Fischer, Kirsten, Cramer, Paula, Busch, Raymonde, Stilgenbauer, Stephan, Bahlo, Jasmin, Schweighofer, Carmen D., Boettcher, Sebastian, Staib, Peter, Kiehl, Michael, Eckart, Michael J., Kranz, Gabriele, Goede, Valentin, Elter, Thomas, Buehler, Andreas, Winkler, Dirk, Kneba, Michael, Doehner, Hartmut, Eichhorst, Barbara F., Hallek, Michael and Wendtner, Clemens-Martin (2011). Bendamustine Combined With Rituximab in Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia: A Multicenter Phase II Trial of the German Chronic Lymphocytic Leukemia Study Group. J. Clin. Oncol., 29 (26). S. 3559 - 3567. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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Abstract

Purpose The objective of this trial was to evaluate safety and efficacy of bendamustine combined with rituximab (BR) in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL). Patients and Methods Seventy-eight patients, including 22 patients with fludarabine-refractory disease (28.2%) and 14 patients (17.9%) with deletion of 17p, received BR chemoimmunotherapy. Bendamustine was administered at a dose of 70 mg/m(2) on days 1 and 2 combined with rituximab 375 mg/m(2) on day 0 of the first course and 500 mg/m(2) on day 1 during subsequent courses for up to six courses. Results On the basis of intent-to-treat analysis, the overall response rate was 59.0% (95% CI, 47.3% to 70.0%). Complete response, partial response, and nodular partial response were achieved in 9.0%, 47.4%, and 2.6% of patients, respectively. Overall response rate was 45.5% in fludarabine-refractory patients and 60.5% in fludarabine-sensitive patients. Among genetic subgroups, 92.3% of patients with del(11q), 100% with trisomy 12, 7.1% with del(17p), and 58.7% with unmutated IGHV status responded to treatment. After a median follow-up time of 24 months, the median event-free survival was 14.7 months. Severe infections occurred in 12.8% of patients. Grade 3 or 4 neutropenia, thrombocytopenia, and anemia were documented in 23.1%, 28.2%, and 16.6% of patients, respectively. Conclusion Chemoimmunotherapy with BR is effective and safe in patients with relapsed CLL and has notable activity in fludarabine-refractory disease. Major but tolerable toxicities were myelosuppression and infections. These promising results encouraged us to initiate a further phase II trial evaluating the BR regimen in patients with previously untreated CLL.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Busch, RaymondeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schweighofer, Carmen D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettcher, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staib, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kiehl, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eckart, Michael J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kranz, GabrieleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goede, ValentinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Elter, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buehler, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Winkler, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kneba, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, Barbara F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-489133
DOI: 10.1200/JCO.2010.33.8061
Journal or Publication Title: J. Clin. Oncol.
Volume: 29
Number: 26
Page Range: S. 3559 - 3567
Date: 2011
Publisher: AMER SOC CLINICAL ONCOLOGY
Place of Publication: ALEXANDRIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
FLUDARABINE PLUS CYCLOPHOSPHAMIDE; THERAPY; CHEMOIMMUNOTHERAPY; CHLORAMBUCIL; GUIDELINES; DIAGNOSIS; REGIMEN; CELLMultiple languages
OncologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/48913

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