Long-Term Outcomes and Safety of Continuous Lenalidomide Plus Dexamethasone (Len+Dex) Treatment in Patients (Pts) with Relapsed or Refractory Multiple Myeloma (RRMM)

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2929-2929 ◽  
Author(s):  
Meletios Athanasios Dimopoulos ◽  
Mohamad Hussein ◽  
Arlene S Swern ◽  
Donna M. Weber
Keyword(s):  
Dose Reduction ◽  
Median Duration ◽  
Cox Regression ◽  
Incidence Rates ◽  
Long Term Outcomes ◽  
Cox Regression Analysis ◽  
Β2 Microglobulin ◽  
Grade 3

Abstract Abstract 2929 Background: Two pivotal phase 3 trials (MM-009 and MM-010) randomized 704 pts to assess Len+Dex vs placebo plus dexamethasone (Dex) in RRMM. The results demonstrated the significant overall survival (OS) benefit of Len+Dex vs Dex (38.0 vs 31.6 mos; p =.045) despite crossover of 48% of Dex pts to the Len+Dex arm at unblinding or progression (Dimopoulos MA et al. Leukemia 2009;23 :2147-52). This is an analysis of the long-term outcomes and safety of continuous Len+Dex treatment. Methods: This retrospective analysis pooled pts treated with Len+Dex in MM-009 and MM-010, with a median follow-up of 48 mos for surviving pts. A subset of pts with progression-free survival (PFS) of ≥ 2 yrs was selected. Prognostic factors for PFS within this subgroup of pts were identified by incorporating all baseline covariates with a univariate p <.15 into multivariate Cox regression analyses, and all possible models were fitted using SAS 9.2. Adverse event (AE) management and dosing for pts with PFS ≥ 2 yrs was compared with that for all pts treated with Len+Dex in order to evaluate if differences in pt management could contribute to better clinical outcomes. Incidence rates for AEs were calculated using person-yrs of follow-up. Data from pts who received Len+Dex in MM-009 (up to July 23, 2008) and MM-010 (up to March 2, 2008) were included in this analysis. Results: Among all pts treated with Len+Dex (N = 353), a total of 64 pts (18%) achieved PFS ≥ 2 yrs. For these 64 pts, median age was 61 yrs (range 33–81 yrs), 48% received > 1 prior therapy, and 57% had β2-microglobulin levels of ≥ 2.5mg/L. All these pts achieved a ≥ partial response (PR), including 67% with a ≥ very good PR and 50% with a complete response. Median time to first response was 2.8 mos (range 1.9–18.2 mos) which is comparable to that of all pts treated with Len+Dex. Median duration of response was not reached vs 15.5 mos, respectively. With median follow-up of 49 mos, the 3-yr OS is 94% (95% confidence interval [CI] 88.06–99.94). In a multivariate Cox regression analysis, shorter PFS was predicted with higher baseline β2-microglobulin level (hazard ratio [HR] 1.07; 95% CI 1.02–1.12) and lower hemoglobin (HR 0.91; 95% CI 0.84–0.99), as well as a higher number of prior therapies (HR 1.18; 95% CI 1.02–1.37). The median duration of treatment was longer among pts with PFS ≥ 2 yrs vs all pts treated with Len+Dex (46.2 mos [range 11.3–58.3] vs 9.8 mos [range 3.8–24], respectively). A higher proportion of these pts had a dose reduction within 12 mos after start of therapy vs all pts treated with Len+Dex (57% vs 24%, respectively). Dex dose was reduced in 27% of pts with PFS ≥ 2 yrs. Among pts without Len dose reduction, 31% had Dex dose reduction within the first 4 cycles. Granulocyte colony-stimulating factor was administered for the management of neutropenia in 39% of pts with PFS ≥ 2 yrs vs 25% of all pts treated with Len+Dex. Low discontinuation rates due to AEs were observed in both groups (12.5% vs 18.7%, respectively). The incidence rates per 100 person-yrs for grade 3–4 AEs among pts with PFS ≥ 2 yrs vs all pts treated with Len+Dex (N = 353) were, respectively: neutropenia (14.9 vs 29), febrile neutropenia (0.9 vs 2.3), thrombocytopenia (2.6 vs 10.2), anemia (4.4 vs 9.5), infection (11.8 vs 20.9), deep vein thrombosis/pulmonary embolism (2.2 vs 8.9), fatigue (2.2 vs 5.5), neuropathy (1.8 vs 3.4), and gastrointestinal disorders (5.3 vs 9.7). The incidence rates per 100 person-yrs for second primary malignancies (SPMs) were similar to that of all pts treated with Len+Dex, respectively: myelodysplastic syndromes (0 vs 0.4), solid tumor (1.8 vs 1.3), and non-melanoma skin cancer (2.3 vs 2.4). These rates are comparable to those expected in people aged > 50 yrs generally (1.4 per 100 person-yrs) (Altekruse SF et al. SEER Cancer Statistics Review, 1975–2007). Conclusions: Long-term continuous therapy with Len+Dex has demonstrated efficacy and is generally well tolerated in pts with RRMM. Overall, 18% of patients treated with Len+Dex achieve a PFS of > 2 yrs. No increase in SPMs was observed with long term Len+Dex therapy. With appropriate AE management, the incidence rates of grade 3–4 AEs remain low. This analysis demonstrates the value of AE management and the need for appropriate dose-adjustment to maintain tolerability, allowing pts to remain on therapy for maximal benefit. Disclosures: Dimopoulos: Celgene Corporation: Consultancy, Honoraria. Hussein:Celgene Corporation: Employment. Swern:Celgene Corporation: Employment. Weber:Celgene Corporation: Honoraria, Research Funding.

scholarly journals Evaluation of different late left ventricular remodeling definitions for predicting long-term outcomes in acute myocardial infarction patients undergoing percutaneous coronary intervention

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
S Zhang ◽  
X Xie ◽  
C He ◽  
X Lin ◽  
M Luo ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ventricular Remodeling ◽  
Cox Regression ◽  
Left Ventricular Remodeling ◽  
Left Ventricular ◽  
Long Term Outcomes ◽  
Cox Regression Analysis ◽  
Long Term Mortality

Abstract Background Late left ventricular remodeling (LLVR) after the index acute myocardial infarction (AMI) is a common complication, and is associated with poor outcome. However, the optimal definition of LLVR has been debated because of its different incidence and influence on prognosis. At present, there are limited data regarding the influence of different LLVR definitions on long-term outcomes in AMI patients undergoing percutaneous coronary intervention (PCI). Purpose To explore the impact of different definitions of LLVR on long-term mortality, re-hospitalization or an urgent visit for heart failure, and identify which definition was more suitable for predicting long-term outcomes in AMI patients undergoing PCI. Methods We prospectively observed 460 consenting first-time AMI patients undergoing PCI from January 2012 to December 2018. LLVR was defined as a ≥20% increase in left ventricular end-diastolic volume (LVEDV), or a &gt;15% increase in left ventricular end-systolic volume (LVESV) from the initial presentation to the 3–12 months follow-up, or left ventricular ejection fraction (LVEF) &lt;50% at follow up. These parameters of the cardiac structure and function were measuring through the thoracic echocardiography. The association of LLVR with long-term prognosis was investigated by Cox regression analysis. Results The incidence rate of LLVR was 38.1% (n=171). The occurrence of LLVR according to LVESV, LVEDV and LVEF definition were 26.6% (n=117), 31.9% (n=142) and 11.5% (n=51), respectively. During a median follow-up of 2 years, after adjusting other potential risk factors, multivariable Cox regression analysis revealed LLVR of LVESV definition [hazard ratio (HR): 2.50, 95% confidence interval (CI): 1.19–5.22, P=0.015], LLVR of LVEF definition (HR: 16.46, 95% CI: 6.96–38.92, P&lt;0.001) and LLVR of Mix definition (HR: 5.86, 95% CI: 2.45–14.04, P&lt;0.001) were risk factors for long-term mortality, re-hospitalization or an urgent visit for heart failure. But only LLVR of LVEF definition was a risk predictor for long-term mortality (HR: 6.84, 95% CI: 1.98–23.65, P=0.002). Conclusions LLVR defined by LVESV or LVEF may be more suitable for predicting long-term mortality, re-hospitalization or an urgent visit for heart failure in AMI patients undergoing PCI. However, only LLVR defined by LVEF could be used for predicting long-term mortality. FUNDunding Acknowledgement Type of funding sources: None. Association Between LLVR and outcomes Kaplan-Meier Estimates of the Mortality

scholarly journals Atrial Substrate Underlies the Recurrence after Catheter Ablation in Patients with Atrial Fibrillation

2020 ◽  
Vol 9 (10) ◽  
pp. 3164
Author(s):  
Yong-Soo Baek ◽  
Jong-Il Choi ◽  
Yun Gi Kim ◽  
Kwang-No Lee ◽  
Seung-Young Roh ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Cox Regression ◽  
Long Term Outcomes ◽  
Recurrence Rates ◽  
Index Procedure ◽  
Cox Regression Analysis ◽  
Circumferential Pulmonary Vein Isolation

Prediction of recurrences after catheter ablation of atrial fibrillation (AF) remains challenging. We sought to investigate the long-term outcomes after AF catheter ablation. A total of 2221 consecutive patients who underwent catheter ablation for symptomatic AF were included in this study (mean age 55 ± 11 years, 20.3% women, and 59.0% paroxysmal AF). Extensive ablation, in addition to circumferential pulmonary vein isolation, was more often accomplished in patients with non-paroxysmal AF than in those with paroxysmal AF (87.4% vs. 25.3%, p < 0.001). During a median follow-up of 54 months, sinus rhythm (SR) was maintained in 67.1% after index procedure. After redo procedures in 418 patients, 83.3% exhibited SR maintenance. Recurrence rates were similar for single and multiple procedures (17.4% vs. 16.7%, p = 0.765). Subanalysis showed that the extent of late gadolinium enhancement (LGE), as assessed by cardiac magnetic resonance, is greater in patients with recurrence than in those without recurrence (36.2 ± 23.9% vs. 21.8 ± 13.7%, p < 0.001). Cox-regression analysis revealed that non-paroxysmal AF (hazard ratio (HR) 2.238, 95% confidence interval (CI) 1.905–2.629, p < 0.001), overweight (HR 1.314, 95% CI 1.107–1.559, p = 0.020), left atrium dimension ≥ 45 mm (HR 1.284, 95% CI 1.085–1.518, p = 0.004), AF duration (HR 1.020 per year, 95% CI 1.006–1.034, p = 0.004), and LGE ≥ 25% (HR 1.726, 95% CI 1.330–2.239, p < 0.001) are significantly associated with AF recurrence after catheter ablation. This study showed that repeated catheter ablation improves the clinical outcomes of patients with non-paroxysmal AF, suggesting that AF substrate based on LGE may underpin the mechanism of recurrence after catheter ablation.

scholarly journals Long-Term Outcomes of IgG4-Related Ophthalmic Disease in a Chinese IgG4-Related Disease Cohort

2021 ◽  
Vol 8 ◽  
Author(s):  
Linyang Gan ◽  
Xuan Luo ◽  
Yunyun Fei ◽  
Linyi Peng ◽  
Jiaxin Zhou ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Combination Therapy ◽  
Cox Regression ◽  
Long Term Outcomes ◽  
Cox Regression Analysis ◽  
Ocular Lesions ◽  
Ophthalmic Disease ◽  
Risk Of Relapse

Purpose: To define the treatment response and long-term outcomes of a large IgG4-related ophthalmic disease (IgG4-ROD) cohort.Methods: A total of 132 patients with a minimum follow-up of 1 year were included in this study. Demographic, clinical, and laboratory data were collected. Treatment response was assessed by the IgG4-RD responder index (IgG4-RD RI). Risk factors for relapse were analyzed with the multivariate Cox regression analysis.Results: The median follow-up time was 39 months. Lacrimal gland involvement was detected in 87.9% of cases. Extraocular muscles, the trigeminal nerve, and other soft tissue were affected in 25.8, 6.1, and 18.2% of patients. The relapse rate of watchful waiting, glucocorticoid monotherapy, immunosuppressant monotherapy, and combination therapy was 50.0, 51.7, 50.0, and 26.7% (p = 0.038), respectively. The combination therapy group exhibited shorter glucocorticoids therapy duration (36 vs. 48 months, p = 0.009) and maintenance period (24 vs. 42 months, p = 0.003). At the 6th month, the median IgG4-RD RI declined from 12 to 1 and 105 (79.5%) patients achieved complete response (CR). Relapse occurred in 49 (37.1%) patients. The multivariate Cox regression analysis exhibited that CR at the 6th month was an independent protective factor for relapse. Patients with multiple ocular lesions suffered from a higher risk of relapse. No patient had severe adverse reactions to the treatment in this study.Conclusion: Relapse was common in patients with IgG4-ROD. Patients receiving combination therapy showed a lower relapse rate and a shorter glucocorticoids therapy period. The presence of multiple ocular lesions was associated with a higher risk of relapse. CR at the 6th month might be a predictor for a better prognosis in IgG4-ROD. Thus, a more aggressive regimen should be prescribed for patients with a poor initial response.

scholarly journals Low-Blood Lymphocyte Number and Lymphocyte Decline as Key Factors in COPD Outcomes: A Longitudinal Cohort Study

Respiration ◽  
2021 ◽  
pp. 1-13
Author(s):  
Umberto Semenzato ◽  
Davide Biondini ◽  
Erica Bazzan ◽  
Mariaenrica Tiné ◽  
Elisabetta Balestro ◽  
...  
Keyword(s):  
Cox Regression ◽  
Chronic Obstructive ◽  
Long Term Outcomes ◽  
Obstructive Pulmonary Disease ◽  
Cox Regression Analysis ◽  
Incidence And Mortality ◽  
Multiple Samples ◽  
Over Time

<b><i>Background:</i></b> Smokers with and without chronic obstructive pulmonary disease (COPD) are at risk of severe outcomes like exacerbations, cancer, respiratory failure, and decreased survival. The mechanisms for these outcomes are unclear; however, there is evidence that blood lymphocytes (BL) number might play a role. <b><i>Objective:</i></b> The objective of this study is to investigate the relationship between BL and their possible decline over time with long-term outcomes in smokers with and without COPD. <b><i>Methods:</i></b> In 511 smokers, 302 with COPD (COPD) and 209 without COPD (noCOPD), followed long term, we investigated whether BL number and BL decline over time might be associated with long-term outcomes. Smokers were divided according to BL number in high-BL (≥1,800 cells/µL) and low-BL (&#x3c;1,800 cells/µL). Clinical features, cancer incidence, and mortality were recorded during follow-up. BL count in multiple samples and BL decline over time were calculated and related to outcomes. <b><i>Results:</i></b> BL count was lower in COPD (1,880 cells/µL) than noCOPD (2,300 cells/µL; <i>p</i> &#x3c; 0.001). 43% of COPD and 23% of noCOPD had low-BL count (<i>p</i> &#x3c; 0.001). BL decline over time was higher in COPD than noCOPD (<i>p</i> = 0.040). 22.5% of the whole cohort developed cancer which incidence was higher in low-BL subjects and in BL decliners than high-BL (31 vs. 18%; <i>p</i> = 0.001) and no decliners (32 vs. 19%; <i>p</i> = 0.002). 26% in the cohort died during follow-up. Furthermore, low-BL count, BL decline, and age were independent risk factors for mortality by Cox regression analysis. <b><i>Conclusion:</i></b> BL count and BL decline are related to worse outcomes in smokers with and without COPD, which suggests that BL count and decline might play a mechanistic role in outcomes deterioration. Insights into mechanisms inducing the fall in BL count could improve the understanding of COPD pathogenesis and point toward new therapeutic measures.

Long-Term Clinical Outcome in Elderly Patients Undergoing Mitral Valve Repair

2020 ◽  
Author(s):  
Julia Götte ◽  
Armin Zittermann ◽  
Kavous Hakim-Meibodi ◽  
Masatoshi Hata ◽  
Rene Schramm ◽  
...  
Keyword(s):  
Mitral Valve ◽  
General Population ◽  
Elderly Patients ◽  
Cox Regression ◽  
Functional Class ◽  
Tricuspid Valve Repair ◽  
Valve Repair ◽  
Cox Regression Analysis

Abstract Background Long-term data on patients over 75 years undergoing mitral valve (MV) repair are scarce. At our high-volume institution, we, therefore, aimed to evaluate mortality, stroke risk, and reoperation rates in these patients. Methods We investigated clinical outcomes in 372 patients undergoing MV repair with (n = 115) or without (n = 257) tricuspid valve repair. The primary endpoint was the probability of survival up to a maximum follow-up of 9 years. Secondary clinical endpoints were stroke and reoperation of the MV during follow-up. Univariate and multivariable Cox regression analysis was performed to assess independent predictors of mortality. Mortality was also compared with the age- and sex-adjusted general population. Results During a median follow-up period of 37 months (range: 0.1–108 months), 90 patients died. The following parameters were independently associated with mortality: double valve repair (hazard ratio, confidence interval [HR, 95% CI]: 2.15, 1.37–3.36), advanced age (HR: 1.07, CI: 1.01–1.14 per year), diabetes (HR: 1.97, CI: 1.13–3.43), preoperative New York Heart Association (NYHA) functional class (HR: 1.41, CI: 1.01–1.97 per class), and operative creatininemax levels (HR: 1.32, CI: 1.13–1.55 per mg/dL). The risk of stroke in the isolated MV and double valve repair groups at postoperative year 5 was 5.0 and 4.1%, respectively (p = 0.65). The corresponding values for the risk of reoperation were 4.0 and 7.0%, respectively (p = 0.36). Nine-year survival was comparable with the general population (53.2 vs. 53.1%). Conclusion Various independent risk factors for mortality in elderly MV repair patients could be identified, but overall survival rates were similar to those of the general population. Consequently, our data indicates that repairing the MV in elderly patients represents a suitable and safe surgical approach.

scholarly journals The Role of Hydraulic Silicate Cements on Long-Term Properties and Biocompatibility of Partial Pulpotomy in Permanent Teeth

Materials ◽  
2021 ◽  
Vol 14 (2) ◽  
pp. 305
Author(s):  
Chung-Min Kang ◽  
Saemi Seong ◽  
Je Seon Song ◽  
Yooseok Shin
Keyword(s):  
Regression Analysis ◽  
Cox Regression ◽  
Antimicrobial Properties ◽  
Permanent Teeth ◽  
Success Rates ◽  
Pulp Tissue ◽  
Cox Regression Analysis ◽  
Clinical Variables

The use of hydraulic silicate cements (HSCs) for vital pulp therapy has been found to release calcium and hydroxyl ions promoting pulp tissue healing and mineralized tissue formation. The present study investigated whether HSCs such as mineral trioxide aggregate (MTA) affect their biological and antimicrobial properties when used as long-term pulp protection materials. The effect of variables on treatment outcomes of three HSCs (ProRoot MTA, OrthoMTA, and RetroMTA) was evaluated clinically and radiographically over a 48–78 month follow-up period. Survival analysis was performed using Kaplan–Meier survival curves. Fisher’s exact test and Cox regression analysis were used to determine hazard ratios of clinical variables. The overall success rate of MTA partial pulpotomy was 89.3%; Cumulative success rates of the three HSCs were not statistically different when analyzed by Cox proportional hazard regression analysis. None of the investigated clinical variables affected success rates significantly. These HSCs showed favorable biocompatibility and antimicrobial properties in partial pulpotomy of permanent teeth in long-term follow-up, with no statistical differences between clinical factors.

scholarly journals 439 Conservative Versus Surgical Management of Complicated Diverticulitis - A Retrospective Study of Long-Term Outcomes

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
E Durity ◽  
G Elliott ◽  
T Gana
Keyword(s):  
Complicated Diverticulitis ◽  
Complication Rates ◽  
Long Term Outcomes ◽  
Female Ratio ◽  
Stoma Reversal ◽  
Group A ◽  
Grade 3 ◽  
Group B

Abstract Introduction Management of complicated diverticulitis has shifted towards a conservative approach over time. This study evaluates the feasibility and long-term outcomes of conservative management. Method We retrospectively evaluated a consecutive series of patients managed with perforated colonic diverticulitis from 2013-2017. Results Seventy-three (73) patients were included with a male to female ratio of 1:2. Thirty-one (31) underwent Hartmann’s procedure (Group A) and 42 patients were managed with antibiotics +/- radiological drainage (Group B). Mean follow-up was 64.9 months (range 3-7 years). CT Grade 3 and 4 disease was observed in 64.5% and 40.4% of Group A and Group B patients, respectively. During follow-up, 9 (21.4%) Group B patients required Hartmann’s. Group A had longer median length of stay compared to Group B (25.1 vs 9.2 days). Post-operative complications occurred in 80.6% with 40% being Clavien-Dindo grade III or higher in group A. Stoma reversal was performed in 8 patients (25.8%). Conclusions In carefully selected cases, complicated diverticulitis including CT grade 3 and 4 disease, can be managed conservatively with acceptable recurrence rates (16.7% at 30 days, 4.8% at 90 days, 19.0% at 5 years). Surgical intervention on the other hand, carries high post-operative complication rates and low stoma reversal rates.

Long-term outcomes of kidney donors with fibromuscular dysplasia

2021 ◽  
Author(s):  
Horacio E Adrogue ◽  
Andrew Evans ◽  
Dina N Murad ◽  
Hana Nguyen ◽  
Sean A Hebert ◽  
...  
Keyword(s):  
Fibromuscular Dysplasia ◽  
Cox Regression ◽  
Arterial Disease ◽  
Similar Proportion ◽  
Long Term Outcomes ◽  
No Donor ◽  
Kidney Donors ◽  
Cox Regression Analysis ◽  
Donor Evaluation

Abstract Background Fibromuscular dysplasia (FMD) is a non-atherosclerotic systemic arterial disease that is not infrequently discovered during kidney donor evaluation. Current guidelines do not provide recommendations regarding the use of kidneys from donors with FMD and there is a paucity of data on the outcomes of these donors. Methods The Renal and Lung Living Donor Evaluation (RELIVE) study addressed long-term outcomes of 8922 kidney donors who donated between 1963 and 2007. We compared the development of hypertension, cardiovascular disease (CVD), proteinuria and reduced estimated glomerular filtration rate (eGFR) in 113 kidney donors with FMD discovered during donor evaluation versus 452 propensity score matched donors without FMD. Outcomes modeling with logistic and Cox regression analysis and Kaplan–Meier statistics were performed. Results Donors with FMD were older (51 versus 39 years), were more likely to be women (80% versus 56%) and had a higher systolic blood pressure at donation (124.7 versus 121.3 mmHg) (P &lt; 0.05 for all). After a mean ± standard deviation follow-up of 15.5 ± 8.9 years, a similar proportion of donors with and without FMD were alive, and developed hypertension (22.2% versus 19.8%), proteinuria (20.6% versus 13.7%) and CVD (13.3% versus 13.5%). No donor with FMD developed an eGFR &lt;30 mL/min/1.73 m2 or end-stage kidney disease. The multivariable risk of mortality, CVD and renal outcomes in donors with FMD was not elevated. Conclusions Kidney donors with FMD appear to do well, do not appear to incur increased risks of hypertension, proteinuria, CVD or reduced eGFR, and perhaps carefully selected candidates with FMD can safely donate as long as involvement of other vascular beds is ruled out.

scholarly journals Role of Disease Modifying Treatment in the Risk of Alloimmunization in Transfused Patients with Myelodysplastic Syndromes: A Population-Based Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4253-4253
Author(s):  
Hanne Rozema ◽  
Robby Kibbelaar ◽  
Nic Veeger ◽  
Mels Hoogendoorn ◽  
Eric van Roon
Keyword(s):  
Risk Factors ◽  
Regression Analysis ◽  
Cox Regression ◽  
Population Based ◽  
Incidence Rates ◽  
Blood Products ◽  
Cox Regression Analysis ◽  
In The Beginning ◽  
Observation Period

The majority of patients with myelodysplastic syndromes (MDS) require regular red blood cell (RBC) transfusions. Alloimmunization (AI) against blood products is an adverse event, causing time-consuming RBC compatibility testing. The reported incidence of AI in MDS patients varies greatly. Even though different studies on AI in MDS patients have been performed, there are still knowledge gaps. Current literature has not yet fully identified the risk factors and dynamics of AI in individual patients, nor has the influence of disease modifying treatment (DMT) been explored. Therefore, we performed this study to evaluate the effect of DMT on AI. An observational, population-based study, using the HemoBase registry, was performed including all newly diagnosed MDS patients between 2005 and 2017 in Friesland, a province of the Netherlands. All available information about treatment and transfusions, including transfusion dates, types, and treatment regimens, was collected from the electronic health records and laboratory systems. Follow-up occurred through March 2019. For our patient cohort, blood products were matched for AB0 and RhD, and transfused per the 'type and screen' policy (i.e. electronic matching of blood group phenotype between patient and donor). After a positive antibody screening, antibody identification and Rh/K phenotyping was performed and subsequent blood products were (cross)matched accordingly. The observation period was counted from first transfusion until last transfusion or first AI event. Univariate analyses and cumulative frequency distributions were performed to study possible risk factors and dynamics of AI. DMT was defined as hypomethylating agents, lenalidomide, chemotherapy and monoclonal antibodies. The effect of DMT as a temporary risk period on the risk of AI was estimated with incidence rates, relative risks (RR) and hazard ratios (HR) using a cox regression analysis. Follow-up was limited to 24 months for the cox regression analysis to avoid possible bias by survival differences. Statistical analyses were performed using IBM SPSS 24 and SAS 9.4. Out of 292 MDS patients, 236 patients received transfusions and were included in this study, covering 463 years of follow-up. AI occurred in 24 patients (10%). AI occurred mostly in the beginning of the observation period: Eighteen patients (75%) were alloimmunized after receiving 20 units of RBCs, whereas 22 patients (92%) showed AI after 45 units of RBCs (Figure 1). We found no significant risk factors for AI in MDS patients at baseline. DMT was given to 67 patients (28%) during the observation period. Patients on DMT received more RBC transfusions than patients that did not receive DMT (median of 33 (range: 3-154) and 11 (range: 0-322) RBC units respectively, p<0,001). Four AI events (6%) occurred in patients on DMT and 20 AI events (12%) occurred in patients not on DMT. Cox regression analysis of the first 24 months of follow-up showed an HR of 0.30 (95% CI: 0.07-1.31; p=0.11). The incidence rates per 100 person-years were 3.19 and 5.92 respectively. The corresponding RR was 0.54 (95% CI: 0.16-1.48; p=0.26). Based on our results, we conclude that the incidence of AI in an unselected, real world MDS population receiving RBC transfusions is 10% and predominantly occurred in the beginning of follow-up. Risk factors for AI at baseline could not be identified. Our data showed that patients on DMT received significantly more RBC transfusions but were less susceptible to AI. Therefore, extensive matching of blood products may not be necessary for patients on DMT. Larger studies are needed to confirm the protective effect of DMT on AI. Disclosures Rozema: Celgene: Other: Financial support for visiting MDS Foundation conference.

A phase III multicenter randomized clinical trial to compare cisplatin plus fluorouracil with or without docetaxel as the first-line induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma: Long-term outcomes update.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6032-6032
Author(s):  
Wang Fang FangZheng
Keyword(s):  
Clinical Trial ◽  
Nasopharyngeal Carcinoma ◽  
Induction Chemotherapy ◽  
Phase Iii ◽  
Karnofsky Performance Score ◽  
Long Term Outcomes ◽  
First Line ◽  
Grade 3

6032 Background: A phase III multicenter prospective randomized controlled trial was conducted to compare cisplatin plus 5-fluorourcil with or without docetaxel as first-line induction chemotherapy in the patients with locoregionally advanced nasopharyngeal carcinoma (LANPC). Here, we report on the long-term outcomes and late toxicities of the trial (NCT01536223). Methods: Patients with newly diagnosed LANPC, stage III-IV disease, Karnofsky performance score≥70, without metastasis were eligible and randomly assigned 1:1 to TPF versus PF for three cycles. The primary end point was progression-free survival; local control, OS and advent events were important key secondary end points. The Kaplan-Meier method and the log-rank test were used to conduct and compare the survival curves in this study. Results: Two hundred ninety-nine patients were enrolled. 276 patients (138 TPF and 138 PF) were evaluable. Baseline characteristics were well-balanced between two groups, and the median age was 48 (range, 18-60 years). The ORR rates after induction chemotherapy and chemoradiotherapy were 90.6% and 9797.8% in TPF group and 87.0% (P > 0.05) and 97.8% (P > 0.05), respectively. The median follow-up was 99 months. For all patients, the 5- and 8-year OS and PFS were 76.9% and 74.9%, 72.3% and 69.1%, respectively. PF was associated with a similar PFS versus TPF ( 5-year PFS of 72.4% versus 73.2%, P =.747), and an equivalent OS at 5 years ( 79.2% and 79.1%, P = 0.519). Treatment-related grade 3 to 4 advent events were less frequent with PF compared with TPF. Conclusions: With prolonged follow-up, the survival outcomes in the PF group were not non-inferiority to those in the TPF group, but grade 3 to 4 advent events were less frequent. Clinical trial information: NCT01536223.

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