scholarly journals MO1014PROSPECTIVE STUDY OF SAFETY AND EFFECTIVENESS OF OFATUMUMAB AS A TREATMENT IN REFRACTORY NEPHROTIC SYNDROME (CORTICODEPENDENT AND CORTICORRESISTANT)

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Lina Catherine Hernández Zúñiga ◽  
Ana Vinuesa Jaca ◽  
Pedro Arango Sancho ◽  
Yolanda Calzada Baños ◽  
Elena Codina Sampera ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Complete Remission ◽  
Remission Rate ◽  
First Line ◽  
Female Ratio ◽  
Persistent Proteinuria ◽  
Group 2 ◽  
Anti Cd20 ◽  
Group 1

Abstract Background and Aims Ofatumumab (OFA) is an anti-CD-20 monoclonal antibody useful in nephrotic syndrome refractory to conventional treatments and rituximab (RTX). Our objective is to evaluate the response and safety in patients with nephrotic syndrome (NS) treated with Ofatumumab. Method A prospective descriptive study of 2 years duration (2017-2019) in children with NS refractory to first-line therapies who received treatment with anti-CD20 monoclonal antibodies. To do this, we divided the cohort into 3 groups: Patients with corticodependent NS (CDNS) without response or with adverse effects associated with first-line treatment that preclude its use (Group 1); Corticosteroid-resistant SN (CRNS) (Group 2) and SN with post-transplant recurrence (Group 3). In them, the results of safety and remission rate were evaluated. Results Thirty-three patients (21 with SNCD, 11 with SNCR, and 1 with SN recurrence in transplantation) were included and administered anti-CD20. The male / female ratio was 2: 1 and the mean age at diagnosis was 5.2 years. 100% of the children (33) received RTX and 18.2% (6) OFA. The RTX achieved complete remission in 87.9% (29) and 48.3% of these did not present new relapses after 70 months of follow-up. 100% of Group 1 presented complete remission after RTX, although 52.4% (11) presented at least 1 relapse after 22.9 months (mean 2.5 relapses). In group 2, 72.72% (8) complete remission and 27.2% (3) partial, with persistent proteinuria. 36.4% (4) presented relapse after 17 months of treatment (mean 1 relapse). Of the 6 who received OFA, 83.3% presented complete remission (1 SNCR and 4 SNCD) and 1 patient (SNCD) presented relapse at 24 months (mean follow-up 1 year). The other case, a 13-year-old girl with recurrence of focal segmental glomerulosclerosis (FSGS) in kidney transplantation, presented partial remission after one year of treatment in association with immunoadsorption sessions. Regarding safety, adverse reactions occurred in 6% (2): allergic reaction with 2nd dose of RTX and cytokine release syndrome with 1st dose of OFA. Conclusion Ofatumumab in our series has proven to be an effective and safe drug in difficult-to-manage NS, achieving complete remission in 5 patients who had not previously responded to Rituximab

Impact of Second-Generation Tyrosine Kinase Inhibitors As Second Line Treatment for Patients with Chronic Myeloid Leukemia,

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3780-3780 ◽  
Author(s):  
J Valentin Garcia-Gutierrez ◽  
Pilar Herrera ◽  
Lorena L Abalo ◽  
Maria Dolores Rey ◽  
Maria Calbacho ◽  
...  
Keyword(s):  
Myeloid Leukemia ◽  
Second Generation ◽  
Kinase Inhibitors ◽  
Salvage Treatment ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Group 2 ◽  
Group 1

Abstract Abstract 3780 Background: Imatinib has shown an outstanding improvement in the prognosis of chronic myeloid leukemia (CML) patients. Nevertheless, some of them have proven to be resistant or intolerant to imatinib. For these patients, second-generation tyrosine kinase inhibitors (TKIs) are available. These drugs may be indicated in different circumstances as primary or second resistance, suboptimal responses or intolerance.The real benefits of second-generation TKIs as salvage treatment are surely in dependence with the indication in each case and are, therefore, difficult to evaluate. Second-generation TKIs are being evaluated as first line treatment compared to imatinib with quite favourable outcomes so long, but have not yet been compared with a strategy combining imatinib followed by second-generation TKIs for patients with previous unfavourable responses. Aims: Evaluate the real benefit of second-generation TKIs in second line treatment for CML patients regardless of the indication for its use. Study groups and methods: We have studied 98 patients treated with imatinib as first tyrosin kinase inhibitor (TKI) in our centre. These patients have been classified according whether second-generation TKIs were available or not. Group 1 includes 60 patients treated since 2001 to 2005, when the only salvage treatment was an increased imatinib dose, chemotherapy or allogenic stem cell transplantation. Group 2 includes 38 patients treated since 2005 until today. In the second group second-generation TKIs (dasatinib or nilotinib) were used according to the indications mentioned above. Follow up period was 39 months and 32 months for group 1 and 2 respectively. Sokal risk index was high in 14% and 16%; intermediate 42 % and 40%; and low in 44% and 44 % for group 1 and 2 respectively. Results: The use of second-generation TKIs as second line resulted in significant benefit to patients in terms of responses. Complete cytogenetic responses (CCR) at any time were achieved in 73% and 86% for patients in group 1 and 2 (p=.09). Probability of the achievement of mayor molecular responses (MMR) was 42% vs 71% for group 1 and 2 respectively [p=.009; ratio=0.3 (0.1–0.7)]. Response rates at the last follow up for group 1 and 2 were: MMR: 33% vs 62%; CCR: 68% vs 94% and failure 32% vs 6% (p=.008). Progression free survival (including all the patients who started treatment) was 88% vs 94% for group 1 and 2 respectively. We found no correlation among responses and some prognostic factors (Sokal index, mutations at the TK domain or imatinib plasma levels). Imatinib doses were increased in 21 patients (35%) in group 1 (reasons for increasing doses were failure in 14 patients and suboptimal responses in 7 patients). 10 patients (26%) in group 2 received second-line TKIs as second line treatment (4 because imatinib failure, 3 by suboptimal responses and 3 due to intolerance). Conclussions: The use of second-generation TKIs as salvage has improved the responses of CML patients treated with TKIs. Once the second-generation TKIs has shown benefit compared to imatinib in first line treatment, this therapeutic strategy should be compared vs the use of imatinib followed of second-line TKIs for patients without optimal responses to imatinib. Disclosures: Montalban: Red Temática de Investigación Cooperativa en Cancer (RETICC): Research Funding; Asociación Española contra el Cancer: Research Funding.

Early treatment with dexamethasone intravitreal implants in diabetic macular edema: Naïve versus refractory patients

2021 ◽  
pp. 112067212110248
Author(s):  
Anna V Bux ◽  
Francesca Fortunato ◽  
Antonio Barone ◽  
Vincenzo Russo ◽  
Nicola Delle Noci ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
First Line ◽  
Corrected Visual Acuity ◽  
Real World Setting ◽  
Treatment Naïve ◽  
Group 2 ◽  
Group 1

Purpose: To assess the efficacy and safety of dexamethasone 0.7 mg implants (DEX-I) in patients with diabetic macular edema (DME) either naïve to therapy or refractory to anti-VEGF treatment, in a single-center, real-world setting. Methods: Patients diagnosed with DME and treated with DEX-I were retrospectively enrolled in the study and split in two groups: naïve (Group 1, n = 64) and refractory (Group 2, n = 64) to treatment. Patients were evaluated at baseline, at 1 month, and every 3 months after each DEX-I implant. Main outcome measures were change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to follow-up visits. Results: Significant improvements in BCVA were observed in treatment-naïve patients at 6 months following the first and second DEX-I injection ( p = 0.0023 and p = 0.0063, respectively), with significant reductions in mean CMT at 6 months after all DEX implants. In treatment-refractory patients, mean CMT was significantly reduced from baseline to 6 months ( p < 0.05) after all DEX-I injections, although no changes were observed in BCVA. Conclusions: DEX-I improved visual acuity and macular edema mostly in treatment-naïve patients, suggesting DEX-I may be a viable first-line treatment option in DME.

scholarly journals A simplified in vitro classification for prognosis in adult acute leukemia: the application of in vitro results in remission-predictive models

Blood ◽  
1976 ◽  
Vol 48 (6) ◽  
pp. 795-807
Author(s):  
G Spitzer ◽  
KA Dicke ◽  
EA Gehan ◽  
T Smith ◽  
KB McCredie ◽  
...  
Keyword(s):  
Complete Remission ◽  
Acute Leukemia ◽  
Remission Rate ◽  
Leukemic Cell ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Proliferation In Vitro ◽  
Group 1

Previous classification in vitro of adult acute leukemia incorporating morphology has been complex and difficult to understand. We have devised a simplified classification based solely on leuekemic proliferation in vitro. Seventy-six patients with adult acute leukemia previously untreated were included in this study and received identical chemotherapy. Three groups were recognized. The complete remission rate was 76% in the 21 patients with no leukemic growth in vitro (Group 1), 75% in 36 patients with leukemic cell growth but aggregates of 20 cells or less (Group 2), and only 21% in the 15 patients with aggregates of greater than 20 (Group 3). There was a highly significant difference in complete remission rates between Group 3 and the other two groups (p less than 0.001). Linear logistic regression analysis demonstrated the independence of the growth in vitro from other prognostic variables. A predictive model utilizing the in vitro result more accurately predicted for remission, both retrospectively and prospectively, than a model constructed with presently known prognostic parameters. The cause of death in failures suggested that this system detects resistance to the chemotherapy.

Late Appearance of 14q32/IGH Translocation in Chronic Lumphocytic Leukemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2429-2429
Author(s):  
Francesco Cavazzini ◽  
Gian Matteo Rigolin ◽  
Lara Rizzotto ◽  
Antonella Bardi ◽  
Elisa Tammiso ◽  
...  
Keyword(s):  
Overall Survival ◽  
Clonal Evolution ◽  
Fish Analysis ◽  
Line Treatment ◽  
First Line ◽  
Group 2 ◽  
First Line Treatment ◽  
14Q32 Translocation ◽  
Group 1

Abstract Abstract 2429 Up to 80% of Chronic Lymphocytic Leukemia (CLL) harbour clonal chromosome aberrations having important clinical implications (i.e. 13q deletion, +12, 11q/ATM and 17p/TP53 deletions). 14q32/IGH rearrangements were recently found in 6–19% of CLL patients and were associated with therapy-demanding disease and inferior outcome. Whereas evidence was provided that some of the classical aberrations, such as 11q-, 17p-, may appear late in CLL clinical history, no information is presently available concerning 14q32/IGH translocations. The aim of this study was i) to analyze the incidence of 14q32/IGH translocations occurring at clonal evolution in CLL, ii) to analyze the clinicobiologic significance of late-appearing 14q32/IGH translocations. One hundred-five CLL cases seen at our institution in a 10-year period were submitted to FISH analysis at diagnosis or before 1st line treatment as part of routine diagnostic workup. In 47 patients with indolent disease (untreated or treated with 1 line without relapse, group 1) FISH analysis was repeated after 48–96 months (median 72). In 58 relapsed patients who started 2nd line treatment (group 2), FISH was performed sequentially before administration of the 2nd line and before each subsequent line of therapy. These 105 patients fulfilled the following criteria: a) diagnosis of bona fide CLL based on morphology and immunophenotyping (CD5/CD19+, CD23+ as minimal requirement), b) clinical records available for review, c) successful FISH analysis at diagnosis and during follow-up. Those cases with t (11;14)(q13;q32)/CCND1-IGH or other 14q32/IGH translocations present at diagnosis were excluded from this study. Sequential FISH studies were performed in all patients on peripheral blood (PB) samples using commercially available probes for the identification of deletions at 13q14, 11q22/ATM, 17p13/TP53, of trisomy 12 and of 14q32/IGH translocations. In 10 patients bone marrow (BM) aspiration and/or lymph node (LN) biopsy were studied by FISH as well. The patients were treated at disease progression as defined by NCI criteria. Refractory disease was defined by stable disease or progressive disease during treatment or disease progression within 6 months of from antileukemic treatment using fludarabine alone or in combination with other agents. Time to chemorefractoriness was measured from date of first line treatment to date of refractoriness to fludarabine containing regimen or date of last follow-up. Overall survival was measured from diagnosis to date of last follow-up or death and from initiation of first line treatment to the date of death or last follow-up. At diagnosis 39% of the cases had 13q-, 14% had +12, 7% had 11q- and 3% had 17p-. A late-appearing 14q32/IGH rearrangement was not detected among 47 patients in group 1, whereas 7/58 cases (12,1%) in group 2 showed a 14q32/IGH break in 16–25% of the cells. These 7 patients had the following aberrations at diagnosis: 13q- and 11q- in 1 case, 13q- in 2 cases; 11q- in 1 case, +12 in 2 cases, no aberrations 1 case. The 14q32 translocation appeared after a median time of 64 months (range 51–91). It was associated with the appearance of 17p- in 3/7 cases with one of these presenting also biallelic del13q. In two cases paired BM or LN sample and PB samples were available for FISH studies and the appearance of IgH translocation in the BM or in the LN sample preceded its appearance in PB by 13–58 months. All 7 cases with late appearing 14q32/IGH translocation developed chemorefractoriness to fludarabine regimen with a median TTC of 27 months (range 12–40 months), as compared with a TTC of 67 months (range 1–143 months) in 51 treated patients who did not develop the 14q32 translocation (p=0.0002). Overall survival did not differ significantly either when measured from diagnosis or from 1st line treatment in 7 patients with 14q32 translocation as compared with the appropriate control. We arrived at the following conclusions: i) a late-appearing 14q32/IGH translocation occurred at a relatively high incidence (12,1%) in patients with relapsing disease and not in patients with stable disease, ii) this aberration involved a minority of cells and, in approximately half of the cases, it was associated with other aberrations, reflecting complex clonal evolution, iii) in 2 assessable cases it first appeared first in the BM or LN; iv) the appearance of 14q32/IGH translocation was associated with shorter TTC. Disclosures: No relevant conflicts of interest to declare.

scholarly journals A simplified in vitro classification for prognosis in adult acute leukemia: the application of in vitro results in remission-predictive models

Blood ◽  
1976 ◽  
Vol 48 (6) ◽  
pp. 795-807 ◽  
Author(s):  
G Spitzer ◽  
KA Dicke ◽  
EA Gehan ◽  
T Smith ◽  
KB McCredie ◽  
...  
Keyword(s):  
Complete Remission ◽  
Acute Leukemia ◽  
Remission Rate ◽  
Leukemic Cell ◽  
Significant Difference ◽  
Group 3 ◽  
Group 2 ◽  
Proliferation In Vitro ◽  
Group 1

Abstract Previous classification in vitro of adult acute leukemia incorporating morphology has been complex and difficult to understand. We have devised a simplified classification based solely on leuekemic proliferation in vitro. Seventy-six patients with adult acute leukemia previously untreated were included in this study and received identical chemotherapy. Three groups were recognized. The complete remission rate was 76% in the 21 patients with no leukemic growth in vitro (Group 1), 75% in 36 patients with leukemic cell growth but aggregates of 20 cells or less (Group 2), and only 21% in the 15 patients with aggregates of greater than 20 (Group 3). There was a highly significant difference in complete remission rates between Group 3 and the other two groups (p less than 0.001). Linear logistic regression analysis demonstrated the independence of the growth in vitro from other prognostic variables. A predictive model utilizing the in vitro result more accurately predicted for remission, both retrospectively and prospectively, than a model constructed with presently known prognostic parameters. The cause of death in failures suggested that this system detects resistance to the chemotherapy.

scholarly journals A second course of antithyroid drug therapy for recurrent Graves' disease: an experience in endocrine practice

2015 ◽  
Vol 172 (3) ◽  
pp. 321-326 ◽  
Author(s):  
Xiaomei Liu ◽  
Wei Qiang ◽  
Xingjun Liu ◽  
Lianye Liu ◽  
Shu Liu ◽  
...  
Keyword(s):  
Drug Withdrawal ◽  
Remission Rate ◽  
Antithyroid Drug ◽  
Graves Disease ◽  
Number Of Patients ◽  
Group 2 ◽  
Permanent Remission ◽  
Group 1

ObjectiveThere are scarce reports regarding the prognosis of a second course of antithyroid drug (ATD) therapy on recurrent Graves' disease (GD). The aim of this study was to assess the long-term remission rate after a second ATD therapy and verify significant clinical predictors of a remission.DesignA prospective randomized clinical trial with long-term follow-up was conducted to evaluate the effects of a second course of ATD therapy.MethodsA total of 128 recurrent GD patients who had finished a first regular ATD therapy were enrolled in this study, and prescribed methimazole (MMI) treatment with titration regimen. The patients were randomly assigned to two groups when the drug doses were reduced to 2.5 mg daily (qd). Group 1 was discontinued with 2.5 mg qd after about 5 months. Group 2 was continuously reduced to 2.5 mg every other day (qod) after 5 months and then discontinued with 2.5 mg qod after about a further 5 months. The patients were followed for 48 months after drug withdrawal.ResultsOf the total number of patients, 97 cases (75.78%) achieved permanent remission at the end of follow-up, with the recurrence of 31 cases (24.22%). The remission rate of group 2 (84.62%) was significantly higher than that of group 1 (66.67%) (P=0.024). Cox regression showed that the hazard ratio for recurrence decreased under a high or high normal TSH level at drug withdrawal.ConclusionA second course of ATD therapy can bring about a satisfying long-term remission on recurrent GD. The drug dose of 2.5 mg qod and a high or high normal TSH level at drug withdrawal may increase the likelihood of permanent remission.

Both Higher Level of (bcr,abl) Transcripts and High Hasford Risk Score Are Associated with Cytogenetic Response but Absence of Molecular Remission during First Line Use of Imatinib Mesilate(IM): A Finding Not Observed Following Use among Interferon Failures.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4671-4671
Author(s):  
Selami K. Toprak ◽  
Klara Dalva ◽  
Dilsa Mizrak ◽  
Mutlu Arat ◽  
Muhit Ozcan ◽  
...  
Keyword(s):  
Risk Score ◽  
Prognostic Score ◽  
Response To Treatment ◽  
Quantitative Detection ◽  
Molecular Response ◽  
First Line ◽  
Group 2 ◽  
Hasford Score ◽  
Group 1

Abstract Factors that predict response to treatment in CML has been defined for busulphan and Interferon. Search for prognostic parameters in the imatinib era are still continuing. Very recently a new prognostic scoring of CML patients has been defined by Kantarjian et al (Blood, 2004; 10: 1182).The value of these scoring systems in prediction of molecular response to first line use of IM has not been published yet. With this aim, we have evaluated the hematological and molecular response of all CML patients chronic (n: 74)/accelerated (n: 9) treated with IM in this prospective study. Since IM has been approved for secondary ( May 2001)and primary (May 2003) treatment in Turkey, we have evaluated 22 patients- first line use (Group 1) and 61 Interferon failures (Group 2) following a median follow-up of 9–35 months. Hasford prognostic score was available and calculated in 67 of these patients online at www.pharmacoepi.de/cmlscore.html. Scores were: Group 1 low:8 /medium:5 /high:2; Group 2:low:16 /medium:29 /high:7. In group 2, time from diagnosis to IM treatment was 29 m(3–144). Method: RNA was isolated from blood or marrow (High Pure RNA isolation kit, Roche) and used for quantitative detection of bcr-abl transcripts with “LightCycler t(9;22) Quantification Kit”. Results were expressed as ratio to G6PD standarts. Results: Age and Hasford distribution were comparable in group 1 and 2. The tumor burden (median)according to scoring was Group1: low: 0.014 /high: 0.0453 and Group 2: low: 0.0035 /high: 0.012. Level of bcr-abl transcripts were higher in group1 vs 2(0.03 vs 0.009) and Hasford-high vs low, regardless of previous treatment. We could not show any correlation between Hasford score and transcript level at diagnosis (Pearson, r=.314, p=0.255). 20% of the Group 1-high and 60% of Group 1-low patients achieved major and complete CR at 6m and 12m. Similar evaluation revealed a weaker response rate in Group-2: 21–30% depending on risk score and time (6–12m). Time to mol CR (less than 10e5) occurred at a median of 6 (6–12) months in 26.7% (6m) of Group1 and 9m (3–12) in 7.7% (6m) of Group 2. Resistance developed both in Group 1(2/22) and Group 2 (7/61). Among scored patients, mol CR was achievable in Group-1(only low risk). However in Group 2, molCR could be obtained both in low (n:17) and high (n:17) risk patients. The median levels of bcr,abl transcript were: Group1:0.029 (molCR+) vs 0.059(molCR-) and Group 2: 0.0498 (molCR+) vs 0.0988(molCR−). Conclusion: In accordance with previous reports both molecular and cytogenetic remissions were observed earlier and more frequently among patients who received IM as a first line agent compared to second line use. Among patients being treated after Interferon, Hasford scoring at diagnosis did not have an impact on the prediction of response to IM. This finding is in paralel to Kantarjian’s results. However, in our study de novo CML patients’ bcr,abl transcript levels and the Hasford score showed an association with response. The shorter median follow-up in Group 1 may also have an impact on these results and updates are warranted. Like ours, the recent publications (Brummendorf 2003 and Drummond, 2004) on the correlation of telomere length with Hasford score and the response to treatment with IM support the value of this score in previously untreated patients with CML.

Serum Free Light Chain [FLC] Assay in Multiple Myeloma Patients Who Achieved Negative Immunofixation after Allogeneic Stem Cell Transplantation.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2023-2023 ◽  
Author(s):  
Ulrike Moesbauer ◽  
Heike Schieder ◽  
Helmut Renges ◽  
Francis Ayuk ◽  
Axel Zander ◽  
...  
Keyword(s):  
Complete Remission ◽  
Light Chain ◽  
Free Light Chain ◽  
Serum Free ◽  
Serum Free Light Chain ◽  
Group 3 ◽  
Light Concentration ◽  
Group 2 ◽  
Group 1

Abstract The quantitative assay for free light chains [FLC] has been reported to be sensitive and specific for detecting and monitoring free light chain diseases such as multiple myeloma. To evaluate the sensitivity of FLC for monitoring patients in complete remission for early detection of relapse, the measurement of more than 250 serum free light chains were performed with the commercial available Freelite TM kit [Binding Site] in 26 patients who achieved complete remission with negative immunofixation after dose reduced allogeneic stem cell transplantation. The patient groups were divided in those who remained immunofixation negative [n=12, group 1] during follow-up of at least 1 year and those who had been immunofixation negative but became positive during follow-up [n=9, group 2] and those who had achieved near complete remission with positive immunofixation but then became immunofixation negative during follow-up [n=5, group 3]. In group 1 the measuring of 105 FLC concentration and kappa/lambda ratio was performed in 12 patients. In 10 patients [83 %] free light concentration of kappa or lambda remained within the normal range during follow-up of more than 1 year. In 2 patients [17 %] kappa or lambda FLC concentration was above the normal range, but remained stable without any signs of increasing amount. Group 2 consisted of 9 patients who had been immunofixation negative but became positive during follow-up. In all patients an increase of the corresponding free light chain could be observed in serum. In 4 patients a very close monitoring of immunofixation and free light assay was performed and an at least 25 % increase of the free light concentration in serum was observed at a median of 97 days before immunfixation became positive. In group 3 five patients who had been immunofixation positive became negative during follow-up. In all of the patients the free light concentration was within the range at time of negative immunofixation. The corresponding free light concentration dropped down and reached normal level at a median of 38 days before the patients had achieved negativity of immunofixation. These results suggest that serum free light chain assay allows monitoring of patients with complete remission and might detect early relapse before immunofixation becomes positive. Thus, an early increase of free light chain assay in immunofixation negative patients after allogeneic transplantation might be an useful guide for adoptive immunotherapy strategies to prevent clinical relapse.

scholarly journals Analysis and Study on Epidemiological Features and Prognosis of Nephrotic Syndrome in Xinjiang and Heilongjiang

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jizhang Liu ◽  
Yuxia Zhong ◽  
Liangduan Ding ◽  
Ayinuer Tuluhong ◽  
Burebi Maihemuti ◽  
...  
Keyword(s):  
Nephrotic Syndrome ◽  
Complete Remission ◽  
Immunosuppressive Therapy ◽  
Partial Remission ◽  
Remission Rate ◽  
Continuous Data ◽  
Female Ratio ◽  
Significant Difference ◽  
Male To Female ◽  
Immunoglobulin Levels

Backgrounds. The pathogenesis of nephrotic syndrome (NS) is complex, and there are differences between regions. This study attempted to collect clinicopathological data of patients diagnosed with NS in Xinjiang and Heilongjiang in the past 2 years, so as to explore the onset features of NS and treatment and prognosis of patients in the two regions. Methods. Clinical data of 375 patients diagnosed with NS using renal biopsy in Xinjiang and Heilongjiang from March 2019 to March 2021 were collected. Clinical data of patients before treatment were collected, and the chi-square test was utilized to compare the differences in the sex distribution of two groups. The U test was utilized to compare abnormal distribution continuous data between two groups, such as age, hemoglobin, plasma albumin, proteinuria, and triglycerides. Independent sample t -test was utilized to compare normal distribution continuous data between two groups, such as serum total protein, serum creatinine, blood urea nitrogen, glomerular filtration rate, and total cholesterol. The independent sample t -test was also used to compare the immunoglobulin levels and complement levels between the two groups after treatment, including IgA, IgG, IgM, C3, and C4. Kaplan-Meier method was used to analyze and plot the cumulative curves of complete remission rate and partial remission rate. Results. For 275 NS patients from Xinjiang, the male-to-female ratio was 0.81 : 1. For 84 patients from Heilongjiang, the male-to-female ratio was 1.05 : 1. The onset ages of patients in Xinjiang and Heilongjiang were 22-45 years old and 22-47 years old, respectively. Respectively, there were 221 cases (80.36%) and 66 cases (78.57%) of primary NS in Xinjiang and Heilongjiang. There were 54 cases (19.64%) and 18 cases (21.43%) of secondary NS in Xinjiang and Heilongjiang, respectively. There was no statistically significant difference in cause distribution between the two regions ( p = 0.756 ). After treatment, immunoglobulin levels (IgA ( p = 0.009 ), IgG ( p = 0.002 ), IgM ( p < 0.001 )) and complement C3 ( p < 0.001 ) and C4 ( p < 0.001 ) levels in Xinjiang and Heilongjiang were statistically significant. 129 cases in Xinjiang (46.91%) and 55 cases in Heilongjiang (65.48%) were treated with glucocorticoid (GC) combined with immunosuppressive therapy, respectively. After receiving treatment, 67 (24.36%) of 275 patients in Xinjiang achieved complete remission, 166 (60.36%) achieved partial remission, 22 (26.19%) of 84 patients in Heilongjiang achieved complete remission, and 56 (66.67%) achieved partial remission, and there was no statistically significant difference in remission rate between the two regions ( p = 0.159 ). Patients in Xinjiang and Heilongjiang achieved complete remission at an average of 10.34 weeks (9.98-10.70) and 9.95 weeks (9.26-10.65), respectively. There was no significant difference in complete remission rates between the two regions ( p = 0.663 ). Patients in Xinjiang and Heilongjiang achieved partial remission at an average of 8.76 weeks (8.38-9.14) and 7.99 weeks (7.33-8.65), respectively. There was no significant difference in the partial remission rate between the two regions ( p = 0.065 ). Conclusion. The causes of NS in Xinjiang and Heilongjiang were similar. After treatment, there were differences in immunoglobulin levels (IgA, IgG, IgM) and complement levels (C3, C4) in the two regions. The main treatment methods used in the two regions were GC combined with immunosuppressive therapy. The prognosis of patients in the two regions was similar. The complete remission rate and partial remission rate after treatment in the two regions were similar, and the average time required to achieve complete remission and partial remission was also similar.

90Yttrium Ibritumomab Tiuxetan as First Line Treatment for Follicular Lymphoma. First Results from an International Phase II Clinical Trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 593-593 ◽  
Author(s):  
Christian W. Scholz ◽  
Antonello Pinto ◽  
Werner Linkesch ◽  
Ola Linden ◽  
Andreas Viardot ◽  
...  
Keyword(s):  
Complete Remission ◽  
Follicular Lymphoma ◽  
Partial Remission ◽  
Remission Rate ◽  
First Line ◽  
Molecular Remission ◽  
Ibritumomab Tiuxetan ◽  
Remission Rates ◽  
Grade 3

Abstract Abstract 593 Background: The international FIT Trial (ASH 2007) had shown that Radioimmunotherapy (RIT) with 90Yttrium Ibritumomab Tiuxetan (Zevalin®) significantly improves the remission rate in follicular lymphoma (FL) if given as consolidation after chemotherapy. Since high remission rates are achieved in combination with both mild and aggressive chemotherapy regimens we asked whether chemotherapy is needed at all before applying RIT. Methods: Previously untreated patients with follicular lymphoma Grade I-IIIA from 7 centers in Austria, Germany, Italy, and Sweden have entered a prospective phase II clinical trial. Patients received 90Yttrium Ibritumomab Tiuxetan at the standard single dose of 15 MBq/kg (0.4 mCi/kg). Only stage III and IV FL patients older than 50 y (as required by radiation safety agency) and with clinical need for treatment (tumor lesions increasing at least 50% in the last 6 months, B-Symptoms, bulky disease up to 10cm) were allowed to enter the protocol. The primary end point was the clinical and molecular remission rate six months after primary treatment with 90Yttrium Ibritumomab Tiuxetan. Secondary end points were time to progression as well as safety and tolerability of 90Yttrium Ibritumomab Tiuxetan. Results: 59 of 60 planned patients have been recruited between July 2007 and June 2010. Treatment was well tolerated without severe acute toxicity and with only grade I-II adverse events. Hematological toxicity was modest: 24 patients exhibit Thrombocytopenia (in one case Grade 4, in 13 cases Grade 3) and Neutropenia, (Grade 3 in 13 cases, no grade 4), Anemia (only grade 1–2) was noticed in 5 patients, other side effects were grade 1 or 2. Febrile episodes were not observed after RIT. At the first follow-up 6 months after RIT 25 patients were in complete remission (45%) and 22 patients were in partial remission (40%) adding up to an ORR of 85%. One year after therapy, the response rate is 72% with 52% CR and 20% PR. Among the 33 patients who have reached a follow up of more than 18 months, 52% continue to stay in complete remission, 9% are still in partial remission while 36% of the patients progressed and are off study, either in observation or with a new treatment. At a median follow-up of 23 months the PFS is 17.9 months. 2 Deaths occurred during observation time, both patients had been off study because of progressive disease: one patient died of progressive lymphoma after several lines of salvage chemotherapy, pancreas carcinoma was the cause of death in a further patient about 10 months after lymphoma progression. While 3 more cases of non-hematological cancers (colon adenocarcinoma, oral cavity squamous carcinoma, renal cancer) were recorded during the study, reevaluation of the CT scans done before RIT revealed in 2 of these patients lesions that were preexisting but missed or misinterpreted as lymphoma. In addition, the short latency between RIT and cancer diagnosis makes a causal relationship unlikely in the remaining two cases. Progression to high-grade lymphoma occurred in 3 patients so far. 49% of the patients (n = 28/57) had evidence of BCL2-IgH translocation in peripheral blood and/or bone marrow by PCR analysis. Of 26 patients evaluated 6 months after treatment 19 have turned negative (molecular remission rate MR = 73%). 9 of these MR patients had only achieved partial remission at clinical evaluation, 3 of them achieved a complete remission later during observation while 3 progressed. Ancillary PET studies were performed in 2 centers including sequential evaluation after therapy. Preliminary evaluation suggests that positivity of PET predicts relapse before this becomes clinically evident. Conclusion: Radioimmunotherapy with 90Yttrium Ibritumomab Tiuxetan was very safe and well accepted by patients, it induces high percentages of both clinical and molecular responses when given as first line treatment to patients with advanced stage follicular lymphoma. Remission rates are similar to those achieved by standard chemoimmunotherapy protocols, but absence of infectious episodes and the limited severity of side effects compares extremely well with the toxicity of chemotherapy regimens. Duration of remission will be a crucial issue for final comparison. Our study suggests first line RIT as a valuable option, particularly for older and/or frail patients with FL in need of therapy. Disclosures: No relevant conflicts of interest to declare.

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