Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: Updated results of the CLL8 trial
| Autor: | Stephan Stilgenbauer, Hartmut Döhner, Paula Marlton, Marco Herling, Barbara Eichhorst, Paula Cramer, Eugen Tausch, Michael Hallek, Clemens M. Wendtner, Paolo Ghia, Karl Anton Kreuzer, Jasmin Bahlo, Christian Maurer, Julia von Tresckow, Carmen D. Herling, Sebastian Böttcher, Valentin Goede, Anja Engelke, Petra Langerbeins, Michael Kneba, Kirsten Fischer, Anna-Maria Fink, John F. Seymour, Gabor Kovacs |
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| Přispěvatelé: | Fischer, Kirsten, Bahlo, Jasmin, Fink, Anna Maria, Goede, Valentin, Herling, Carmen Diana, Cramer, Paula, Langerbeins, Petra, Von Tresckow, Julia, Engelke, Anja, Maurer, Christian, Kovacs, Gabor, Herling, Marco, Tausch, Eugen, Kreuzer, Karl Anton, Eichhorst, Barbara, Böttcher, Sebastian, Seymour, John F., Ghia, PAOLO PROSPERO, Marlton, Paula, Kneba, Michael, Wendtner, Clemens Martin, Döhner, Hartmut, Stilgenbauer, Stephan, Hallek, Michael |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Chronic lymphocytic leukemia Immunology Neutropenia Gastroenterology Biochemistry Disease-Free Survival Follow-Up Studie 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Chemoimmunotherapy Obinutuzumab Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Cyclophosphamide Aged Aged 80 and over Antineoplastic Combined Chemotherapy Protocol business.industry Medicine (all) Hazard ratio Remission Induction Hematology Cell Biology Middle Aged medicine.disease Combined Modality Therapy Leukemia Lymphocytic Chronic B-Cell Fludarabine Treatment Outcome chemistry 030220 oncology & carcinogenesis Female Immunotherapy IGHV@ business Rituximab Untreated Chronic Lymphocytic Leukemia Vidarabine 030215 immunology medicine.drug Follow-Up Studies Human |
| Popis: | Despite promising results with targeted drugs, chemoimmunotherapy with fludarabine, cyclophosphamide (FC), and rituximab (R) remains the standard therapy for fit patients with untreated chronic lymphocytic leukemia (CLL). Herein, we present the long-term follow-up of the randomized CLL8 trial reporting safety and efficacy of FC and FCR treatment of 817 treatment-naive patients with CLL. The primary end point was progression-free survival (PFS). With a median follow-up of 5.9 years, median PFS were 56.8 and 32.9 months for the FCR and FC group (hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.50-0.69, P < .001). Median overall survival (OS) was not reached for the FCR group and was 86.0 months for the FC group (HR, 0.68; 95% CI, 0.54-0.89, P = .001). In patients with mutated IGHV (IGHV MUT), FCR improved PFS and OS compared with FC (PFS: HR, 0.47; 95% CI, 0.33-0.68, P < .001; OS: HR, 0.62; 95% CI, 0.34-1.11, P = .1). This improvement remained applicable for all cytogenetic subgroups other than del(17p). Long-term safety analyses showed that FCR had a higher rate of prolonged neutropenia during the first year after treatment (16.6% vs 8.8%; P = .007). Secondary malignancies including Richter's transformation occurred in 13.1% in the FCR group and in 17.4% in the FC group (P = .1). First-line chemoimmunotherapy with FCR induces long-term remissions and highly relevant improvement in OS in specific genetic subgroups of fit patients with CLL, in particular those with IGHV MUT. This trial was registered at www.clinicaltrials.gov as #NCT00281918. |
| Databáze: | OpenAIRE |
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