Publications by authors named "Letizia Gandolfi"

26 Publications

  • Page 1 of 1

Efficacy and safety of biosimilar epoetin alpha in patients with chronic lymphoid neoplasms and chemotherapy-induced anaemia: An observational, retrospective, monocentric analysis.

Hematol Oncol 2018 Feb 23;36(1):136-143. Epub 2017 Mar 23.

Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Bologna, Italy.

Epoetin biosimilars are an alternative to originator erythropoietic agents in the treatment of chemotherapy-induced anaemia; however, their effects in patients with lymphoproliferative disorders remain unclear. This analysis examined the response of patients with lymphoproliferative disorders experiencing chemotherapy-induced anaemia to 4- or 8-week treatment with the biosimilar epoetin alpha. Treatment was initiated at first occurrence of haemoglobin (Hb) < 10 g/dL during chemotherapy and was stopped when Hb was >11 g/dL, when chemotherapy was completed, or in case of transfusion dependency. Response to epoetin alpha was defined as an increase in Hb of >1 g/dL or as an Hb > 11 g/dL. Stability was defined as change in Hb of ±1 g/dL, and no response was indicated by a decrease in Hb of >1 g/dL or acquired transfusion dependence. Overall, 65 patients were enrolled (median age 69 years; 47.7% ≥ 70 years old). Mean Hb levels at the initiation of epoetin alpha was 9.3 ± 0.5 g/dL. Mean Hb levels reached 10.7 ± 1.4 and 10.6 ± 1.5 g/dL at weeks 4 and 8, respectively, in patients on first-line chemotherapy and 11.4 ± 1.6 and 9.7 ± 1.3 g/dL in those on a second- or higher-line regimen. Overall, 70.8% of patients responded, 26.1% had stable Hb, and 3.1% did not respond. Delays or interruption of any chemotherapy cycle due to anaemia occurred in 18 patients. The biosimilar epoetin alpha was well tolerated and allowed patients with non-Hodgkin lymphoma or chronic lymphoproliferative disorders to continue their course of chemotherapy by effectively increasing and maintaining adequate concentrations of Hb.
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http://dx.doi.org/10.1002/hon.2412DOI Listing
February 2018

Leukocytoclastic vasculitis associated with hairy cell leukemia at diagnosis: a case report and review of the literature.

Tumori 2016 Nov 11;102(Suppl. 2). Epub 2016 Nov 11.

Institute of Hematology L. and A. Seràgnoli, University of Bologna, Bologna - Italy.

Background: Autoimmune manifestations may occur in patients with hairy cell leukemia (HCL), and some rare cases of polyarteritis nodosa and leukocytoclastic vasculitis have been reported. However, data regarding the treatment of these cutaneous manifestations are lacking, given the rarity of the concomitance of HCL and vasculitic syndromes.

Case Presentation: We present a 37-year-old man with paraneoplastic leukocytoclastic vasculitis complicating newly diagnosed HCL. The vasculitis completely resolved after the first 3 weekly administrations of cladribine, which is regarded as the gold-standard treatment for this disease. The underlying leukemia showed refractoriness to the same agent, thus requiring a second line of treatment.

Conclusions: The clinical picture we have observed is of interest for the following reasons: i) it confirms an existing pathogenetic relationship between this lymphoproliferative disorder and its cutaneous manifestations, as suggested by the prompt resolution of the purpuric lesions upon cladribine administration; ii) it indicates that cladribine is an effective treatment for HCL-related paraneoplastic syndromes, including leukocytoclastic vasculitis; iii) the evolution and the outcomes of the paraneoplastic manifestations may be independent of those of the underlying leukemia, which showed less than a partial response to its initial treatment.
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http://dx.doi.org/10.5301/tj.5000487DOI Listing
November 2016

Long-Term Responders After Brentuximab Vedotin: Single-Center Experience on Relapsed and Refractory Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma Patients.

Oncologist 2016 12 2;21(12):1436-1441. Epub 2016 Aug 2.

Institute of Hematology "L. e A. Seràgnoli," University of Bologna, Bologna, Italy

Background: Brentuximab vedotin (BV) has shown high overall response rate in refractory/relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL) with reported long-term response duration in clinical trials, but few data are available regarding its role in long-term outcomes in real life.

Patients And Methods: A single-center observational study was conducted on patients treated with BV in daily clinical practice to evaluate the long-term effectiveness of BV in HL and sALCL patients and to check whether clinical trial results are confirmed in a real-life context.

Results: The best response rate in the treated 53 patients (43 HL and 10 sALCL) was 69.8% (with 46.5% complete response [CR]) in HL and 100% (80% CR) for sALCL, respectively. With a median patient follow-up of 36.8 months, the estimated median duration of response was 31.5 months for HL and 17.8 for sALCL, respectively. At the latest available follow-up, 75% of patients were still in response, with 43% without any consolidation. Toxicity was primarily neurological and it was rarely so serious to require dose reduction or interruption. In addition, it always reversed completely after the end of treatment.

Conclusion: Our data showed that 51% of patients treated with BV can be regarded as "long-term responders." Among these cases, for all patients who underwent stem cell transplantation immediately after BV, the procedure was consolidative. For patients who have remained in continuous CR without any consolidation after therapy, BV can induce prolonged disease control.

Implications For Practice: Brentuximab vedotin (BV) has shown a high overall response rate in refractory/relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma, with reported long-term response duration in clinical trials, whereas few data are available regarding its role in long-term outcomes in real life. The data reported in this study suggest that BV can induce the same results in daily clinical practice. The data showed that 51% of patients treated with BV can be regarded as "long-term responders." Among these cases, BV can induce prolonged disease control in patients who have remained in continuous complete response without any consolidation after the drug.
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http://dx.doi.org/10.1634/theoncologist.2016-0112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5153337PMC
December 2016

90-yttrium-ibritumomab tiuxetan consolidation of fludarabine, mitoxantrone, rituximab in intermediate/high-risk follicular lymphoma: updated long-term results after a median follow-up of 7 years.

Cancer Med 2016 Jun 14;5(6):1093-7. Epub 2016 Mar 14.

Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Bologna, Italy.

Radioimmunotherapy (RIT) after an induction phase with conventional chemoimmunotherapy became an attractive strategy of consolidation for patients with advanced follicular lymphoma: in particular, in many studies RIT was represented by yttrium-90-ibritumomab tiuxetan ((90) Y-IT). Independently by the different front-line treatment, updates on the long-term follow-up of these studies are needed because the disease course of follicular lymphoma is characterised by multiple relapses and progressively shorter durations of response. We report updated long-term efficacy and toxicity results of a multicenter phase II study on sequential treatment with four cycles of fludarabine, mitoxantrone, and rituximab followed by (90) Y-IT as front-line therapy for untreated patients with intermediate/high-risk follicular lymphoma. With a median follow-up of 84 months, only 19/49 (38.8%) complete response patients relapsed, yielding an estimated long-term disease-free survival of 62.6%. The 7-year overall survival was 72.7%. Four (7.3%) second acute myeloid leukemia occurred, with a median time following RIT of 42 months. A relevant patients' responsiveness to subsequent therapies occurred: approximately 65% of relapsed patients obtained a good clinical response after the second-line treatment. These data represented the first evidence of a real role even in the long period of 90Y-IT after a fludarabine-containing regimen plus rituximab in the treatment of high-risk follicular lymphoma.
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http://dx.doi.org/10.1002/cam4.684DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4924367PMC
June 2016

High efficacy of the MACOP-B regimen in the treatment of adult Langerhans cell histiocytosis, a 20 year experience.

BMC Cancer 2015 Nov 9;15:879. Epub 2015 Nov 9.

Department of Experimental, Diagnostic and Specialty Medicine- DIMES, Institute of Hematology and Medical Oncology L.A. Seragnoli, University of Bologna, Via Massarenti 9, 40138, Bologna, Italy.

Background: Adult Langerhans cell histiocytosis (LCH) is an orphan disease. Chemotherapy is usually reserved to patients presenting with single system multifocal (SS-m) or multisystem (MS) disease but due to the lack of randomized studies no standard first line therapy has been defined yet. Pediatric regimens based on the vinblastine/prednisone backbone are not well tolerated in adults and probably less effective. We previously demonstrated high efficacy of the dose dense polichemotherapy regimen MACOP-B in 7 adult patients with SS-m or MS-LCH, in terms of high response rate and durable responses. Here we report an update of these data with the purpose of evaluating the long term efficacy of MACOP-B in adult LCH.

Methods: Clinical data of all adult LCH patients (n = 17) diagnosed and treated at our Institution during the past 20-year period were retrospectively reviewed.

Results: A total of 11 patients (6 with SS-m and 5 with MS-LCH) were treated with MACOP-B from 1995 to 2014. The overall response rate was confirmed to be 100 %, with a complete response of 73 % and a partial response rate of 27 %. Overall progression free survival was 64 %, and disease free survival after achievement of initial CR was 87 %. Overall survival rate was 82 % after 6.7 years of median follow-up.

Conclusions: These data confirm high activity of MACOP-B in adult LCH, indicating that a substantial fraction of patients achieve long lasting responses and can be cured with this therapeutic approach.
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http://dx.doi.org/10.1186/s12885-015-1903-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4640159PMC
November 2015

Multisystemic and Multiresistant Langerhans Cell Histiocytosis: A Case Treated With BRAF Inhibitor.

J Natl Compr Canc Netw 2015 Jun;13(6):715-8

From the Institute of Haematology "L. e A. Seràgnoli", and Dermatology, Department of Specialised, Experimental, and Diagnostic Medicine, University of Bologna, Bologna, Italy.

Langerhans cell histiocytosis (LCH) is a rare proliferative disease with a wide spectrum of clinical presentations and, as a consequence, the treatment choice is unclear. Recently, detection of the BRAF V600E mutation changed the perspective of this disease, suggesting a possible use for BRAF inhibitors in its treatment. Herein, a case is presented of a patient with LCH undergoing treatment with vemurafenib after several lines of therapy. After 4 months of vemurafenib treatment, skin lesions associated with cranial involvement were reduced in size at physical evaluation and nuclear imaging assessment showed a very good partial response, with the resolution of multiple lesions. Based on this very good partial response and because the patient tolerated treatment well, the patient was able to continue treatment with vemurafenib until disease progression nearly 10 months later. This approach should be considered for patients with severe and multiresistant LCH with a BRAF mutation. However, more studies are needed to evaluate the efficacy and duration of response in a larger patient population.
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http://dx.doi.org/10.6004/jnccn.2015.0086DOI Listing
June 2015

The role of rituximab and positron emission tomography in the treatment of primary mediastinal large B-cell lymphoma: experience on 74 patients.

Hematol Oncol 2015 Dec 25;33(4):145-50. Epub 2014 Sep 25.

Department of Nuclear Medicine, University of Bologna, Bologna, Italy.

Regarding primary mediastinal large B-cell lymphoma (PMLBCL), there are several controversial topics that warrant further investigation: the superiority of third-generation regimens, the impact of rituximab, the use of involved field radiotherapy (RT) and the assessment of clinical response by positron emission tomography (PET). We report our experience on 74 PMLBCL patients treated with a combination of a third-generation chemotherapy regimen (MACOP-B) and rituximab: an observational retrospective single-centre study was conducted on patients diagnosed and treated between February 2002 and July 2011. All patients were evaluated by computed tomography scan and PET scan; after the final PET evaluation, PET-negative patients were observed, whereas PET-positive patients underwent mediastinal RT. Sixty-one (82.4%) patients achieved a complete response after the MACOP-B plus rituximab regimen; 68.9% presented a positive final PET and were treated with local RT, whereas 31.1% had a negative PET. Five patients relapsed within 12 months. At 10 years, overall survival was 82%, progression-free survival was 87.6% and disease-free survival (DFS) was 90.5% (median follow-up 4 years). No statistically significant differences were observed in DFS between the patients treated also with RT (PET positive) and patients only observed (PET negative): 90.7% vs 90% (p = 0.85), respectively. In our experience, adding rituximab does not change the final results in terms of complete response and DFS utilizing third-generation regimen. Furthermore, the introduction of the PET-guided RT approach leads to a patient-tailored treatment, which preserves the outcome and, at the same time, allows reducing the use of RT.
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http://dx.doi.org/10.1002/hon.2172DOI Listing
December 2015

Fludarabine-Mitoxantrone-Rituximab regimen in untreated indolent non-follicular non-Hodgkin's lymphoma: experience on 143 patients.

Hematol Oncol 2015 Sep 2;33(3):141-6. Epub 2014 Jul 2.

Institute of Hematology 'L. e A. Seràgnoli', University of Bologna, Bologna, Italy.

Indolent non-follicular lymphomas (inFLs) are generally regarded as incurable, apart from extranodal mucosa-associated lymphatic tissue lymphomas, which can be partially cured by surgery, local radiotherapy, or antibiotic treatment. The aim of the present study was to test the degree of effectiveness and the safety of the regimen containing fludarabine, mitoxantrone, and rituximab (FMR) in inFL patients considering all the different entities belonging to this group. An observational retrospective study was conducted on 143 inFL patients providing that their first chemoimmunotherapy performed was FMR regimen and diagnosis from September 2000 to March 2011. There were 32 small lymphocytic lymphomas and 111 marginal zone lymphomas. At the end of treatment, overall response rate was 96.5% with 88% of complete responses (CR) and 8.5% of partial responses. With a median follow-up of 48 months, 10 out of 125 (8%) CR patients had disease relapse, yielding an estimated 9-year disease-free survival (DFS) of 74.9% and an estimated 10-year overall survival of 92.8%. The estimated 9-year progression free survival was 70.5%. The 10 relapsed patients showed lymphoma recurrence within 52 months: after this time, the DFS curve presented a plateau configuration. Only two (1.4%) patients developed a secondary hematological neoplasia. This study showed promising findings for the use of a fludarabine-based regimen in combination with rituximab in the front-line treatment of symptomatic inFL with a noteworthy high percentage of CR associated to an interesting long-term DFS and favorable acute and long-term safety profile.
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http://dx.doi.org/10.1002/hon.2151DOI Listing
September 2015

Role of autologous stem cell transplantation in T-cell lymphoma patients: a single institution retrospective analysis.

Hematol Oncol 2015 Sep 10;33(3):164-5. Epub 2014 Jun 10.

Institute of Hematology 'L. e A. Seràgnoli', University of Bologna, Bologna, Italy.

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http://dx.doi.org/10.1002/hon.2145DOI Listing
September 2015

Prognostic value of interim positron emission tomography in patients with peripheral T-cell lymphoma.

Oncologist 2014 Jul 28;19(7):746-50. Epub 2014 May 28.

Institute of Hematology "L. and A. Seràgnoli," Bologna, Italy

The definition of the role of positron emission tomography (PET) in peripheral T-cell lymphomas (PTCLs) is still under investigation. The purpose of the present observational retrospective study was to assess the early prognostic value of PET after the first three cycles of therapy (PET+3), evaluating visual data in de novo PTCL patients treated in first line with standard chemotherapy and followed by both PET and computed tomography scan. Of 27 PET+3-negative patients, 19 also had a negative PET at the end of treatment (PET+6), whereas 8 of 27 had a positive final one; 6 of 7 PET+3-positive patients had a positive PET+6, whereas only 1 patient had a negative PET+6. Estimated overall survival plotted according to PET+3 results showed 78.6% for negative patients and 21.4% for positive patients at 88.7 months with a significant difference. Patients with negative PET+3 had superior progression-free survival of 72.6% compared with 16.7% of PET+3-positive patients. At the time of this analysis, 17 of 19 (89.5%) patients with negative PET+3 are in continuous complete response (CCR) and only 1 of 7 (14.2%) patients with positive PET+3 is still in CCR. In conclusion, our results indicate that positive PET+3 is predictive of a worse outcome in PTCL, and this significant statistical difference between the two curves could be clinically informative. Larger and prospective studies and harmonization of PET reading criteria are needed.
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http://dx.doi.org/10.1634/theoncologist.2013-0463DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077444PMC
July 2014

Is it really possible to cure hairy cell leukemia patients only with frontline therapy?

Ann Hematol 2014 Sep 22;93(9):1565-9. Epub 2014 Apr 22.

Institute of Hematology "L. and A. Seràgnoli", S. Orsola-Malpighi Hospital, Via Massarenti 9, 40138, Bologna, Italy,

Hairy cell leukemia (HCL) patients could have an excellent prognosis with adequate treatment. Treatments are not generally curative but are extremely effective in inducing long-lasting clinical remissions. An observational retrospective study was conducted on a single-center registry of 144 patients with a median follow-up of 11.5 years, focusing on long-lasting continuous first complete remissions (CR) wondering if patients can be cured only with front-line approach. CR for more than 5 years after first-line therapy were found in 22.2 % cases. The median duration of response was 9.8 years, while for relapsed patients, the first response had a median duration of 2.4 years. Three different subsets of long-lasting first CR were identified: 15 patients are between 5 and 10 years with a median duration of CR of 6.5 years; 7 patients are between 10 and 15 years with a median duration of CR of 12.3 years; and 10 patients present a follow-up superior to 15 years with a median duration of CR of 20.0 years. There is a need for continuous study in this field to better define the optimal therapeutic regimen and, in particular, the biological issues since at least 20-25 % of HCL patients can be cured with only one treatment.
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http://dx.doi.org/10.1007/s00277-014-2081-5DOI Listing
September 2014

Sequential therapy with alternating short courses of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) and R-FM (rituximab, fludarabine, mitoxantrone) followed by autologous stem cell transplantation results in long term remission in advanced follicular lymphoma.

Br J Haematol 2014 Aug 18;166(4):625-8. Epub 2014 Apr 18.

Department of Experimental, Diagnostic and Specialty Medicine, S.Orsola-Malpighi Hospital, University of Bologna, Institute of Hematology and Medical Oncology "L. & A. Seragnòli", Bologna, Italy.

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http://dx.doi.org/10.1111/bjh.12894DOI Listing
August 2014

Extranodal marginal zone B-cell lymphoma of the lung: experience with fludarabine and mitoxantrone-containing regimens.

Hematol Oncol 2013 Dec 5;31(4):183-8. Epub 2012 Dec 5.

Institute of Hematology "L. e A. Seràgnoli", University of Bologna, Bologna, Italy.

Bronchial-associated lymphoid tissue (BALT) lymphoma is an extranodal primary pulmonary lymphoma. The optimal therapy for this rare disease is still debated, and few heterogeneous data are available in literature. The aim of our study was to critically review data of patients with BALT lymphoma treated in first-line therapy with fludarabine and mitoxantrone-containing regimens (with or without rituximab) to investigate the effectiveness and the safety of this approach and patients' survival. An observational retrospective study was performed on homogenous clinical data from 17 patients with biopsy-proven diagnosis of BALT. All the patients were treated with fludarabine and mitoxantrone-containing regimen therapy. Radiological findings were also reviewed to assess the role of (18) fluoro-deoxyglucose positron emission tomography in the initial assessment and in the monitoring of this extranodal lymphoma. A high percentage of response was observed: 82.3% of patients achieved a complete response, 11.8% a partial response. Furthermore, a very remarkable progression-free survival (71%) and overall survival (100%) were estimated at 14 years. No relevant toxicities were registered. Our results support the use of fludarabine and mitoxantrone-containing regimens as first-line therapy in the treatment of BALT lymphoma even if further data are necessary to consolidate our findings. Positron emission tomography scanning may provide additional valuable information in the assessment of BALT lymphoma.
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http://dx.doi.org/10.1002/hon.2039DOI Listing
December 2013

Bortezomib as salvage treatment for heavily pretreated relapsed lymphoma patients: a multicenter retrospective study.

Hematol Oncol 2013 Dec 29;31(4):179-82. Epub 2012 Oct 29.

Department of Hematology and Oncology 'L. and A. Seràgnoli', S. Orsola-Malpighi Hospital, University of Bologna, Italy.

Current treatments for non-Hodgkin lymphomas are not optimally effective. Among new agents, bortezomib seems to play a pivotal role in the regulation of several cell pathways involved in the development of lymphomas. After results were obtained with clinical trials, we aimed to observe treatment with bortezomib in everyday clinical practice. We performed a multicenter retrospective analysis to assess the efficacy of bortezomib in heavily pretreated (median number of previous therapies 4, range 2-6) lymphoma patients in an off-label setting. Bortezomib therapy was scheduled for 4-6 cycles (1.3 mg/m(2) biweekly). Data from 50 patients were collected: 22% had a complete remission, 26% obtained a partial response and the remaining 52% was non-responder. According to histotype, we observed an overall response rate (ORR) of 51.6% in mantle cell lymphomas, an ORR of 60% among follicular lymphoma patients, and an ORR of 50% in the indolent nonfollicular lymphomas. None of diffuse large B-cell lymphoma patients obtained a response. Extra-hematological toxicity was really mild, and peripheral neuropathy occurred in only 5 patients; hematological toxicity was grades 3-4 thrombocytopenia in nine patients and grades 3-4 neutropenia in only three patients. In conclusion, treatment with bortezomib as single agent resulted safe and effective in a subset of heavily pretreated lymphoma patients with usually poor outcome. New future hypotheses of investigation are indicated.
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http://dx.doi.org/10.1002/hon.2036DOI Listing
December 2013

Combination of lenalidomide and rituximab in elderly patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 2 trial.

Clin Lymphoma Myeloma Leuk 2011 Dec 4;11(6):462-6. Epub 2011 May 4.

Institute of Haematology and Medical Oncology "L. e A. Seràgnoli," University of Bologna, Italy.

Background: Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of aggressive non-Hodgkin lymphoma and despite recent chemotherapeutic advances up to half of all patients relapse. Here we report the results from a phase 2, single-arm, single-center trial evaluating the safety and efficacy of lenalidomide plus rituximab in elderly patients with relapsed or refractory DLBCL.

Patients And Methods: Between March and June 2009, elderly patients (65 years of age or older) with relapsed/refractory DLBCL who had been heavily pretreated were recruited. Oral lenalidomide (20 mg/d for 21 days of each 28-day cycle) was initiated for four cycles and rituximab (375 mg/m(2)) was administered on day 1 and day 21 of each 28-day cycle for four cycles. After this induction phase, patients achieving a complete response (CR), partial response (PR), or stable disease (SD) were given lenalidomide maintenance therapy at the same schedule for another 8 months.

Results: A total of 23 patients with a median of three prior treatments (range, 2 to 8) were included. The overall response rate (CR + PR) at the end of the induction phase was 35% (n = 8). Ten patients (7 CR, 1 PR, and 2 SD patients) were eligible for lenalidomide maintenance and 8 of these patients achieved a CR. Adverse events were manageable and the most common included neutropenia and thrombocytopenia.

Conclusion: Oral lenalidomide in combination with rituximab is active in elderly patients with relapsed/refractory DLBCL with a high percentage of patients achieving a continuous CR after lenalidomide maintenance.
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http://dx.doi.org/10.1016/j.clml.2011.02.001DOI Listing
December 2011

Primary bone lymphoma: evaluation of chemoimmunotherapy as front-line treatment in 21 patients.

Clin Lymphoma Myeloma Leuk 2011 Aug 7;11(4):321-5. Epub 2011 May 7.

Institute of Hematology and Medical Oncology "L. e A. Seràgnoli," University of Bologna, Bologna, Italy.

Background: We performed a retrospective investigation to assess the efficacy of chemotherapy and rituximab as front-line treatment for primary bone lymphoma (PBL).

Patients And Methods: Between 1999 and 2009, 21 previously untreated patients received a diagnosis of PBL. All the patients were treated with anthracycline-containing chemotherapeutic regimens, with the addition of rituximab; 11 patients received consolidative radiation therapy after induction treatment.

Results: Patients' median age was 34 years (range, 18-82 years); all presented with diffuse large B-cell lymphoma. Complete responses were seen in 95.2% of the patients treated. No relapses were observed at a median follow-up of 43.9 months. Eight-year overall survival and disease-free survival were 95.2% and 100.0%, respectively.

Conclusion: These data indicate that the combined chemotherapy plus rituximab treatment may represent a suitable front-line approach in PBL, with a high rate of responses and an excellent long-term survival.
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http://dx.doi.org/10.1016/j.clml.2011.03.021DOI Listing
August 2011

Midtreatment 18F-fluorodeoxyglucose positron-emission tomography in aggressive non-Hodgkin lymphoma.

Cancer 2011 Mar 19;117(5):1010-8. Epub 2010 Oct 19.

Institute of Hematology and Medical Oncology L. e A. Seràgnoli, Policlinico Sant'Orsola-Malpighi, University of Bologna, Bologna, Italy.

Background: The use of (18) F-fluorodeoxyglucose positron-emission tomography (PET) scan has increased considerably in the clinical management of non-Hodgkin lymphoma patients, and its role as a prognostic factor during chemotherapy has been established recently.

Methods: Between May 2003 and May 2009, 91 newly diagnosed patients with primary mediastinal large B-cell lymphoma (PMLBCL) and diffuse large B-cell lymphoma (DLBCL) were treated with 12 weekly cycles of rituximab-MACOP-B (n = 12 patients with PMLBCL), 6 cycles of rituximab-CHOP21 (n = 65 patients with DLBCL, aged < 60 years and 1 patient with PMLBCL), or 8 weekly cycles of rituximab-VNCOP-B (n = 13 DLBCL patients, aged ≥ 60 years). All patients underwent a staging PET examination at baseline and a midtreatment (interim) PET examination after 6 weeks of rituximab-MACOP-B treatment, 3 cycles of rituximab-CHOP21 treatment, or 4 weeks of rituximab-VNCOP-B treatment and again at the end of the chemo-immunotherapy regimen.

Results: At midtreatment evaluation, 35 patients showed a persistently positive PET scan; only 6 (17%) of these patients achieved a continuous complete response (CCR). However, 56 patients presented with a negative interim PET, and 50 (89%) of these patients achieved and maintained a CCR. Comparison between the 2 PET groups indicated a statistically significant association between PET findings and event-free survival (P = .0001) and overall survival (P = .0001).

Conclusions: The results of this study indicated that midtreatment PET may represent a significant step forward in helping physicians make crucial decisions on further treatment. Cancer 2011. © 2010 American Cancer Society.
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http://dx.doi.org/10.1002/cncr.25579DOI Listing
March 2011

Yttrium-90 ibritumomab tiuxetan as a single agent in patients with pretreated B-cell lymphoma: evaluation of the long-term outcome.

Clin Lymphoma Myeloma Leuk 2010 Aug;10(4):258-61

Institute of Hematology and Medical Oncology L. e A. Seràgnoli, University of Bologna, Bologna, Italy.

Background: Based on historical data on the role of radioimmunotherapy (RIT) in pretreated non-Hodgkin lymphoma, we reviewed our hospital's clinical database.

Patients And Methods: Between 2005 and 2008, 57 patients previously treated with at least 1 rituximab-containing chemotherapy were treated with Yttrium-90-labeled ibritumomab tiuxetan ((90)Y-IT). The median number of pretreatments was 3 (range, 1-9 pretreatments). A total of 46 patients had stage III/IV disease (31 with bone marrow involvement); 6 had bulky disease. According to histology, 53 were follicular lymphoma (FL), 2 were marginal zone lymphoma, and 2 were small lymphocytic lymphoma.

Results: Overall response rate was 93% (53 of 57); complete response (CR) rate was 70% (40 of 57). Twenty-six of 40 patients (65%) who obtained a CR are in continuous CR (CCR) with a median follow-up of 20 months (range, 10-42 months); 4 of them still maintain their CCR after 36 months. All patients achieving a CCR had FL, and 21 of them with stage III/IV disease; 12 of 26 had been heavily pretreated (>or= 3 previous treatments), and 2 had had autologous stem cell transplantation. Toxicity was primarily hematologic and mostly transient; no grade 4 extrahematologic toxicity was observed.

Conclusion: This study confirms the safety and high efficacy of (90)Y-IT RIT in heavily pretreated FL patients, with the possibility of having a subset of long-term responders.
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http://dx.doi.org/10.3816/CLML.2010.n.054DOI Listing
August 2010

Hairy cell leukemia: evaluation of the long-term outcome in 121 patients.

Cancer 2010 Oct;116(20):4788-92

Institute of Hematology and Medical Oncology "L. e A. Seragnoli," University of Bologna, Bologna, Italy.

Background: Historically, the first treatment choices for hairy cell leukemia (HCL) were splenectomy and alpha-interferon. Recently, purine analogues (pentostatin and cladribine) changed radically the treatment modality, inducing complete and durable responses in the majority of patients.

Methods: The authors analyzed the outcome of different lines of therapy in 121 HCL patients followed in their institute from 1986 to 2008, with a median follow-up of 105 months. Patients were divided into subgroups according to the number of treatments; Group A included 121 patients who underwent a front-line therapy, Group B patients (n =53) were treated with 2 lines, Group C patients (n = 34) with 3 lines, Group D patients (n = 17) with 4 lines, and Group E patients (n = 8) with 5 lines.

Results: In Group A, 92 (77%) patients obtained a complete response (CR), 23 (18%) a partial response, and the remaining 6 (5%) a minor or no response; median duration of response was 2.7 years. In Group B, 53 relapsed patients achieved a second CR rate of 73.5%; median duration of response was 2.5 years. Group C contained 34 patients in a second relapse, with a CR rate after the third line of treatment of 70.5% (median duration of response, 2.2 years). In Group D, 11 (64.7%) patients obtained a CR (median duration of response, 1.6 years), and in Group E 4 (50%) of 8 patients achieved a CR (median duration of response, 1.3 years).

Conclusions: This study confirms the high risk (>40% of all patients) of retreatment of HCL patients and the need to maximize primary response.
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http://dx.doi.org/10.1002/cncr.25243DOI Listing
October 2010

Phase II trial of short-course R-CHOP followed by 90Y-ibritumomab tiuxetan in previously untreated high-risk elderly diffuse large B-cell lymphoma patients.

Clin Cancer Res 2010 Aug 11;16(15):3998-4004. Epub 2010 Jun 11.

Institute of Hematology and Medical Oncology L. e A. Seràgnoli, Policlinico Sant'Orsola-Malpighi, University of Bologna, Via Massarenti 9, Bologna, Italy.

Purpose: This study aimed to evaluate the efficacy and safety of the treatment with (90)Y-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 > or =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 (90)Y-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 (90)Y-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%. (90)Y-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 (90)Y-ibritumomab tiuxetan in high-risk elderly DLBCL patients.
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http://dx.doi.org/10.1158/1078-0432.CCR-10-0162DOI Listing
August 2010

Cyclophosphamide, doxorubicin, vincristine, methotrexate, bleomicin and prednisone plus rituximab in untreated young patients with low-risk (age-adjusted international prognostic index 0-1) diffuse large B-cell lymphoma.

Leuk Lymphoma 2009 Nov;50(11):1824-9

Institute of Haematology and Medical Oncology L. & A. Seràgnoli, University of Bologna, Bologna, Italy.

Young patients (aged 18-60 years) with good-prognosis diffuse large B-cell lymphoma (DLBCL) [0 and 1 risk factor according to age-adjusted international prognostic index (aa-IPI)] are distinguished from patients with poor-prognosis. Six cycles of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) in combination with rituximab achieved best results in young patients with low-risk DLBCL. We retrospectively analyzed the data of 82 patients (18-60 years) with untreated aa-IPI 0-1 DLBCL, from six Italian institutions, who underwent, between January 2002 and January 2007, rituximab-cyclophosphamide, doxorubicin, vincristine, methotrexate, bleomicin and prednisone (R-MACOP-B) therapy followed, in patients with bulky presentation, by 30-36 Gy involved-field radiation therapy (34 patients). An overall response rate was noted in 77 out of 82 (94%) patients (75 patients had a complete response (91%), 2 patients had a partial response). With a median follow-up of 46 months, 7-year progression-free and overall survival were estimated to be 91% and 94%, respectively. R-MACOP-B regimen followed by involved-field radiation on bulky presentation is safe and very effective in the treatment of young patients with low-risk DLBCL.
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http://dx.doi.org/10.3109/10428190903216796DOI Listing
November 2009

Pretransplantation positron emission tomography scan is the main predictor of autologous stem cell transplantation outcome in aggressive B-cell non-Hodgkin lymphoma.

Cancer 2008 Nov;113(9):2496-503

Institute of Hematology and Medical Oncology L. & A. Seràgnoli, University of Bologna, Bologna, Italy.

Background: Limited data exist about the role of second-line chemotherapy response assessed by positron emission tomography (PET) as a prognostic factor in patients with aggressive non-Hodgkin Lymphoma (NHL) who undergo autologous stem cell transplantation (ASCT). The objective of this analysis was to investigate the main determinants of prognosis in patients with aggressive B-cell NHL who undergo ASCT, focusing on the impact of pretransplantation PET, secondary age-adjusted International Prognostic Index (sAA-IPI) score, histology, and previous response to first-line chemotherapy.

Methods: Seventy-five patients with diffuse, large B-cell lymphoma or grade 3 follicular lymphoma who were treated at the author' institution with second-line chemotherapy (combined ifosfamide, etoposide, and epirubicin [IEV]) followed by ASCT between September 2002 and September 2006 were included. All patients were evaluated by PET after 1 to 3 courses of IEV chemotherapy before ASCT, and all patients received a conditioning regimen of combined carmustine, etoposide, cytosine arabinoside, and melphalan. The prognostic impact of pretransplantation PET, sAA-IPI score, histology, and previous response to first-line chemotherapy was evaluated by univariate and multivariate analyses.

Results: Seventy-two of 75 patients underwent ASCT. In a univariate analysis for progression-free survival (PFS) and overall survival (OS), a significant association was observed with pretransplantation PET (PFS, P< .00001; OS, P< .01) and previous first-line response (PFS, P= .02; OS, P= .04). In the multivariate framework, pretransplantation PET was identified as the only independent prognostic factor (PFS, P< .001; OS, P= .01).

Conclusions: The current data indicated that pretransplantation PET is the main prognostic predictor in patients with aggressive B-cell NHL who are scheduled for ASCT.
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http://dx.doi.org/10.1002/cncr.23861DOI Listing
November 2008