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  • 1
    In: Cancer, Wiley, Vol. 112, No. 4 ( 2008-02-15), p. 856-862
    Type of Medium: Online Resource
    ISSN: 0008-543X , 1097-0142
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2008
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  • 2
    In: Blood, American Society of Hematology, Vol. 108, No. 11 ( 2006-11-01), p. 2478-2478
    Abstract: We conducted a prospective, single-arm, open-label, non-randomized, multicenter, phase II to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a novel new approach combining induction chemotherapy with Fludarabine and Mitoxantrone (FM) followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated indolent non-follicular lymphoma (indolent non-FL). Patient eligibility was represented by: patients age 18 years or older with biopsy-proven, untreated, bidimensionally measurable stage II, stage III, or stage IV indolent non-FL expressing the CD20 antigen; WHO performance status of 0 to 2. All patients were notified of the investigational nature of this study and signed a written informed consent approved in accordance with institutional guidelines, including the Declaration of Helsinki. The study was approved by the institutional review boards. Patients were treated with standard FM chemotherapy every 28 days for 6 cycles. Patients were restaged 4 to 8 weeks after completion of the sixth cycle of FM chemotherapy. Patients achieving at least a partial response after 6 cycles of FM chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was greater than 1500/μL, the platelet count exceeded 100.000/μL, and the bone marrow examination at the completion of FM chemotherapy demonstrated no more than 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). At data reporting for this abstract, 29 patients were enrolled and 26 were evaluable for response. Of these 26 patients, all are evaluable for induction chemotherapy FM regimen and 17 of them also are evaluable after 90Y Ibritumomab Tiuxetan treatment. Histologically, 11 had marginal zone lymphoma, 10 had lymphoplasmacytic lymphoma, and 5 had small lymphocytic lymphoma; 10 were male and 16 female; the median age was 61 years (range 45–82); 4 were stage III, and 21 stage IV. After the FM treatment the overall response rate was 81%, including 50% CR and 31% PR. Time to event analyses, including TTP and duration of response are pending further follow-up. Treatment was well tolerated; grade ≥ 3 AEs were seen in 13 patients; the most common grade ≥ 3 AEs was neutropenia. Among the actual 17 evaluable patients subsequentially treated with 90Y Ibritumomab Tiuxetan, 2/4 (50%) patients improved their remission status from PR to CR. The 90Y Ibritumomab Tiuxetan toxicity included grade ≥ 3 hematologic AEs in 15 patients; the most common grade ≥ 3 AEs were neutropenia (10 patients) and thrombocytopenia (15 patients). Transfusions of red cells and/or platelets were given to 6 patients. These preliminary data indicate the feasibility, tolerability, and efficacy of the FM plus 90Y Ibritumomab Tiuxetan regimen for patients with untreated indolent non-FL. Final efficacy and safety data will be presented.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2006
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  • 3
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 4763-4763
    Abstract: Follicular lymphoma (FL) has been considered as low-grade malignant B-cell lymphoma usually characterized by an indolent course with a continuous pattern of relapse and a median survival of 10 years. The therapeutic approach to FL is particularly controversial. One of the effective strategies is the combination of fludarabine-containing regimens (particularly, Fludarabine and Mitoxantrone) with anti-CD20 monoclonal antibody. Single-agent radioimmunotherapy activity, in particular Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin), has been demonstrated in heavily pretreated FL patients. The results of these studies support a further evaluation of 90Y Ibritumomab Tiuxetan in combination with chemotherapy earlier in the time course of FL. Recently, some phase II trials showed that the sequential combination of conventional chemotherapy (CHOP) and 90Y Ibritumomab Tiuxetan has useful activity in the treatment of FL patients, with no unexpected toxicities observed. We conducted a prospective, single-arm, open-label, non-randomized, multicenter, phase II to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a novel new approach combining induction chemotherapy with oral Fludarabine and Mitoxantrone (FM) followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated elderly FL. Patient eligibility was represented by: patients age 18 years or older with biopsy-proven, untreated, bidimensionally measurable stage II, stage III, or stage IV FL expressing the CD20 antigen; performance status of 0 to 2, a pretreatment granulocyte cell count of 1500/μL or greater, and a platelet count of 100.000/μL or greater. All patients were notified of the investigational nature of this study and signed a written informed consent approved in accordance with institutional guidelines, including the Declaration of Helsinki. The study was approved by the institutional review board. Patients were treated with standard FM chemotherapy (in this case, Fludarabine was administered orally at the dose 40 mg/m2/day for 3 consecutive days) every 21 days for 6 cycles. Patients were restaged 4 to 8 weeks after completion of the sixth cycle of FM chemotherapy. Patients achieving at least a partial response after 6 cycles of FM chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was greater than 1500/μL, the platelet count exceeded 100.000/μL, and the bone marrow examination at the completion of CHOP chemotherapy demonstrated no more than 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). A total of 60 patients have to be enrolled and preliminary results of this trial will be presented.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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  • 4
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 2720-2720
    Abstract: Abstract 2720 Poster Board II-696 Introduction: In 2008 we published a phase II trial abuot the combination of 6 cycles of CHOP plus 90Y-IT for previously untreated elderly patients with DLBCL. The CCR was 95% with OS at 2 years of 95% and PFS at 2 years of 75%. The results of this study support a further evaluation of 90Y-IT in combination of chemotherapy. We conducted a prospective, single-arm, non-randomized, phase II trial with CHOP plus Rituximab followed by 90Y-IT reducing the number of CHOP cycles from 6 to 4 but introducing Rituximab. The rational is to utilize all the therapeutic approaches (chemotherapy, immunotherapy and radioimunotherapy) reducing conventional chemotherapy and probably related toxicity. Patients and Methods: Patient elegibility was represented by: patients older than 60 years with biopsy proven, untreated, bidimensionally mesurable stage II, III or IV DLBCL. Expression the CD-20 antigen; WHO performance status of 0 to 2. patients were treated with standard CHOP chemotherapy plus Rituximab every 21 days for 4 cycles. Patients were restaged 4 to 6 weeks after completion of 4 cycles of R-CHOP chemotherapy. Patients achieving CR, PR or SD after chemotherapy were eligible for consolidation with 90Y-IT provided the granulocyte count was greater than 1500/microl, the platelet count exceded 100.000/microl and the bone marrow examination at the completion of chemotherapy demostrated no more than 25% involvement with lymphoma. All patients were to receive a single dose of 90Y-IT 14.8 MBq/kg (0.4 mCi/kg). Fifty-five patients have been enrolled: 26 were male and 29 female; the median age was 70 years (range 60–83); 17 were stage II, 38 were stage III-IV. Results: Fifty-one patients had completed the R-CHOP treatment and the overall response rate was 94.1% including 30 (58.8%) of patients in CR and 17 (35.3%) in PR. Treatment was well tolerated; grade 3–4 AEs are comparable with previous experience and the most common grade 3–4 AEs was neutropenia. At this time 47 patients had just received 90Y-IT and 45 are evaluable. In particular, 9/17 (52.9%) patients converted from PR to CR after treatment with 90Y-IT. Conclusions: These preliminary data indicate that radioimmunotherapy appears highly effective and feasible as “consolidation” after 4 cycles of immunochemotherapy in elderly DLBCL patients, improving quality of response without any cumulative toxicity. Disclosures: Off Label Use: The drug Yttrium 90 (90Y) Ibritumomab Tiuxetan (90Y-IT) (Zevalin) is off-label for Diffuse Large B-Cell Lymphoma (DLBCL).
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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  • 5
    In: Leukemia & Lymphoma, Informa UK Limited, Vol. 46, No. 12 ( 2005-12-01), p. 1839-1841
    Type of Medium: Online Resource
    ISSN: 1042-8194 , 1029-2403
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2005
    detail.hit.zdb_id: 2030637-4
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  • 6
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 1659-1659
    Abstract: Abstract 1659 Poster Board I-685 Background Hodgkin lymphoma (HL) is a curable malignancy with a long-term survival of around 80%. FDG-PET is a noninvasive imaging modality widely used in lymphoma patients. Early PET assessment of response to therapy is a routine part of management in HL patients, and an independent, strong predictor of progression-free survival. Patients and Methods 178 patients, with a diagnosis of HL, underwent to an early PET evaluation during their course of chemotherapy and were considered eligible for the study. 85 patients (48%) were male and 93 (52%) female; the median age at diagnosis was 33 (13-78) years. 6 patients (3%) had stage I disease; 106 patients (60%) stage II; 34 (19%) stage III and 32 (18%) stage IV (bone marrow involvement in 5 cases). B-symptoms were detected in 81 patients (46%). A mediastinal bulk was detected in 54 cases (30%). The majority of patients (173, 97%) underwent to ABVD as first line therapy; 5 received BEACOPP chemotherapy (3%). Early PET evaluation was performed after the second course of therapy. Results were classified into complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) according to International Workshop standardized response criteria. PET scan was performed again at the end of the first-line treatment. 44 patients have been addressed to a second-line therapy, in presence of PR, PD or relapsing disease; in particular, 39 patients received an autologous stem-cells transplantation (ASCT), and 3 an allogeneic bone marrow transplantation (ABMT). Results At a median follow up of 41,85 (5,23-141,77) months, 152 patients are alive and in CR; 7 in PR; 3 alive with SD and 7 present a PD. 9 patients have died. 150 patients presented with a negative PET after 2 cycles, and 28 with a positive one (26 in PR, 1 with SD and 1 with PD). More specifically, of the 178 initial patients, 150 (84%) had a negative early PET and 28 (16%) a positive early PET. Of those with a negative PET, 135 (90%) experienced a continuous CR, while among those with a positive early PET, none obtained at least a stable CR. Of this unfavourable group of patients, 9 (32%) reached, and still maintain, a CR after ASCT. Conclusions Our experience indeed confirms the highly predictive value of a negative early PET during the therapy for HL. Moreover we may suggest the potential role of ASCT in inducing a CR in around one-third of those unfavorable patients with a positive early interim PET. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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    detail.hit.zdb_id: 80069-7
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  • 7
    In: Blood, American Society of Hematology, Vol. 106, No. 11 ( 2005-11-16), p. 4765-4765
    Abstract: In the last 20 years, the major improvement over the use of CHOP has been the addition of anti-CD20 immunotherapy (Rituximab). This advancement was first demonstrated in a randomized trial in elderly patients with diffuse large B-cell lymphoma (DLBCL). Single-agent radioimmunotherapy activity, in particular Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin), has been demonstrated in heavily pretreated DLBCL patients. Recently, the preliminary data of a phase II trial have showed that 90Y Ibritumomab Tiuxetan have useful activity in the treatment of relapsed/refractory elderly DLBCL (Morschhauser et al, Blood 2004, 104: 41a), with no unexpected toxicities observed. The results of this study support a further evaluation of 90Y Ibritumomab Tiuxetan in combination with chemotherapy earlier in the time course of elderly DLBCL. We conducted a prospective, single-arm, open-label, non-randomized, phase II to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a novel new approach combining induction chemotherapy with CHOP followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated elderly DLBCL. Patient eligibility was represented by: patients older than 60 years with biopsy-proven, untreated, bidimensionally measurable stage II, stage III, or stage IV DLBCL expressing the CD20 antigen; performance status of 0 to 2, a pretreatment granulocyte cell count of 1500/μL or greater, and a platelet count of 100.000/μL or greater. All patients were notified of the investigational nature of this study and signed a written informed consent approved in accordance with institutional guidelines, including the Declaration of Helsinki. The study was approved by the institutional review board. Patients were treated with standard CHOP chemotherapy every 21 days for 6 cycles. Patients were restaged 4 to 8 weeks after completion of the sixth cycle of CHOP chemotherapy. Patients achieving at least a partial response after 6 cycles of CHOP chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was greater than 1500/μL, the platelet count exceeded 100.000/μL, and the bone marrow examination at the completion of CHOP chemotherapy demonstrated no more than 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). A total of 20 patients have been enrolled and preliminary results of this trial will be presented.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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    detail.hit.zdb_id: 80069-7
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  • 8
    In: Blood, American Society of Hematology, Vol. 108, No. 11 ( 2006-11-01), p. 2431-2431
    Abstract: In the last 20 years, the major improvement over the use of CHOP has been the addition of anti-CD20 immunotherapy (Rituximab). This advancement was first demonstrated in a randomized trial in elderly patients with diffuse large B-cell lymphoma (DLBCL). Single-agent radioimmunotherapy activity, in particular Yttrium 90 (90Y) Ibritumomab Tiuxetan (Zevalin®), has been demonstrated in heavily pretreated DLBCL patients. Recently, the preliminary data of a phase II trial have showed that 90Y Ibritumomab Tiuxetan have useful activity in the treatment of relapsed/refractory elderly DLBCL (Morschhauser et al, Blood 2004, 104: 41a), with no unexpected toxicities observed. The results of this study support a further evaluation of 90Y Ibritumomab Tiuxetan in combination with chemotherapy earlier in the time course of elderly DLBCL. We conducted a prospective, single-arm, open-label, non-randomized, phase II to evaluate the efficacy and safety of 90Y Ibritumomab Tiuxetan of a novel new approach combining induction chemotherapy with CHOP followed by consolidation with 90Y Ibritumomab Tiuxetan for patients with previously untreated elderly DLBCL. Patient eligibility was represented by: patients older than 60 years with biopsy-proven, untreated, bidimensionally measurable stage II, stage III, or stage IV DLBCL expressing the CD20 antigen; WHO performance status of 0 to 2. All patients signed a written informed consent approved in accordance with institutional guidelines. The study was approved by the institutional review board. Patients were treated with standard CHOP chemotherapy every 21 days for 6 cycles. Patients were restaged 4 to 6 weeks after completion of the sixth cycle of CHOP chemotherapy. Patients achieving at least a partial response after 6 cycles of CHOP chemotherapy were eligible for consolidation with 90Y Ibritumomab Tiuxetan provided the granulocyte count was greater than 1500/μL, the platelet count exceeded 100.000/μL, and the bone marrow examination at the completion of CHOP chemotherapy demonstrated no more than 25% involvement with lymphoma. All patients were to receive a single dose of 90Y Ibritumomab Tiuxetan 14.8 MBq/kg (0.4 mCi/kg) up to a maximum dose of 1184 MBq (32 mCi). A total of 20 patients have been enrolled: 12 were male and 8 female; the median age was 68 years (range 61–84); 6 were stage II, 14 stage III-IV. After the CHOP treatment the overall response rate was 100%, including 15 (75%) CR and 5 (25%) PR. Treatment was well tolerated; grade ≥ 3 AEs were seen in 13 patients; the most common grade ≥ 3 AEs was neutropenia. After the treatment of all 20 patients with 90Y Ibritumomab Tiuxetan, 4/5 (80%) patients improved their remission status from PR to CR. The 90Y Ibritumomab Tiuxetan toxicity included grade ≥ 3 hematologic AEs in 11/20 patients; the most common grade ≥ 3 AEs were neutropenia (11 patients) and thrombocytopenia (7 patients). Transfusions of red cells and/or platelets were given to 2 patients. Time to event analyses, including TTP and duration of response are pending further follow-up. These preliminary data indicate the feasibility, tolerability, and efficacy of the CHOP plus 90Y Ibritumomab Tiuxetan regimen for patients with untreated elderly DLBCL.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    RVK:
    RVK:
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2006
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 9
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 27 ( 2007-09-20), p. 4293-4297
    Abstract: To determine the antitumor activity of the proteasome inhibitor bortezomib in patients with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma unspecified (PTCLU) with isolated skin involvement. Patients and Methods From May 2005 to June 2006 at our institute, we treated patients with previously pretreated CTCL or PTCLU using bortezomib as a single agent, at a dose of 1.3 mg/m 2 intravenously on days 1, 4, 8, and 11, every 21 days for a total of six cycles. Results Fifteen patients were registered, of whom 12 (10 CTCL, all mycosis fungoides, and two PTCLU with isolated skin involvement) were assessable. The overall response rate was 67%, with two (17%) complete remissions and six (50%) partial remissions. The remaining four patients had disease progression. Histologically, the responder patients were seven with CTCL and one with PTCLU with isolated skin involvement. All responses were durable, lasting from 7 to 14 or more months. Overall, the drug was well tolerated, with no grade 4 toxicity. The most common grade 3 toxicities were neutropenia (n = 2), thrombocytopenia (n = 2), and sensory neuropathy (n = 2). Conclusion This study suggests that bortezomib was well tolerated and has significant single-agent activity in patients with cutaneous T-cell lymphoma.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2007
    detail.hit.zdb_id: 2005181-5
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  • 10
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 16, No. 15 ( 2010-08-01), p. 3998-4004
    Abstract: Purpose: This study aimed to evaluate the efficacy and safety of the treatment with 90Y-ibritumomab tiuxetan following a short-course of rituximab with cyclophosphamide-adriamycin-vincristine-prednisone (R-CHOP) in high-risk elderly patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Experimental Design: From December 2006 to October 2008, 55 high-risk elderly (age ≥60 years) untreated DLBCL patients were treated in seven Italian institutions with a short-course of chemotherapy consisting of four cycles of R-CHOP21 followed by 90Y-ibritumomab tiuxetan 6 to 10 weeks later. Results: Of the 55 patients, 48 underwent radioimmunotherapy. The overall response rate to the entire treatment regimen was 80%, including 73% complete remissions and 7% partial remissions. Eight (50%) of the 16 patients who achieved less than a complete response with CHOP improved their remission status after 90Y-ibritumomab tiuxetan administration. With a median follow-up of 18 months, the 2-year progression-free survival was estimated to be 85%, with a 2-year overall survival of 86%. 90Y-ibritumomab tiuxetan toxicity consisted of grade 3 to 4 hematologic toxicity in 28 of 48 patients, mainly neutropenia (23 patients) and thrombocytopenia (15 patients). Red cells and/or platelets transfusions were given to three patients. Conclusion: This study evaluated the feasibility, efficacy, and safety of a short-course R-CHOP21 regimen followed by 90Y-ibritumomab tiuxetan in high-risk elderly DLBCL patients. Clin Cancer Res; 16(15); 3998–4004. ©2010 AACR.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
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    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2010
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    detail.hit.zdb_id: 2036787-9
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