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  • 1
    Article
    Article
    Bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukaemia: updated results of a randomized phase III trial (2012)
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    In: British Journal of Haematology, October 2012, Vol.159(1), pp.67-77
    Description: The efficacy of bendamustine chlorambucil in a phase trial of previously untreated patients with inet stage chronic lymphocytic leukaemia () was re‐evaluated after a median observation time of 54 months in ay 2010. Overall survival () was analysed for the first time. At follow‐up, investigator‐assessed complete response () rate (21·0% vs 10·8%), median progression‐free survival (21·2 vs 8·8 months; 65 years, responders and non‐responders. However, patients with objective response or a experienced a significantly longer than non‐responders or those without a . Significantly more patients on chlorambucil progressed to second/further lines of treatment compared with those on bendamustine (78·3% vs 63·6%; =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 patients, with the achievement of a or objective response appearing to prolong . Bendamustine should be considered as a preferred first‐line option over chlorambucil for patients ineligible for fludarabine, cyclophosphamide and rituximab.
    Keywords: Bendamustine ; Chlorambucil ; Chronic Lymphocytic Leukaemia ; Complete Response ; Overall Survival
    ISSN: 0007-1048
    E-ISSN: 1365-2141
    DOI: 10.1111/bjh.12000
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  • 2
    Article
    Article
    The value of the MDR1 reversal agent PSC-833 in addition to daunorubicin and cytarabine in the treatment of elderly patients with previously untreated acute myeloid leukemia (AML), in relation to MDR1 status at diagnosis (2005)
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    Language: English
    In: Blood, 15 October 2005, Vol.106(8), pp.2646-54
    Description: To determine whether MDR1 reversal by the addition of the P-glycoprotein (P-gp) inhibitor PSC-833 to standard induction chemotherapy would improve event-free survival (EFS), 419 untreated patients with acute myeloid leukemia (AML) aged 60 years and older were randomized to receive 2 induction cycles of daunorubicin and cytarabine with or without PSC-833. Patients in complete remission were then given 1 consolidation cycle without PSC-833. Neither complete response (CR) rate (54% versus 48%; P = .22), 5-year EFS (7% versus 8%; P = .53), disease-free survival (DFS; 13% versus 17%; P = .06) nor overall survival (OS; 10% in both arms; P = .52) were significantly improved in the PSC-833 arm. An integrated P-gp score (IPS) was determined based on P-gp function and P-gp expression in AML cells obtained prior to treatment. A higher IPS was associated with a significantly lower CR rate and worse EFS and OS. There was no significant interaction between IPS and treatment arm with respect to CR rate and survival, indicating also a lack of benefit of PSC-833 in P-gp-positive patients. The role of strategies aimed at inhibitory P-gp and other drug-resistance mechanisms continues to be defined in the treatment of patients with AML.
    Keywords: ATP Binding Cassette Transporter, Subfamily B, Member 1 -- Metabolism ; Cyclosporins -- Therapeutic Use ; Cytarabine -- Therapeutic Use ; Daunorubicin -- Therapeutic Use ; Leukemia, Myeloid, Acute -- Drug Therapy
    ISSN: 0006-4971
    E-ISSN: 15280020
    DOI: 10.1182/blood-2005-04-1395
    URL: View this record in MEDLINE/PubMed
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  • 3
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    Article
    Detection of circulating monoclonal lymphocytes in multiple myeloma patients by analysis of gene rearrangements: Correlation with progressive disease (1993)
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    Language: English
    In: Leukemia Research, 1993, Vol.17(4), pp.341-345
    Description: Multiple myeloma is characterized by the proliferation of a monoclonal plasma cell population that essentially spreads in the bone marrow. However, immunological data and studies on clonal gene rearrangements have provided evidence for circulating malignant B-lymphocytes. Herein, we report on the detection and clinical significance of monoclonal lymphocytes in the peripheral blood of multiple myeloma patients. Applying the analysis of immunoglobulin gene rearrangements, clonal circulating lymphocytes were found in 8 out of 37 patients. In three of these eight patients, DNA from the bone marrow could be examined as well, and the same gene rearrangement as in peripheral blood was detected. This observation indicates that the monoclonal lymphocytes in the peripheral blood are part of the malignant plasma cell clone in the bone marrow. There was a strong correlation between progressive stage III disease and the detection of circulating tumour cells, whereas neither in stable stage III nor stage I disease could clonal gene rearrangements be detected. Our findings indicate the high incidence of monoclonal lymphocytes in the peripheral blood from patients with progressive multiple myeloma. This may be of importance with respect to cell harvesting strategies for autologous peripheral stem cell transplantation in multiple myeloma.
    Keywords: Multiple Myeloma ; Monoclonal Lymphocytes ; Gene Rearrangements ; Medicine
    ISSN: 0145-2126
    E-ISSN: 1873-5835
    DOI: 10.1016/0145-2126(93)90021-C
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  • 4
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    Article
    Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia (2009)
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    Language: English
    In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 10 September 2009, Vol.27(26), pp.4378-84
    Description: This randomized, open-label, parallel-group, multicenter study was designed to compare the efficacy and safety of bendamustine and chlorambucil in previously untreated patients with advanced (Binet stage B or C) chronic lymphocytic leukemia (CLL). Patients (〈or= 75 years of age) were randomly assigned to receive bendamustine 100 mg/m(2)/d intravenously on days 1 to 2, or chlorambucil 0.8 mg/kg (Broca's normal weight) orally on days 1 and 15; treatment cycles were repeated every 4 weeks for a maximum of six cycles. The response to treatment was assessed according to National Cancer Institute Working Group criteria, and the final determination of response was made by a blinded independent review committee. A total of 319 patients were randomly assigned (162 bendamustine, 157 chlorambucil). Complete or partial responses were achieved in 110 (68%) of 162 bendamustine-treated and 48 (31%) of 157 chlorambucil-treated patients (P 〈 .0001). More patients showed complete responses with bendamustine than with chlorambucil (31% v 2%). Median progression-free survival was 21.6 months with bendamustine and 8.3 months with chlorambucil (P 〈 .0001). Bendamustine was also associated with an improvement in duration of remission, compared with chlorambucil (median, 21.8 v 8.0 months). Hematologic National Cancer Institute Common Toxicity Criteria grade 3 to 4 adverse events were more common with bendamustine than with chlorambucil (occurring in 40% v 19% of patients). Severe infections (grade 3 to 4) occurred in 8% of bendamustine-treated patients and 3% of chlorambucil-treated patients. Bendamustine offers significantly greater efficacy than chlorambucil, and a manageable toxicity profile, when used as first-line therapy in patients with advanced CLL.
    Keywords: Chlorambucil -- Therapeutic Use ; Leukemia, Lymphocytic, Chronic, B-Cell -- Drug Therapy ; Nitrogen Mustard Compounds -- Therapeutic Use
    E-ISSN: 1527-7755
    DOI: 10.1200/JCO.2008.20.8389
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  • 5
    Article
    Article
    Mesenchymal stem cells remain of host origin even a long time after allogeneic peripheral blood stem cell or bone marrow transplantation (2005)
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    Language: English
    In: Experimental Hematology, May 2005, Vol.33(5), pp.605-611
    Description: Plasticity of hematopoietic stem cells (HSC) has gained major interest in stem cell research. In order to investigate whether HSC may differentiate into mesenchymal stem cells (MSC), we assessed chimerism in peripheral blood (PB), mononuclear cell fractions (MNC) of bone marrow, and MSC derived from bone marrow (BM) from 27 up to 4225 days after allogeneic transplantation. We applied fluorescence in situ hybridization using X/Y gene probes in sex-mismatched and STR-PCR in sex-matched patients. MSC could have been generated in 27 of 55 bone marrow samples derived from 20 patients. Fifteen patients received peripheral blood stem cell transplants (PBSCT), including CD34-selected PBSCT in two. Five patients received bone marrow. While all patients had chimerism in PB and MNC of the BM, in all but one patient BM-derived MSC were of recipient origin. This single patient showed reproducibly MSC of donor origin in a frequency of 1% after having received a CD34-selected PBSCT. Looking at graft collections, MSCs were easily generated from BM specimens, while no MSC could be derived from PBSC samples. Even though HSC have been found to differentiate into a variety of nonhematological cell types, they usually do not differentiate into MSC after allogeneic transplantation.
    Keywords: Medicine
    ISSN: 0301-472X
    E-ISSN: 1873-2399
    DOI: 10.1016/j.exphem.2005.02.004
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  • 6
    Article
    Article
    Fludarabine and Bendamustine in Refractory and Relapsed Indolent Lymphoma-a Multicenter Phase I/II Trial of the East German Society of Hematology and Oncology (OSHO) (2004)
    Details
    Language: English
    In: Leukemia & Lymphoma, 01 September 2004, Vol.45(9), pp.1821-1827
    Description: The therapy of patients with relapsed or refractory indolent lymphoma relies on the development of new drug combinations. The drugs bendamustine and fludarabine have cytotoxic activity as monotherapy in indolent lymphoma and show synergism in vitro. In this study, we combined both drugs in a multicenter clinical phase I/II trial to evaluate their toxicity and efficacy. Bendamustine was given at 30 or 40 mg/m2/d (dose levels 1 and 2), fludarabine at 30 mg/m2/d, each drug on days 1 to 3. Six cycles were to be given every 4 weeks. A total of 29 patients with relapsed or refractory indolent lymphoma were included in the study. During phase I, 9 patients were treated at dose level 1 and 7 patients at dose level 2. Thirteen patients were added to the study during phase II. Fourteen patients had follicular lymphoma, 11 patients mantle cell lymphoma, 2 patients lymphoplasmocytic and 2 patients nodal marginal zone lymphoma. Median age was 62 years (range 39-74). All patients were in stages III or IV of their disease and had received prior chemotherapy with or without additional radio- or immunotherapy. The dose limiting toxicity was hematotoxicity in all cases and occurred in 3 of 7 evaluable patients at dose level I and in 3 of 7 patients at dose level 2. One patient at dose level 2 died of sepsis in neutropenia with persistent thrombocytopenia. The study was continued at dose level 1 (phase II). Analysis of 19 evaluable patients treated at dose level 1 reveiled hematotoxicity CTC grade III in 47% and grade IV in 26%. Neutropenic fever occurred in 4 patients (21%). On an intent-to-treat basis, 45% or 32% of all patients at dose level 1 reached CR or PR, respectively. Nine of 9 patients with mantle cell lymphoma responded to therapy. The overall response rate was 77%. Eight of 15 responders relapsed after a median follow-up time of 14 months (range 2-43). The major complication of fludarabine in combination with bendamustine is hematotoxicity. Dose level 1 with 30 mg/m2/d of both drugs on days 1 to 3 was defined as the recommended dose. Despite unfavorable prognostic features (histologic subtype, stage of disease, pretreatment) response rates were good with this regimen.
    Keywords: Fludarabine ; Bendamustine ; Indolent Lymphoma ; Relapse ; Phase I/II ; Medicine
    ISSN: 1042-8194
    E-ISSN: 1029-2403
    DOI: 10.1080/1042819042000223822
    URL: View record in Taylor & Francis (Access to full text may be restricted)
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  • 7
    Article
    Article
    CD34-related coexpression of MDR1 and BCRP indicates a clinically resistant phenotype in patients with acute myeloid leukemia (AML) of older age (2007)
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    Language: English
    In: Annals of Hematology, 2007, Vol.86(5), pp.329-337
    Description: Clinical resistance to chemotherapy in acute myeloid leukemia (AML) is associated with the expression of the multidrug resistance (MDR) proteins P-glycoprotein, encoded by the MDR1 / ABCB1 gene, multidrug resistant-related protein (MRP/ABCC1), the lung resistance-related protein (LRP), or major vault protein (MVP), and the breast cancer resistance protein (BCRP/ABCG2). The clinical value of MDR1 , MRP1 , LRP / MVP , and BCRP messenger RNA (mRNA) expression was prospectively studied in 154 newly diagnosed AML patients ≥60 years who were treated in a multicenter, randomized phase 3 trial. Expression of MDR1 and BCRP showed a negative whereas MRP1 and LRP showed a positive correlation with high white blood cell count (respectively, p  〈 0.05, p  〈 0.001, p  〈 0.001 and p  〈 0.001). Higher BCRP mRNA was associated with secondary AML ( p  〈 0.05). MDR1 and BCRP mRNA were highly significantly associated ( p  〈 0.001), as were MRP1 and LRP mRNA ( p  〈 0.001) expression. Univariate regression analyses revealed that CD34 expression, increasing MDR1 mRNA as well as MDR1 / BCRP coexpression, were associated with a lower complete response (CR) rate and with worse event-free survival and overall survival. When adjusted for other prognostic actors, only CD34-related MDR1/BCRP coexpression remained significantly associated with a lower CR rate ( p  = 0.03), thereby identifying a clinically resistant subgroup of elderly AML patients.
    Keywords: MDR1 ; MRP1 ; LRP ; BCRP ; Genes ; Elderly AML
    ISSN: 0939-5555
    E-ISSN: 1432-0584
    DOI: 10.1007/s00277-007-0269-7
    URL: View full text in Springer
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  • 8
    Article
    Article
    A phase I trial of interferon α-2b with folinic acid and 5-fluorouracil administered by 4-hour infusion in metastatic colorectal carcinoma (1992)
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    Language: English
    In: Seminars in Oncology, 1992, Vol.19(2), pp.197-203
    Description: Preclinical data suggest that both folinic acid and interferon may enhance the efficacy of 5-fluorouracil (5-FU) in colorectal carcinoma. We therefore initiated a phase I trial evaluating the doses, safety, and pharmacokinetics of the combination of recombinant interferon (IFN) alpha-2b with folinic acid (FA) and 5-FU. Seventeen patients with colorectal cancer who failed local chemotherapy received 5-FU as a 4-hour infusion, preceded by a bolus of FA and IFN. The 5-FU dose was escalated over the range of 400 to 650 mg/m2/d for a period of 7 days. Folinic acid was administered as a bolus in a fixed dose of 200 mg/m2/d and IFN as 5 million U/d subcutaneously on days 1 to 7. A total of 89 courses of therapy were completed for the 17 patients, of which there were 10 paired courses with a combination of 5-FU and IFN or 5-FU alone, being performed to analyze the pharmacokinetics and modulation of 5-FU by IFN. The maximum tolerated dose of 5-FU using this combination and a 4-hour schedule was 600 mg/m2/d for 7 days. The dose-limiting toxicity of this regimen was diarrhea. Mucositis and myelosuppression was not a marked problem at dose levels of 400 and 500 mg/m2/d for 7 days. However, at a dose level of 600 to 650 mg/m2/d for 7 days, grade 3 and 4 (WHO) leukopenia occurred in 50% and mucositis occurred in 33%. At a given dose of 5 million U, IFN did not significantly influence 5-FU serum levels. Mean steady-state serum levels of 5-FU at 500 mg/m2 given as a 4-hour infusion were 16.55 +/- 9.34 mumol/L and 18.23 +/- 12.77 mumol/L with and without IFN, respectively. Mean area under the curve (mumol/L x min) was 4,008 +/- 2,133 and 5,114 +/- 2,567 with and without interferon, respectively. Objective responses were seen in one of 17 of these heavily pretreated patients and stable disease was seen in seven of 17 patients. The recommended dose of 5-FU for use of phase II studies is 500 mg/m2/d for 7 days. We conclude that the toxicity of 5-FU plus FA with and without IFN alpha-2b can be reduced by using a 4-hour infusion instead of a bolus.
    Keywords: Medicine
    ISSN: 0093-7754
    E-ISSN: 1532-8708
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  • 9
    Article
    Article
    Abstract (1992)
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    Language: English
    In: Annals of Hematology, 1992, Vol.65, pp.A1-A146
    ISSN: 0939-5555
    E-ISSN: 1432-0584
    DOI: 10.1007/BF02044602
    Source: Springer Science & Business Media B.V.
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