scholarly journals Daratumumab Single Agent and Daratumumab Plus Pomalidomide and Dexametasone in Relapsed/Refractory Multiple Myeloma: A Real Life Retrospective Evaluation

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4516-4516 ◽  
Author(s):  
Antonio Branca ◽  
Amy Buros ◽  
Donghoon Yoon ◽  
Larry J Suva ◽  
Niels Weinhold ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Event ◽  
High Risk ◽  
Disease Progression ◽  
Single Agent ◽  
Low Risk ◽  
High Risk Patients ◽  
Risk Patients ◽  
Group 2 ◽  
Group 1

Abstract Background. In the last twenty years, the outcome of multiple myeloma (MM) has markedly improved. Daratumumab is the first anti-CD38 monoclonal antibody (mAb) recently approved for the treatment of relapsed refractory multiple myeloma (RRMM). In this study we have evaluated the efficacy of daratumumab single agent and daratumumab plus pomalidomide and dexamethasone in low and high risk RRMM patients. Design and Methods. From November 2015 to March 2016, 25 and 39 RRMM patients were treated with therapy using daratumumab single agent (Group 1: median age 67, range 40-83) and daratumumab plus pomalidomide and dexamethasone respectively (Group 2: median age 71, range 45-87). In both groups, patients received daratumumab IV 16 mg/kg once a week (weeks 1-8), followed by every other week (weeks 9-24) and then once a month until disease progression or unacceptable toxicities. In Group 2 pomalidomide was administered at dosages from 1 mg to 4 mg daily according to tolerability for 21 days every 28 days, along with dexamethasone 40 mg weekly. The median time form the time of diagnosis was 7.1 years and 5.5 years in Group 1 and Group 2 respectively. In both groups, patients had received a median of 4 prior treatments. In Group 1, 80% of the patients had disease refractory to the last therapy received, 68% had disease double refractory to IMiDs and PIs, and 28% (7 patients) had GEP high risk signature. In Group 2, 78% of the patients had disease refractory to last therapy, 84% had double refractory disease and 37% (14 patients) had high GEP risk signature. Results. In the single agent group, the overall response rate (ORR) was 28%: CR 4% (1 patient), 4% VGPR (1 patient), PR 20% (5 patients). With a median follow up of 3.5 months, 48% of patients were still on treatment and 52% had discontinued treatment for disease progression. The ORR according to last GEP70 was 40% and 0% in the low risk and high risk patients respectively. All high risk patients had discontinued treatment for disease progression within the second month of treatment. In the second group, the ORR was 41%: CR 5% (2 patients), 3% VGPR (1 patient), and 33% PR (13 patients). After a median follow up of 4 months, 77% (30 patients) of patients were still on treatment, 20% (8 patients) discontinued treatment for disease progression and 3% (1 patient) of patients had discontinued treatment for adverse event grade 4. The ORR was 50% (4% CR, 4% VGPR, and 42% PR) in low risk patients and 21% (7% CR and 14% PR) in high risk patients. Infusion-related reactions were mild (54% of patients had an event of any grade, and 4% and 2% had an adverse event of grade 3 in Group 1 and Group 2 respectively). The most common non hematological adverse event of grade 3 or 4 was pneumonia (4% and 8% in Group 1 and Group 2 respectively). PFS of Group 1 and 2 are shown in Figure 1. Conclusion. Daratumumab single agent had a favorable safety profile and encouraging efficacy in patients with heavily pretreated and refractory myeloma, and the combination of daratumumab with pomalidomide and dexamethasone was well tolerated and improved the outcome in low risk patients, even in double refractory disease. Encouraging results have been observed as well in patients with high risk GEP 70 signature. Figure 1 Figure 1. Disclosures Davies: Takeda: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Morgan:Univ of AR for Medical Sciences: Employment; Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Bristol Meyers: Consultancy, Honoraria; Janssen: Research Funding.

scholarly journals Appropriate secondary prevention and clinical outcomes after acute myocardial infarction according to atherothrombotic risk stratification: The FAST-MI 2010 registry

2018 ◽  
Vol 26 (4) ◽  
pp. 411-419 ◽  
Author(s):  
Victoria Tea ◽  
Marc Bonaca ◽  
Chekrallah Chamandi ◽  
Marie-Christine Iliou ◽  
Thibaut Lhermusier ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
High Risk ◽  
Secondary Prevention ◽  
High Risk Patients ◽  
Risk Patients ◽  
St Elevation ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background Full secondary prevention medication regimen is often under-prescribed after acute myocardial infarction. Design The purpose of this study was to analyse the relationship between prescription of appropriate secondary prevention treatment at discharge and long-term clinical outcomes according to risk level defined by the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Secondary Prevention (TRS-2P) after acute myocardial infarction. Methods We used data from the 2010 French Registry of Acute ST-Elevation or non-ST-elevation Myocardial Infarction (FAST-MI) registry, including 4169 consecutive acute myocardial infarction patients admitted to cardiac intensive care units in France. Level of risk was stratified in three groups using the TRS-2P score: group 1 (low-risk; TRS-2P=0/1); group 2 (intermediate-risk; TRS-2P=2); and group 3 (high-risk; TRS-2P≥3). Appropriate secondary prevention treatment was defined according to the latest guidelines (dual antiplatelet therapy and moderate/high dose statins for all; new-P2Y12 inhibitors, angiotensin-converting-enzyme inhibitor/angiotensin-receptor-blockers and beta-blockers as indicated). Results Prevalence of groups 1, 2 and 3 was 46%, 25% and 29% respectively. Appropriate secondary prevention treatment at discharge was used in 39.5%, 37% and 28% of each group, respectively. After multivariate adjustment, evidence-based treatments at discharge were associated with lower rates of major adverse cardiovascular events (death, re-myocardial infarction or stroke) at five years especially in high-risk patients: hazard ratio = 0.82 (95% confidence interval: 0.59–1.12, p = 0.21) in group 1, 0.74 (0.54–1.01; p = 0.06) in group 2, and 0.64 (0.52–0.79, p < 0.001) in group 3. Conclusions Use of appropriate secondary prevention treatment at discharge was inversely correlated with patient risk. The increased hazard related to lack of prescription of recommended medications was much larger in high-risk patients. Specific efforts should be directed at better prescription of recommended treatment, particularly in high-risk patients.

scholarly journals Does pre-emptive onlay mesh reinforcement of midline laparotomies reduce incidence of incisional hernia in high–risk patients?

2019 ◽  
Vol 6 (7) ◽  
pp. 2300
Author(s):  
Hosam F. Abdelhameed ◽  
Samir A. Abdelmageed
Keyword(s):  
High Risk ◽  
Incisional Hernia ◽  
Chronic Wound ◽  
Midline Laparotomy ◽  
High Risk Patients ◽  
Wound Pain ◽  
Risk Patients ◽  
Onlay Mesh ◽  
Group 2 ◽  
Group 1

Background: One of the major morbidity after abdominal surgery is incisional hernia. In high risk patients its incidence reaches 11-20% despite various optimal closure techniques for midline laparotomy. Our aim is to evaluate the efficacy of onlay mesh placement in reducing the incidence of incisional hernia in those high risk patients.Methods: A total of 65 high risk patients suspected to develop post-operative incisional hernia underwent midline abdominal laparotomies. Patients were divided into two groups; group1 (30 patients) for whom the incision was closed by conventional method and group2 (35 patients) for whom the incision was closed with reinforcement by onlay polypropylene mesh. The primary end point was the occurrence of incisional hernia while the secondary end point was post-operative complications including subcutaneous seroma, chronic wound pain, and surgical site infection (SSI). Patients were followed up for two years.Results: The base line characteristics of the two groups were similar. The incidence of incisional hernia is significantly reduced 1/35 (2.8%) in group 2 while it was 6/30 (20%) in group 1. As regard seroma and chronic wound pain they increased in (group2) 6/35 (17.14%) and 5/35(14.28%) respectively compared to (group 1) which was 4/30 (13.33%) and 2/30 (6.66%). SSI occurred in 1/35 (2.85%) in group 2 and in 1/30 (3.33%) in group 1.Conclusions: Prophylactic onlay mesh reinforcement of the midline laparotomy for high risk patients can be used safely and markedly reduces the incidence of incisional hernia with little morbidity.

Outcome of Adult AML at First Relapse Following a Risk-Oriented Strategy: An Update of the Northern Italy Leukemia Group (NILG) Experience

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4385-4385 ◽  
Author(s):  
Irene Cavattoni ◽  
Enrico Morello ◽  
Elena Oldani ◽  
Tamara Intermesoli ◽  
Ernesta Audisio ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
High Risk ◽  
Risk Category ◽  
High Dose ◽  
High Risk Patients ◽  
Risk Patients ◽  
First Relapse ◽  
Group 2 ◽  
Standard Risk ◽  
Group 1

Abstract INTRODUCTION The impact on post-relapse survival of selected prognostic factors and salvage therapy (finalized to perform an allo-SCT) was retrospectively analyzed in 172 patients (patients) with relapsed non-APL AML, who had been initially treated with standard induction and risk-adapatiented consolidation. The aim was to identify factors associated with a better outcome at first relapse. METHODS All 172 patients were at first recurrence following consolidation of CR1 with high-dose Ara-C (HiDAC) multicycle therapy supported by blood stem cells (standard risk, as defined by mixed clinical-cytogenetic criteria) or allo-SCT in case of high-risk prognostic profile. Median age at relapse was 55 y (range 21–70). CR1 duration was &lt;6 months in 50 patients (29%), ranging from 0.6 to 52,7 mo (median 9,1). High risk patients were 128/172 (74%) and 43/172 patients (25%) had an unfavourable cytogenetics (CG). One hundred-eleven patients (64%) received HiDAC and 24 (14%) an allo-SCT according to study design. RESULTS 140 patients (81%) received salvage treatment. The remaining 32 patients (19%) received palliation and all of them died. The median OS was 17.1 mo, with a 2yOS of 34%. Favorable prognostic factors identified by univariate analisys were: favourable or intermediate CG (p=0,007), standard risk category according to first line protocol (p=0.004), availibility of a HLA matched donor (p= 0.048), achievement of an early CR1(p=0,000), HiDAC as first line therapy(p=0,000), alloHSCT perfomed at relapse (p=0,000) and a DFS from CR1&gt;12 mo (p=0,000). In multivariate analysis favourable or intermediate CG and DFS &gt;12 mo were confirmed as independent prognostic factors (p=0,036 and p=0,001 respectively). Among the 140 patients, 50 received an allo-SCT following relapse (36%, group 1), and the remaining 90 (64%, group 2) received high dose chemotherapy alone (85), autologous SCT (2), or DLI (3, in case of previous alloSCT). Both groups were comparable regarding age &gt;55 y, prior allo-SCT and risk class at diagnosis. After salvage therapy, 44 patients(88%) in the group 1 achieved CR2, compared to 26 patients (29%) in the group 2. The median duration of CR2 was 9 mo (range 2–64) and 3 mo (range 1–34) in group 1 and 2 respectively. NRM was 17/140: 12 patients (24%) in the allo-SCT group and 5 (6%) in group 2. The 2yOS was 57% and 23% respectively (p=0,000). Moreover, among 50 alloSCT patients, survival was affected by risk category at diagnosis: 2yOS of 19 (38%) standard risk patients was 83% compared to 42% in 31 high risk patients (62%) (p=0.01). This risk stratification has no impact on OS in the group 2. CONCLUSIONS DFS &gt; 12 mo and standard risk category at diagnosis, according to NILG protocol, are the most important independent positive prognostic factors impacting OS of AML relapsed patients. The availibility of a HLA matched donor and a subsequent intensification with alloSCT may offer substantial salvage rates and its outcome is affected by the risk stratification at diagnosis. Nevertheless, high risk patients could benefit from alloSCT, reaching an 2yOS of 42%.

scholarly journals Evaluation of Functional and Cytogenetic High-Risk Multiple Myeloma Using Real-World Data

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4093-4093
Author(s):  
Ankit Kansagra ◽  
Eric Hansen ◽  
Andrew J. Belli ◽  
Stefanie Goran ◽  
Ching-Kun Wang
Keyword(s):  
Multiple Myeloma ◽  
High Risk ◽  
Disease Progression ◽  
Real World ◽  
Multivariate Analyses ◽  
Rapid Disease Progression ◽  
High Risk Patients ◽  
Risk Patients ◽  
High Risk Populations ◽  
Equity Ownership

Abstract Introduction: Multiple myeloma (MM) is a heterogeneous disease with wide variability in outcomes. The presence of cytogenetic abnormalities in MM is of critical importance for prognosis and risk stratification. However, patients who may or may not have sufficient cytogenetic abnormalities to classify as high-risk can still experience rapid disease progression despite therapy, or functional high risk (FHR) disease. These two high risk cohorts comprise vulnerable subpopulations who have a significant burden of disease, and it is critical that we understand the underlying patient characteristics and optimal treatment sequence. We sought to investigate these two high risk patient populations treated in the contemporary real-world practice setting. Methods: A total of 1719 patients were identified in the COTA real-world database as having been diagnosed with active MM on or after January 1, 2015 and classified as either FHR, cytogenetic high risk (CHR), or both. The COTA real-world database is a USA-based real-world evidence database comprised of longitudinal, Health Insurance Portability and Accountability Act (HIPAA)-compliant, data on the diagnosis, clinical management, and outcomes of patients with cancer. Of the 1719 patients, 1260 were identified to be FHR, defined as relapse &lt;18 months from initial active MM diagnosis. A total of 459 patients were identified as CHR, among which 347 were both FHR and CHR. CHR was defined as a patient having at least one of the following abnormalities: t(4;14), t(14;16), t(14;20), del(17p), 1q gain, or hypoploid. Line of therapy was applied programmatically using an algorithm based on International Myeloma Working Group criteria and clinical guidance. The primary outcome was time to next treatment (TTNT) calculated using the Kaplain Meier method. Univariate and multivariate analyses were conducted to understand predictors of rapid disease progression among high-risk patients. Results: In our real-world population, FHR patients tended to be slightly younger, African American, and treated predominantly in the academic setting (Table 1). First-line (1L) and second-line (2L) treatment patterns by category are shown in Table 2. A lower proportion of FHR patients received 1L immunomodulators as compared to the other high-risk groups, while almost half of the CHR patients received 1L stem cell transplant (SCT). In 2L, among patients not receiving 2L SCT, a higher proportion of CHR patients received a daratumamab-based treatment as compared to FHR (23.2% vs. 12.0%, respectively). We observed a longer median (95% CI) TTNT for high-risk patients receiving 2L daratumamab-based treatment as compared to patients who did not: 8.5 months (6.4-13.0) vs. 6.0 months (5.3-6.9), p=0.07 (Figure 1). Univariate and multivariate analyses showed age at diagnosis (HR: 0.98, CI: 0.97, 0.99), normal cytogenetics (HR: 0.78, CI: 0.63, 0.97), 1L immunomodulator (HR: 0.39, CI: 0.22, 0.69), 1L proteasome inhibitor (HR: 1.4, CI: 1.1, 1.8), and 1L SCT (HR: 0.22, CI: 0.15, 0.32) as significant predictors of rapid disease progression. Conclusions: Our study provides important insights comparing high risk populations with MM treated in the real-world setting. A higher proportion of CHR patients received 1L SCT and this provided the longest 1L TTNT as compared to other treatments. In 2L, among patients not receiving 2L SCT, we observed a trend towards significantly longer TTNT provided by dara-based treatment as compared to non-dara based treatment; however, our TTNT is lower than progression-free survival results observed in pivotal trials. We identified potential underlying differences in our patient populations that may be driving the predictors of rapid disease progression, including 1L SCT eligibility and renal disease, and these will be further investigated in propensity score matched populations. Future research will continue to explore optimal treatment sequences in high-risk populations with multiple myeloma to improve patient outcomes. These data highlight an urgent need to better predict FHR patients at diagnosis and develop clinical trials incorporating novel compounds in high risk patients. Figure 1 Figure 1. Disclosures Hansen: COTA, Inc.: Current Employment. Belli: COTA, Inc.: Current Employment, Other: Equity ownership. Goran: COTA, Inc.: Current Employment. Wang: COTA, Inc.: Current Employment, Other: Equity ownership.

AS-265: Incidence After the Use of Clopidogrel 150 mg + Aspirin 81 mg in Group 1 Versus Clopidogrel 75 mg + Aspirin 81 mg in Group 2 After Drug-Eluting Stenting for 1 Month in High-Risk Patients

2009 ◽  
Vol 103 (9) ◽  
pp. 112B
Author(s):  
Saad Mohammed Alkasab ◽  
Menwar M. Alanazi ◽  
Mohammad Alshehri ◽  
Rida Nourallah ◽  
Yahya Alhebaishi ◽  
...  
Keyword(s):  
High Risk ◽  
High Risk Patients ◽  
Risk Patients ◽  
Drug Eluting ◽  
Group 2 ◽  
Group 1

scholarly journals Results of neuroblastoma treatment in Lithuania: a single centre experience

2017 ◽  
Vol 24 (2) ◽  
pp. 128-137 ◽  
Author(s):  
Austėja Juškaitė ◽  
Indrė Tamulienė ◽  
Jelena Rascon
Keyword(s):  
Survival Rate ◽  
High Risk ◽  
Age At Diagnosis ◽  
Mycn Amplification ◽  
Disease Group ◽  
High Risk Patients ◽  
Risk Patients ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background. Neuroblastoma (NB) is the most common extracranial solid tumour in children. This is a very rare disease with heterogeneous biology varying from complete spontaneous regression to a highly aggressive tumour responsible for 15% of malignancy-related death in early childhood. Analyses of survival rates in Europe have shown a considerable difference between Northern/Western and Eastern European countries. Treatment results of NB in Lithuania have never been analyzed. Aim. To assess the survival rate of children with NB according to initial spread of the disease, age at diagnosis, the MYCN amplification, risk group, and treatment period. Patients and methods. A retrospective single-centre analysis of patients’ records was performed. Children diagnosed and treated for NB between 2000 and 2015 at the Centre of Paediatric Oncology and Haematology of the Children’s Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos were included. The patients were divided into three groups according to the spread of the disease: group 1 – patients with local NB older than 12 years of age; group 2 – stage IV patients, also called the M stage; group 3 – infants with stages 4S and MS. The patients were stratified into three risk groups – low, intermediate and high risk. Estimates of five-year overall survival (OS5y) were calculated using the Kaplan-Meier method comparing survival probability according to spread of the disease, age at diagnosis, the MYCN amplification, risk group and treatment period (2000–2007 vs 2008–2015). Results. Overall 60 children (31 girls and 29 boys) with NB were included. The median age at diagnosis was 1.87 years (ranged from 4 days to 15 years). Seventy-eight percent of cases were found to be differentiated or undifferentiated NB, 22% – ganglioneuroblastoma. The local form of the disease was predominant: 57% (34/60) of patients were allocated to the group 1, 37% (22/60) with initial metastatic disease were assigned to group 2, and infants with 4S or MS stage comprising 7% (4/60) allocated to group 3, respectively. The probability of OS5y for the entire cohort was 71% with the median follow-up of 8.8 ± 4.8 years. The probability of OS5y for local disease (group 1) was significantly higher compared to metastatic disease (group 2) (94% vs. 34%, p = 0.001, respectively) as well as for infants compared to children older than 12 months at the time of diagnosis (90% vs 60%, p = 0.009, respectively). The MYCN gene amplification had a negative influence on OS5y, with 78% of MYCN-negative patients surviving in comparison to 40% of MYCN-positive patients who did not survive (p = 0.153). The high-risk patients had significantly worse OS5y than children with intermediated or low risk (35% vs. 82% vs. 100%, respectively, p = 0.001). Comparison of OS5y between two treatment periods in the entire patient population revealed a non-significant increase in survival from 66% in the 2000–2007 period to 82% in the 2008–2015 period (p = 0.291), mostly due to a dramatic improvement achieved for high-risk patients whose survival rate increased from 9% in the 2000–2007 period to 70% in the 2008–2015 period (p = 0.009). Conclusions. There was a slight predominance of low-risk patients, probably due to a higher number of infants. A better probability of OS5y was confirmed in infants with local disease and in MYCN-negative patients. The OS5y for children treated for NB at our institution over 16 years increased from 66% in the 2000–2007 period to 82% in the 2008–2015 period with the most significant improvement achieved for high risk patients. The current survival rate of children treated for NB at our institution is in line with the reported numbers in Northern and Western European countries.

Prediction of Survival in Multiple Myeloma Based on Gene Expression Profiles Reveals Cell Cycle and Chromosomal Instability Signatures in High-Risk Patients and Hyperdiploid Signatures in Low-Risk Patients: A Study of the Intergroupe Francophone du Myélome

2008 ◽  
Vol 26 (29) ◽  
pp. 4798-4805 ◽  
Author(s):  
Olivier Decaux ◽  
Laurence Lodé ◽  
Florence Magrangeas ◽  
Catherine Charbonnel ◽  
Wilfried Gouraud ◽  
...  
Keyword(s):  
Gene Expression ◽  
Cell Cycle ◽  
Multiple Myeloma ◽  
High Risk ◽  
Prognostic Markers ◽  
Expression Profiles ◽  
Gene Expression Profiles ◽  
Low Risk ◽  
High Risk Patients ◽  
Risk Patients

Purpose Survival of patients with multiple myeloma is highly heterogeneous, from periods of a few weeks to more than 10 years. We used gene expression profiles of myeloma cells obtained at diagnosis to identify broadly applicable prognostic markers. Patients and Methods In a training set of 182 patients, we used supervised methods to identify individual genes associated with length of survival. A survival model was built from these genes. The validity of our model was assessed in our test set of 68 patients and in three independent cohorts comprising 853 patients with multiple myeloma. Results The 15 strongest genes associated with the length of survival were used to calculate a risk score and to stratify patients into low-risk and high-risk groups. The survival-predictor score was significantly associated with survival in both the training and test sets and in the external validation cohorts. The Kaplan-Meier estimates of rates of survival at 3 years were 90.5% (95% CI, 85.6% to 95.3%) and 47.4% (95% CI, 33.5% to 60.1%), respectively, in our patients having a low risk or high risk independently of traditional prognostic factors. High-risk patients constituted a homogeneous biologic entity characterized by the overexpression of genes involved in cell cycle progression and its surveillance, whereas low-risk patients were heterogeneous and displayed hyperdiploid signatures. Conclusion Gene expression–based survival prediction and molecular features associated with high-risk patients may be useful for developing prognostic markers and may provide basis to treat these patients with new targeted antimitotics.

scholarly journals Can We Safely Reduce the Administration of 131-iodine in Patients With Differentiated Thyroid Cancer? – Experience of the Brugmann Hospital in Brussels

2020 ◽  
Author(s):  
Laura Iconaru ◽  
Felicia Baleanu ◽  
Georgiana Taujan ◽  
Ruth Duttmann ◽  
Linda Spinato ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
High Risk ◽  
Differentiated Thyroid Cancer ◽  
Low Risk ◽  
Response To Treatment ◽  
American Thyroid Association ◽  
Risk Of Recurrence ◽  
Risk Patients ◽  
Group 2 ◽  
Group 1

Abstract Background131-iodine administration after surgery remains a standard practice in differentiated thyroid cancer (DTC). In 2014, the American Thyroid Association presented new guidelines for the staging and management of DTC, including no systematic 131I in patients at low-risk of recurrence and a reduced 131I activity in intermediate risk.The present study aims at evaluating the rate of response to treatment following this new therapeutic management compared to our previous treatment strategy in patients with DTC of different risks of recurrence.MethodsPatients treated and followed up for DTC according to the 2014-ATA guidelines (Group 2) were compared to those treated between 2007 and 2014 (Group 1) in terms of general characteristics, risk of recurrence (based on the 2015-ATA recommendations), preparation to iodine administration, cumulative administered 131I activity and response to treatment. ResultsIn total, 136 patients were included: 78 in Group 1 and 58 in Group 2. The two groups were not statistically different in terms of clinical characteristics nor risk stratification: 42.3% in Group 1 and 31% in Group 2 were classified as low risk, 38.5% and 48.3% as intermediate risk and 19.2% and 20.7% as high risk (P=0.38). Preparation to iodine administration consisted in rhTSH stimulation in 23.4% of the patients in Group 1 and 97.4% in Group 2 (p<0.001). 131-iodine was administered to 47/78 patients (60%) in Group 1 (5 at low risk of recurrence) and 39/58 patients (67%) in Group 2 (0 with a low risk). Among the treated patients, median 131I cumulative activity was significantly higher in Group 1 (3.70GBq [100mCi] range 1.11-20.35 GBq [30-550 mCi]) than in Group 2 (1.11 GBq [30 mCi], range 1.11-11.1 GBq [30-300 mCi], P<0.001. Complete response was found in 89.7% in Group 1 vs. 94.8% in Group 2 (P=0.52). ConclusionsUsing the 2015-ATA evidence-based guidelines for the management of DTC, meaning no 131I administration in low-risk patients, a low activity in intermediate and even high risk patients, and an almost systematic use of rhTSH stimulation before radioiodine therapy allowed us to reduce significantly the median administered 131I activity, with a similar rate of complete therapeutic response.

scholarly journals Outcomes of Maintenance Treatment Post Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients: A Canadian Single Center Experience

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2710-2710
Author(s):  
Mina Dehghani ◽  
Shona Philip ◽  
Anthony Quint ◽  
Lenicio Siqueira ◽  
Selay Lam ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
High Risk ◽  
Board Of Directors ◽  
Maintenance Treatment ◽  
Risk Group ◽  
Single Agent ◽  
Advisory Committees ◽  
Entire Cohort ◽  
High Risk Patients ◽  
Risk Patients

Abstract Introduction: Despite the significant advances in treatment of patients with multiple myeloma, therapy of patients with high risk disease remains challenging. Maintenance treatment with Lenalidomide following autologous stem cell transplant (ASCT) is the standard of care in patients with multiple myeloma; however its efficacy in patients with high risk features is conflicting. The efficacy of proteasome inhibitors (PI) ± lenalidomide (Len) maintenance in high risk patients has been evaluated in other studies with discrepant results with respect to improvement in long term outcomes. In this study we sought to assess the impact of various maintenance strategies on outcomes of transplant eligible newly diagnosed myeloma patients in the real world setting. Methods: This is a retrospective, single center Canadian cohort study (London, Canada) with the primary objective to compare the PFS in the high risk transplant eligible (TE) newly diagnosed multiple myeloma (NDMM) patients receiving maintenance treatment versus no maintenance post ASCT, diagnosed from January 1,2007 to April 30,2021. Secondary objectives are comparison of PFS, OS and overall response rate (ORR) based on risk group and various maintenance strategies. ORR is defined as partial response or better. To investigate the effect of different variables on survival outcomes we used Kaplan-Meier curves, univariate and multivariate cox regression analysis. Results: In total, 155 TE- NDMM patients were included. 61 (39%) were high risk defined as: deletion 17p, t (4; 14), t (14; 16), 1q amp. One hundred and thirty (84%) patients received PI or Len-based induction therapy. Of the entire cohort, 53 (34%) patients received maintenance treatment post ASCT: 41 Len to progression, 12 Len+Pi. In the entire cohort, ORR was 71% (38 of 53) for patients who received maintenance and 53% (55 of 102) for those who did not receive maintenance (p=0.7). In the 61 high risk patients, 33 received maintenance: 11 Len+PI and 22 Len single agent. ORR was significantly better for maintenance, 63% (21 of 33) compared to 11% (3 of 27) for no maintenance (p=0.0054). Maintenance therapy also influenced PFS. In total, median PFS was significantly higher in patients who received maintenance; with 63% of patients alive and on therapy at 60 months, compared to no maintenance with median PFS of 40 months (HR 0.46,95% CI(025-0.85),p= 0.011). A subgroup analysis of the impact of maintenance between the standard and high risk groups suggested excellent PFS for both: 56.8% for standard and 67.1% for high risk at 60 months. On the other hand, median PFS was dismal for the high risk no maintenance group: only 19 months versus 45.5 months in the standard group ( HR=0.14,95% CI(0.05-0.38), p &lt;0.0001). Dual versus single drug maintenance strategy had no impact on PFS. Median PFS was the same for the patients who received Len+PI or Len single agent, not yet reached (NYR) in both (p=0.47). In the entire cohort there was no difference in the median OS, NYR in both groups at 60 months; 51% in maintenance, 53% in no maintenance (p=0.25). Similarly in the high risk patients median OS was not different, 61 months in maintenance vs NYR in no maintenance (45% vs 52% at 60 months, p=0.38). OS was also not different in high risk patients who received Len+PI vs Len single agent maintenance, NYR vs 61 months (p= 0.68). In the standard risk group median OS was NYR at 60 months in both maintenance and no maintenance groups (p=0.57) Conclusion: In this Canadian single center retrospective cohort study we compared PFS and OS in patients with TE-NDMM who received maintenance compared to those with no maintenance treatment post ASCT. We found PFS was significantly improved in the high risk patients who received maintenance treatment but we found no impact on dual versus single maintenance strategy. This further validates the findings of large phase 3 clinical trials illustrating a positive impact of maintenance treatment post ASCT irrespective of the cytogenetics risk in the real world setting. Although the maintenance treatment could not entirely overcome the worse outcome in the high risk group, more than 40% of the high risk patients who received maintenance were still alive at 60 months. The question of the best maintenance strategy for high risk myeloma patients remains open and further studies are warranted Figure 1 Figure 1. Disclosures Lam: Beigene: Honoraria, Membership on an entity's Board of Directors or advisory committees; SeaGen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Hoffmann-La Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Millennium: Honoraria, Membership on an entity's Board of Directors or advisory committees; Servier: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Johnson & Johnson: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Meyers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees. Phua: Amgen: Honoraria; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria; NovoNordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Honoraria. Louzada: Pfizer: Honoraria; Janssen: Honoraria; Amgen: Honoraria; Celgene: Honoraria.

scholarly journals Can we safely reduce the administration of 131-iodine in patients with differentiated thyroid cancer? – experience of the Brugmann hospital in Brussels

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Laura Iconaru ◽  
Felicia Baleanu ◽  
Georgiana Taujan ◽  
Ruth Duttmann ◽  
Linda Spinato ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
High Risk ◽  
Differentiated Thyroid Cancer ◽  
Low Risk ◽  
Response To Treatment ◽  
Intermediate Risk ◽  
Risk Of Recurrence ◽  
Risk Patients ◽  
Group 2 ◽  
Group 1

Abstract Background 131-iodine (131I) administration after surgery remains a standard practice in differentiated thyroid cancer (DTC). In 2014, the American Thyroid Association presented new guidelines for the staging and management of DTC, including no systematic 131I in patients at low-risk of recurrence and a reduced 131I activity in intermediate risk. The present study aims at evaluating the rate of response to treatment following this new therapeutic management compared to our previous treatment strategy in patients with DTC of different risks of recurrence. Methods Patients treated and followed up for DTC according to the 2014-ATA guidelines (Group 2) were compared to those treated between 2007 and 2014 (Group 1) in terms of general characteristics, risk of recurrence (based on the 2015-ATA recommendations), preparation to 131I administration, cumulative administered 131I activity and response to treatment. Results In total, 136 patients were included: 78 in Group 1 and 58 in Group 2. The two groups were not statistically different in terms of clinical characteristics nor risk stratification: 42.3% in Group 1 and 31% in Group 2 were classified as low risk, 38.5 and 48.3% as intermediate risk and 19.2 and 20.7% as high risk (P = 0.38). Two patients (one in each group) with distant metastases were excluded from the analysis. Preparation to 131I administration consisted in rhTSH stimulation in 23.4% of the patients in Group 1 and 100% in Group 2 (p < 0.001). 131I was administered to 46/77 patients (59.7%) in Group 1 (5 at low risk of recurrence) and 38/57 patients (66.7%) in Group 2 (0 with a low risk). Among the patients treated by 131I, median cumulative activity was significantly higher in Group 1 (3.70GBq [100 mCi] range 1.11–11.1 GBq [30–300 mCi]) than in Group 2 (1.11 GBq [30 mCi], range 1.11–7.4 GBq [30–200 mCi], P < 0.001). Complete response was found in 90.9% in Group 1 vs. 96.5% in Group 2 (P = 0.20). Conclusions Using the 2015-ATA evidence-based guidelines for the management of DTC, meaning no 131I administration in low-risk patients, a low activity in intermediate and even high risk patients, and a systematic use of rhTSH stimulation before 131I therapy allowed us to reduce significantly the median administered 131I activity, with a similar rate of complete therapeutic response.

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