Lower Malignancy Rates in Renal Allograft Recipients Converted to Sirolimus-Based, Calcineurin Inhibitor-Free Immunotherapy: 24-Month Results From the CONVERT Trial
| Autor: | E Maller, Joan M. Korth-Bradley, John F. Neylan, Josefina Alberú, Robert Goldberg-Alberts, Martin S. Polinsky, Francesco Paolo Schena, Josep M. Campistol, M Rial, M.D Pascoe |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Graft Rejection Male medicine.medical_specialty Skin Neoplasms Randomization Adolescent medicine.medical_treatment Urology Malignancy law.invention Immunocompromised Host Young Adult Randomized controlled trial law medicine Humans Transplantation Homologous Child Adaptor Proteins Signal Transducing Aged Sirolimus Transplantation business.industry Contraindications Immunosuppression Middle Aged medicine.disease Kidney Transplantation Calcineurin Regimen Immunology Female business Immunosuppressive Agents Follow-Up Studies medicine.drug |
| Zdroj: | Transplantation. 92:303-310 |
| ISSN: | 0041-1337 |
| DOI: | 10.1097/tp.0b013e3182247ae2 |
| Popis: | BACKGROUND Long-term immunosuppression imposes increased malignancy risk in renal allograft recipients, significantly contributing to overall morbidity and mortality. This study examined malignancy rates in renal allograft recipients at 2 years after conversion to a sirolimus (SRL)-based, calcineurin inhibitor (CNI)-free regimen. METHODS This open-label, randomized, multicenter study (the CONVERT Trial) randomly assigned 830 patients to SRL conversion (n=555) or CNI continuation (n=275). Patients with history of posttransplant lymphoproliferative disease or known/suspected malignancy within 5 years before screening were excluded. As part of standard safety measurements, subjects were monitored for any malignancy occurrence; both skin and nonskin malignancies were reported, even if the patient discontinued from the therapy. Malignancy rates were analyzed based on exposure time to study drugs (i.e., number of events per 100 person-years of follow-up). RESULTS At 2 years postconversion, the total number of malignancies per 100 person-years of exposure was significantly lower among SRL conversion patients compared with CNI continuation (2.1 vs. 6.0, P |
| Databáze: | OpenAIRE |
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