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  • 1
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    Online Resource
    Bendamustine Versus Chlorambucil as First-Line Treatment in B Cell Chronic Lymphocytic Leukemia: An Updated Analysis from An International Phase III Study.
    American Society of Hematology ; 2008
    In:  Blood Vol. 112, No. 11 ( 2008-11-16), p. 2091-2091
    Details
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 2091-2091
    Abstract: Introduction: Bendamustine is a purine analog/alkylator hybrid agent with a unique mechanism of action, which has shown good clinical efficacy and acceptable tolerability in various hematological malignancies, including Hodgkin’s disease, non-Hodgkin’s lymphoma, and multiple myeloma. Patients and Methods: The efficacy and safety of bendamustine and chlorambucil have been compared in a randomized, open-label, multicenter, Phase III trial in patients with previously untreated advanced (Binet stage B/C) B cell chronic lymphocytic leukemia: an updated analysis from this trial is presented here. Patients were randomized to receive bendamustine (100 mg/m2 on days 1 + 2) or chlorambucil (0.8 mg/kg on days 1 and 15) for up to 6 treatment cycles. The median cumulative dose per patient was 1820 mg and 517 mg for bendamustine and chlorambucil, respectively. The primary endpoints were overall remission rate (ORR), which was defined as complete response, nodular partial response or partial response, and progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. The response to treatment was evaluated by a blinded Independent Response Assessment Committee. Results: A total of 319 patients were randomized (162 bendamustine, 157 chlorambucil), of whom all were included in the efficacy analysis and 312 were evaluable for safety. The mean (± SD) number of treatment cycles was 4.8 ± 1.7 in the bendamustine group and 4.6 ± 1.7 in the chlorambucil group; the median duration of follow-up was 29.2 months (29.8 bendamustine, 27.8 chlorambucil). The ORR was significantly higher with bendamustine than with chlorambucil (67% versus 30%, P & lt;0.0001). The median PFS was 21.5 months with bendamustine and 8.3 months with chlorambucil (P & lt;0.0001). No difference in OS was seen between groups. Most doses were given on schedule. The mean overall relative dose intensity was 86% and 96% in the bendamustine and chlorambucil treatment groups, respectively. At least 1 grade 3/4 neutropenia occurred in 43% of bendamustine-treated patients and 21% of those receiving chlorambucil. Grade 3/4 infections were documented in 7% of bendamustine-treated patients and 4% of chlorambucil-treated patients. Conclusion: This study has shown that bendamustine offers significantly greater efficacy than chlorambucil, with manageable toxicity, and should be considered as first-line chemotherapy for patients with advanced B-CLL.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V112.11.2091.2091
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 2
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    Bendamustine Versus Chlorambucil in Treatment-Naive Patients with B-Cell Chronic Lymphocytic Leukemia (B-CLL): Results of an International Phase III Study.
    American Society of Hematology ; 2007
    In:  Blood Vol. 110, No. 11 ( 2007-11-16), p. 2043-2043
    Details
    In: Blood, American Society of Hematology, Vol. 110, No. 11 ( 2007-11-16), p. 2043-2043
    Abstract: Introduction: Bendamustine (BEN) is a purine analog / alkylator hybrid agent with a particular mechanisms of action that provides effective treatment for a number of hematologic and non-hematologic malignancies. It is used primarily for chemo-naïve, relapsed or refractory B-CLL as well as for other types of non-Hodgkin’s lymphomas. The aim of this randomized phase III, open-label, multicenter study was to compare the efficacy and safety of BEN versus chlorambucil (CLB) in treatment-naïve patients (pts) with B-CLL Binet stage B/C. Patients and Methods: Pts with untreated B-CLL were randomized to receive BEN (100 mg/m2 on days 1+2) or CLB (0.8 mg/kg on days 1+15) for up to 6 treatment cycles. Primary endpoints were overall remission rate (ORR), defined as complete response (CR), nodular partial response (nPR) and partial response (PR), confirmed after 8 weeks, and progression-free survival (PFS). Secondary endpoints were duration of remission, overall survival (OS), safety, and quality of life (QoL). Follow-up was for ≥12 months after completion of treatment of the last patient, or until progression for pts with CR, nPR or PR and stable disease, or until death or lost to follow-up. A 5-stage, adaptive-group, sequential procedure was used with planned interim analyses to adjust the number of pts. Safety and efficacy were assessed by an Independent Data Monitoring Committee. Results: 305 pts were randomized to receive BEN (n=156) or CLB (n=149). As 7 pts did not receive study medication, 298 pts were included in the safety analysis. At the time of this analysis, 264 pts (139 BEN; 125 CLB) were available for the efficacy analysis. For both treatment groups: median age was 64 years; 70% had Binet stage B and 30% Binet stage C disease; median number of cycles/patient was 6; median follow-up was 18.5 months. ORR was significantly higher with BEN than with CLB (68% vs 39%; p & lt;0.0001), with a CR of 30% vs 2%, respectively. Among the subgroups with Binet stage B and C disease, ORR was 70% and 61%, respectively, with BEN, vs 47% and 22%, respectively, with CLB. Median PFS (Kaplan-Meier estimate) was 21.7 months with BEN and 9.3 months with CLB (p & lt;0.0001), and median duration of remission was 18.9 months with BEN and 6.1 months with CLB (p & lt;0.0001). No difference in OS was seen between groups. Toxicity of BEN was manageable and did not impair QoL when compared with CLB. Infection rates (common toxicity criteria grades III+IV) were low in both groups (5.8% BEN; 3.5% CLB). Conclusions: BEN was significantly more effective than CLB in achieving remissions in treatment-naïve pts with B-CLL Binet stage B/C; median PFS and duration of remission were also significantly longer. Furthermore, safety data indicate that BEN toxicities are manageable and the drug is well tolerated. On the basis of these results, BEN should be considered as first-line chemotherapy for patients with B-CLL Binet stage B or C.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V110.11.2043.2043
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2007
    detail.hit.zdb_id: 1468538-3
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  • 3
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    Online Resource
    Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial
    Wiley ; 2012
    In:  British Journal of Haematology Vol. 159, No. 1 ( 2012-10), p. 67-77
    Details
    In: British Journal of Haematology, Wiley, Vol. 159, No. 1 ( 2012-10), p. 67-77
    Abstract: The efficacy of bendamustine versus chlorambucil in a phase III trial of previously untreated patients with B inet stage B/C chronic lymphocytic leukaemia ( CLL ) was re‐evaluated after a median observation time of 54 months in M ay 2010. Overall survival ( OS ) was analysed for the first time. At follow‐up, investigator‐assessed complete response ( CR ) rate (21·0% vs 10·8%), median progression‐free survival (21·2 vs 8·8 months; P  〈   0·0001; hazard ratio 2·83) and time to next treatment (31·7 vs 10·1 months; P  〈   0·0001) were improved for bendamustine over chlorambucil. OS was not different between groups for all patients or those ≤65 years, 〉 65 years, responders and non‐responders. However, patients with objective response or a CR experienced a significantly longer OS than non‐responders or those without a CR . Significantly more patients on chlorambucil progressed to second/further lines of treatment compared with those on bendamustine (78·3% vs 63·6%; P  =   0·004). The benefits of bendamustine over chlorambucil were achieved without reducing quality of life. In conclusion, bendamustine is significantly more effective than chlorambucil in previously untreated CLL patients, with the achievement of a CR or objective response appearing to prolong OS . Bendamustine should be considered as a preferred first‐line option over chlorambucil for CLL patients ineligible for fludarabine, cyclophosphamide and rituximab.
    Type of Medium: Online Resource
    ISSN: 0007-1048 , 1365-2141
    URL: Issue
    URL: Article
    DOI: 10.1111/bjh.2012.159.issue-1
    DOI: 10.1111/bjh.12000
    RVK:
    XA 34100
    Language: English
    Publisher: Wiley
    Publication Date: 2012
    detail.hit.zdb_id: 1475751-5
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  • 4
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    Online Resource
    A randomized clinical trial comparing systemic radiotherapy versus chemotherapy versus local radiotherapy in small cell lung cancer
    Elsevier BV ; 1989
    In:  European Journal of Cancer and Clinical Oncology Vol. 25, No. 6 ( 1989-6), p. 933-937
    Details
    In: European Journal of Cancer and Clinical Oncology, Elsevier BV, Vol. 25, No. 6 ( 1989-6), p. 933-937
    Type of Medium: Online Resource
    ISSN: 0277-5379
    URL: Article
    DOI: 10.1016/0277-5379(89)90150-8
    Language: English
    Publisher: Elsevier BV
    Publication Date: 1989
    detail.hit.zdb_id: 2220742-9
    detail.hit.zdb_id: 283367-0
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  • 5
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    Online Resource
    Characteristics of Immunoglobulin Deficiency in Patients with Untreated Multiple Myeloma Stage II and III.
    American Society of Hematology ; 2004
    In:  Blood Vol. 104, No. 11 ( 2004-11-16), p. 4861-4861
    Details
    In: Blood, American Society of Hematology, Vol. 104, No. 11 ( 2004-11-16), p. 4861-4861
    Abstract: Introduction: It is well known that multiple myeloma (MM) is often associated with immunoglobulin (Ig) deficiency and increased risk of infection. We evaluated the Ig levels in 150 patients with MM stage II and III as part of a phase III randomised study comparing the effectiveness of melphalane and prednisolone versus bendamustine and prednisolone. Patients and methods: 150 patients at a median age of 68 years, with untreated MM stage II, n = 19, and stage III, n = 131, were evaluated. MM type was IgG, IgA, light chain, and biclonal in 106 (70,7 %), 32 (21,3 %), 11 (7,5 %), 1 (0,7 %) patients respectively. Serum Ig levels were measured in all patients prior to chemotherapy. Normal values for IgG were 7,02 – 14,6 g/l, for IgA 0,24 – 3,81 g/l, and for IgM 0,54 – 2,27 g/l. Only Ig classes other than the myeloma protein class were evaluated. Results: Patients with IgG MM had a median serum IgA of 0,4 g/l (range 0 – 7,9), and a median IgM level of 0,2 g/l (0 – 5,6). In 106 patients with IgG MM, IgA serum levels were below, within normal, and above normal values in 36 (34 %), 69 (65,1 %), and 1 (0,9 %) patients, respectively. On the other hand, IgM levels in these patients were below, within normal, and above normal values in 94 (88,7 %), 9 (8,5 %), and 3 (2,8 %) patients, respectively. Median IgG for IgA MM patients was 3,7 g/l (range 0,1 – 11,8), and median IgM in these 32 patients was 0,2 g/l (range 0 – 1,3). IgG levels were below and within normal in 28 (87,5 %), 4 (12,5 %) patients, respectively. Similarly, IgM level were below, and within normal range in 30 (93,8 %), and 2 (6,3 %) patients with IgA MM. Lastly, median IgG in patients with light chain myeloma was 6,3 g/l (range 2,1 – 9,7), median IgA, and median IgM were 0,4 g/l (range 0,1 – 1,7), and 0,3 g/l (range 0,1 – 0,8), respectively. IgG, IgA, and IgM were below normal values in 8 (72,7 %), 3 (27,3 %), and 9 (81,8 %), respectively. Conclusion: Most patients with untreated MM have markedly reduced serum Ig levels. The correlation of reduced Ig level to the incidence of infections is being evaluated. The effect of chemotherapy on Ig levels is currently being assessed in our phase III study.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V104.11.4861.4861
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2004
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 6
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    Bendamustine Versus Chlorambucil in Treatment-Naive B-CLL Patients.
    American Society of Hematology ; 2004
    In:  Blood Vol. 104, No. 11 ( 2004-11-16), p. 4817-4817
    Details
    In: Blood, American Society of Hematology, Vol. 104, No. 11 ( 2004-11-16), p. 4817-4817
    Abstract: Introduction: Bendamustine (BEN) provides effective treatment of hematologic as well as of non-hematologic malignancies. It is characterized by an unique activity profile which differs from common nitrogen mustard drugs. In particular, it causes only partial cross resistance to other alkylating agents, anthracyclines and anti-metabolites, respectively. BEN is used in patients with chemo naïve, relapsed or refractory chronic lymphocytic leukemia (CLL), however, no head-to-head study has been performed so far. Therefore, a multicenter, international phase III study was initiated to compare the activity of BEN against chlorambucil in treatment-naive B-CLL patients with Binet stage B/C. Patients and Methods: Patients are randomized to either Arm A (BEN 100 mg/m2, d 1+2) or to Arm B (chlorambucil 0,8mg/kg Broca’s weight, d 1+15) to receive a maximum of 6 treatment cycles. Primary objectives are overall remission rate and progression-free survival. The anticipated effects are an overall remission rate of 60% vs. 30% and a median progression free survival of 20 vs.14 months. Secondary objectives are additional efficacy parameters, safety, and quality of life. The study design is adaptive with four interim analyses to adjust the final number of patients, plus one safety analysis. A maximum of 350 patients is planned. Toxicities regarding hemoglobin, platelets and neutrophils are graded according to the NCIWG for CLL, while leukocyte and lymphocyte counts are graded according to CTC as in many other CLL trials. Results and Summary: To assess safety, twenty patients in each treatment arm with at least one completed treatment cycle have been evaluated. The results have been reviewed by an independent data monitoring committee (IDMC). It was concluded that the dosages selected for both treatment arms are safe and that the study is to be continued. Furthermore, another safety analysis was performed with respect to the rate of major infections in the same patient cohort after having completed study treatment. While the infection rate has been reported to be 29% in patients treated with fludarabine as published by Rai et al., in our study two BEN-patients (10%) experienced major infections whereas none occurred in the chlorambucil arm. One BEN-patient developed fever CTC grade 3 without neutropenia. Another patient experienced pneumonia CTC grade 2 requiring hospitalization and intravenous antibiotic treatment. In the BEN-arm, 87% of the scheduled dose was applied whereas 89% was given in the chlorambucil arm. Patients treated with BEN remained longer on study as compared to the chlorambucil patients. The toxicity rate, both hematologic and non-hematologic, was in favour for chlorambucil. In total, three patients were withdrawn from study due to toxicity: one patient in each treatment arm due to infection and one BEN-patient due to an allergic reaction. Meanwhile, the first planned interim analysis on remission rate was done. 43 patients in each treatment arm were evaluated. The IDMC recommended to continue the study. A second interim analysis will be performed after 160 patients will have completed the first tumor evaluation to adjust the number of patients finally required.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V104.11.4817.4817
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2004
    detail.hit.zdb_id: 1468538-3
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  • 7
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    SYNTHESIS AND CHARACTERIZATION OF SOME NEW PHASE II METABOLITES OF THE ALKYLATOR BENDAMUSTINE AND THEIR IDENTIFICATION IN HUMAN BILE, URINE, AND PLASMA FROM PATIENTS WITH CHOLANGIOCARCINOMA
    American Society for Pharmacology & Experimental Therapeutics (ASPET) ; 2005
    In:  Drug Metabolism and Disposition Vol. 33, No. 7 ( 2005-07), p. 984-992
    Details
    In: Drug Metabolism and Disposition, American Society for Pharmacology & Experimental Therapeutics (ASPET), Vol. 33, No. 7 ( 2005-07), p. 984-992
    Type of Medium: Online Resource
    ISSN: 0090-9556 , 1521-009X
    URL: Article
    DOI: 10.1124/dmd.105.003624
    Language: English
    Publisher: American Society for Pharmacology & Experimental Therapeutics (ASPET)
    Publication Date: 2005
    detail.hit.zdb_id: 1500213-5
    SSG: 15,3
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  • 8
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    Online Resource
    Entwicklungsgeschichte: Bendamustin gestern, heute, morgen
    S. Karger AG ; 2013
    In:  Oncology Research and Treatment Vol. 36, No. Suppl. 1 ( 2013), p. 2-10
    Details
    In: Oncology Research and Treatment, S. Karger AG, Vol. 36, No. Suppl. 1 ( 2013), p. 2-10
    Type of Medium: Online Resource
    ISSN: 2296-5270 , 2296-5262
    URL: Article
    DOI: 10.1159/000346104
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2013
    detail.hit.zdb_id: 2749752-5
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  • 9
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    Bendamustine in the Treatment of Chronic Lymphocytic Leukemia -Consistent Superiority Over Chlorambucil in Elderly Patients and Across Clinically Defined Risk Groups.
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 2367-2367
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 2367-2367
    Abstract: Abstract 2367 Poster Board II-344 Introduction: Bendamustine is a purine analog/alkylator hybrid agent with a unique mechanism of action, which has shown good clinical efficacy and acceptable tolerability in various hematological malignancies. Chronic lymphocytic leukemia (CLL) is a disease of the elderly, and presents with a variety of clinical characteristics which influence the prognosis. We analyzed tolerability and efficacy of bendamustine (BEN) in comparison to chlorambucil (CLB) in clinical risk groups defined by age and specific indicators of disease activity. Patients and Methods: The efficacy and safety of BEN and CLB have been compared in a randomized, open-label, multicenter, phase III trial in patients with previously untreated advanced (Binet stage B/C) CLL. Patients were randomized to receive BEN (100 mg/m2 on days 1 + 2) or CLB (0.8 mg/kg on days 1 and 15) for up to 6 treatment cycles. The primary endpoints were overall remission rate (ORR), which was defined as complete or partial response, and progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. The response to treatment was evaluated by a blinded Independent Response Assessment Committee. Results: A total of 319 patients were randomized (162 bendamustine, 157 chlorambucil), of whom all were included in the efficacy analysis, while 312 were evaluable for safety. Median age was 64 years (35 to 78). The median number of treatment cycles was 6 in both study arms, regardless of an age above or below 65 years. The median observation time was 35 months. ORR was significantly higher with BEN than with CLB (68% versus 31%, P 〈 0.0001). The median PFS was 21.6 months with BEN and 8.3 months with CLB (P 〈 0.0001). So far, there is no difference in OS (median not reached with BEN versus 65.4 months with CLB; p = 0.16). No significant difference in the remission rates became apparent when comparing patients below and above the age of 65 years (ORR 71.6 % versus 63.5 % with BEN, p 〉 0.3; and 28.4 % versus 32.5 % with CLB, p 〉 0.6). PFS was not influenced by age above 65 years, stage of disease (Binet stage B versus C), or elevated LDH. However, patients without B symptoms had a longer median PFS with BEN than those patients with B symptoms (30.4 months versus 17.7 months; p 〈 0.0001), whereas median PFS was not affected by the presence of B symptoms in patients with CLB (8.9 months in both patient groups). Conclusion: This study has shown that bendamustine offers significantly greater efficacy than chlorambucil in the elderly and across clinically defined major risk groups, even in the presence of B symptoms. BEN should be considered as first-line chemotherapy for patients with advanced CLL. Disclosures: Knauf: mundipharma: Consultancy, Honoraria; cephalon: Consultancy, Honoraria. Klein:mundipharma: Consultancy, Honoraria. Merkle:mundipharma: Consultancy, Honoraria. Montillo:mundipharma Italy: Consultancy, Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.2367.2367
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
    detail.hit.zdb_id: 1468538-3
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  • 10
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    A phase I study of bendamustine hydrochloride administered once every 3 weeks in patients with solid tumors
    Ovid Technologies (Wolters Kluwer Health) ; 2007
    In:  Anti-Cancer Drugs Vol. 18, No. 5 ( 2007-06), p. 587-595
    Details
    In: Anti-Cancer Drugs, Ovid Technologies (Wolters Kluwer Health), Vol. 18, No. 5 ( 2007-06), p. 587-595
    Type of Medium: Online Resource
    ISSN: 0959-4973
    URL: Article
    DOI: 10.1097/CAD.0b013e3280149eb1
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2007
    detail.hit.zdb_id: 2025803-3
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