Publications by authors named "Pierluigi Zinzani"

22 Publications

  • Page 1 of 1

Frontline Siltuximab and Rituximab in TAFRO syndrome: A case report.

Eur J Haematol 2020 Oct 16;105(4):505-507. Epub 2020 Jul 16.

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

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http://dx.doi.org/10.1111/ejh.13473DOI Listing
October 2020

The classic prognostic factors in advanced Hodgkin's lymphoma patients are losing their meaning at the time of Pet-guided treatments.

Ann Hematol 2020 Feb 23;99(2):277-282. Epub 2019 Dec 23.

Policlinico S.Orsola-Malpighi, Istituto di Ematologia "Seragnoli", Bologna, Italy.

The International Prognostic Score (IPS) is the most commonly used risk stratification tool for patients with advanced Hodgkin lymphoma (HL). It incorporates seven clinical parameters independently associated with a poorer outcome: male sex, age, stage IV, hemoglobin level, white blood cell and lymphocyte counts, and albumin level. Since the development of the IPS, there have been significant advances in therapy and supportive care. Recent studies suggest that the IPS is less discriminating due to improved outcomes with ABVD therapy. The aim of the present study was to asses if classic prognostic factors maintain their prognostic meaning at the time of response-adapted treatment based on interim PET scans. We evaluated the prognostic significance of IPS in the 520 advanced stage HL patients enrolled in the PET-guided, HD0801 trial in which PET2-positive patients underwent a more intense treatment with an early stem-cell transplantation after 2 cycles of ABVD. We observed that in these patients, the IPS completely loses its prognostic value together with all the single parameters that contribute to the IPS. Furthermore, neutrophils, monocytes, lymphocytes, and the ratio among them also no longer had any predictive value. We believe that the substantial improvement in survival outcomes in PET2-positive patients treated with early autologous transplantation could explain the complete disappearance of the residual prognostic significance of the IPS.
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http://dx.doi.org/10.1007/s00277-019-03893-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6976582PMC
February 2020

Cutaneous leukocytoclastic vasculitis in B-cell chronic lymphocytic leukemia patients.

G Ital Dermatol Venereol 2019 Oct 26;154(5):605-606. Epub 2018 Feb 26.

Unit of Dermatology, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.

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http://dx.doi.org/10.23736/S0392-0488.18.05916-3DOI Listing
October 2019

PET in natural killer/T-cell lymphoma: the debate continues.

Lancet Haematol 2015 Feb 28;2(2):e50-1. Epub 2015 Jan 28.

Hematology Unit, Policlinico S Orsola, Università di Bologna, Bologna 40138, Italy.

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http://dx.doi.org/10.1016/S2352-3026(15)00004-6DOI Listing
February 2015

Appropriate use of bendamustine in first-line therapy of chronic lymphocytic leukemia. Recommendations from SIE, SIES, GITMO Group.

Leuk Res 2014 Nov 7;38(11):1269-77. Epub 2014 Jul 7.

University of Bologna, Bologna, Italy.

By using the GRADE system we produced the following recommendations for the use of bendamustine in the first-line treatment of CLL: (1) bendamustine with rituximab is recommended in elderly fit patients potentially eligible to FCR; (2) Bendamustine alone is recommended in patients who are candidate to chlorambucil alone; (3) Rituximab-bendamustine is recommended in patients not eligible to FCR, but suitable to receive rituximab. Consensus-based recommendations addressed evidence-orphan issues concerning the use of bendamustine in genetically-defined high-risk patients and the appropriate dose of bendamustine as single agent or in association with rituximab.
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http://dx.doi.org/10.1016/j.leukres.2014.06.017DOI Listing
November 2014

Lenalidomide plus R-CHOP21 in elderly patients with untreated diffuse large B-cell lymphoma: results of the REAL07 open-label, multicentre, phase 2 trial.

Lancet Oncol 2014 Jun 13;15(7):730-7. Epub 2014 May 13.

Struttura Complessa Ematologia e Dipartimento Oncologia Medica, Spedali Civili, Brescia, Italy.

Background: Up to 40% of elderly patients with untreated diffuse large B-cell lymphoma (DLBCL) given a regimen of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) relapse or develop refractory disease. Lenalidomide has high activity in relapsed or refractory aggressive B-cell lymphomas. In phase 2 of the REAL07 trial, we aimed to establish the safety and efficacy of the combination of lenalidomide and R-CHOP21 in elderly patients with untreated DLBCL.

Methods: REAL07 was an open-label, multicentre trial that was done in 13 centres in Italy and one in Germany. Eligible patients were aged 60-80 years; had newly diagnosed, untreated, CD20-positive, Ann Arbor stage II-IV DLBCL or grade 3b follicular lymphoma; had an Eastern Cooperative Oncology Group performance status of 0-2; had an International Prognostic Index (IPI) risk of low-intermediate, intermediate-high, or high; and were fit according to comprehensive geriatric assessment. Participants were to receive 15 mg oral lenalidomide on days 1-14 of six 21-day cycles, and standard doses of R-CHOP21 chemotherapy (375 mg/m(2) intravenous rituximab, 750 mg/m(2) intravenous cyclophosphamide, 50 mg/m(2) intravenous doxorubicin, and 1·4 mg/m(2) intravenous vincristine on day 1, and 40 mg/m(2) oral prednisone on days 1-5). The primary endpoint was frequency of overall response (complete response [CR] and partial response [PR]), which was assessed by (18)F-fluorodeoxyglucose ((18)F-FDG) PET at the end of the treatment. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00907348.

Findings: 49 patients were included in phase 2: nine had been enrolled into phase 1 between Oct 23, 2008, and June 4, 2009, and had received the maximum tolerated dose of 15 mg lenalidomide; and 40 were enrolled into phase 2 between April 28, 2010, and June 3, 2011. 45 patients (92%, 95% CI 81-97) achieved a response (42 [86%] CR; three [6%] PR). Three patients (6%) did not respond and one (2%) died for reasons unrelated to treatment or disease. 277 (94%) of 294 planned cycles of lenalidomide and R-CHOP21 were completed. Grade 3-4 neutropenia was reported in 87 cycles (31%), grade 3-4 leukopenia in 77 (28%), and grade 3-4 thrombocytopenia in 35 (13%). No grade 4 non-haematological adverse events were reported. No patients died during the study as a result of toxic effects.

Interpretation: Lenalidomide with R-CHOP21 is effective and safe in elderly patients with untreated DLBCL.

Funding: Fondazione Italiana Linfomi and Celgene.
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http://dx.doi.org/10.1016/S1470-2045(14)70191-3DOI Listing
June 2014

The role of surgery for haematologic neoplasms of bone.

Acta Orthop Belg 2012 Jun;78(3):382-92

Department of Orthopaedics, University of Bologna, Istituto Ortopedico Rizzoli and Ospedale S. Orsola, Bologna, Italy.

We report on 205 patients with haematologic neoplasms of bone treated from 1985 to 2009. There were 77 patients with primary bone lymphoma, 77 with myeloma and 51 with plasmacytoma. All patients had medical treatments; 43 patients had wide and 162 intralesional surgery. Mean follow-up was 5 years (median, 3.5 years); 11 patients were lost to followup. At the latest examination, 99 patients were alive without disease, 20 were alive with disease and 75 were dead of disease; 13 patients (6.7%) had local recurrence; 12 patients (24%) with plasmacytoma developed myeloma. Survival to death was significantly higher after wide resection for lymphoma and plasmacytoma, but not for myeloma. Survival to local recurrence was not statistically different between wide and intralesional surgery for any haematologic neoplasm. Surgical complications including aseptic loosening, infection, neurological deficits and breakage of implants occurred in 21 patients (11%).
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June 2012

SIE, SIES, GITMO updated clinical recommendations for the management of chronic lymphocytic leukemia.

Leuk Res 2012 Apr 1;36(4):459-66. Epub 2011 Sep 1.

Dipartimento di Biotecnologie Cellulari ed Ematologia, Università degli Studi La Sapienza, Roma, Italy.

By using GRADE system we updated the guidelines for management of CLL issued in 2006 from SIE, SIES and GITMO group. We recommended fludarabine, cyclophosphamide, rituximab (FCR) in younger and selected older patients with a good fitness status, no unfavourable genetics (deletion 17p and/or p53 mutations), and a less toxic treatment in nonfit and elderly patients. In patients without unfavourable genetics, relapsed after 24 months the same initial treatment including rituximab can be considered. In patients with unfavourable genetics, refractory or relapsed within 24 months from a prior fludarabine-based treatment, allogeneic SCT or experimental treatments should be given.
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http://dx.doi.org/10.1016/j.leukres.2011.08.013DOI Listing
April 2012

Late FDG PET normalization after radioimmunotherapy in a patient with non-Hodgkin lymphoma.

Clin Nucl Med 2009 Nov;34(11):777-8

Unità Operativa di Medicina Nucleare, Policlinico S. Orsola-Malpighi, Bologna, Italy.

Fluoro-deoxy-glucose positron emission tomography (FDG PET) has largely been used for response assessment after treatment of lymphoma, resulting in a very sensitive and specific imaging technique for the detection of residual disease. For this reason FDG PET has recently been proposed to be integrated in the International Workshop Criteria. In this report, a patient with non-Hodgkin lymphoma was treated with radioimmunotherapy for disease relapse, demonstrated by PET. Post-treatment evaluation was performed 9 weeks after treatment, and PET showed almost complete disappearance of tracer uptake, but with faint persistence of uptake at 1 iliac node and thus was a suspect for residual disease. However, a wait-and-see approach was decided and the patient was rescanned with PET 18 weeks after treatment, and the results were finally negative. This case indicates that after completion of radioimmunotherapy it may be recommended to wait several weeks before performing a PET scan and, in case of minimal findings, to consider a short-term re-evaluation.
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http://dx.doi.org/10.1097/RLU.0b013e3181b81c34DOI Listing
November 2009

Positive selection and transplantation of autologous highly purified CD133(+) stem cells in resistant/relapsed chronic lymphocytic leukemia patients results in rapid hematopoietic reconstitution without an adequate leukemic cell purging.

Biol Blood Marrow Transplant 2007 Oct 24;13(10):1224-32. Epub 2007 Aug 24.

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

We assessed the capacity of positively selected autologous CD133(+) hematopoietic stem cells (HSCs) to reconstitute lymphomyelopoiesis in chronic lymphocytic leukemia (CLL) patients receiving myeloablative chemotherapy. Ten resistant/relapsed CLL patients underwent HSC mobilization with chemotherapy and granulocyte-colony stimulating factor (G-CSF). Positive selection of circulating CD133(+) HSCs was performed by immunomagnetic technique. Highly purified HSCs were reinfused after busulphan/melphalan myeloablative treatment. A median number of 4.2 x 10(6) CD34(+) cells/kg and of 3.14 x 10(6) CD133(+) cells/kg were collected. Immunomagnetic selection resulted in the reinfusion of a median number of 2.45 x 10(6) CD133(+) cells/kg (median purity: 94.8%; median recovery: 84%) and 2.4 x 10(6) CD34(+) cells/kg (median purity: 93%; median recovery: 71%). HSC selection resulted in a median T cell and CD19(+)/CD5(+) cell depletion of 3.85 log and 2.8 log, respectively. At the molecular level, however, 7 of 8 valuable purified HSC fractions were contaminated by leukemic cells. All CLL patients showed rapid and sustained myeloid engraftment after reinfusion of purified CD133(+) cells. Immunologic reconstitution was comparable to that routinely observed in patients reinfused with unmanipulated leukapheresis products and no late infectious complications were observed. With a median follow-up of 28 months for transplanted patients, 5 patients are in clinical complete remission, 3 are in partial remission, and 1 is in progression. In conclusion, the reinfusion of highly purified CD133(+) HSCs allowed the rapid and sustained recovery of hematopoiesis after myeloablative treatment in resistant/relapsed CLL patients. However, the purging potential of positive selection of CD133(+) cells is not adequate to achieve tumor-free autografts.
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http://dx.doi.org/10.1016/j.bbmt.2007.07.004DOI Listing
October 2007

Role of interferon-alpha administration after 2-deoxycoformycin in the treatment of hairy cell leukemia patients.

Eur J Haematol 2006 Aug;77(2):109-13

Hematology Unit, University of Siena, Siena, Italy.

Background And Objective: Hairy cell leukemia (HCL) is a rare chronic B-cell lymphoproliferative disorder which is treated effectively by interferon-alpha (IFN-alpha), deoxycoformycin (DCF) and 2-clorodeoxyadenosine (2-CdA). As a third of patients treated with DCF do not achieve a complete remission (CR) and many of them tend to relapse, we evaluated the potential role of IFN-alpha, randomly administered after DCF, in increasing the number of patients attaining CR and/or duration of CR.

Methods: From March 1997 to December 2000, 167 previously untreated HCL patients, from 37 Italian institutions, were enrolled in the study. A total of 138 males and 29 females, with a median age of 55 yr were included in the study. All patients received six courses of DCF 4 mg/m(2) i.v. every other week and then two additional courses once a month. Complete and partial responders were randomly assigned to receive or not receive IFN-alpha at a dose of 3 MU s.c. three times a week for 6 months.

Results: Of the 167 patients enrolled in the study, 145 (86.8%) obtained a CR or a partial remission (PR) and were therefore suitable for randomization. One hundred and thirty-five patients were successively randomized to receive IFN-alpha (63 cases; arm A) or not (72 cases; arm B). Progression of disease was observed in eight (arm A) and 12 (arm B) patients with a median time of 27.8 and 26.9 months, respectively. As far as the improvement in response was concerned, no significant difference in the two subgroups was observed. In fact, five patients in arm A and six patients in arm B showing a good PR at the end of DCF therapy, subsequently attained a late CR.

Conclusions: From our data there does not appear to be any significant role for IFN-alpha in improving the proportion and the duration of CR in HCL patients previously treated with DCF.
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http://dx.doi.org/10.1111/j.1600-0609.2006.00670.xDOI Listing
August 2006

Diagnostic role of 18F-FDG PET in gastric MALT lymphoma.

Nucl Med Rev Cent East Eur 2006 ;9(1):37-40

Department of Nuclear Medicine - PET Unit, Policlinico S. Orsola-Malpighi Hospital, Bologna, Italy.

Background: The aim of the study was to evaluate the usefulness of 18F-FDG-PET in patients with gastric lymphoma, in particular those affected by mucosa-associated lymphoid tissue (MALT) type and aggressive gastric non-Hodgkin's lymphoma (NHL).

Material And Methods: The study group consists of 15 patients with a previous diagnosis of gastric NHL referred to our PET centres in Bologna Hospital and Rovigo Hospital, Italy, in the period 2003-2004. In 9/15 patients the subsequent histological evaluation was consistent with a gastric MALT lymphoma, while aggressive gastric NHL was diagnosed in the other 6/15. PET scan was carried out in patients with known active disease in order to stage or re-stage disease prior to treatment or in patients in complete clinical remission to monitor disease during follow up. Patients were considered in complete clinical remission if free from disease for at least 8 months after chemotherapy or surgery.18F-FDG PET was performed following standard procedures.

Results: Overall 18F-FDG-PET was true positive in all cases of gastric MALT and non-MALT aggressive NHL with known active disease, while no pathological 18F-FDG uptake was evident in the subjects who were in complete clinical remission. The degree of 18F-FDG uptake (mean SUVmax values) in MALT lymphoma was much less intense in comparison to aggressive gastric NHL, suggesting a prognostic role of SUV calculation in gastric lymphomas.

Conclusion: Our data demonstrate the significant accuracy of 18F-FDG-PET in detecting active disease in gastric lymphoma of both MALT and non-MALT NHL type. A higher SUV value appears to be related to a more aggressive disease.
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August 2006

Potential pitfalls of 18F-FDG PET in a large series of patients treated for malignant lymphoma: prevalence and scan interpretation.

Nucl Med Commun 2005 Aug;26(8):689-94

Nuclear Medicine Department, S. Orsola-Malpighi Hospital, Bologna, Italy.

Objective: To evaluate the prevalence and scan interpretation criteria useful in identifying non-tumoural F-FDG focal uptakes (potential pitfalls) in patients who had been previously treated for a malignant lymphoma studied by positron emission tomography (PET).

Materials: Nine hundred and ninety-six consecutive PET scans obtained in 706 patients with malignant lymphoma were reviewed. All patients had been previously treated by first-line chemo-radiotherapy, plus surgery when required, and were then studied by FDG PET to investigate suspected recurrence at doubtful or inconclusive conventional radiological imaging (ultrasound, computed tomography, magnetic resonance imaging). PET was obtained with patients in the fasted condition and after i.v. injection of 370 MBq of F-FDG; imaging was acquired 60-90 min later. In patients with focal FDG uptake the final diagnosis was reached on the basis of histological findings or long-term follow-up.

Results: Thirty-one of 134 PET scans (23.1%) showing focal FDG uptake were diagnosed as non-tumoural radiotracer uptake, related to the presence of brown fat in seven cases, thymic hyperplasia in five, muscles contraction in four, lymph node unspecific inflammation in four, mediastinal/pulmonary unspecific inflammation in four, gastritis in two, colitis in two, bacterial abscess in one, lactating breast in one, and herpes zoster in one. Each of the above cited situations has been reported in the literature, generally in the form of sporadic reports, as a potential cause of misinterpretation (false positive) in reading a PET scan with the potential for incorrect patient management. An accurate diagnosis in these patients was important for the following therapeutic decision making.

Conclusions: In the whole series of patients with treated malignant lymphoma, the prevalence of non-tumoural FDG focal uptake during follow-up was relatively low (3.1%); conversely, it was relatively high when considering the sub-group of 'positive' PET only (23.1%). The importance of knowing these situations in order to avoid misinterpretation in reading PET scans needs to be emphasized. In this light, an accurate patient's history and a skilful nuclear medicine physician are very important factors. For the same purpose, it is reasonable to think that the use of hybrid PET/CT tomographs could also play an important role in helping to identify non-tumoural FDG focal uptake.
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http://dx.doi.org/10.1097/01.mnm.0000171781.11027.bbDOI Listing
August 2005

18F-FDG PET in malignant lymphoma: significance of positive findings.

Eur J Nucl Med Mol Imaging 2005 Jul 23;32(7):749-56. Epub 2005 Mar 23.

UO Medicina Nucleare, Policlinico S.Orsola-Malpighi, Via Massarenti, Bologna 40100 Italy.

Purpose: The aim of this study was to evaluate the significance of increased uptake of 18F-fluorodeoxyglucose (FDG) in patients with malignant lymphoma (ML) studied by positron emission tomography (PET).

Methods: A total of 1,120 consecutive scans carried out in 848 patients were reviewed; all patients had a diagnosis of ML [574 non-Hodgkin's lymphoma (NHL) and 274 Hodgkin's disease (HD)] and were studied at completion of therapy, for suspected recurrence or during follow-up. PET was carried out after intravenous injection of 370 MBq of 18F-FDG; images were recorded after 60-90 min. Patients were selected whose reports indicated areas of increased FDG uptake. PET findings were considered positive for lymphomatous localisation when uptake occurred at sites of previous disease, in asymmetrical lymph nodes or in nodes unlikely to be affected by inflammation (mediastinal, except for hilar, and abdominal). PET findings were adjudged negative for neoplastic localisations in the following instances: physiological uptake (urinary, muscular, thymic or gastrointestinal in patients without MALT), symmetrical nodal uptake, uptake in lesions unrelated to lymphoma that had already been identified by other imaging methods at the time of PET scan, uptake at sites atypical for lymphoma, very low uptake and non-focal uptake. PET findings were compared with the results of other diagnostic procedures (including CT and ultrasound), biopsy findings and follow-up data.

Results: Overall, 354 scans (in 256 patients) showed increased FDG uptake (244 scans in NHL and 110 in HD): in 286 cases, FDG uptake was considered pathological and indicative of ML, in 41 cases the findings were described as uncertain or equivocal and in 37 cases, FDG uptake was considered unrelated to ML (in ten scans, concurrent findings of abnormal FDG uptake attributed to ML and uptake assigned to other causes were obtained) . Of the 286 patients with positive PET findings, 274 (95.8%) were found to have residual or recurrent ML (i.e. true positives). Four of the 41 patients with inconclusive findings turned out to have ML, while in 13 patients, pathological processes other than ML could be identified as the cause of FDG uptake. ML was excluded in all patients with findings reported as non-pathological (100% true-negative rate). Therefore, the false-positive rate in our series was about 5%. The main cause of increased FDG uptake mimicking ML was inflammation.

Conclusion: Our data confirm that 18F-FDG-PET has very high but not absolute specificity for ML. As already suggested, increased FDG uptake may also be observed in patients without active disease; in most cases, however, non-pathological FDG accumulation is properly identified. Less frequently, inconclusive scans are encountered; these cases are usually caused by inflammation, which subsequently resolves.
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http://dx.doi.org/10.1007/s00259-004-1748-xDOI Listing
July 2005

Phase II study of a single pegfilgrastim injection as an adjunct to chemotherapy to mobilize stem cells into the peripheral blood of pretreated lymphoma patients.

Haematologica 2005 Feb;90(2):225-31

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

Background And Objectives: The aim of this study was to evaluate the efficacy of pegfilgrastim, in combination with salvage chemotherapy, in mobilizing CD34(+) stem cells into the peripheral blood of pretreated lymphoma patients.

Design And Methods: This was an open-label phase II study including 25 pretreated patients (Hodgkin's disease=4; aggressive non-Hodgkin's lymphoma=21). The primary end-point of the study was the successful mobilization of a target cell dose of 2x10(6) CD34(+) cells/kg in lymphoma patients receiving ifosfamide, epirubicin and etoposide (IEV) chemotherapy and a fixed dose (6 mg) of pegfilgrastim given as single subcutaneous injection.

Results: Following chemotherapy, all patients had grade 4 neutropenia that lasted a median of 1.5 days (1-3). Pegfilgrastim treatment was well tolerated and only 2/25 patients required pain-control medication. CD34+ cells were mobilized in all patients. The median (range) peak value of peripheral blood CD34+ cells after IEV chemotherapy and pegfilgrastim was 141x10(6)/L (12.8-386) and occurred almost invariably on day +14 (13-16). Twenty-three of the 25 patients underwent a single standard volume leukapheresis to collect a median of 8.7x10(6) CD34(+) cells/kg (1.78-17.3). Twenty four/25 patients (96%) reached the target cell dose of 2x10(6) CD34(+) cells/kg. High concentrations of circulating CD34+ cells (> 50x10(6)/L) were observed for several days after the achievement of the peak value. All the study patients were transplanted with their pegfilgrastim-mobilized CD34(+) cells and showed a rapid and sustained engraftment after high-dose chemotherapy.

Interpretation And Conclusions: Our results show that pegfilgrastim as an adjunct to chemotherapy is a predictable and highly effective mobilization regimen in pretreated lymphoma patients.
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February 2005

18F-FDG PET early after radiotherapy in lymphoma patients.

Cancer Biother Radiopharm 2004 Oct;19(5):606-12

U.O. Medicina Nucleare, PET Unit, Policlinico S. Orsola-Malpighi, Bologna, Italy.

Objective: The aim of this study was to evaluate the rate of postactinic inflammatory alterations that could lead to false-positive results in FDG-PET images, in a group of lymphoma patients studied with positron emission tomography (PET) early after the end of radiation therapy.

Materials And Methods: Sixteen (16) consecutive patients were referred to our center for malignant lymphoma; 14 of 16 patients had a mediastinal bulky mass at diagnosis. Each patient underwent chemotherapy and then radiotherapy (RT): for clinical reasons, shortly after RT (range, 25-56 days; mean, 38.7 days) a FDG PET scan was required to evaluate the effect of therapy. We intravenously injected 370 MBq of 18F-FDG, and after 60-90 minutes we recorded images.

Results: Despite a relatively short time after RT, there was no pathological tracer uptake in 13 of 16 patients. In 3 cases, a mild increase in FDG uptake was observed, but no findings which would lead to a false-positive diagnosis. In 2 of 3 cases, postactinic pneumopathy was diagnosed (PET scan performed 51 and 52 days after RT); while in 1 patient, soft-tissue inflammation was present (PET scan performed 42 days after RT).

Conclusion: Our data indicates that the rate of postactinic PET inflammatory alterations in lymphoma patients is not very high and appear to be not strictly linked to the elapsed time since the end of RT treatment.
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http://dx.doi.org/10.1089/cbr.2004.19.606DOI Listing
October 2004

Primary non-Hodgkin's lymphoma of the bone: treatment and analysis of prognostic factors for Stage I and Stage II.

Int J Radiat Oncol Biol Phys 2004 Jul;59(3):760-4

Radiation Oncology Department, University of Bologna, Bologna, Italy.

Purpose: Primary non-Hodgkin's lymphomas of the bone (PLB) are very rare diseases accounting for 3%-5% of primary bone tumors. The best treatment for PLB has not been found yet. We report on the experience of the Radiation Oncology Department of Bologna University, Italy, relative to the diagnosis and treatment of this disease.

Methods And Material: Seventy-seven patients with newly diagnosed PLB were treated from June 1983 to October 2001. Fifty-six were male (72.7%) and 21 were female (27.3%); the median age was 41.8 years, with a range of 16-84 years. The majority of patients had B-cell high-grade histology. The median follow-up was 149 months. Forty-four patients had a solitary bone lesion (Stage I); and in 33 patients, the tumor was spread to locoregional lymphatic area (Stage II). All patients were treated with radiotherapy (RT) with a median dose of 40 Gy (range, 36-54 Gy), and 67 received an additional anthracycline-based regimen of chemotherapy (combined modality therapy [CMT]).

Results: After therapy 73 of 77 patients (94.8%) reached a complete remission. At a median time of 23 months, 14 of 77 patients (18.2%) had a disease relapse. Four of them were treated with RT alone (in these cases tumor lesions were <3 cm and located at sites different from mandible); 10 patients were treated with combined RT and CMT. Actuarial disease-free survival (DFS) and overall survival (OS) at 15 years were, respectively, 76.6% and 88.3%. No local failures were seen. Prognostic factors such as age, sex, stage, and bulky lesions were analyzed. Age (<40 vs. >40 years) was the only significant factor for DFS (85.3% vs. 66.6%, p = 0.03). Bulky lesions apparently did not affect OS (90.9% vs. 72.7%). However, the difference has no statistical significance (p = 0.05). Acute and late toxicity related to the treatment was moderate.

Conclusions: In PLB the CMT seems to produce a better outcome than RT alone; that still remains the best treatment for local disease control. Radiation therapy alone should be reserved for mandibular tumors, which are usually very small and earlier diagnosed.
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http://dx.doi.org/10.1016/j.ijrobp.2003.11.020DOI Listing
July 2004

Fludarabine + prednisone +/- alpha-interferon followed or not by alpha-interferon maintenance therapy for previously untreated patients with chronic lymphocytic leukemia: long term results of a randomized study.

Haematologica 2003 Dec;88(12):1348-57

Dipartimento di Biotecnologie Cellulari ed Ematologia, University La Sapienza, via Benevento 6, 00161 Rome, Italy.

Background And Objectives: Fludarabine is an effective therapy for patients with chronic lymphocytic leukemia (CLL) and interferon-alpha (IFN-alpha) has been reported to have anti-leukemic activity in CLL patients. A randomized study was designed to evaluate whether the addition of IFN-alpha to a first-line treatment with fludarabine and prednisone could increase the response rate in patients with advanced CLL and whether IFN-alpha given as maintenance therapy could improve the duration of response.

Design And Methods: One hundred and thirty-three patients were randomized to receive fludarabine (25 mg/m2/i.v., days 9-13) and prednisone (20 mg/m2, days 1, 3, 5, 7 and 14 and 40 mg/m2, days 9-13) (arm A: 66 patients) or in addition to the same schedule, IFN-alpha (2 MUI/sc, days 1, 3, 5, 7, 9, 11, 13 and 15) (arm B: 67 patients). Seventy-eight patients responsive to therapy entered the post-remission phase of the study in which 41 patients were randomized to receive IFN-alpha (3 MUI three times a week) and 37 to clinical observation.

Results: A similar response rate (complete responses + partial responses) was observed in the 2 arms: 86% for arm A and 84% for arm B (p = 0.4). A longer response duration was observed in patients who achieved a complete response (p = 0.001) and in patients who received maintenance therapy with IFN-alpha (p < 0.05). However, the quality of response was the only significant and independent factor influencing response duration (p < 0.01). No benefits in terms of infection-related mortality and morbidity could be ascribed to IFN-alpha administration.

Interpretation And Conclusions: In previously untreated CLL patients with advanced disease a high response rate is obtained from first-line fludarabine and prednisone and no benefit is derived from the addition of IFN-alpha to this regimen. The achievement of a good quality response to therapy was the only independent predictor of a prolonged response.
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December 2003

Monitoring of minimal residual disease after CHOP and rituximab in previously untreated patients with follicular lymphoma.

Blood 2002 Feb;99(3):856-62

Divisione di Ematologia, Ospedali Riuniti Bergamo, Largo Barozzi 1, 24100 Bergamo, Italy.

Minimal residual disease (MRD) following sequential administration of CHOP and rituximab was studied in previously untreated patients with follicular lymphoma. At diagnosis, the presence of Bcl-2/IgH-positive cells in the peripheral blood (PB) and/or bone marrow (BM) was demonstrated in all patients (n = 128) by polymerase chain reaction (PCR) analysis. Patients who achieved a clinical response following CHOP but remained PCR-positive were eligible for rituximab (375 mg/m(2) intravenously, weekly for 4 weeks). After CHOP, 57% achieved a complete response (CR), 37% a partial response (PR), and 6% were nonresponders (NR). At this stage, patients proving PCR-negative (n = 41) or failing to achieve a clinical response (n = 8) were excluded from rituximab treatment. Seventy-seven patients received rituximab and entered a scheduled MRD follow-up program. At the first molecular follow-up (+12 weeks), 59% had converted to PCR negativity in the BM and PB, with a further increase documented at the second control (+28 weeks) with 74% PCR negative. At the last molecular follow-up (+44 weeks), 63% of the patients remained PCR negative. At 3 years, the estimated overall survival of all patients is 95% (95% confidence interval [CI], 86-98). For patients achieving PCR-negative status following CHOP and therefore excluded from rituximab treatment, freedom from recurrence (FFR) was 52% (95% CI, 28-71). For patients treated with rituximab, a durable PCR-negative status was associated with a better clinical outcome since FFR was 57% (95% CI, 23-81) compared with 20% (95% CI, 4-46) in patients who never achieved or lost the molecular negativity (P <.001).
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http://dx.doi.org/10.1182/blood.v99.3.856DOI Listing
February 2002