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Pettitt, Andrew R.; Jackson, Richard; Carruthers, Stacey; Dodd, James; Dodd, Susanna; Oates, Melanie; Johnson, Gillian G.; Schuh, Anna; Matutes, Estella; Dearden, Claire E.; Catovsky, Daniel; Radford, John A.; Bloor, Adrian; Follows, George A.; Devereux, Stephen; Kruger, Anton; Blundell, Julie; Agrawal, Samir; Allsup, David; Proctor, Stephen; Heartin, Earnest; Oscier, David; Hamblin, Terry J.; Rawstron, Andrew;

Alemtuzumab in Combination With Methylprednisolone Is a Highly Effective Induction Regimen for Patients With Chronic Lymphocytic Leukemia and Deletion of TP53: Final Results of the National Cancer Research Institute CLL206 Trial

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  • Medientyp: E-Artikel
  • Titel: Alemtuzumab in Combination With Methylprednisolone Is a Highly Effective Induction Regimen for Patients With Chronic Lymphocytic Leukemia and Deletion of TP53: Final Results of the National Cancer Research Institute CLL206 Trial
  • Beteiligte: Pettitt, Andrew R.; Jackson, Richard; Carruthers, Stacey; Dodd, James; Dodd, Susanna; Oates, Melanie; Johnson, Gillian G.; Schuh, Anna; Matutes, Estella; Dearden, Claire E.; Catovsky, Daniel; Radford, John A.; Bloor, Adrian; Follows, George A.; Devereux, Stephen; Kruger, Anton; Blundell, Julie; Agrawal, Samir; Allsup, David; Proctor, Stephen; Heartin, Earnest; Oscier, David; Hamblin, Terry J.; Rawstron, Andrew;
  • Erschienen: American Society of Clinical Oncology (ASCO), 2012
  • Erschienen in: Journal of Clinical Oncology
  • Sprache: Englisch
  • DOI: 10.1200/jco.2011.35.9695
  • ISSN: 1527-7755; 0732-183X
  • Schlagwörter: Cancer Research ; Oncology
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Purpose</jats:title><jats:p> In chronic lymphocytic leukemia (CLL), TP53 deletion/mutation is strongly associated with an adverse outcome and resistance to chemotherapy-based treatment. In contrast, TP53 defects are not associated with resistance to the anti-CD52 monoclonal antibody alemtuzumab or methylprednisolone. In an attempt to improve the treatment of TP53-defective CLL, a multicenter phase II study was developed to evaluate alemtuzumab and methylprednisolone in combination. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Thirty-nine patients with TP53-deleted CLL (17 untreated and 22 previously treated) received up to 16 weeks of treatment with alemtuzumab 30 mg three times a week and methylprednisolone 1.0 g/m<jats:sup>2</jats:sup> for five consecutive days every 4 weeks. Antimicrobial prophylaxis consisted of cotrimoxazole, itraconazole, and aciclovir (or valganciclovir for asymptomatic cytomegalovirus viremia). The primary end point was response as assigned by an end-point review committee. Secondary end points were safety, progression-free survival (PFS) and overall survival (OS). </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> The overall response rate, complete response rate (including with incomplete marrow recovery), median PFS, and median OS were 85%, 36%, 11.8 months, and 23.5 months, respectively, in the entire cohort and 88%, 65%, 18.3 months, and 38.9 months, respectively, in previously untreated patients. Grade 3 to 4 hematologic and glucocorticoid-associated toxicity occurred in 67% and 23% of patients, respectively. Grade 3 to 4 infection occurred in 51% of the overall cohort and in 29% of patients less than 60 years of age. Treatment-related mortality was 5%. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Alemtuzumab plus methypredisolone is the most effective induction regimen hitherto reported in TP53-deleted CLL. The risk of infection is age related and, in younger patients, seems only marginally higher than that associated with rituximab, fludarabine, and cyclophosphamide. </jats:p></jats:sec>
  • Zugangsstatus: Freier Zugang