as many patients have improved outcomes despite the presence of high-risk features. The impact of adverse prognostic factors, such as unmutated IGHV, on survival has been ameliorated by continuous treatment with BTK inhibitors, but not by finite-duration therapy with venetoclax-based combinations. Furthermore, TP53 abnormalities continue to be associated with worse outcomes in the era of novel agents. New treatment modalities, such as pirtobrutinib, lisocabtagene maraleucel, and ongoing studies combining BTK inhibitors with venetoclax, raise new questions on the significance of prognostic factors of survival for patients with CLL. Areas covered: Herein, we summarized the available literature on patients with CLL harboring high-risk biomarkers, with a focus on data from key clinical trials. Expert opinion: Testing for prognostic biomarkers will remain relevant to identify patients who may have increased benefit from novel therapeutic strategies, such as combination therapies and novel agents. Patients with high-risk disease should be encouraged to participate in clinical trials. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Improving the antitumor activity of R-CHOP with NGR-hTNF in primary CNS lymphoma: final results of a phase 2 trial

Author

Ferreri, Andrés J.M., Calimeri, Teresa, Ponzoni, Maurilio, Curnis, Flavio, Conte, Gian Marco, Scarano, Eloise, Rrapaj, Eltjona, De Lorenzo, Daniela, Cattaneo, Dario, Fallanca, Federico, Nonis, Alessandro, Foppoli, Marco, Lopedote, Paolo, Citterio, Giovanni, Politi, Letterio S., Sassone, Marianna, Angelillo, Piera, Guggiari, Elena, Steffanoni, Sara, Tarantino, Vittoria, Ciceri, Fabio, Bordignon, Claudio, Anzalone, Nicoletta, and Corti, Angelo

Published
2020
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7. R-CHOP preceded by blood-brain barrier permeabilization with engineered tumor necrosis factor-α in primary CNS lymphoma

Author

Ferreri, Andrés J.M., Calimeri, Teresa, Conte, Gian Marco, Cattaneo, Dario, Fallanca, Federico, Ponzoni, Maurilio, Scarano, Eloise, Curnis, Flavio, Nonis, Alessandro, Lopedote, Paolo, Citterio, Giovanni, Politi, Letterio S., Foppoli, Marco, Girlanda, Stefania, Sassone, Marianna, Perrone, Salvatore, Cecchetti, Caterina, Ciceri, Fabio, Bordignon, Claudio, Corti, Angelo, and Anzalone, Nicoletta

Published
2019
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19. MYD88 L265P mutation and interleukin‐10 detection in cerebrospinal fluid are highly specific discriminating markers in patients with primary central nervous system lymphoma: results from a prospective study

Author

Ferreri, Andrés J. M., primary, Calimeri, Teresa, additional, Lopedote, Paolo, additional, Francaviglia, Ilaria, additional, Daverio, Rita, additional, Iacona, Chiara, additional, Belloni, Cristina, additional, Steffanoni, Sara, additional, Gulino, Alessandro, additional, Anghileri, Elena, additional, Diffidenti, Angelo, additional, Finardi, Annamaria, additional, Gagliardi, Filippo, additional, Anzalone, Nicoletta, additional, Nonis, Alessandro, additional, Furlan, Roberto, additional, De Lorenzo, Daniela, additional, Terreni, Maria R., additional, Martinelli, Vittorio, additional, Sassone, Marianna, additional, Foppoli, Marco, additional, Angelillo, Piera, additional, Guggiari, Elena, additional, Falini, Andrea, additional, Mortini, Pietro, additional, Filippi, Massimo, additional, Tarantino, Vittoria, additional, Eoli, Marica, additional, Ciceri, Fabio, additional, Doglioni, Claudio, additional, Tripodo, Claudio, additional, Locatelli, Massimo, additional, Cangi, Maria Giulia, additional, and Ponzoni, Maurilio, additional

Published
2021
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20. Blood-Brain Barrier Permeabilization with Engineered Tumor Necrosis Factor-α Followed by R-CHOP Is an Active and Safe Salvage Therapy in Primary CNS Lymphoma

Author

Ferreri, Andrés, primary, Calimeri, Teresa, additional, Ponzoni, Maurilio, additional, Curnis, Flavio, additional, Conte, Gian Marco, additional, Scarano, Eloise, additional, Rrapaj, Eltjona, additional, De Lorenzo, Daniela, additional, Cattaneo, Dario, additional, Fallanca, Federico, additional, Nonis, Alessandro, additional, Foppoli, Marco, additional, Lopedote, Paolo, additional, Citterio, Giovanni, additional, Politi, Letterio S., additional, Sassone, Marianna, additional, Angelillo, Piera, additional, Guggiari, Elena, additional, Steffanoni, Sara, additional, Tarantino, Vittoria, additional, Ciceri, Fabio, additional, Bordignon, Claudio, additional, Anzalone, Nicoletta, additional, and Corti, Angelo, additional

Published
2020
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21. Clinical Relevance of MYD88 L265P Mutation and Interleukin-10 Level in Cerebrospinal Fluid of Patients with Both Newly Diagnosed and Relapsed Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

Author

Ferreri, Andres JM, primary, Calimeri, Teresa, additional, Lopedote, Paolo, additional, Francaviglia, Ilaria, additional, Daverio, Rita, additional, Iacona, Chiara, additional, Belloni, Cristina, additional, Steffanoni, Sara, additional, Anghileri, Elena, additional, Diffidenti, Angelo, additional, Finardi, Annamaria, additional, Gagliardi, Filipppo, additional, Anzalone, Nicoletta, additional, Nonis, Alessandro, additional, Furlan, Roberto, additional, Angelillo, Piera, additional, Sassone, Marianna, additional, De Lorenzo, Daniela, additional, Terreni, Maria Rosa, additional, Foppoli, Marco, additional, Guggiari, Elena, additional, Tarantino, Vittoria, additional, Eoli, Marika, additional, Ciceri, Fabio, additional, Doglioni, Claudio, additional, Locatelli, Massimo, additional, Ponzoni, Maurilio, additional, and Cangi, Maria Giulia, additional

Published
2019
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23. R-CHOP Preceded By Engineered Tumor Necrosis Factor (TNF) in Patients with Relapsed or Refractory (r/r) Primary CNS Lymphoma (PCNSL): Results of Antitumor Activity, Safety and Blood-Brain Barrier (BBB) Permeabilization in the "Ingrid" Phase II Trial

Author

Ferreri, Andres JM, primary, Calimeri, Teresa, additional, Conte, Gian Marco, additional, Cattaneo, Dario, additional, Fallanca, Federico, additional, Ponzoni, Maurilio, additional, Scarano, Eloise, additional, Sassone, Marianna, additional, Perrone, Salvatore, additional, Cecchetti, Caterina, additional, Lopedote, Paolo, additional, Ilariucci, Fiorella, additional, Rudà, Roberta, additional, Angelucci, Emanuele, additional, Visco, Carlo, additional, Pisani, Francesco, additional, Fabbri, Alberto, additional, Petrucci, Luigi, additional, Bregni, Marco, additional, Marino, Dario, additional, Gini, Guido, additional, Ciceri, Fabio, additional, Corti, Angelo, additional, and Anzalone, Nicoletta, additional

Published
2018
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24. R-CHOP preceded by blood-brain barrier permeabilization (BBBp) by NGR-tumor necrosis factor (NGR-hTNF) in patients with relapsed or refractory primary CNS lymphoma (rrPCNSL): First results of the “INGRID” phase II trial.

Author

Ferreri, Andres J., primary, Calimeri, Teresa, additional, Conte, Gian Marco, additional, Lopedote, Paolo, additional, Foppoli, Marco, additional, Girlanda, Stefania, additional, Corti, Angelo, additional, Cattaneo, Dario, additional, Fallanca, Federico, additional, Nonis, Alessandro, additional, Ponzoni, Maurilio, additional, Citterio, Giovanni, additional, Politi, Letterio, additional, Sassone, Marianna, additional, Perrone, Salvatore, additional, Cecchetti, Caterina, additional, Ciceri, Fabio, additional, Bordignon, Claudio, additional, and Anzalone, Nicoletta, additional

Published
2018
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25. R-CHOP preceded by blood-brain barrier permeabilization with engineered tumor necrosis factor-a in primary CNS lymphoma

Author

Ferreri, Andrés J. M., Calimeri, Teresa, Conte, Gian Marco, Cattaneo, Dario, Fallanca, Federico, Ponzoni, Maurilio, Scarano, Eloise, Curnis, Flavio, Nonis, Alessandro, Lopedote, Paolo, Citterio, Giovanni, Politi, Letterio S., Foppoli, Marco, Girlanda, Stefania, Sassone, Marianna, Perrone, Salvatore, Cecchetti, Caterina, Ciceri, Fabio, Bordignon, Claudio, Corti, Angelo, and Anzalone, Nicoletta

Abstract

Patients with primary central nervous system lymphoma (PCNSL) are treated with high-dose methotrexate-based chemotherapy, which requires hospitalization and extensive expertise to manage related toxicity. The use of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) could overcome these difficulties, but blood-brain barrier (BBB) penetration of related drugs is poor. Tumor necrosis factor-a coupled with NGR (NGR-hTNF), a peptide targeting CD13+ vessels, induces endothelial permeabilization and improves tumor access of cytostatics. We tested the hypothesis that NGR-hTNF can break the BBB, thereby improving penetration and activity of R-CHOP in patients with relapsed/refractory PCNSL (NCT03536039). Patients received six R-CHOP21 courses, alone at the first course and preceded by NGR-hTNF (0.8 µg/m2) afterward. This trial included 2 phases: an “explorative phase” addressing the effect of NGR-hTNF on drug pharmacokinetic parameters and on vessel permeability, assessed by dynamic contrast-enhanced magnetic resonance imaging and 99mTc-diethylene-triamine-pentacetic acid–single-photon emission computed tomography, and the expression of CD13 on tumor tissue; and an “expansion phase” with overall response rate as the primary end point, in which the 2-stage Simon Minimax design was used. At the first stage, if =4 responses were observed among 12 patients, the study accrual would have continued (sample size, 28). Herein, we report results of the explorative phase and the first-stage analysis (n = 12). CD13 was expressed in tumor vessels of all cases. NGR-hTNF selectively increased vascular permeability in tumoral/peritumoral areas, without interfering with drug plasma/cerebrospinal fluid concentrations. The NGR-hTNF/R-CHOP combination was well tolerated: there were only 2 serious adverse events, and grade 4 toxicity was almost exclusively hematological, which were resolved without dose reductions or interruptions. NGR-hTNF/R-CHOP was active, with 9 confirmed responses (75%; 95% confidence interval, 51-99), 8 of which were complete. In conclusion, NGR-hTNF/R-CHOP was safe in these heavily pretreated patients. NGR-hTNF enhanced vascular permeability specifically in tumoral/peritumoral areas, which resulted in fast and sustained responses.

Published
2019
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26. R-CHOP preceded by blood-brain barrier permeabilization with engineered tumor necrosis factor-α in primary CNS lymphoma

Author

C. Cecchetti, Salvatore Perrone, Angelo Corti, Claudio Bordignon, Flavio Curnis, Marianna Sassone, Giovanni Citterio, Maurilio Ponzoni, Andrés J.M. Ferreri, Teresa Calimeri, Letterio S. Politi, Gian Marco Conte, Dario Cattaneo, Marco Foppoli, Eloise Scarano, Fabio Ciceri, Federico Fallanca, Alessandro Nonis, Stefania Girlanda, Nicoletta Anzalone, Paolo Lopedote, Ferreri, Andrés J M, Calimeri, Teresa, Conte, Gian Marco, Cattaneo, Dario, Fallanca, Federico, Ponzoni, Maurilio, Scarano, Eloise, Curnis, Flavio, Nonis, Alessandro, Lopedote, Paolo, Citterio, Giovanni, Politi, Letterio, Foppoli, Marco, Girlanda, Stefania, Sassone, Marianna, Perrone, Salvatore, Cecchetti, Caterina, Ciceri, Fabio, Bordignon, Claudio, Corti, Angelo, and Anzalone, Nicoletta

Subjects
Male, Oncology, Vincristine, medicine.medical_specialty, Cell Membrane Permeability, Cyclophosphamide, Recombinant Fusion Proteins, medicine.medical_treatment, Immunology, Neuroimaging, Vascular permeability, CD13 Antigens, Blood–brain barrier, Biochemistry, Central Nervous System Neoplasms, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Doxorubicin, Tomography, Emission-Computed, Single-Photon, Chemotherapy, Tumor Necrosis Factor-alpha, business.industry, Lymphoma, Non-Hodgkin, Primary central nervous system lymphoma, Cell Biology, Hematology, medicine.disease, Immunohistochemistry, Treatment Outcome, medicine.anatomical_structure, Blood-Brain Barrier, Research Design, Prednisone, Female, Rituximab, business, Biomarkers, medicine.drug
Abstract

Patients with primary central nervous system lymphoma (PCNSL) are treated with high-dose methotrexate-based chemotherapy, which requires hospitalization and extensive expertise to manage related toxicity. The use of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) could overcome these difficulties, but blood-brain barrier (BBB) penetration of related drugs is poor. Tumor necrosis factor-α coupled with NGR (NGR-hTNF), a peptide targeting CD13+ vessels, induces endothelial permeabilization and improves tumor access of cytostatics. We tested the hypothesis that NGR-hTNF can break the BBB, thereby improving penetration and activity of R-CHOP in patients with relapsed/refractory PCNSL (NCT03536039). Patients received six R-CHOP21 courses, alone at the first course and preceded by NGR-hTNF (0.8 μg/m2) afterward. This trial included 2 phases: an “explorative phase” addressing the effect of NGR-hTNF on drug pharmacokinetic parameters and on vessel permeability, assessed by dynamic contrast-enhanced magnetic resonance imaging and 99mTc-diethylene-triamine-pentacetic acid–single-photon emission computed tomography, and the expression of CD13 on tumor tissue; and an “expansion phase” with overall response rate as the primary end point, in which the 2-stage Simon Minimax design was used. At the first stage, if ≥4 responses were observed among 12 patients, the study accrual would have continued (sample size, 28). Herein, we report results of the explorative phase and the first-stage analysis (n = 12). CD13 was expressed in tumor vessels of all cases. NGR-hTNF selectively increased vascular permeability in tumoral/peritumoral areas, without interfering with drug plasma/cerebrospinal fluid concentrations. The NGR-hTNF/R-CHOP combination was well tolerated: there were only 2 serious adverse events, and grade 4 toxicity was almost exclusively hematological, which were resolved without dose reductions or interruptions. NGR-hTNF/R-CHOP was active, with 9 confirmed responses (75%; 95% confidence interval, 51-99), 8 of which were complete. In conclusion, NGR-hTNF/R-CHOP was safe in these heavily pretreated patients. NGR-hTNF enhanced vascular permeability specifically in tumoral/peritumoral areas, which resulted in fast and sustained responses.

Published
2019
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