scholarly journals P14.73 Toxicity and outcomes of reduced-dose whole brain radiotherapy as consolidation treatment for patients with CNS lymphoma in real life setting

2019 ◽  
Vol 21 (Supplement_3) ◽  
pp. iii84-iii85
Author(s):  
P Lesueur ◽  
G Damaj ◽  
K Hoang-Xuan ◽  
V Rolland ◽  
A Schmitt ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Real Life ◽  
Young Patients ◽  
Complete Response ◽  
Induction Treatment ◽  
High Dose ◽  
First Line ◽  
Reduced Dose ◽  
Real Life Setting

Abstract BACKGROUND Optimal treatment strategy for newly diagnosed primary PCNSL remains controversial. The high risk of radio-induced late-delayed neurotoxicity in patients who achieve long-term disease control constrains the use of classical consolidation WBRT. So as to reduce side cognitive effects, Morris et al, reported a phase II study, to assess the efficacy and toxicity of consolidation reduced-dose (23.4Gy) WBRT (rdWBRT) for patients with complete response after high dose methotrexate based chemotherapy. The study reported a 2-year PFS rate for these patients of 77%, with no evidence of significant cognitive decline during the follow-up (FU) period. The aim of this retrospective study was to report toxicity and outcomes of rdWBRT, in patients < 60 years old with complete response (CR) after HD-MTX based chemotherapy, in real life setting, without selection bias. MATERIAL AND METHODS Patients were selected from the French LOC network database, a nationwide database centralizing since 2011 information from 28 different centers in France, representing the main centers involved in PCNSL management. Patients were retrospectively selected according to the following criteria: 1) Pathological diagnosis of diffuse large B cell PCNSL; 2) age>18 and <60 years; 3) immunocompetent status; 4) First line induction treatment based on high dose MTX (At least MTX>1.5 g/m2); 5) CR according to the IPCG criteria after first-line induction treatment. Patients should have received a rdWBRT (23.4Gy in 13 fractions of 1.8Gy). RESULTS Twenty seven patients, were included. The median FU from initial diagnosis was 28.5 months [9.6–50.7]. Median age was 50.2 years [25–60]. Median Karnofsky Performans Status (KPS) was 90% [40–100%]. Seventeen patients had a multi focal disease at diagnosis (meningeal involvement n=6, in ophthalmic involvement n=4). PFS rates were 85% IC95[76–100 %], 65% IC95 [45–85%] and 65% IC95 [45–85%] at 1, 2, and 3 years respectively. The OS rates were 100%, 90,5% IC95 [77–100%] and 85%IC95 [69–100%]. 8 patients relapsed, with a median time from radiotherapy to recurrence of 6.5months [2.4–17]. All recurrences were outside the initially involved site(s), and 62.5% of tumors recurred as multifocal disease. All patients received salvage treatment, including intensive chemotherapy with autologous stem cell transplantation in 4 cases. No acute grade III-IV toxicity related to rdWBRT was reported. Neuropsychological follow up was available for 14 patients with no cognitive impairment at last follow up. CONCLUSION This is the largest retrospective study evaluating outcomes of rdWBRT for PCNSL young patients with CR after HD-MTX chemotherapy. Real life setting data from this study are quite reassuring, and rdWBRT could be considered as an efficient and safe consolidation strategy in this population. We need a longer FU to confirm the absence of cognitive deterioration.

First-line CyborD treatment for graft ineligible multiple myeloma patients: Real-life efficacy and tolerability.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e20516-e20516
Author(s):  
Dominic Duquette ◽  
Marie-Michelle Germain
Keyword(s):  
Multiple Myeloma ◽  
Elderly Population ◽  
Renal Toxicity ◽  
Real Life ◽  
Complete Response ◽  
High Rate ◽  
First Line ◽  
Grade 3 ◽  
First Line Treatment

e20516 Background: CyborD is a regimen that was widely adopted in Canada around 2010 despite very little data supporting it’s use. The aim of the study is to describe the efficacy and tolerability of First line CyborD regimen for graft ineligible myeloma patients. Methods: This is a retrospective study at two centres in the CHU de Québec for patients with graft ineligible multiple myeloma patients treated with first line CyborD regimen between 2013 and 2018. The objectives are to describe the efficacy and tolerability of CyborD and to document PFS and OS. Results: 51 patients were included in this study with a median follow-up of 31 months. Partial response or better (≥ PR) was obtain in 84% of patients and 63% of patients achieved a very good response or better (≥ VGPR). A high rate of 26% of complete response (CR) was also obtained. A median PFS of 30 months was obtained while 75% of patients were still alive at that time. Estimated survival at 48 months was 63%. Severe toxicities (grade 3 or 4) were seen as anemia (20%), neutropenia (10%), bacterial infection (16%), diarrhea (12%) and renal toxicity (4%). Side effects related to dexamethasone in this fragile patient population reached 69% of patients but only 28% needed a dose reduction. Conclusions: First-line CyborD treatment was highly effective for graft ineligible multiple myeloma patients and this is a very well tolerated regimen. It compares favorably to RD regimen making it still an excellent first-line treatment for this elderly population. [Table: see text]

scholarly journals Prognostic Comparison Between ISS and R-ISS in Real-Life Setting of Myeloma Patients: An Example of Utilization of Electronic Biobank Database

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5645-5645
Author(s):  
Samu Kurki ◽  
Klaus Tamminen ◽  
Tatu Miettinen ◽  
Kari Remes
Keyword(s):  
Board Of Directors ◽  
Real Life ◽  
Hazard Ratio ◽  
Line Treatment ◽  
First Line ◽  
Advisory Committees ◽  
Kaplan Meier ◽  
Real Life Setting ◽  
First Line Treatment

Abstract Introduction: Identification of patients with high-risk (HR) multiple myeloma (MM) is important to optimise their treatment. In 2015, revised International Staging System (R-ISS) guidelines were published (Palumbo, 2015) where HR cytogenetics (CG) and elevated serum lactase dehydrogenase (LDH) were added to the traditional ISS staging criteria. Thus, R-ISS stage III includes one of the HR CG abnormalities or elevated LDH, ISS stage I patients have no HR CG and normal LDH; the rest of patients belong to R-ISS stage II. There are limited data on the prevalence of R-ISS groups in comparison to the old ISS grouping and impact on clinical outcomes in the real-life setting. The aim of the present analysis was to use structured longitudinal electronic health records (EHR) provided by the Finnish Auria Biobank to compare the prevalence and survival outcome between patients in ISS and R-ISS groups in a real-life patient cohort of 100 patients treated at Turku University Hospital. Auria Biobank covers roughly 15% of the population of Finland and collects samples with the associated data from all diseases treated at Turku University Hospital based on the Finnish Biobank Act. Methods: Auria Biobank database was analysed retrospectively for all MM-patients diagnosed between 2008-2013 (incident cohort) and whose fluorescence in situ hybridization analysis was performed at the time of diagnosis. Data for age, gender, LDH, creatinine, ISS, R-ISS, CG, time to next treatment and overall survival were collected from Auria Biobank. Classification into ISS groups was done based on data at the time of diagnosis and OS. Classification into R-ISS staging was done according to IMWG (Palumbo, 2015). For HR CG at least one of the following CG abnormalities was required: del(17), t(4:14), or t(14:16). Estimated glomerular filtration rate was calculated by using the CKD-EPI formula. Drug treatments were classified as conventional (e.g. melphalan + prednisolone) or novel (proteasome inhibitors, IMIDs). Descriptive methods and Kaplan-Meier survival analysis were used for comparison of the groups. Results: The median age of the 100 patients was 64 yrs (range: 37 - 80), and 43% were female. At the time of diagnosis, 17% of patients had high risk CG status, 32% had at least moderate kidney failure (estimated glomerular filtration rate <60ml/min) and 26 % had elevated LDH. 41% patients received autologous stem cell transplant and 64% and 14% were treated with novel and conventional treatments in first line, respectively. 26%, 48% and 26% were classified to ISS stage I, II and III groups respectively, and 21%, 63% and 16% to R-ISS stage I, II and III groups, respectively. Criteria to include patients into R-ISS III were HR CG in 62 %, elevated LDH in 69 % and 31 % fulfilled both criteria. Neither ISS- nor R-ISS staging had any influence on first line treatment decisions between novel and conventional treatments. In all patients 2-year OS (from diagnosis) was 82% (median OS not yet reached). The 2-year OS in ISS I, II and III groups was 90%, 88%, and 60% respectively, and in R-ISS I, II and III groups 87%, 85% and 42%, respectively. R-ISS had a statistically significant effect on survival time (log rank P=0.032), with R-ISS III patients having a 3.8-fold risk of death compared to R-ISS I (Fig 1). R-ISS III patients had also shorter (ns) treatment free survival than R-ISS I patients (HR 2.1, log rank P=0.479) (Fig 2). No statistically significant difference was observed between the survival curves stratified by ISS staging groups. Conclusion: The new R-ISS staging system, using additional information including CG-profile and serum LDH, separated in our real-life setting more profoundly patients with poor prognosis than the old ISS staging. Structured EHRs can successfully be used to derive useful clinical and prognostic data from real-life MM patients. Figure 1 Kaplan-Meier curves for overall survival in different R-ISS groups. Time is measured from diagnosis to death or end of follow-up. Log rank P=0.032. R-ISS III vs. R-ISS I hazard ratio 3.8. Figure 1. Kaplan-Meier curves for overall survival in different R-ISS groups. Time is measured from diagnosis to death or end of follow-up. Log rank P=0.032. R-ISS III vs. R-ISS I hazard ratio 3.8. Figure 2 Kaplan-Meier curves for time to next treatment in different R-ISS groups. Time is measured from beginning of first line treatment to beginning of second line treatment or end of follow-up. Log rank P=0.479. R-ISS III vs. R-ISS I hazard ratio 2.1. Figure 2. Kaplan-Meier curves for time to next treatment in different R-ISS groups. Time is measured from beginning of first line treatment to beginning of second line treatment or end of follow-up. Log rank P=0.479. R-ISS III vs. R-ISS I hazard ratio 2.1. Disclosures Tamminen: Aava Healthcare group: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy; Roche: Employment; Takeda: Employment. Remes:Amgen: Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Teva: Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Allogeneic Hematopoietic Stem Cell Transplantation in First Line High Risk Multiple Myeloma Patients: Evolving Strategies with the Immunomodulating Drugs.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3116-3116
Author(s):  
Mauricette Michallet ◽  
Mohamad Sobh ◽  
Jean El-Cheikh ◽  
Stéphane Morisset ◽  
Anne Sirvent ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
High Risk ◽  
Board Of Directors ◽  
Induction Treatment ◽  
High Dose ◽  
First Line ◽  
Advisory Committees ◽  
Β2 Microglobulin

Abstract Abstract 3116 We evaluated in this study the efficacy and toxicity of a pilot tandem auto-HSCT strategy followed by reduced intensity conditioning (RIC) and allogeneic HSCT with the post-allo-HSCT introduction of bortezomib and donor lymphocyte infusion (DLI) in high risk multiple myeloma (MM) patients (Group1). We compared our results to those observed after traditional tandem auto-RIC-allo-HSCT without bortezomib after allo-HSCT (Group2). Groups 1 and 2 were compared to matched patients not receiving allo-HSCT from the IFM previous prospective studies. Matching variables were: diagnosis date, age, gender, β2 microglobulin, cytogenetics and induction treatment, the matching ratio was 1:3. Groups 1 & 2 included MM patients of age ≤ 65 years who previously received vincristine, doxorubicin and high-dose dexamethasone (VAD) or bortezomib plus dexamethasone (VD) as induction treatment followed by auto-HSCT. Only patients who achieved at least a partial response (PR) after auto-HSCT were included. Patients must have an HLA identical related or unrelated donor, and at least one of the following factors: β2 microglobulin level >3mg/L, del13, t(4;14) or del17p. The conditioning regimen combined fludarabine 30 mg/m2/d (d-5→d-1), busilvex IV 3.2 mg/kg/d (d-4, d-3) and ATG 2.5 mg/kg/d (d-2, d-1). GVHD prophylaxis consisted on cyclosporine A 3mg/Kg from day -1 with the addition of methotrexate at days 1, 3 and 6 in case of ABO incompatibility. In group1, by day 90 post-allo-HSCT, patients not in CR received 4 cycles of bortezomib 1.3 mg/kg (21 days cycle, on days 1, 4, 8 and 11); if the CR was not achieved, increasing doses of DLI were administered. Allo-HSCT groups included 25 patients (12 in group1 and 13 in group2), 18 males and 7 females with a median age of 51 years [28–67], there were 15 IgG, 6 IgA and 4 light chains MM. Fourteen (56%) patients had del13, 7 (28%) del17 and 17 (68%) had β2 microglobulin level >3mg/L. Induction treatment was VAD in 16 (64%) patients and VD in 9 (36%). Twenty-one (84%) patients received high dose melphalan (200 mg/m2) while the rest received a dose of 140 mg/m2; auto-HSCT was performed after a median time of 5.5 months [3.6–15.3] from diagnosis. The median time between auto-HSCT and allo-HSCT was 3.8 months [2.5–8.5]. The stem cell source was peripheral HSC in 22 (88%) of cases and the median number of infused CD34+ cells was 6.1×106cells/Kg (range: 2–13) from 16 identical siblings and 9 HLA (10/10) matched unrelated donors. Sex matching was as follow: F→M:9, F→F:3, M→F: 4 and M→M:9 and for ABO compatibility, 18 (72%) were compatible, 1 had minor incompatibility and 6 major incompatibility. At allo-HSCT, one patient was in CR, 4 in very good partial response (VGPR) and 20 patients were in PR. The matched population included 36 controls for group1 and 39 for group2. At Day 90 after allo-HSCT, all patients engrafted, 10 patients were in CR and 15 patients were in less than CR. Nine patients in group1 received bortezomib, 3 reached a CR while the 6 others were still in PR and received increasing doses of DLI. There were 8 acute GVHD [7 grade II (3 in group1) and 1 grade III in group1] and 11 chronic GVHD [3 lim. (all in group1) and 8 ext. (1 in group 1)]. No GVHD reactivation was observed after DLI. At the last follow-up, 14 patients are alive (9 in group1 and 5 in group2), 10 patients were in durable CR1 post-allo-HSCT and 4 patients in PR after DLI; 11 patients died (3 in group1: all from progression; 8 in group2: 5 from progression and 3 from TRM). After a median follow-up of 55 months [3–142], the median OS was not reached in group1 vs. 65 months (51-NR) in its matched patients (p=0.027); and it was 96 months (49-NR) in group2 vs. 91 months (32-NR) in its matched patients (p=0.77). The median PFS was 49 months (29-NA) in group1 vs. 25 months (21–35) in its matched patients (p=0.0045); and it was 31 months (22-NR) in group2 vs. 28 months (21–40) in its matched patients (p=0.0776). The encouraging results observed in group1, in terms of OS, PFS and toxicity are due to the introduction of IV busilvex and better ATG administration schedule in addition to the immunomodulating role of bortezomib in the elimination of the residual disease. In addition, we showed a good GVL effect after DLI with a durable stability of the disease without any important GVHD complication. According to our promising results, we should reconsider the allo-HSCT in the context of first line treatment for high risk MM patients. Disclosures: Nicolini: Novartis, Bristol Myers-Squibb, Pfizer, ARIAD, and Teva: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Attal:celgene: Membership on an entity's Board of Directors or advisory committees; janssen: Membership on an entity's Board of Directors or advisory committees.

Gemcitabine and Oxaliplatinum (GemOx): An Effective Regimen in Patients with Refractory and Relapsing Hodgkin Lymphoma

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4845-4845
Author(s):  
Antonio Gutierrez ◽  
Jose Rodriguez ◽  
Andres Lopez ◽  
Jordi Martinez-serra ◽  
Jorge Gines ◽  
...  
Keyword(s):  
Stem Cell ◽  
Retrospective Study ◽  
Stem Cell Transplantation ◽  
Hodgkin Lymphoma ◽  
Cell Transplantation ◽  
Induction Treatment ◽  
High Dose ◽  
Cell Transplant ◽  
Grade 3

Abstract Abstract 4845 Hodgkin lymphoma (HL) represents 10–15% of all types of lymphoma. At present, more than 70% of patients can be cured with current strategies based on chemotherapy with or without radiotherapy. However, one third of the cases finally relapses and needs salvage regimens usually consolidated with high dose chemotherapy and autologous stem cell transplantation. The number of regimens and drugs available are limited and new protocols that increase the efficacy with manageable toxicity are needed. In the present communication we report the results of a retrospective study using the GemOx schema that combines the efficacy of gemcitabine in Hodgkin lymphoma with oxaliplatin, a less toxic and effective platinum-based drug. Patients and methods: Patients were eligible for this retrospective study, according to the following criteria: diagnosis of HL, which relapsed or failed to achieve complete remission after induction treatment. They received GemOx regimen that consisted of gemcitabine 1000mg/m2 and oxaliplatin 100mg/m2 on day 1. Treatment was given every 15 days if feasible or every 21 days. To evaluate response and toxicity Cheson criteria and OMS toxicity scale were used respectively. Results: Between 2003 and 2012, 29 patients with Hodgkin lymphoma were retrospectively included in this study. All patients had recurrent (n=17) or refractory (n=12) disease. Median age was 24 (14–76) years and 50% had an International Prognosis Score (IPS) higher than 2. Patients received a mean of 2.79 previous regimens and 79% more than 1 regimen before GemOx with 48% relapsing after a prior autologous stem cell transplant (ASCT). Median follow-up was 41 months. 76% of patients responded (31% complete responses; CR). Responses were better in the relapsed setting or partial response (PR) (85% with a 45% of CR) compared to the truly refractory cases (55% PR) (p=0.037). Main prognostic factors for HL were assessed to view their impact on survival. Factors related with progression- free survival (PFS) and overall survival (OS) were age lower than 45 years, response to GemOx and consolidation with stem cell transplantation (p=0.001). Presence of B-symptoms at diagnosis also influenced OS. Neurologic toxicity was present in 9% of patients, all of them grade I or II. Hematologic toxicity was also common, including grade 3 or 4 neutropenia in 23% of patients, and grade 3 or 4 thrombocytopenia in 33%. Nausea and vomiting occurred in all the patients at grade 2, or lower. At last follow-up, 13 patients (45%) are alive and remain free of progression. However, 16 patients (54%) had died: 12 (41%) due to progression of disease, 3 (10%) due to complications due to a subsequent allogenic transplant (graft versus host disease, thrombotic thrombocytopenic purpura and bleeding) and 1 due to pneumonia. PFS was better in patients consolidated with autologous or allogeneic transplantation (100%) compared with patients not consolidated (14%) (p=0.009). PBSC collection after GemOx and G-CSF was successful for all of candidates. Conclusions: 1) GemOx regimen is effective in relapsed or refractory Hodgkin lymphoma with manageable toxicity; 2) Results are better in relapsed or chemosensitive disease compared to truly refractory cases; 3) No mobilization failures were observed; 4) Consolidation after response is needed. Disclosures: No relevant conflicts of interest to declare.

Salvage Chemotherapy for Patients With Advanced Pure Seminoma

2002 ◽  
Vol 20 (1) ◽  
pp. 297-301 ◽  
Author(s):  
Jacqueline Vuky ◽  
Satish K. Tickoo ◽  
Joel Sheinfeld ◽  
Jennifer Bacik ◽  
Alison Amsterdam ◽  
...  
Keyword(s):  
Complete Response ◽  
High Dose Chemotherapy ◽  
Salvage Chemotherapy ◽  
High Dose ◽  
First Line ◽  
Stem Cell Rescue ◽  
Conventional Dose ◽  
Pure Seminoma ◽  
Disease Free

PURPOSE: We describe the response to conventional or high-dose salvage chemotherapy in patients with advanced seminoma who experience disease progression after receiving first-line platinum-based treatment. PATIENTS AND METHODS: Twenty-seven patients with progressive, advanced, pure seminoma were treated with salvage chemotherapy. Fifteen patients were treated with conventional-dose cisplatin-and-ifosfamide combination chemotherapy. Twelve patients were treated with high-dose chemotherapy followed by autologous stem-cell rescue. RESULTS: Fifteen patients (56%) achieved a complete response (CR), nine achieved CR with a conventional-dose cisplatin and ifosfamide program, and six experienced CR after high-dose chemotherapy. Fourteen patients (52%) are alive and disease-free, with 13 (48%) continuously disease-free at a median follow-up of 72 months. Twelve (57%) of 21 patients whose pretreatment tumors were studied morphologically were found to have seminoma with atypia. Eight patients underwent resection after salvage chemotherapy; six with histologic findings of necrotic debris/fibrosis alone are alive and disease-free at last follow-up. Both patients with viable seminoma found at surgery died of disease. CONCLUSION: Most patients with advanced seminoma are cured with standard first-line programs of cisplatin and etoposide with or without bleomycin. A small minority of patients with pure seminoma have resistant tumors and require salvage chemotherapy. In this setting, approximately 50% of patients with recurrent pure seminoma achieve durable CR with conventional or high-dose salvage chemotherapy. Identification of biologic markers to predict clinical outcome and an enhanced understanding of the basic biologic features of seminoma may lead to improvements in the management of this disease.

90Yttrium-Ibritumomab Tiuxetan Consolidation of First Remission in Advanced-Stage Follicular Non-Hodgkin Lymphoma: Updated Results After a Median Follow-Up of 7.3 Years From the International, Randomized, Phase III First-Line Indolent Trial

2013 ◽  
Vol 31 (16) ◽  
pp. 1977-1983 ◽  
Author(s):  
Franck Morschhauser ◽  
John Radford ◽  
Achiel Van Hoof ◽  
Barbara Botto ◽  
Ama Z.S. Rohatiner ◽  
...  
Keyword(s):  
Survival Rates ◽  
Progression Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
Induction Treatment ◽  
Advanced Stage ◽  
First Line ◽  
Ibritumomab Tiuxetan ◽  
First Remission

PurposeUpdated results are presented after a median follow-up of 7.3 years from the phase III First-Line Indolent Trial of yttrium-90 (90Y) –ibritumomab tiuxetan in advanced-stage follicular lymphoma (FL) in first remission.Patients and MethodsPatients with CD20+stage III or IV FL with complete response (CR), unconfirmed CR (CRu), or partial response (PR) after first-line induction treatment were randomly assigned to90Y-ibritumomab consolidation therapy (rituximab 250 mg/m2days −7 and 0, then90Y-ibritumomab 14.8 MBq/kg day 0; maximum 1,184 MBq) or no further treatment (control). Primary end point was progression-free survival (PFS) from date of random assignment.ResultsFor 409 patients available for analysis (90Y-ibritumomab, n = 207; control, n = 202), estimated 8-year overall PFS was 41% with90Y-ibritumomab versus 22% for control (hazard ratio [HR], 0.47; P < .001). For patients in CR/CRu after induction, 8-year PFS with90Y-ibritumomab was 48% versus 32% for control (HR, 0.61; P = .008), and for PR patients, it was 33% versus 10% (HR, 0.38; P < .001). For90Y-ibritumomab consolidation, median PFS was 4.1 years (v 1.1 years for control; P < .001). Median time to next treatment (TTNT) was 8.1 years for90Y-ibritumomab versus 3.0 years for control (P < .001) with approximately 80% response rates to second-line therapy in either arm, including autologous stem-cell transplantation. No unexpected toxicities emerged during long-term follow-up. Estimated between-group 8-year overall survival rates were similar. Annualized incidence rate of myelodysplastic syndrome/acute myeloblastic leukemia was 0.50% versus 0.07% in90Y-ibritumomab and control groups, respectively (P = .042).Conclusion90Y-ibritumomab consolidation after achieving PR or CR/CRu to induction confers 3-year benefit in median PFS with durable 19% PFS advantage at 8 years and improves TTNT by 5.1 years for patients with advanced FL.

Rituximab-CHOP (R-CHOP) and Radiotherapy (RT) for Primary Mediastinal Large B-Cell Lymphoma (PMLBCL).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2745-2745 ◽  
Author(s):  
Theodoros P. Vassilakopoulos ◽  
Maria K. Angelopoulou ◽  
Zacharoula Galani ◽  
Sotirios Sachanas ◽  
Andreas Katsigiannis ◽  
...  
Keyword(s):  
Performance Status ◽  
Young Patients ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
High Dose ◽  
Free Survival ◽  
Historical Controls ◽  
Cell Support

Abstract Background: MACOP-B or even chemotherapy (CT) with consolidation high dose therapy with autologous stem cell support (HDT-ASCT) have been considered superior to CHOP in PMLBCL. However, in the absence of randomized trials, there is no established optimal treatment for these patients. The role of R-CHOP in PMLBCL, which usually affects young patients, has not been established. Aims: To evaluate the efficacy of R-CHOP±RT in PMLBCL and to compare this approach with CHOP±RT administered to historical controls. Patients and Methods: Between 1994 and 2006, 74 patients with PMLBCL were treated in 6 participating centers. R-CHOP displaced CHOP in the treatment of PMLBCL at a given timepoint in each center. Thus 31 consecutive patients who received R-CHOP, were compared with 43 consecutive historical controls, who had been treated with CHOP prior to that point. Results: The median age of the patients was 30 years (17–82), only 2 patients (3%) were older than 60 years, and 47/74 (64%) were females. All individual IPI parameters as well as B-symptoms were also balanced between the two groups, with the exception of performance status. The median follow-up of currently alive patients was 28 and 73 months for patients treated with R-CHOP±RT and CHOP±RT respectively, the complete response (CR/CRu) rate was 97% vs 67% (p=0.002), and the overall response rate was 100% vs 79%, respectively (p=0.007). All relapses after CHOP occurred within 22 months from diagnosis. The 3-year failure free survival (FFS) was 93±5% vs 53±8% for patients who received R-CHOP±RT vs CHOP±RT (p=0.0006). Within the subgroup of patients with L/LI risk IPI, the corresponding 3-year FFS rates were 95±5% vs 58±10% (p=0.007), while they were 90±9% vs 45±12% (p=0.03) among patients with HI/H risk IPI. The 3-year event free survival (EFS) for all patients was 90±5% vs 51±8% (p=0.001). The 3-year overall survival (OS) was 97±3% vs 67±7% (p=0.008), while the 3-year lymphoma specific survival (LSS) was 100% vs 67±7% (p=0.002). Conclusions: R-CHOP and RT provided impressive results with no cases of primary refractory disease, no lymphoma-related deaths and only 2 failures recorded so far after a median follow-up of 28 months among 31 patients. Patients treated with R-CHOP had significantly higher CR, FFS, EFS, OS, and LSS rates, when compared with CHOP-treated historical controls. Based on these results we continue to treat PMLBCL patients with R-CHOP and RT, avoiding more intensive strategies. Further studies are warranted to investigate whether RT is needed after R-CHOP, especially in the case of a negative post-chemotherapy PET-scan.

scholarly journals Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study

2021 ◽  
Author(s):  
Riccardo G. Borroni ◽  
Piergiorgio Malagoli ◽  
Luigi Gargiulo ◽  
Mario Valenti ◽  
Giulia Pavia ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Plaque Psoriasis ◽  
Real Life ◽  
Severity Index ◽  
First Line ◽  
Life Effectiveness ◽  
Real Life Setting ◽  
Humanized Monoclonal Antibody ◽  
Previously Treated ◽  
Interleukin 23

Risankizumab is a humanized monoclonal antibody that binds the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis. This retrospective study included 66 consecutive adults with moderate-to-severe psoriasis vulgaris treated with risankizumab in monotherapy up to week 40 in a “real-life” setting. At week 40, 98.7%, 85.7% and 62.3% of patients achieved a Psoriasis Area and Severity Index (PASI) reduction ≥ 75% (PASI 75), PASI 90 and PASI 100, respectively. Patients who had not responded to 2 or more previous biologic treat­ments were significantly less likely to achieve PASI 75/90 at week 16 and PASI 90/100 at week 40 compared with those who had been previously treated with only 1 biologic, and compared with those treated with risankizumab as a first-line biologic. Increasing body mass index decreased the chances of reaching PASI 90 at week 40. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment. These data suggest that the efficacy of risankizumab for plaque psoriasis in “real-life” clinical practice could differ from pivotal clinical trials data.

scholarly journals POS0693 EFFICACY AND SAFETY OF BELIMUMAB IN PATIENTS WITH LUPUS NEPHRITIS IN REAL-LIFE SETTING: RESULTS FROM A LARGE, NATIONWIDE, MULTICENTRIC, PROSPECTIVE COHORT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 594-595
Author(s):  
F. Saccon ◽  
M. Gatto ◽  
M. Zen ◽  
M. Fredi ◽  
F. Regola ◽  
...  
Keyword(s):  
Lupus Erythematosus ◽  
Independent Predictor ◽  
Rescue Therapy ◽  
Real Life ◽  
Multivariate Logistic Regression Analysis ◽  
Class Iii ◽  
Baseline Serum ◽  
Renal Response ◽  
Real Life Setting

Background:LN is still a severe manifestation of Systemic lupus erythematosus (SLE) and multitarget therapy is needed to control the disease especially in refractory cases.Objectives:To evaluate renal response in SLE patients with glomerulonephritis (GN) treated with Belimumab in real-life setting.Methods:Patients with proteinuria >0.5 g/24 h and/or active sediment at baseline enrolled in a multicentre Italian cohort of SLE patients (BeRLiSS study), treated with monthly iv Belimumab 10 mg/kg plus standard of care were considered in this study. Complete renal response (CRR) was defined as proteinuria <0.5 g/24 h, estimated glomerular filtration rate (eGFR)≥90ml/min/1.73m2 and no rescue therapy. Primary efficacy renal response (PERR) was defined as proteinuria ≤0.7 g/24 h, eGFR ≥60ml/min/1.73m2 and no rescue therapy. Prevalence and predictive factors of CRR and PERR at 12 and 24 months after Belimumab initiation were analyzed by multivariate logistic regression analysis.Results:A total of 91 patients were considered in this study, 79 female, mean age 40.51±9.03 years, mean disease duration 12.18±8.15 years, median follow-up time after Belimumab initiation 22 months. Twenty patients had baseline proteinuria ≥0.5 <1 g/day, 17 ≥1 <2 g/day, 13 ≥2 g/day. Belimumab was started at GN onset in 20 (22%) patients and at the time of a renal flare in all other cases. Seventy-five patients underwent a renal biopsy: 1 class I, 4 class II, 14 class III, 47 class IV and 9 class V. Baseline serum creatinine was 82.44±29.26 umol/L; 15 patients showed eGFR<60ml/min/1.73m2 at baseline. Immunosuppresants were taken by 70 (76.9%) patients: 47 micofenolate, 15 azathioprine and 5 ciclosporine. Sixty patients (65.9%) were on antimalarials. During follow-up 34 (37.4%) patients achieved CRR. Among them 5 (14.7%) patients relapsed and 29 (85.3%) patients maintained remission. Mean time to achieved CRR was 9.71±5.91 months.High levels of baseline proteinuria were a negative independent predictor of CRR and PERR at 6 months (OR 0.044 CI95% 0.006-0.320 p=0.002 and OR 0.232 CI95% 0.091-0.596 p=0.002) and 12 months (OR 0.029 CI95% 0.002-0.556 p=0.019 and OR 0.056 CI95% 0.009-0.327 p=0.001). High levels of baseline creatinine were a negative independent predictor of renal response. Renal response at 6 months was a strong predictive factor of renal response at 12 and 24 months.Conclusion:Belimumab is an effective add-on therapy in the treatment of GN in real-life practice setting.Disclosure of Interests:None declared

scholarly journals AB0369 EFFICACY AND SAFETY OF RITUXIMAB ORIGINATOR AND BIOSIMILAR IN PRIMARY SJÖGREN’S SYNDROME IN A REAL-LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1485.3-1485
Author(s):  
F. Carubbi ◽  
A. Alunno ◽  
P. Cipriani ◽  
V. Pavlych ◽  
C. DI Muzio ◽  
...  
Keyword(s):  
Disease Activity ◽  
Real Life ◽  
Primary Sjögren’S Syndrome ◽  
Efficacy And Safety ◽  
Research Support ◽  
Treatment Groups ◽  
Real Life Setting ◽  
Patient Reported ◽  
Time Point

Background:Over the last 2 decades rituximab (RTX) has been widely used, albeit off-label, in primary Sjögren’s syndrome (pSS). Several studies reported that B-lymphocyte depletion with RTX is effective in this disease not only by reducing disease activity but also by affecting the inflammation and the lymphoid organization that occur in target tissues. With the recent release of several RTX biosimilars (bRTX) on the market, the demonstration of their interchangeability with RTX originator (oRTX) is required.Objectives:To compare efficacy and safety of oRTX and bRTX in pSS patients in a real-life setting.Methods:Clinical records of pSS patients referring to a tertiary rheumatology clinic were retrospectively evaluated. Patients having received at least 2 courses of either oRTX or bRTX (1000 mg IV infusion, repeated after 2 weeks -1 course- and the course repeated after 24 weeks) with complete data at baseline and after 3, 6, 9 and 12 months of treatment were enrolled. Disease activity was assessed with the EULAR SS disease activity index (ESSDAI) and its clinical version without the biological domain (ClinESSDAI). Patient-reported symptoms were assessed with the EULAR SS Patient Reported Index (ESSPRI).Results:Seven patients that received oRTX and 7 patients that received bRTX were enrolled. Baseline clinical features, including ESSDAI and ESSPRI were similar in the 2 treatment groups. Both compounds significantly reduced ESSDAI and ESSPRI as early as 3 months and no difference between the groups was observed at any time point (Figure 1). Of interest, ESSDAI slowly decreased until month 6 when the most pronounced reduction was observed. Conversely, ESSPRI dropped to its lowest values already at month 3. With regard to safety, at 12 months of follow-up no adverse event was observed in any of the treatment groups.Conclusion:At 12 months of follow-up, oRTX and bRTX display similar efficacy and safety profiles. The improvement of patient reported outcomes is faster than the improvement of disease activity with both compounds. Our data support interchangeability of oRTX and bRTX in pSS.References:[1]Carubbi F et al. Arthritis Res Ther. 2013;15(5):R172[2]Carubbi F et al. Lupus. 2014;23(13):1337-49Figure 1 ESSDAI and ESSPRI values at every time point in the 2 treatment groups. Asterisks indicate p values <0.05 compared to the other treatment group at the same time pointDisclosure of Interests:Francesco Carubbi Speakers bureau: Francesco Carubbi received speaker honoraria from Abbvie and Celgene outside this work., Alessia Alunno: None declared, Paola Cipriani Grant/research support from: Actelion, Pfizer, Speakers bureau: Actelion, Pfizer, Viktoriya Pavlych: None declared, claudia di muzio: None declared, Roberto Gerli: None declared, Roberto Giacomelli Grant/research support from: Actelion, Pfizer, Speakers bureau: Abbvie, Roche, Actelion, BMS, MSD, Ely Lilly, SOBI, Pfizer

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