Comparison of cladribine plus cyclophosphamide with fludarabine plus cyclophosphamide as first-line therapy for chronic lymphocytic leukemia: a phase III randomized study by the Polish Adult Leukemia Group (PALG-CLL3 Study)
| Autor: | Magdalena Piotrowska, Krzysztof Lewandowski, Jaroslaw Piszcz, Andrzej Zdunczyk, Krzysztof Jamroziak, Ilona Seferynska, Beata Stella-Holowiecka, Jadwiga Dwilewicz-Trojaczek, Aleksandra Kostyra, Krystyna Zawilska, Lech Konopka, Bernadetta Ceglarek, Tadeusz Robak, Andrzej Hellmann, Stanisław Potoczek, Joanna Gora-Tybor, Jerzy Z. Blonski, Anna Dmoszynska, Malgorzata Calbecka, Krzysztof Warzocha |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Cyclophosphamide Chronic lymphocytic leukemia Gastroenterology Immunophenotyping Internal medicine Antineoplastic Combined Chemotherapy Protocols Medicine Humans FC Regimen Cladribine Survival rate Aged Neoplasm Staging Aged 80 and over business.industry Remission Induction Middle Aged medicine.disease Leukemia Lymphocytic Chronic B-Cell Fludarabine Surgery Survival Rate Regimen Leukemia Treatment Outcome Oncology Cytogenetic Analysis Female business Vidarabine medicine.drug |
| Zdroj: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 28(11) |
| ISSN: | 1527-7755 |
| Popis: | Purpose Little is known about comparison of the activity of different purine nucleoside analogs in chronic lymphocytic leukemia (CLL). We conducted a randomized phase III trial to compare efficacy and safety of cladribine and fludarabine, each combined with cyclophosphamide, in previously untreated progressive CLL. Patients and Methods Patients received cladribine at 0.12 mg/kg combined with cyclophosphamide at 250 mg/m2 for 3 days intravenously (CC regimen) or fludarabine at 25 mg/m2 combined with cyclophosphamide at 250 mg/m2 for 3 days intravenously (FC regimen), every 28 days for up to six cycles. The primary end point was complete response (CR) rate. Secondary end points included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and treatment-related toxicity. Results Of 423 randomly assigned patients (211 to CC and 212 to FC), 395 were evaluated in the final analysis. The CR and ORR reached 47% and 88% in the CC arm and 46% and 82% in the FC arm (P = .25 and P = .11, respectively). The median PFS was 2.34 years with CC and 2.27 years with FC (P = .51). OS and grade 3/4 treatment-related toxicity were also comparable. Moreover, we did not observe any significant differences in CC and FC efficacy across different patient prognostic subgroups that included patients with 17p13 (TP53 gene) deletion who had poor survival in both study arms. Conclusion Cladribine and fludarabine in combination with cyclophosphamide are equally effective and safe first-line regimens for progressive CLL. Both combinations have unsatisfactory activity in patients with 17p13 (TP53 gene) deletion. |
| Databáze: | OpenAIRE |
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