Safety and efficacy of resin 90Y-microspheres in 548 patients with colorectal liver metastases progressing on systemic chemotherapy.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 264-264 ◽  
Author(s):  
Andrew S. Kennedy ◽  
David Ball ◽  
Steven J. Cohen ◽  
Michael Cohn ◽  
Douglas M. Coldwell ◽  
...  
Keyword(s):  
Adverse Events ◽  
Systemic Chemotherapy ◽  
Biologic Agents ◽  
Background Characteristics ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Grade 3 ◽  
Hospital Stay Duration ◽  
90Y Microspheres

264 Background: 90Y-microspheres (radioembolization) are administered via the hepatic artery following failure of one or more lines of fluoropyrimidine-based systemic chemotherapy, with or without biologic agents in colorectal carcinoma metastatic (mCRC) to the liver. Methods: A retrospective review of consecutively treated patients with mCRC from July 2002 to December 2011 at 11 U.S. institutions was conducted. Data on background characteristics, prior chemotherapy, surgery/ablation, radiotherapy, vascular procedures, 90Y treatment (SIR-Spheres; Sirtex Medical), subsequent adverse events (grade 3+) and survival were documented. Median follow-up was 8.5 mo. (IQR 4.3–15.6). Trends in the occurrence of adverse events for patients receiving 1, 2, or 3+ lines of systemic chemotherapy were evaluated by Fisher’s Exact. Kaplan Meier estimates compared the overall survival of patients across lines of chemotherapy. Results: A total of 548 patients were included; majority were male (61%), Caucasian (66%), mean age 61 years; received median of 2 (range 1–6) lines of chemotherapy prior to 90Y therapy. Median tumor/liver ratio at 90Y therapy was 15% (IQR 23%). Median 90Y activity administered was 1.18 GBq (IQR 0.48). Hospital stay duration was <24 hours for most cases (97.8%). The most common adverse events (grade 3+) following 90Y therapy included: abdominal pain 6.6% (n=36), GI ulceration 1.8% (10), nausea 1.5% (8), vomiting 1.6% (9), fatigue 6.0% (33), ascites 3.5% (19), hyperbilirubinemia 5.7% (31) and anorexia 1.1% (6). A comparison of 1, 2 and 3+ lines of chemotherapy versus grade 3+ adverse events to 3 months post-90Y therapy revealed no significant difference (p>0.05). Corresponding median survivals (95% CI) were 13.0 (10.5–14.6), 9.0 (7.8–11.0) and 8.1 (6.4–9.3) months, respectively (p<0.0001). Conclusions: 90Y microsphere therapy appears to have a favorable risk/benefit ratio in patients with mCRC who have failed prior systemic chemotherapy. These data show a clinically relevant survival benefit for 90Y therapy in patients not responding to chemotherapy, including those heavily pre-treated (3+ lines).

scholarly journals Impact of Early Switching to Nilotinib As Second Line TKI in Patients with Chronic Myeloid Leukemia Who Were Intolerant to, Suboptimal to and Failed Imatinib: The Thai Multi-Centered Study

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4267-4267
Author(s):  
Pongtep Viboonjuntra ◽  
Arnuparp Lekhakula ◽  
Kanchana Chansung ◽  
Chittima Sirijerachai ◽  
Pimjai Niparuck ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Real Life ◽  
Progression Free Survival ◽  
Second Line ◽  
Free Survival ◽  
Kaplan Meier ◽  
Grade 3 ◽  
The Impact

Abstract Introduction : To date, the ELN recommendation and NCCN guidelines are the principle mile stones to follow up the treatment response and to make the decision of TKIs switching. However, in real life practice, many factors influence changing the real switching date from the date had an indication. This study aims to analyze the impact of early switching to second line TKI, nilotinib, in real life practice, for the CML patients who failed, had sub-optimal response or were intolerant to imatinib. Methods : This prospective study was conducted through 7 medical centers in Thailand between 1st of September 2009 and 31st of August 2011. Adult CML patients of age ≥ 18 years old, in chronic and accelerated phase, who had failure, suboptimal response or intolerance to imatinib, based on ELN 2009 guideline, were included and were eligible with nilotinib 400 mg twice daily. Prospective data collection for 24 months of each patient was performed. The main objective was to identify the impact of early switching to nilotinib on major molecular response (MMR). The other objectives were to observe the efficacy of nilotinib including overall survival, progression free survival and the safety. The survival results were presented as Kaplan-Meier survival curves. For the comparison of the treatment groups, the Kaplan-Meier estimator with the corresponding log-rank test for equality of survivor functions across treatment group was applied. Results : The final 108 cases were analysed. The median age was 47 (17-79) years with the proportion of male to female of 1.4:1 respectively. The median duration of the prior imatinib treatment was 18 months (2-142 months). The median duration between the date of indication and the date of real switching was 3.1 months (0-62.8 months) with 50% changing less than 3 months, 26.9% between 3 months and 12 months, and 23.1% changing longer than 12 months. The indication of switching included 63.6% failure to imatinib, 29% intolerance to imatinib and 7.4% suboptimal to imatinib. On the nilotinib switching, 70.4% completed 24 months follow-up, and 29.6% discontinued treatment mostly because of unsatisfactory results or adverse events. Evaluation was made every 3 months based on 2009 ELN recommendation. At 3 months, 57%, 20%, and 8% of the patients achieved CHR, CCyR and MMR, respectively. Those who did not achieve CHR at 3 months never achieved MMR, while 86 % of those who achieved CCyR at 3 months achieved MMR. All CML achieving MMR at 3 months had sustained MMR throughout the study period (24 months). Imatinib suboptimal response had better outcome than imatinib failure and imatinib intolerance groups. A preliminary analysis of BCR-ABL mutation was performed on 90 cases, and mutations were found on 21 cases. Two of them were T315I which were excluded from the study. The cases with mutation had poorer response to treatment than those without mutation. There was one case with initial G250E mutation developing T315I mutation after treatment with nilotinib. At 24 months, one case progressed to accelerated phase and 3 cases progressed to blastic transformation. The 2-year overall survival and 2-year progression-free survival and were 98.9% and 96.9% (figure 1 and 2), respectively. The interquatile analysis was done to identify the groups of cumulative MMR according to the duration between the date of indication and the date of real switching to nilotinib. The patients who switched to nilotinib within 12 months after date of indication could have a greater chance to achieved MMR than those who switched treatment later than 12 months (p(log-rank) = 0.002) (figure 3). Skin rash, musculoskeletal pain, and infection were the three most common non-hematologic adverse events, However, most of them were grade 1-2, except for 4 cases with grade 3-4 infections. Grade 3-4 hematologic adverse events included thrombocytopenia (12%), neutropenia (11%), anemia (5%) and leucopenia (4%), and most of them were manageable. Although biochemical abnormalities were commonly found, most of them were mild. Conclusions : Nilotinib, as a second line treatment showed excellent efficacy and tolerability. Indication for nilotinib treatment, initial mutation status and depth of response at 3 months after treatment can predict outcomes of the patients. However, the patients will have a greater chance to achieve MMR if they switched to nilotinib within 12 months after the date of indication for changing. Disclosures No relevant conflicts of interest to declare.

scholarly journals PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness

2020 ◽  
Vol 8 (1) ◽  
pp. e001507
Author(s):  
Antonio Carlo Bossi ◽  
Valentina De Mori ◽  
Carlotta Galeone ◽  
Davide Pietro Bertola ◽  
Margherita Gaiti ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Repeated Measures ◽  
Long Term Results ◽  
Italian Population ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Significant Difference

IntroductionSitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population.Research design and methodsWe evaluated long-term clinical data from the single-arm PERsistent Sitagliptin Treatment & Outcomes (PERS&O) study, which collected information on 440 patients with TD2 (275 men, 165 women; mean age 64.1 years; disease median duration: 12 years) treated with sitagliptin ‘add-on’. For each patient, we estimated the 10-year cardiovascular (CV) risk using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Drug survival was evaluated using Kaplan-Meier survival curves; repeated measures mixed effects models were used to evaluate the evolution of glycated hemoglobin (HbA1c) and CV risk during sitagliptin treatment.ResultsAt baseline, most patients were overweight or obese (median body mass index (BMI) (kg/m2) 30.2); median HbA1c was 8.4%; median fasting plasma glucose: 172 mg/dL; median UKPDS RE score: 24.8%, being higher in men (median 30.2%) than in women (median 17.0%) as expected. Median follow-up from starting sitagliptin treatment was 5.6 years. From Kaplan-Meier curves, the estimated median drug survival was 32.8 months when considering discontinuation for any cause and 58.4 months when considering discontinuation for loss of efficacy. A significant improvement in HbA1c was evident during treatment with sitagliptin (p<0.01): the reduction was rapid (median HbA1c after 4–6 months: 7.5%) and continued at longer follow-up. When comparing patients treated with sitagliptin versus those stopping sitagliptin and switching to another antihyperglycemic drug, we detected a significant difference in the evolution of HbA1c in favor of patients who continued sitagliptin treatment. The UKPDS RE score at 10 years and the BMI significantly improved during treatment with sitagliptin (p<0.001). Adverse events were relatively uncommon.ConclusionPatients with T2D treated with sitagliptin achieved an improvement in metabolic control and a reduction in CV risk and did not experience relevant adverse events.

scholarly journals Individualized, Low Dose, Fixed Duration Lenalidomide Maintenance Is an Effective Strategy in High MRD Disease Post Chemo-Immunotherapy in CLL: Outcomes of a Randomized Controlled Trial

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5471-5471
Author(s):  
Nishant Jindal ◽  
Man Updesh Singh Sachdeva ◽  
Arihant Jain ◽  
Gaurav Prakash ◽  
Alka Khadwal ◽  
...  
Keyword(s):  
Adverse Events ◽  
Maintenance Therapy ◽  
Low Dose ◽  
Novel Agents ◽  
Fixed Duration ◽  
Significant Difference ◽  
Comorbidity Burden ◽  
Early Progression ◽  
Grade 3

Introduction Chemo-immunotherapy (CIT) continues to be an acceptable treatment option in CLL without deletion 17. Patients with early progression (<2 years) have poor response to second line chemoimmunotherapy and a reduced PFS with every subsequent relapse. In developed countries, novel agents like ibrutinib and venetoclax are the standard of care for relapsed CLL and are finding approval as part of frontline therapy as well. In middle to low socio demographic index (SDI) countries, these drugs cost 4 to 40 times the per capita GDP and are unlikely to be affordable to a majority in near future. Therefore, strategies to prolong PFS and the time to next treatment are still relevant in these settings. Lenalidomide has shown promise as maintenance treatment in CLL in two large randomized trials (CLLM1 and CALGB). In this randomized trial, we evaluated the efficacy and safety of individualized, low dose, fixed duration, lenalidomide maintenance versus observation in non-deletion 17p CLL. Methods The study period was from January 2018 to June 2019. CLL patients who had achieved at least partial remission (iwCLL response criteria) after frontline CIT were included in the study. Patients with deletion 17p or mutated TP53 were excluded. Baseline and follow-up bone marrow MRD assessment was done using 8-color flow cytometry with a detection threshold of 10-4. MRD was classified into three groups; nil: < 10-4, intermediate: 10-4 to 10-2 and high: >10-2. Patients were randomly assigned to lenalidomide maintenance or observation. Lenalidomide was started at 5 mg every alternate day and escalated to a maximum dose of 10 mg daily in a 20/28 day schedule as per patient tolerance. Maintenance therapy was given for a fixed duration of 6 cycles. PFS was defined as the time from study recruitment to progression or death due to any cause. Haematological toxicity was graded using the iwCLL guidelines for grading of toxicity and other adverse events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE). Results A total of 32 patients were included in the study and randomized to lenalidomide maintenance (n=19) or observation (n=13). The two arms were matched for cytogenetics, comorbidity burden, disease status and MRD at recruitment. At a median follow up of 10.5 months, median PFS was not reached for either arm with no significant difference between the two arms (p=0.338). High MRD at the end of treatment was associated with an increased risk of early progression (p=0.165). Lenalidomide showed PFS benefit in the high MRD subgroup (median PFS 7 months vs. not reached), with a trend towards statistical significance (p=0.067) (see figure). Skin toxicity was the most common adverse event and was more common in the lenalidomide arm (63.2%). Grade 3 neutropenia was reported in only 5.3% patients in the lenalidomide arm. Incidence of grade 3 or more severe infections was not different between the two arms. Conclusions Maintenance therapy with 6 cycles of dose-escalated lenalidomide is safe and may afford PFS benefit in patients with non-deletion 17p CLL and high MRD at the end of frontline chemo-immunotherapy. The CLLM1 and the CALGB trials had a fixed ramp up dosing schedule of lenalidomide and reported more adverse events (38% and 71% grade 3/4 neutropenia) compared to our individualized, low dose lenalidomide protocol. The encouraging results of this study warrant further investigation into the role of lenalidomide maintenance in CLL in larger trials, especially in low and middle SDI setting where access to novel agents is limited and is going to remain so in the foreseeable future. Figure Disclosures No relevant conflicts of interest to declare. OffLabel Disclosure: Lenalidomide maintenance in CLL

scholarly journals Pomalidomide Plus Low-Dose Dexamethasone (Pom/Dex) in Relapsed Lenalidomide Refractory Myeloma: Long Term Follow up and Comparison of 2 Mg Vs 4 Mg Doses

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4780-4780
Author(s):  
Martha Q. Lacy ◽  
Betsy R. LaPlant ◽  
Kristina M Laumann ◽  
Shaji Kumar ◽  
Morie A Gertz ◽  
...  
Keyword(s):  
Overall Survival ◽  
Research Funding ◽  
Cell Transplant ◽  
Survival Curves ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Grade 3 ◽  
Dose Levels

Abstract Background: Pomalidomide has demonstrated excellent activity in patients with relapsed, lenalidomide refractory, multiple myeloma (MM). Between November 2007 and March 2012, we enrolled 285 patients with relapsed MM on 5 sequential phase 2 trials; patients received pomalidomide at 2mg or 4 mg daily with weekly dexamethasone (Pom/dex). The approved dose of pomalidomide is 4 mg for 21 of 28 days. We wished to compare efficacy, tolerability and long-term outcomes between cohorts treated with 2 mg or 4mg daily continuously and 4mg daily for 21/28 days. Methods: After excluding two ineligible patients, 283 patients with lenalidomide refractory, relapsed MM from 5 sequential cohorts were analyzed. These patients were divided into 3 groups: Group1 received Pom 2mg for 28/28 day cycle (N= 69), Group 2 received Pom 4 mg for 28/28 day cycle (N= 95) and Group 3 received Pom 4mg for 21/28 day cycle (N= 119). All patients received oral dexamethasone given 40 mg daily on days 1, 8, 15, and 22. Response was assessed by the IMWG Uniform Response criteria. All patients received aspirin 325 mg daily for DVT prophylaxis or full dose anticoagulation. Results: The median age was 63 years (32-85); 35% were female. The median time from diagnosis was 53 months and the median number of prior regimens was 4. 127 (46%) had high-risk molecular markers. Prior therapies (% received) included lenalidomide (100%), thalidomide (46%), bortezomib (78%), autologous stem cell transplant (71%), and allogeneic transplant (4%). The median follow-up is 16.4 months (3.2-64.4). Forty eight percent are alive and 26% remain progression free; 15 patients are continuing to receive treatment. Frequency of AEs by groups are shown in Table 1. The most notable difference is grade 3+ neutropenia seen in 39% of group 1 and 56% and 57% of groups 2 and 3. Confirmed responses of PR or better were seen in 29% (group1), 35% (group2) and 24% (group3). Median duration of response (DOR) was 14.1 months (group1), 14.5 months (group2) and 10.2 months (group3). Median PFS was 5.5 months (group1), 6.9 months (group2) and 4.3 months (group3). Although the dose level cohorts were sequential rather than randomized, we compared OS between the dose levels in an exploratory manner. There was no significant difference in OS between dose levels (p=0.26). Median overall survival (OS) was 16.6 months (group1), 21.9 months (group2) and 16.0 months (group3). Conclusions: Pom/dex is active and well tolerated even in heavily pretreated patients Responses are durable. Response rates and overall toxicity are similar between the 2 mg and 4 mg doses. Neutropenia is more common in those receiving doses of 4mg daily or for 21/28 days compared to those receiving 2 mg daily. Table 1. All Grades Grade 3+ 2mg 28 Day 4mg 28 Day 4mg 21 Day 2mg 28 Day 4mg 28 Day 4mg 21 Day Anemia 68% 58% 74% 14% 15% 27% Lymphopenia 22% 51% 11% 16% 32% 8% Neutropenia 71% 82% 77% 39% 57% 56% Thrombocytopenia 51% 61% 63% 10% 9% 23% Leukopenia 59% 77% 72% 26% 38% 39% Pneumonia 7% 11% 12% 6% 7% 11% Fatigue 51% 65% 60% 9% 5% 8% Neuropathy 28% 32% 28% 0% 3% 0% Elevated Blood Glucose 10% 21% 8% 4% 6% 3% Pneumonitis 3% 2% 3% 3% 1% 1% VTE (Thrombosis) 3% 3% 3% 1% 3% 3% Secondary Malignancy 0% 2% 1% 0% 2% 1% Figure1. Kaplan Meier Overall Survival Curves Figure1. Kaplan Meier Overall Survival Curves Disclosures Lacy: Celgene: Research Funding. Fonseca:Medtronic, Otsuka, Celgene, Genzyme, BMS, Lilly, Onyx, Binding Site, Millennium, AMGEN: Consultancy, patent for the prognostication of MM based on genetic categorization of the disease. He also has sponsored research from Cylene and Onyx Other, Research Funding. Bergsagel:Novartis: Research Funding; Constellation Pharmaceutical: Research Funding; OncoEthix: Research Funding; MundiPharma: Research Funding. Stewart:Novartis: Consultancy; Celgene: Consultancy; Bristol Myers Squibb: Consultancy; Array BioPharma: Consultancy; Sanofi: Consultancy; Takeda Pharmaceuticals International Co.: Research Funding. Reeder:Millennium, Celgene, Novartis: Research Funding. Mikhael:Onyx: Research Funding; Celgene: Research Funding; Sanofi: Research Funding; Novartis: Research Funding.

The Efficacy of Etoposide-Based Therapy in Adult Secondary Hemophagocytic Lymphohistiocytosis

2021 ◽  
pp. 1-9
Author(s):  
Leonard Naymagon ◽  
Douglas Tremblay ◽  
John Mascarenhas
Keyword(s):  
Hemophagocytic Lymphohistiocytosis ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Rank Test ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Significant Difference ◽  
The Impact

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.

scholarly journals Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair

Hernia ◽  
2021 ◽  
Author(s):  
M. M. J. Van Rooijen ◽  
T. Tollens ◽  
L. N. Jørgensen ◽  
T. S. de Vries Reilingh ◽  
G. Piessen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hernia Repair ◽  
Hernia Recurrence ◽  
Recurrence Rates ◽  
Elective Repair ◽  
Significant Difference ◽  
Grade 3

Abstract Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

scholarly journals Correlation of Triiodothyronine Level with In-Hospital Cardiac Function and Long-Term Prognosis in Patients with Acute Myocardial Infarction

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Jianqing She ◽  
Jiahao Feng ◽  
Yangyang Deng ◽  
Lizhe Sun ◽  
Yue Wu ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Survival Analysis ◽  
Cardiac Function ◽  
Thyroid Function ◽  
Major Adverse Cardiovascular Events ◽  
Free Triiodothyronine ◽  
Kaplan Meier ◽  
Significant Difference

Objective. The pathophysiologic mechanism of how thyroid function is related to the development and prognosis of acute myocardial infarction (AMI) remains under explored, and there has been a lack of clinical investigations. In this study, we investigate the relationship between triiodothyronine (T3) level and cardiac ejection fraction (EF) as well as probrain natriuretic peptide (NT-proBNP) on admission and subsequent prognosis in AMI patients. Methods. We measured admission thyroid function, NT-proBNP, and EF by echocardiography in 345 patients diagnosed with AMI. Simple and multiregression analyses were performed to investigate the correlation between T3 level and EF as well as NT-proBNP. Major adverse cardiovascular events (MACE), including new-onset myocardial infarction, acute heart failure, and cardiac death, were documented during the follow-up. 248 participants were separated into three groups based on T3 and free triiodothyronine (FT3) levels for survival analysis during a 2-year follow-up. Results. 345 patients diagnosed with AMI were included in the initial observational analysis. 248 AMI patients were included in the follow-up survival analysis. The T3 levels were found to be significantly positively correlated with EF (R square=0.042, P<0.001) and negatively correlated with admission NT-proBNP levels (R square=0.059, P<0.001), which is the same with the correlation between FT3 and EF (R square=0.053, P<0.001) and admission NT-proBNP levels (R square=0.108, P<0.001). Kaplan-Meier survival analysis revealed no significant difference with regard to different T3 or FT3 levels at the end of follow-up. Conclusions. T3 and FT3 levels are moderately positively correlated with cardiac function on admission in AMI patients but did not predict a long-time survival rate. Further studies are needed to explain whether longer-term follow-up would further identify the prognosis effect of T3 on MACE and all-cause mortality.

scholarly journals Management of Advanced Medullary Thyroid Carcinoma with Vandetanib: Case Series

2021 ◽  
Vol 5 (1) ◽  
pp. 01-07
Author(s):  
Andrés Flórez R
Keyword(s):  
Partial Response ◽  
Adverse Events ◽  
Thyroid Carcinoma ◽  
Medullary Thyroid Carcinoma ◽  
Stable Disease ◽  
Case Series ◽  
Medullary Thyroid ◽  
The Mean ◽  
Grade 3

Objective: To describe the tumor response and adverse events in patients with advanced medullary thyroid carcinoma (MTC) treated with vandetanib at the National Cancer Institute in Bogotá, Colombia. Materials and Methods: Case series including five patients with advanced MTC treated with vandetanib from April 2011 to August 2018 and a minimum follow-up of 6 months. Results: 5 patients met the inclusion criteria, including 3 women. The mean age was 49 years. A total of 4 patients underwent total thyroidectomy prior to starting vandetanib. The main indication for vandetanib was progression of liver metastasis (4 patients). Regarding treatment response, 3 patients presented stable disease, 1 patient showed partial response, and 1 had disease progression. The mean treatment duration was 16.5 months. Grade 3 or 4 adverse events were observed in three patients, 1 with diarrhea, 1 with hypertension, and 1 with rash. All symptoms improved with dose reduction or temporary suspension of vandetanib. Conclusions: The management of advanced MTC with vandetanib allows for prolonged disease control (stable disease or partial response). Although adverse events are frequent, most are mild and severe cases are manageable.

Pembrolizumab plus enzalutamide for enzalutamide-resistant metastatic castration-resistant prostate cancer (mCRPC): Updated analyses after one additional year of follow-up from cohorts 4 and 5 of the KEYNOTE-199 study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5042-5042
Author(s):  
Julie N Graff ◽  
Scott T. Tagawa ◽  
Christopher J. Hoimes ◽  
Winald R. Gerritsen ◽  
Ulka N. Vaishampayan ◽  
...  
Keyword(s):  
Antitumor Activity ◽  
Safety Data ◽  
Standard Of Care ◽  
Castration Resistant Prostate Cancer ◽  
Fisher Syndrome ◽  
Castration Resistant ◽  
Kaplan Meier ◽  
Phase 2 Study ◽  
Grade 3

5042 Background: KEYNOTE-199 (NCT02787005) is a multicohort phase 2 study to evaluate pembrolizumab (pembro) in mCRPC. A previous analysis of patients with RECIST-measurable (cohort 4 [C4]) or bone-predominant nonmeasurable (cohort 5 [C5]) disease who were chemotherapy-naive and had progression while on enzalutamide (enza) found that pembro + enza showed antitumor activity and manageable safety. Long-term outcomes are of interest with immunotherapy; hence, updated efficacy and safety data after an additional 1 year of follow-up are presented. Methods: Pts were eligible if they had resistance to enza after prior response. Prior treatment with abiraterone was allowed. Pts received pembro 200 mg Q3W for up to 35 cycles + enza QD until progression, unacceptable toxicity, or withdrawal. Primary end point was ORR per RECIST v1.1 by blinded independent central review (BICR) in C4. Secondary end points were DOR (C4), and DCR, rPFS, OS and safety (both cohorts). Results: 126 pts (C4, 81; C5, 45) were treated. Median age was 72 years (range 43-92), 32.5% had visceral disease and 87.3% previously received ≥6 mo of enzalutamide; 121 pts (96.0%) discontinued, most because of progressive disease. Median (range) time from enrollment to data cutoff was 31.7 mo (23.1-37.1) in C4 and 35.5 mo (22.9-37.3) in C5. In C4, confirmed ORR was 12.3% (95% CI 6.1-21.5) (2 CRs, 8 PRs); median (range) DOR was 8.1 mo (2.5+ to 15.2), and 62.5% had a response ≥6 mo (Kaplan-Meier estimate). Additional efficacy analyses are outlined in the table. A total of 27.2% and 28.9% of pts in C4 and C5, respectively, experienced grade ≥3 treatment-related adverse events. Two pts in C4 died of immune-related AEs (Miller Fisher syndrome and myasthenia gravis). Incidence of any-grade (34.1%) and grade 3 or 4 (5.6%) rash, regardless of relatedness to treatment, was higher than previously reported for individual agents but manageable with standard-of-care treatments; 2 pts discontinued because of rash. Conclusions: After an additional 1 year of follow-up, pembro + enza continued to show antitumor activity and a manageable safety profile in pts with mCRPC who became resistant to enza. The treatment combination is being further evaluated in the ongoing phase 3 KEYNOTE-641 trial (NCT03834493). Clinical trial information: NCT02787005. [Table: see text]

First-line treatment with Bendamustine plus Rituximab for patients with indolent non-Hodgkin’s lymphoma or Mantle cell lymphoma: Real-world experience.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19540-e19540
Author(s):  
Rouslan Kotchetkov ◽  
David Susman ◽  
Lauren Gerard ◽  
Erica DiMaria ◽  
Derek Wayne Nay
Keyword(s):  
Adverse Events ◽  
Hodgkin’S Lymphoma ◽  
Cell Lymphoma ◽  
Hodgkin's Lymphoma ◽  
First Line ◽  
Non Hodgkin’S Lymphoma ◽  
Non Hodgkin's Lymphoma ◽  
Mantle Cell ◽  
Grade 3

e19540 Background: Bendamustine plus rituximab (B+R) was established as a preferred first line therapy for patients with previously untreated indolent non-Hodgkin’s lymphoma based on the BRIGHT and STIL trials. However, only few reports on efficacy and safety data of this combination in the real-world setting are available to-date. Methods: We conducted a retrospective review of patients who received therapy with standard doses of B+R in our cancer center from June 2013 to January 2021. Patients with indolent non-Hodgkin’s lymphoma (iNHL) and mantle cell lymphoma (MCL) who received more than one cycle of B+R were evaluated. Results: Amongst a total of 201 patients 56% were males and 44% females. Median age at B+R initiation was 72 years (range 34-94). Follicular lymphoma (FL) (50.3%), marginal zone lymphoma (MZL) (19.4%), and lymphoplasmacytic lymphoma (LPL) (14.5%) were the most common iNHL. Stage 3 and 4 diseases represented 19.9% and 68.6% of patients. Extranodal disease was found in 35.8%. The proportion of patients with high risk disease was 48.5% for FL (FLIPI ≥3), 86.6% for LPL (WMISS score ≥2), and 80.5% for MCL (MIPI score ≥6.2). Prior history of secondary malignancy had 23.4% of patients; 11.4% patients had ECOG 3. Most common indications for B+R initiation were bulky symptomatic lymphadenopathy (69.1%), cytopenia (36.8%) and constitutional symptoms (36.8%). Fifty-eight percent of patients had more than one indication for therapy. Median number of B+R cycles delivered was 6 (range: 1-6), median dose of bendamustine was 90 mg/m2 (range 45-90). Full doses of treatment were given in 66.7% of patients, reduced in 33.3% with mean dose 78.3 mg/m2. A total of 50.8% completed 6 cycles with no delays, in 49.2% treatment was delayed (mean delay time 1.8 weeks). Overall response was 94.5%, with 77.6% complete and 16.9% partial remission. Median duration of follow-up was 35 months (range: 4-91). At the end of follow-up, event free survival (EFS) was 77.1% and overall survival (OS) was 79.6%. Six percent of patients relapsed, 8% developed secondary hematological malignancies, including 14 cases of aggressive B-cell lymphoma and 2 cases of MDS. 16.9% of patients required support with G-CSF. Grade 3-4 neutropenia was recorded in 22.4%, febrile neutropenia in 7.5%, grade 3-4 anemia in 7.9%, and grade 3-4 thrombocytopenia in 3.9% of patients. Rituximab-associated infusion reactions, skin rash, thrombophlebitis, and infection were the most common non-hematological adverse events. A total of 80.6% of patients proceeded to rituximab maintenance. Conclusions: B+R chemoimmunotherapy is feasible to administer in non-clinical trial setting. Despite more dose reduction as compared to STIL trial, B+R retained its efficacy with comparable EFS and OS. No new adverse events or increase in secondary malignancies were found.

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