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1.
Nat Med ; 29(4): 869-879, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-37069359

RESUMO

Autologous hematopoietic stem cell transplantation (ASCT) improves survival in multiple myeloma (MM). However, many individuals are unable to collect optimal CD34+ hematopoietic stem and progenitor cell (HSPC) numbers with granulocyte colony-stimulating factor (G-CSF) mobilization. Motixafortide is a novel cyclic-peptide CXCR4 inhibitor with extended in vivo activity. The GENESIS trial was a prospective, phase 3, double-blind, placebo-controlled, multicenter study with the objective of assessing the superiority of motixafortide + G-CSF over placebo + G-CSF to mobilize HSPCs for ASCT in MM. The primary endpoint was the proportion of patients collecting ≥6 × 106 CD34+ cells kg-1 within two apheresis procedures; the secondary endpoint was to achieve this goal in one apheresis. A total of 122 adult patients with MM undergoing ASCT were enrolled at 18 sites across five countries and randomized (2:1) to motixafortide + G-CSF or placebo + G-CSF for HSPC mobilization. Motixafortide + G-CSF enabled 92.5% to successfully meet the primary endpoint versus 26.2% with placebo + G-CSF (odds ratio (OR) 53.3, 95% confidence interval (CI) 14.12-201.33, P < 0.0001). Motixafortide + G-CSF also enabled 88.8% to meet the secondary endpoint versus 9.5% with placebo + G-CSF (OR 118.0, 95% CI 25.36-549.35, P < 0.0001). Motixafortide + G-CSF was safe and well tolerated, with the most common treatment-emergent adverse events observed being transient, grade 1/2 injection site reactions (pain, 50%; erythema, 27.5%; pruritis, 21.3%). In conclusion, motixafortide + G-CSF mobilized significantly greater CD34+ HSPC numbers within two apheresis procedures versus placebo + G-CSF while preferentially mobilizing increased numbers of immunophenotypically and transcriptionally primitive HSPCs. Trial Registration: ClinicalTrials.gov , NCT03246529.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Compostos Heterocíclicos , Mieloma Múltiplo , Adulto , Humanos , Mieloma Múltiplo/tratamento farmacológico , Transplante Autólogo , Estudos Prospectivos , Compostos Heterocíclicos/farmacologia , Compostos Heterocíclicos/uso terapêutico , Mobilização de Células-Tronco Hematopoéticas/métodos , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Células-Tronco Hematopoéticas/metabolismo , Antígenos CD34/metabolismo , Fator Estimulador de Colônias de Granulócitos/farmacologia , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Fatores Imunológicos/uso terapêutico
2.
Transpl Immunol ; 75: 101705, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36055435

RESUMO

Treatment of neoplastic diseases resistant to conventional chemotherapies is still an open challenge. The increasing development of chemical molecules or monoclonal antibodies able to recognize precise molecular targets of cancer disease has played an increasingly important role in treating patients suffering from solid or hematological tumors, and constitutes the basis of so-called 'targeted therapy'. Immunotherapy has become a cornerstone for treating refractory or relapsed cancer disease patients after standard chemotherapies. Immune checkpoint (including PD-1) inhibitors are essential drugs that significantly improve the therapeutic possibilities for neoplastic patients. Still, foreseeable or unpredictable adverse effects can potentially arise during or after the end of therapy. Specifically, toxicity involving several organs is capable of delaying or preventing the continuation of programmed treatment, as described in this case, where we will discuss the possibility of toxicity affecting various organs (kidney, muscle tissue, and thyroid) attributed to nivolumab and which resulted in temporary ineligibility for allogeneic transplantation.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Doença de Hodgkin , Hipotireoidismo , Miosite , Insuficiência Renal , Humanos , Inibidores de Checkpoint Imunológico , Receptor de Morte Celular Programada 1 , Doença de Hodgkin/tratamento farmacológico , Doença de Hodgkin/patologia , Transplante Homólogo , Miosite/tratamento farmacológico , Insuficiência Renal/tratamento farmacológico , Hipotireoidismo/tratamento farmacológico
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