Details

Autor(en) / Beteiligte

• Herling, Carmen D
• Cymbalista, Florence
• Groß-Ophoff-Müller, Carolin
• Bahlo, Jasmin
• Robrecht, Sandra
• Langerbeins, Petra
• Fink, Anna-Maria
• Al-Sawaf, Othman
• Busch, Raymonde
• Porcher, Raphael
• Cazin, Bruno
• Dreyfus, Brigitte
• Ibach, Stefan
• Leprêtre, Stéphane
• Fischer, Kirsten
• Kaiser, Florian
• Eichhorst, Barbara
• Wentner, Clemens-Martin
• Hoechstetter, Manuela A
• Döhner, Hartmut
• Leblond, Veronique
• Kneba, Michael
• Letestu, Remi
• Böttcher, Sebastian
• Stilgenbauer, Stephan
• Hallek, Michael
• Levy, Vincent

Titel

Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial

Ist Teil von

• Leukemia, 2020-08, Vol.34 (8), p.2038-2050

Ort / Verlag

England: Nature Publishing Group

Erscheinungsjahr

2020

Quelle

MEDLINE

Beschreibungen/Notizen

• We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care "watch and wait" for these patients.