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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; [...]

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

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  • Media type: E-Article
  • Title: 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
  • Contributor: 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; [...]
  • imprint: Springer Science and Business Media LLC, 2020
  • Published in: Leukemia
  • Language: English
  • DOI: 10.1038/s41375-020-0747-7
  • ISSN: 0887-6924; 1476-5551
  • Origination:
  • Footnote:
  • Description: <jats:title>Abstract</jats:title><jats:p>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 &lt;12 months, serum thymidine kinase &gt;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&amp;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&amp;W patients (median not reached vs. 18.5 months, <jats:italic>p</jats:italic> &lt; 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&amp;W, <jats:italic>p</jats:italic> = 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.</jats:p>