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  • 1
    Language: English
    In: Acta clinica Croatica, June 2017, Vol.56(2), pp.262-269
    Description: There is a small but well recognized group of patients with multiple myeloma (MM), characterized by multiple bone lesions and low tumor burden, the so-called macrofocal form of MM (MF-MM). The aim of the study was to analyze the incidence, clinical manifestation, therapeutic outcome and prognosis of patients with MF-MM treated with bortezomib-based therapy and radiotherapy, in comparison to classic MM. There were 148 MM patients treated with bortezomibbased regimens, with 15 (10.1%) of them meeting the criteria for MF-MM. Comparative analysis involved disease- and therapy-related variables and markers of bone metabolism in MF-MM and classic MM groups. Event-free survival (EFS) and median survival (MS) were analyzed. Patients in MF-MM and classic MM groups had similar mean age and sex distribution. Patients with MF-MM had advanced myeloma bone disease (MBD), significantly lower clonal plasma cell infiltration in bone marrow, and lower paraprotein level. These patients were predominantly in an early International Staging System stage, showed non-secretory and light-chain variants, and significant association with extramedullary plasmacytomas. EFS was 20 months in MF-MM group versus 13 months in classic MM group (nonsignificant difference). MS was 42 months in both MF-MM and classic MM groups. MF-MM presents with imbalance of the minimal tumor burden and massive bone involvement. Along with advanced skeletal manifestations, these patients showed features of preserved bone marrow and no end-organ damages. Following bortezomib-based therapy and radiotherapy, the EFS and MS did not differ between MF-MM and classic MM groups.
    Keywords: Bone and Bones – Pathology ; Bortezomib – Therapeutic Use ; Multiple Myeloma ; Radiotherapy ; Antineoplastic Agents -- Administration & Dosage ; Bone Neoplasms -- Drug Therapy ; Bortezomib -- Administration & Dosage ; Multiple Myeloma -- Drug Therapy
    ISSN: 0353-9466
    E-ISSN: 13339451
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  • 2
    Language: English
    In: Acta clinica Croatica, June 2011, Vol.50(2), pp.273-9
    Description: A severe complication of the administration of bisphosphonate-containing medications is known as bisphosphonate-associated osteonecrosis of the jaws (BONJ). A case series of three patients affected by BONJ is presented. These patients currently represent the only described cases of BONJ in Bulgaria. Exposed necrotic bone of the mandible was observed in two patients and the maxilla was affected in the third case. Two of the patients had been treated with zoledronate for metastatic prostate cancer and one patient for metastatic endometrioid cancer. All three patients underwent surgical treatment. One of the patients received conservative surgical debridement, i.e. removal of necrotic bone only, and primary wound closure. Conservative surgical debridement and application of local medications without wound closure were used in the other two patients. All three patients received systemic antibiotic treatment. No evidence of disease progression was observed during the follow-up period of 3 to 12 months. The surgical approach utilized in the present study is discussed in the light of the etiopathogenesis, prevention and treatment of BONJ.
    Keywords: Bisphosphonate-Associated Osteonecrosis of the Jaw -- Pathology ; Bone Density Conservation Agents -- Adverse Effects ; Diphosphonates -- Adverse Effects ; Imidazoles -- Adverse Effects
    ISSN: 0353-9466
    E-ISSN: 13339451
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 3
    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
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  • 4
    Language: English
    In: Haematologica, October 2012, Vol.97(10), pp.1562-9
    Description: Previous data suggest that the response of chronic myeloid leukemia cells to imatinib is dose-dependent. The potential benefit of initial dose intensification of imatinib in pre-treated patients with chronic phase chronic myeloid leukemia remains unknown. Two hundred and twenty-seven pre-treated patients with chronic myeloid leukemia in chronic phase were randomly assigned to continuous treatment with a standard dose of imatinib (400 mg/day; n=113) or to 6 months of high-dose induction with imatinib (800 mg/day) followed by a standard dose of imatinib as maintenance therapy (n=114). The rates of major and complete cytogenetic responses were significantly higher in the high-dose arm than in the standard-dose arm at both 3 and 6 months (major cytogenetic responses: 36.8% versus 21.2%, P=0.01 and 50.0% versus 34.5%, P=0.018; complete cytogenetic responses: 22.8% versus 6.2%, P〈0.001 and 40.4% versus 16.8%, P〈0.001) on the basis of an intention-to-treat analysis. At 12 months, the difference between treatment arms remained statistically significant for complete cytogenetic responses (40.4% versus 24.8%, P=0.012) but not for major cytogenetic responses (49.1% versus 44.2%, P=0.462). The rate of major molecular responses was also significantly better at 3 and 6 months in the high-dose arm (month 3: 14.9% versus 3.5%, P=0.003; month 6: 32.5% versus 8.8%, P〈0.001). Overall and progression-free survival rates were comparable between arms, but event-free survival was significantly worse in the high-dose arm (P=0.014). Standard-dose imatinib remains the standard of care for pre-treated patients with chronic phase chronic myeloid leukemia (Clinicaltrials.gov identifier: NCT00327262).
    Keywords: Antineoplastic Agents -- Therapeutic Use ; Benzamides -- Therapeutic Use ; Leukemia, Myeloid, Chronic-Phase -- Drug Therapy ; Piperazines -- Therapeutic Use ; Protein Kinase Inhibitors -- Therapeutic Use ; Pyrimidines -- Therapeutic Use
    ISSN: 03906078
    E-ISSN: 1592-8721
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  • 5
    Language: English
    In: Haematologica, May 2012, Vol.97(5), pp.784-91
    Description: Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma. We conducted an international, randomized, open-label, four-arm, phase III trial to compare three different doses of thalidomide (100, 200, or 400 mg/day) with standard dexamethasone in patients who had received one to three prior therapies. The primary end-point was time to progression. In the intent-to-treat population (N=499), the median time to progression was 6.1, 7.0, 7.6, and 9.1 months in patients treated with dexamethasone, and thalidomide 100, 200, and 400 mg/day, respectively; the difference between treatment groups was not statistically significant. In the per-protocol population (n=465), the median time to progression was 6.0, 7.0, 8.0, and 9.1 months, respectively. In patients who had received two or three prior therapies, thalidomide significantly prolonged the time to progression at all dose levels compared to the result achieved with dexamethasone. Response rates and median survival were similar in all treatment groups, but the median duration of response was significantly longer in all thalidomide groups than in the dexamethasone group. Adverse events reported in the thalidomide groups, such as fatigue, constipation and neuropathy, confirmed the known safety profile of thalidomide. Although thalidomide was not superior to dexamethasone in this randomized trial, thalidomide monotherapy may be considered an effective salvage therapy option for patients with relapsed/refractory multiple myeloma, particularly those with a good prognosis and those who have received two or three prior therapies. The recommended starting dose of thalidomide monotherapy is 400 mg/day, which can be rapidly reduced for patients who do not tolerate this treatment. ( NCT00452569).
    Keywords: Drug Resistance, Neoplasm ; Angiogenesis Inhibitors -- Therapeutic Use ; Antineoplastic Agents, Hormonal -- Therapeutic Use ; Dexamethasone -- Therapeutic Use ; Multiple Myeloma -- Drug Therapy ; Neoplasm Recurrence, Local -- Drug Therapy ; Thalidomide -- Therapeutic Use
    ISSN: 03906078
    E-ISSN: 1592-8721
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  • 6
    Language: English
    In: Folia medica, 2004, Vol.46(3), pp.5-11
    Description: Multiple myeloma has recently been found to induce considerable imbalance in the newly identified system of osteoprotegerin (OPG), receptor activator of nuclear factor KB ligand (RANKL) and RANK. The binding of RANKL to RANK on the surface of osteoclastic precursors in the presence of m-CSF activates the signalling pathways for differentiation and proliferation of an osteoclastic line. OPG is a decoy circulating receptor for RANKL which blocks its binding to RANK. There are at least three mechanisms by which myeloma cells affects the OPG/ RANKL/RANK system: 1: The adhesion between the myeloma / stromal cells and the osteoblastic precursors stimulates the system by increasing the production of RANKL. 2: Some myeloma lines produce independently membrane-bound or free RANKL. 3: The normal and mutated plasma cells bind, degrade and block the OPG production from the stromal cells. The OPG/RANKL/RANK system is the latest therapeutic target in the treatment of myeloma bone disease. The first results from the application of a synthetic analogue of OPG, as well as of RANKL antagonists or RANK inhibitors show decrease of the number of osteoclasts, osteolytic lesions and M-gradient.
    Keywords: Antineoplastic Agents -- Pharmacology ; Bone Neoplasms -- Drug Therapy ; Carrier Proteins -- Metabolism ; Membrane Glycoproteins -- Metabolism ; Multiple Myeloma -- Drug Therapy
    ISSN: 0204-8043
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 7
    Language: English
    In: The Internet Journal of Hematology, March 22, 2009, Vol.5(2)
    Description: Tumor-like extramedullary hematopoiesis with liver localization in beta-thalassemia is an extremely rare clinical phenomenon and a prerequisite for serious deferential diagnostic problems. We present a case of homozygous beta-thalassemia in a 23-year-old woman. The patient was examined by abdominal ultrasonography and CT scan because of biliary crisis and found to have microconcrements in the gallbladder and a tumor-like formation (34 x 30 mm) in the 7th liver segment. Conventional cholecystectomy was performed. The histological examination showed it focal extramedullary hematopoiesis with an underlying diagnosis of Cooley's anemia. Differential diagnostic difficulties and necessary diagnostic steps are discussed. Fine needle biopsy and/or immunohistochemical examination are the best methods for the precise diagnosis of extramedullary hematopoiesis.
    Keywords: Beta Thalassemia -- Development And Progression ; Hematopoiesis -- Observations ; Liver -- Properties
    ISSN: 1540-2649
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  • 8
    Language: English
    In: Haematologica, June 2010, Vol.95(6), pp.908-13
    Description: Imatinib 400 mg/day is the standard treatment for patients with chronic phase chronic myeloid leukemia. Recent reports suggested higher and more rapid cytogenetic and molecular responses with higher doses of imatinib. In this prospective international, multicenter phase III study, 227 patients with pre-treated Philadelphia chromosome-positive, BCR-ABL-positive chronic myeloid leukemia were randomized to a standard-dose imatinib arm (400 mg/day) or a high-dose imatinib arm (800 mg/day for 6 months followed by 400 mg/day as maintenance therapy). In this planned interim analysis hematologic, cytogenetic and molecular responses as well as toxicity were evaluated. Compared to the standard-dose, high-dose imatinib led to higher rates of major and complete cytogenetic responses at both 3 months (major: 21% versus 37%, P=0.01; complete: 6% versus 25%, P〈0.001) and 6 months (major: 34% versus 54%, P=0.009; complete: 20% versus 44%, P〈0.001). This was paralleled by a significantly higher major molecular response rate at 6 months in the high-dose imatinib arm (11.8% versus 30.4%; P=0.003). At 12 months, the rates of major cytogenetic response (the primary end-point) were comparable between the two arms (57% versus 59%). In contrast to non-hematologic toxicities, grade 3/4 hematologic toxicities were more common in the high-dose arm. Cumulative complete cytogenetic response rates were higher in patients without dose reduction in the high-dose arm (61%) than in the patients with no dose reduction in the standard-dose arm (36%) (P=0.014). This is the first randomized phase III trial in patients with pre-treated chronic phase chronic myeloid leukemia demonstrating improvements in major cytogenetic response, complete cytogenetic response and major molecular response rates with high-dose imatinib therapy (ClinicalTrials.gov Identifier: NCT00327262).
    Keywords: Cytogenetic Analysis ; Leukemia, Myelogenous, Chronic, BCR-Abl Positive -- Drug Therapy ; Piperazines -- Administration & Dosage ; Pyrimidines -- Administration & Dosage
    ISSN: 03906078
    E-ISSN: 1592-8721
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  • 9
    Language: English
    In: Folia medica, 2009, Vol.51(4), pp.53-7
    Description: In recent years, the incidence of osteonecrosis of the jaw (ONJ) as an unknown complication in patients receiving bisphosphonates (BP) has been on the increase. According to literature data it is in the range of 0.83% to 11.9%. ONJ has been mostly reported in patients with malignancies--mainly in multiple myeloma (MM) patients, followed by patients with bone metastases from breast and prostatic cancer. The view that is supported by a growing body of researchers in the discussion on the etiopathogenetic relationship between ONJ and BPs is that ONJ seems to be a class-specific side effect rather than a result of the use of a specific drug. The major risk factor for development of ONJ is not the BP type, but the time of their administration and accumulation in the bone structures. More than 70% of the ONJ patients report preceding dental problems. The immunosuppressive effects of chemo- and radiotherapy, the impaired bone remodeling resulting from corticoid therapy, the antiangiogenetic properties of thalidomide slow down the reparative processes in the oral cavity and appear as a predisposing factor for the development of ONJ. Possibilities for successful treatment are limited; conservative approaches and least surgery, if larger areas are involved, are recommended. Dental prophylaxis is of particular importance. We present a 66-year-old man with multiple myeloma, IgG, BJ(k), II A KC (after Durie and Salmon staging system). ONJ was diagnosed one year after the disease onset, during which the patient received chemotherapy and was administered concurrently 14 cycles of BPs (pamidronate/zolendronate). The diagnosis was based on clinical, radiologic and histological evidence. Surgical removal of the necrotic sequesters and antibiotic treatment produced a clinical improvement. This rare, refractory complication requires the joint efforts of hematologists, oncologists, and maxillofacial surgeons to diagnose, manage prophylactically and treat.
    Keywords: Diphosphonates -- Adverse Effects ; Jaw Diseases -- Chemically Induced ; Multiple Myeloma -- Complications ; Osteonecrosis -- Chemically Induced
    ISSN: 0204-8043
    E-ISSN: 13142143
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 10
    Language: English
    In: Folia medica, 2009, Vol.51(2), pp.5-11
    Description: POEMS syndrome (polyneuropathy, organomegaly, M-protein, and skin changes) is a rare plasma cell disease with small tumour mass and multisystem involvement. Since 2003 POEMS syndrome has been a nosological entity with approved diagnostic criteria, though its etiology and pathogenesis are still not clear. Males are more often affected, with peak incidence in the 5th and 6th decades. The major diagnostic problems are difficult detection of plasma cell infiltration in the osteosclerotic lesions and M-gradient most often low concentration IgA (lamda). We present a case of POEMS syndrome in a 47-year-old male patient who initially presented with edema of the lower limbs, moderate lymphadenopathy, hepatosplenomegaly, histological findings of Castleman disease with marked sinusoidal angioproliferation in the lymph nodes and multiple osteosclerotic lesions. Pleural effusion, ascitis, renal failure, progressive lower limbs polyneuropathy with invalidisation of the patient developed later. The attempts to detect lymphoproliferative process by myelogram, trephine biopsy, histological examination of lymph node and the spleen were ineffective and deceptively non-informative, neither did immunoelectrophoresis reveal M-grade. Diagnosis was made after bone biopsy of the largest osteosclerotic lesion and immunofixation (monoclonal IgA, lamda in the serum). The patient underwent treatment with alkylating agents and corticosteroids, radiation of the predominant osteosclerotic lesions and therapy with radioactive strontium. The general condition improved, lymphadenomegaly, skin lesions, pleural effusion and ascitis regressed and renal function was restored. There was a minor improvement of the neurological symptoms. Autollogous stem-cell transplantation is also recommended in literature for patients with generalized bone lesions or progressive and disease-resistant therapy.
    Keywords: Poems Syndrome -- Diagnosis
    ISSN: 0204-8043
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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