Active Immunotherapy with FavId® (Id/KLH) Following Rituximab Induction: Long-Term Follow-Up of Response Rate Improvement (RRI) and Disease Progression in Follicular Lymphoma Patients (pts).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 691-691 ◽  
Author(s):  
Omer N. Koc ◽  
Charles Redfern ◽  
Peter H. Wiernik ◽  
Fred Rosenfelt ◽  
Jane N. Winter ◽  
...  
Keyword(s):  
Disease Progression ◽  
Median Time ◽  
Response Rate ◽  
Published Data ◽  
Late Response ◽  
Gm Csf ◽  
Best Response ◽  
Long Term Follow Up

Abstract Background: Studies of Id/KLH immunotherapy in treatment naïve (TN) fNHL pts following first remission from chemotherapy have demonstrated a prolonged duration of remission. We expanded this approach in a PhII trial to include TN and relapsed/refractory (R/R) pts with stable disease (SD) or PR or CR/CRu following 4 wkly doses of rituximab. We report here long term follow up of RRI, defined as the % of pts who converted from SD to PR or PR to CR/CRu following initiation of Id/KLH treatment, and analysis of disease progression. Treatment: Pts received rituximab (375mg/m2 i.v. wkly x 4 during wk1–4) and those with stable or responsive disease received Id/KLH (1 mg s.q. mo x 6) starting on wk 12 along with GM-CSF (250 mcg, s.q.) on days 1–4. Pts continued to receive booster injections on a reduced schedule until disease progression. Radiological scans, performed every 3 mos, were reviewed centrally. Disease progression and response were assessed using modified Cheson criteria. This data analysis was performed 32 mo from end of enrollment. Results: 103 pts were enrolled and received rituximab; 89 pts had ≥SD and received Id/KLH + GM-CSF of whom, 54 were R/R, and 35 were TN. The overall response rate (ORR) was 47% (42/89) at mo 3. After the initiation of Id/KLH dosing, ORR improved to 63% (56/89). In RRI pts, median time to best response was 9.1 mos from start of rituximab treatment (5.2 – 29.6 mos). 12 of 39 PR pts (31%) converted to CR/Cru. 14 of 43 SD pts (33%) converted to PR. Pt Groups # of Pts % Prog Free Median TTP Est by K-M (mo) Pts w/RRI 26 69% 37.9 TN rituximab responders 23 70% Not Reached (NR) Rituximab responders (All) 42 60% NR Non Responders (All) 47 36% 14.9 All Pts 89 47% 18.2 TN Pts (All) 35 66% NR Relapsed Pts (All) 54 37% 16.8 Conclusion: RRI following FavId is seen in nearly one third of pts. The magnitude of this improvement, the number of conversions to CR/CRu and median time to best response (9 mo and as late as 29.6 mo) suggests this is likely to be a FavId effect rather than late response to rituximab. Responders and TN pts show more durable responses compared to previously published data for rituximab therapy. FavId may also confer a benefit for nonresponders and R/R pts relative to rituximab alone. To confirm benefit of FavId following rituximab induction, a placebo controlled PhIII study was initiated; it completed enrollment in Jan 06. RRI data from this study is expected to be available in Nov 06.

Long Term Follow up of Patients with Immune Thrombocytopenia Receiving Rituximab

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 4675-4675 ◽  
Author(s):  
Khalid Al-Habsi ◽  
Murtadha K. Al-Khabori ◽  
Muhanna Al-Muslahi ◽  
Anil Pathare ◽  
Khalil Al Farsi ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Median Time ◽  
Immune Thrombocytopenia ◽  
Response Rate ◽  
Age At Diagnosis ◽  
Second Line ◽  
Long Term Follow Up ◽  
Chronic Immune Thrombocytopenia

Abstract Abstract 4675 Introduction: Rituximab has been used in the management of chronic immune thrombocytopenia (ITP) with promising results. The risk of losing response, however, is yet to be determined with long term follow up. Method: We retrospectively analyzed 32 consecutive patients (20 females, 12 males) with ITP (including 6 patients with secondary ITP) treated with rituximab in two tertiary care hospitals in Oman between May 2006 and May 2011. Response criteria were based on the International Consensus report (Rodeghiero F et al. Blood 2009). Result: The median age at diagnosis was 25 years (range, 4 – 58). Clinical presentation ranged from mild echymosis to more severe central nervous system bleeding. Patients received a median of one line of therapy before rituximab (range, 1–4), including 3 patients who failed splenectomy. Patients received intravenous rituximab using 375 mg/m2 once weekly for 4 weeks. The median time from diagnosis to receiving rituximab was 21 months (range, 1– 177). Only one patient was positive for Hepatitis C virus, but no hepatitis B or HIV positive in this cohort. Anti nuclear antibody was positive in 34% (10/29) of patients. The median hemoglobin and platelet counts at diagnosis were 12 g/dl (range, 5–16) and 11×109/L (range, 1–60) respectively. The median follow up time after rituximab was 26 months (95% confidence interval: 11–40). The overall cumulative response rate was 59% (partial response of 15% and complete response of 44%). The median time to respond was 30 days (Standard error [SE] 49) with a response rate of 44% at 4 weeks (95% Confidence interval: 29–62%). The multivariable Cox model analysis (variables include: age at diagnosis, gender, number of previous therapies and primary vs. secondary) revealed none of the variables included to be statistically significant. The cumulative rate of loss of response was 32% (6/19) with a median time to lose response of 54 months (SE, 0.03). In patients who lost response, the median time to lose response was 17 months (SE, 14). Of the 6 patients who lost response, 4 received a second course of rituximab and all 4 achieved a full response. No major side effects to rituximab were reported during the follow up. Conclusion: Rituximab is an effective and a well tolerated second line therapy for ITP. The response to rituximab can be maintained for a long duration with a high rate of response after retreatment. None of the pretreatment variables studied carried a significant predictive value for response. The study was limited by the small sample size and further larger prospective studies are recommended. Disclosures: Off Label Use: Rituximab was used in our study as a second line for the management of chronic immune thrombocytopenia.

scholarly journals Long-term follow-up after colorectal endoscopic submucosal dissection in 182 cases

2021 ◽  
Vol 09 (02) ◽  
pp. E258-E262
Author(s):  
Christian Suchy ◽  
Moritz Berger ◽  
Ingo Steinbrück ◽  
Tsuneo Oyama ◽  
Naohisa Yahagi ◽  
...  
Keyword(s):  
Case Series ◽  
En Bloc Resection ◽  
Bloc Resection ◽  
Published Data ◽  
Low Grade ◽  
Recurrence Rates ◽  
En Bloc ◽  
Long Term Follow Up

Abstract Background and study aims We previously reported a case series of our first 182 colorectal endoscopic submucosal dissections (ESDs). In the initial series, 155 ESDs had been technically feasible, with 137 en bloc resections and 97 en bloc resections with free margins (R0). Here, we present long-term follow-up data, with particular emphasis on cases where either en bloc resection was not achieved or en bloc resection resulted in positive margins (R1). Patients and methods Between September 2012 and October 2015, we performed 182 consecutive ESD procedures in 178 patients (median size 41.0 ± 17.4 mm; localization rectum vs. proximal rectum 63 vs. 119). Data on follow-up were obtained from our endoscopy database and from referring physicians. Results Of the initial cohort, 11 patients underwent surgery; follow-up data were available for 141 of the remaining 171 cases (82,5 %) with a median follow-up of 2.43 years (range 0.15–6.53). Recurrent adenoma was observed in 8 patients (n = 2 after margin positive en bloc ESD; n = 6 after fragmented resection). Recurrence rates were lower after en bloc resection, irrespective of involved margins (1.8 vs. 18,2 %; P < 0.01). All recurrences were low-grade adenomas and could be managed endoscopically. Conclusions The rate of recurrence is low after en bloc ESD, in particular if a one-piece resection can be achieved. Recurrence after fragmented resection is comparable to published data on piecemeal mucosal resection.

Abstract TP127: Mortality and Recurrence in Atherosclerotic Ischemic Stroke: Long-term Follow-up

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Miguel A Barboza ◽  
Rodrigo Uribe ◽  
Fabiola Serrano ◽  
Luis C Becerra-Pedraza ◽  
D. K Mantilla-Barbosa ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Functional Outcome ◽  
Median Time ◽  
Smoking History ◽  
Stroke Recurrence ◽  
Active Smoking ◽  
Long Term Outcome ◽  
Long Term Follow Up

Background and purpose: Atherosclerotic ischemic stroke is the second most frequent etiology of stroke in the adult population. Functional outcome, mortality and recurrence of stroke rates on the long-term follow-up are poorly studied. This study investigates long-term outcome among patients with ischemic stroke secondary to atherosclerotic causality, and identifies the main factors associated with poor outcome, recurrence, and death. Methods: We analyzed data from our consecutive acute ischemic stroke database, over a period of 25 years (1990-2015). The endpoints were: bad outcome (Modified Rankin Score ≥3), recurrence and mortality at discharge, and final follow-up. Multivariate Cox and Kaplan-Meier analysis were used to estimate the probability of death and recurrence. Results: A total of 946 consecutive atherosclerotic stroke patients were included (571 [60.4%] males, median age 65 years [interquartile range 57-73 years] for the entire population); dyslipidemia (64.2%), hypertension (63.3%), diabetes (35.0%), and active smoking history (31.8%) were the most prevalent risk factors.After a median follow-up of 38 months (IQR 12-75 months), 59.3% patients had a bad outcome at discharge. A result of 26.1% had stroke recurrence (median time until recurrence: 9 months [IQR 12-84 months], with 12.9% cases presenting ≥2 recurrences), and 24.1% were dead (median time to death: 18.5 months [IQR 11-74 months]) at the final follow-up period. After multivariate adjustment, hypertension (HR 4.2, CI 95% 2.8-6.1; p<0.001) was the strongest predictor of recurrence. Additionally, diabetes (HR 2.6, CI 95% 2.0-3.5; p<0.001), bad functional outcome after recurrence (HR 2.3, CI 95% 1.9-2.9; p<0.001), age ≥65 years (HR 2.2, CI 95% 1.7-2.9; p<0.001), and active smoking (HR 1.8, CI 95% 1.3-2.3; p<0.001) were the strongest predictors of mortality. Conclusions: Atherosclerotic ischemic stroke has a high rate of recurrence, associated mainly with hypertension. Mortality is predicted by diabetes, bad functional outcome at recurrence, and older age.

Long-term follow-up: no effect of therapeutic vaccination with HIV-1 p17/p24:Ty virus-like particles on HIV-1 disease progression

Vaccine ◽  
2002 ◽  
Vol 20 (17-18) ◽  
pp. 2343-2347 ◽  
Author(s):  
Catharina E.A. Lindenburg ◽  
Ineke Stolte ◽  
Miranda W. Langendam ◽  
Frank Miedema ◽  
Ian G. Williams ◽  
...  
Keyword(s):  
Disease Progression ◽  
Therapeutic Vaccination ◽  
Virus Like Particles ◽  
Long Term Follow Up ◽  
Hiv 1

COVID-19 and hematologic diseases: Risk factors and long-term follow-up of CHRONOS19 Registry.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18715-e18715
Author(s):  
Kristina Zakurdaeva ◽  
Olga A. Gavrilina ◽  
Anastasia N. Vasileva ◽  
Sergei Dubov ◽  
Vitaly S. Dubov ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mechanical Ventilation ◽  
Disease Progression ◽  
Primary Endpoint ◽  
Acute Leukemias ◽  
Risk Of Death ◽  
All Cause Mortality ◽  
Long Term Follow Up

e18715 Background: Pts with hem diseases are at high risk of COVID-19 severe course and mortality. Emerging data on risk factors and outcomes in this patient population is of great value for developing strategies of medical care. Methods: CHRONOS19 is an ongoing nationwide observational cohort study of adult (≥18 y) pts with hem disease (both malignant and non-malignant) and lab-confirmed or suspected (clinical symptoms and/or CT) COVID-19. Primary objective was to evaluate treatment outcomes. Primary endpoint was 30-day all-cause mortality. Long-term follow-up was performed at 90 and 180 days. Data from 14 centers was collected on a web platform and managed in a deidentified manner. Results: As of data cutoff on January 27, 2021, 575 pts were included in the registry, 486 of them eligible for primary endpoint assessment, n(%): M/F 243(50%)/243(50%), median age 56 [18-90], malignant disease in 452(93%) pts, induction phase/R/R/remission 160(33%)/120(25%)/206(42%). MTA in 93(19%) pts, 158(33%) were transfusion dependent, comorbidities in 278(57%) pts. Complications in 335(69%) pts: pneumonia (67%), CRS (8%), ARDS (7%), sepsis (6%). One-third of pts had severe COVID-19, 25% were admitted to ICU, 20% required mechanical ventilation. All-cause mortality at 30 days – 17%; 80% due to COVID-19 complications. At 90 days, there were 14 new deaths: 6 (43%) due to hem disease progression. Risk factors significantly associated with OS are listed in Tab 1. In multivariate analysis – ICU+mechanical ventilation, HR, 53.3 (29.1-97.8). Acute leukemias were associated with higher risk of death, HR, 2.40 (1.28-4.51), less aggressive diseases (CML, CLL, MM, non-malignant) – with lower risk of death, HR, 0.54 (0.37-0.80). No association between time of COVID-19 diagnosis (Apr-Aug vs. Sep-Jan) and risk of death. COVID-19 affected treatment of hem disease in 65% of pts, 58% experienced treatment delay for a median of 4[1-10] weeks. Relapse rate on Day 30 and 90 – 4%, disease progression on Day 90 detected in 13(7%) pts; 180-day data was not mature at the time of analysis. Several cases of COVID-19 re-infection were described. Conclusions: Thirty-day all-cause mortality in pts with hem disease was higher than in general population with COVID-19. Longer-term follow-up (180 days) for hem disease outcomes and OS will be presented. [Table: see text]

scholarly journals Incidence of response and long-term follow-up in patients with hairy cell leukemia treated with recombinant interferon alfa-2a [see comments]

Blood ◽  
1990 ◽  
Vol 75 (4) ◽  
pp. 839-845 ◽  
Author(s):  
E Berman ◽  
G Heller ◽  
S Kempin ◽  
T Gee ◽  
LL Tran ◽  
...  
Keyword(s):  
Disease Progression ◽  
Hairy Cell Leukemia ◽  
Interferon Alfa ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Minor Response ◽  
Recombinant Interferon ◽  
Long Term Follow Up

Abstract Thirty-five evaluable patients with hairy cell leukemia (HCL) were treated with recombinant interferon alfa-2a (rIFN-alpha 2a), given at a dose of 3 X 10(6) units (U) intramuscularly (IM) daily for 6 months followed by 3 X 10(6) U IM three times a week for an additional 18 months in a single institution study. All treatment was stopped after 24 months. Sixty-nine percent of patients achieved a partial response, 11% a minor response, and 3% (one patient) had stable disease. Six patients (17%) did not respond to rIFN-alpha 2a. Two patients (6%) achieved a response but later progressed on treatment. A total of 23 patients completed 2 years of treatment and are evaluable for long-term follow-up at a median of 20 months postcompletion of therapy (range 9 to 32 months). Eleven patients (48%) have had progression of their disease at a median of 10 months (range .5 to 25 months) after treatment was discontinued. Statistical analysis of pretreatment patient characteristics did not reveal any factor(s) associated with a high probability of responding to rIFN-alpha 2a; however, analysis of post-treatment variables measured after 2 years of treatment suggested that a low platelet count was associated with a high rate of disease progression. These findings are compared with other published trials using rIFN-alpha 2b, a similar but not identical rIFN preparation. We conclude that while rIFN-alpha 2a has a high overall response incidence, the rate of disease progression after therapy is discontinued approaches 50%, and that a subset of patients can be identified who are at high risk for recurrence after completing 2 years of treatment.

T1 Top Line Results of the DETECT Enzymatic Debridement Multicenter Randomized Controlled Trial

2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S1-S1
Author(s):  
William L Hickerson ◽  
Jeremy Goverman ◽  
Sigrid A Blome-Eberwein ◽  
Adam Singer ◽  
Lucy Wibbenmeyer
Keyword(s):  
Median Time ◽  
Wound Closure ◽  
The United States ◽  
Acute Stage ◽  
Phase Iii ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Long Term Follow Up

Abstract Introduction Bromelain Based Debridement (BBD) of deep burns is approved for use in Europe, Argentina, Russia, South Korea, Peru and Israel. In the United States it is an investigational product and currently there are 2 multicenter RCTs (DETECT – adults, CIDS – children). Patient enrollment in the DETECT adult trial has been completed. The aim of this abstract is to present the acute stage top line results of the DETECT trial. Methods 175 adult patients suffering from deep burns were included in a phase III multicenter, multinational, randomized, controlled, assessor blinded trial. Patients were randomized to 3 arms – BBD, Standard of Care (SOC), or Gel vehicle (Placebo control) in a 3:3:1 ratio (75 BBD, 75 SOC, 25 Gel). The primary endpoint was the incidence of complete eschar removal (BBD vs Gel). Additional acute stage endpoints included the time to complete eschar removal, incidence of surgical eschar removal and eschar removal associated blood loss.Time to complete wound closure (BBD vs SOC) was assessed as a safety endpoint. Following the acute stage, a long-term follow up period of 2 years is being conducted. Results Patient demographics and wound baseline characteristics were comparable across study arms.The incidence of complete eschar removal was significantly higher for BBD vs Gel patients (93.3% vs 4%, p&lt; 0.0001). The incidence of surgical eschar removal was significantly lower for BBD vs SOC patients (4% vs 72%, p&lt; 0.0001). The median time to complete eschar removal was significantly shorter for BBD vs SOC patients (1 day vs 3.8 days, p&lt; 0.0001). Calculated eschar removal associated blood loss was significantly lower for BBD vs SOC patients (14ml vs 815ml, p&lt; 0.0001). The median time to complete wound closure was similar for BBD and SOC patients (27 and 28 days). The overall safety profile of BBD treated patients was good and consistent with the safety data known from previous studies.The results of the long term follow up period are not yet available. Conclusions The acute stage results of this robust phase III RCT demonstrate the safety and efficacy of BBD and are in line with previous trial results. Applicability of Research to Practice The results of this trial may help pave the way for US approval of BBD.

scholarly journals Spindle Epithelial Tumor with Thymus-like Element of the Thyroid Gland

2012 ◽  
Vol 4 (2) ◽  
pp. 74-76 ◽  
Author(s):  
V Satyanarayana ◽  
Dajiram Govonda Mote
Keyword(s):  
Thyroid Gland ◽  
Case Reports ◽  
English Literature ◽  
Diagnostic Feature ◽  
Published Data ◽  
Epithelial Tumor ◽  
Children And Adolescent ◽  
Long Term Follow Up

ABSTRACT Spindle epithelial tumor with thymus-like different ion (SETTLE) is an extremely rare tumor arising from thyroid gland which was first time recognized and reported by Chan and Rosai. It is believed to be arising from the branchial pouch or the remnant of thymus within the thyroid gland as it reveals primitive thymic elements. It has been reported more than 20 times as an individual case reports in the searched English literature. It mostly occurs in the children and adolescent but cases of SETTLE are reported in adults and even in elderly patients. Age of patient is not diagnostic feature of the SETTLE tumor. According to the published data, SETTLE tumor has an indolent course but delayed blood-borne distant metastases is seen in the cases with long-term follow-up. The present case is 13-year-old boy who presented with solitary nodule of left lobe of the thyroid without any other symptoms. The patient was subjected to ipsilateral hemithyroidectomy. The histopathological report revealed the diagnosis of SETTLE tumor which was confirmed with the immunohistochemistry. The patient is followed-up regularly and there is no evidence of metastasis with more than 4 years follow-up. There are no existing guidelines regarding the optimum treatment and the duration of follow-up due to paucity of data about management of SETTLE tumor. The long-term follow-up is needed to detect recurrence or metastases. How to cite this article Mote DG, Satyanarayana V. Spindle Epithelial Tumor with Thymus-like Element of the Thyroid Gland. World J Endoc Surg 2012;4(2):74-76.

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