A decision-analytic model of idelalisib in relapsed or refractory patients with follicular lymphoma in the United States.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 30-30 ◽  
Author(s):  
Nathaniel Smith ◽  
Alexander Xenakis ◽  
Rachel Beckerman ◽  
Jagpreet Chhatwal ◽  
Stephanie A. Gregory ◽  
...  
Keyword(s):  
Health Outcomes ◽  
Follicular Lymphoma ◽  
Survival Data ◽  
Treatment Options ◽  
Standard Of Care ◽  
The United States ◽  
Sensitivity Analyses ◽  
Decision Analytic Model ◽  
Current Standard ◽  
Utilization Data

30 Background: There are currently few treatment options for relapsed/refractory (RR) indolent non-Hodgkin’s lymphoma (iNHL) patients. Idelalisib (IDELA) is a first-in class PI3Kδ inhibitor with substantial clinical efficacy in iNHL patients refractory to rituximab and an alkylating agent. A single-arm clinical trial (Study 101-09) showed RR iNHL patients treated with IDELA have a median of 11 and 20.3 months of progression-free and overall survival (PFS and OS), respectively. Efficacy was also demonstrated in patients with iNHL subtypes such as follicular lymphoma (FL). The objective of this study was to project the health outcomes of IDELA versus the current standard of care for US FL patients. Methods: A partitioned survival model simulated a cohort of RR FL patients over 10 year time horizon. Patients first received IDELA or an aggregate comparator of current RR iNHL chemotherapy regimens in a progression-free state before transitioning to a progressive-disease state where they received palliative care until death. Survival data was fit and extrapolated from Study 101-09 (IDELA) for FL patients. A real-world database claims analysis provided survival, disease- and treatment-related adverse event (AEs) profiles, and medical resource utilization data for RR iNHL patients for the comparator. All outcomes were discounted at 3%. Results: Claims data predicted a median of 6.16 and 13.04 months of PFS and OS, respectively, for the comparator. Our model suggests that IDELA treatment improved health outcomes over 10 years versus the comparator, increasing life-months (LMs) and progression-free life-months (PFLMs) by 9.94 and 4.63 mos, respectively. Over 1 year, IDELA reduced both AEs and hospitalisations in FL patients by 40.3% and 49.8%, respectively. Deterministic and probabilistic sensitivity analyses demonstrated the model results are robust across different methods of survival extrapolation. Conclusions: IDELA was projected to improve health outcomes in RR FL patients compared to current treatments, largely driven by improved PFS and OS; short-term reductions in AEs and hospitalisation were specifically related to a delayed disease progression.

scholarly journals Co-Clinical Trials: An Innovative Drug Development Platform for Cholangiocarcinoma

2021 ◽  
Vol 14 (1) ◽  
pp. 51
Author(s):  
Brinda Balasubramanian ◽  
Simran Venkatraman ◽  
Kyaw Zwar Myint ◽  
Tavan Janvilisri ◽  
Kanokpan Wongprasert ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Therapy ◽  
Drug Development ◽  
Surgical Resection ◽  
Treatment Options ◽  
Standard Of Care ◽  
Time Data ◽  
Current Standard ◽  
Innovative Drug ◽  
Curative Intent

Cholangiocarcinoma (CCA), a group of malignancies that originate from the biliary tract, is associated with a high mortality rate and a concerning increase in worldwide incidence. In Thailand, where the incidence of CCA is the highest, the socioeconomic burden is severe. Yet, treatment options are limited, with surgical resection being the only form of treatment with curative intent. The current standard-of-care remains adjuvant and palliative chemotherapy which is ineffective in most patients. The overall survival rate is dismal, even after surgical resection and the tumor heterogeneity further complicates treatment. Together, this makes CCA a significant burden in Southeast Asia. For effective management of CCA, treatment must be tailored to each patient, individually, for which an assortment of targeted therapies must be available. Despite the increasing numbers of clinical studies in CCA, targeted therapy drugs rarely get approved for clinical use. In this review, we discuss the shortcomings of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy drugs. The increased availability of targeted therapy drugs for treatment is expected to facilitate the application of precision medicine in CCA.

Network meta-analysis (NMA) of immuno-oncology (IO) monotherapy as first-line (1L) treatments (txs) for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression ≥50%.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21091-e21091
Author(s):  
Nicholas Freemantle ◽  
Yingxin Xu ◽  
Florence Wilson ◽  
Patricia Guyot ◽  
Chieh-I Chen ◽  
...  
Keyword(s):  
Advanced Nsclc ◽  
Meta Analysis ◽  
Objective Response ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Sensitivity Analyses ◽  
Current Standard ◽  
Feasibility Assessment ◽  
Hazard Ratios ◽  
Nsclc Patients

e21091 Background: For advanced NSCLC patients (pts) with high (≥50%) PD-L1 expression, effective IO mono options with survival benefits are approved (pembrolizumab mono, current standard of care) and emerging (cemiplimab). In a recent Phase 3 trial, cemiplimab, a high-affinity, highly potent human PD-1 inhibitor approved for tx of advanced cutaneous squamous cell carcinoma, demonstrated significantly improved overall survival (OS) and progression-free survival (PFS) vs chemotherapy (CT) in advanced NSCLC pts with PD-L1 ≥50%. A systematic literature review and NMA were conducted to identify/compare the efficacy/safety from randomized controlled trials (RCTs) for cemiplimab vs pembrolizumab or other IO mono published 2010–19. Methods: Relevant RCTs were identified by searching Embase, MEDLINE, Cochrane, and conference proceedings with predefined search strategies according to ISPOR, NICE, and PRISMA guidelines. An NMA with time-varying hazard ratios (HRs) was performed for OS and PFS. Analyses were conducted for objective response rate (ORR), Grade (G) 3–5 all-cause adverse events (AE), G3–5 immune-mediated AE (IMAE) and discontinuation due to AEs (DAE). Fixed-effect models were used due to limited evidence. Results with standard constant HRs and various sensitivity analyses were conducted to account for differences in RCT designs and other txs. Results: The feasibility assessment determined that EMPOWER-Lung 1, KEYNOTE-024, and KEYNOTE-042 trials were eligible. IMpower110 was excluded since an incompatible PD-L1 assay (SP142) was used for pt selection. For 1L advanced NSCLC with PD-L1 ≥50%, cemiplimab was associated with significantly greater PFS and ORR, and comparable OS, G3–5 AEs, IMAEs, and all-cause DAEs vs pembrolizumab (Table). At 2 yrs, numerically more pts receiving cemiplimab vs pembrolizumab were alive (59% vs 49%) and significantly more were alive w/o progression (37% vs 18%). Conclusions: In advanced NSCLC pts with PD-L1 ≥50%, cemiplimab mono demonstrated significant improvements in PFS and ORR, and comparable OS, safety/tolerability vs pembrolizumab.[Table: see text]

The Emerging Hispanic Use of Online Health Information in the United States

2012 ◽  
pp. 251-265
Author(s):  
Nicole St. Germaine-McDaniel
Keyword(s):  
United States ◽  
Health Outcomes ◽  
Health Information ◽  
Sense Of Community ◽  
Treatment Options ◽  
The United States ◽  
English Speakers ◽  
Preventative Care ◽  
Spanish Speaking ◽  
Spanish Speaking Population

As health-information websites become more popular, healthcare corporations have worked quickly to create Spanish-language sites to reach the Spanish-speaking population. However, changes have to be made in order to effectively adapt to the Spanish-speaking audience. In order to be successful, site designers must create a sense of community by having interactive elements and by advertising these sites through radio or television with well-known celebrities or known figures in the healthcare realm. Further, care must be taken to ensure that the information in these sites is culturally appropriate for this audience. The successful health information website can be a strong tool for educating both Spanish and English speakers alike about preventative care, as well as treatment options, which in turn can improve health outcomes.

Reversal of Renal Insufficiency in an Aging Cat: A 5-year Multi-Crossover Case Study

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Robert Dennis ◽  
John Dennis
Keyword(s):  
Palliative Care ◽  
Renal Insufficiency ◽  
Treatment Options ◽  
Low Frequency ◽  
Standard Of Care ◽  
Omega 3 ◽  
Current Standard ◽  
Invasive Treatment ◽  
Non Invasive ◽  
Electro Magnetic

Renal failure is a leading cause of suffering and death in domestic cats, with approximately 1 in 3 cats affected.  Current standard-of-care treatment usually involves palliative care, diets restricted in protein and phosphorus, plenty of fluids, and sometimes vitamin D and Omega-3.  But even with early detection, which is difficult, treatment options are limited and often are not very effective.  Dietary restrictions and palliative care are often the best that can be offered, but the creatinine levels tend to inexorably creep upward toward eventual kidney failure and death.  We report the effectiveness of the use of a low-frequency, low-intensity, non-invasive treatment using Pulsed Electro-Magnetic Fields, specifically tuned to inductively generate micro-electric currents in deep tissues (ICES®-PEMF).  This report chronicles the return to normal and then reversion to renal insufficiency in a single cat, when ICES®-PEMF was applied, then withheld, then applied again, over three cycles of application and non-application, over a 5-year period. A return to normal creatinine levels, with a subsequent return to renal insufficiency as indicated by loss of control of creatinine, correlated precisely with the application and non-application of ICES®-PEMF.  The pattern observed during each cycle was as follows:  when applied 2 to 3 times weekly for 20-60 minutes each treatment, creatinine levels declined to normal range within 2-3 months.  During periods when treatment was discontinued, creatinine levels began to climb to high levels again.  We suggest the further study and potential use of ICES®-PEMF as an effective, inexpensive, safe, non-invasive treatment for feline kidney disease.

scholarly journals Towards Personalization in the Curative Treatment of Gastric Cancer

2020 ◽  
Vol 10 ◽  
Author(s):  
Astrid E. Slagter ◽  
Marieke A. Vollebergh ◽  
Edwin P. M. Jansen ◽  
Johanna W. van Sandick ◽  
Annemieke Cats ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Treatment Options ◽  
Treatment Strategies ◽  
Standard Of Care ◽  
Molecular Characteristics ◽  
Perioperative Chemotherapy ◽  
Current Standard ◽  
Common Cancer ◽  
Resectable Gastric Cancer

Gastric cancer is the fifth most common cancer worldwide and has a high mortality rate. In the last decades, treatment strategy has shifted from an exclusive surgical approach to a multidisciplinary strategy. Treatment options for patients with resectable gastric cancer as recommended by different worldwide guidelines, include perioperative chemotherapy, pre- or postoperative chemoradiotherapy and postoperative chemotherapy. Although gastric cancer is a heterogeneous disease with respect to patient-, tumor-, and molecular characteristics, the current standard of care is still according to a one-size-fits-all approach. In this review, we discuss the background of the different treatment strategies in resectable gastric cancer including the current standard, the specific role of radiotherapy, and describe the current areas of research and potential strategies for personalization of therapy.

scholarly journals Therapeutic Updates for Relapsed and Refractory Classical Hodgkin Lymphoma

Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2887
Author(s):  
Timothy J Voorhees ◽  
Anne W Beaven
Keyword(s):  
Hodgkin Lymphoma ◽  
Treatment Options ◽  
Standard Of Care ◽  
The United States ◽  
Autologous Stem Cell Transplant ◽  
Salvage Chemotherapy ◽  
Brentuximab Vedotin ◽  
Novel Agents ◽  
Cell Transplant ◽  
T Cell Therapy

Hodgkin lymphoma (HL) is a B-cell malignancy representing approximately one in ten lymphomas diagnosed in the United States annually. The majority of patients with HL can be cured with chemotherapy; however, 5–10% will have refractory disease to front-line therapy and 10–30% will relapse. For those with relapsed or refractory (r/r) HL, salvage chemotherapy followed by autologous stem cell transplant (ASCT) is standard of care, but half of patients will subsequently have disease progression. Relapse following ASCT has been associated with exceedingly poor prognosis with a median survival of only 26 months. However, in recent years, novel agents including brentuximab vedotin (BV) and programmed cell death protein 1 monoclonal antibodies (anti-PD-1, nivolumab and pembrolizumab) have been shown to extend overall survival in r/r HL. With the success of novel agents in relapsed disease after ASCT, these therapies are beginning to show clinically meaningful response rates prior to ASCT. Finally, a new investigation in r/r HL continues to produce promising treatment options even after ASCT including CD30 directed chimeric antigen receptor T-cell therapy. In this review, we will discuss the recent advances of BV and anti-PD-1 therapy prior to ASCT, novel approaches in r/r HL after ASCT, and review active clinical trials.

Survival gains in multiple myeloma from 2003 to 2014.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 98-98
Author(s):  
Rafael Fonseca ◽  
Anupam B. Jena ◽  
Desi Peneva ◽  
Zoe Clancy
Keyword(s):  
Multiple Myeloma ◽  
Survival Data ◽  
Treatment Options ◽  
The United States ◽  
Novel Therapies ◽  
Full Sample ◽  
The Past ◽  
Improvement In Survival ◽  
Second Wave ◽  
Novel Agent

98 Background: Survival probabilities for patients with multiple myeloma have increased considerably over the past several decades, and a conservative estimate of 5-year survival today is approximately 50%, perhaps higher with optimal treatment. Treatment options for multiple myeloma have grown significantly beginning in 2003 with the approval of bortezomib, followed by approvals for lenalidomide and thalidomide in 2006. The second wave of novel agent approvals began in 2012 with carfilzomib, followed by pomalidomide in 2013. The aim of this study was to estimate the survival gains associated with multiple myeloma therapies after the introduction of novel therapies beginning in 2003 in the United States. Methods: We estimated survival gains for multiple myeloma patients diagnosed in the 5-year period from 2010-2014—who had access to newer therapies like lenalidomide, bortezomib, pomalidomide, and carfilzomib—compared with patients diagnosed in the 5 years prior to the approval of bortezomib (1998–2002). We used data from the Surveillance, Epidemiology, and End Results (SEER) Program cancer registry and a generalized gamma regression survival model. The sample from SEER included patients aged > 18 years who had a diagnosis of multiple myeloma between 1983 and 2014. Results: Of 88,462 patients identified in the full sample, 14,446 patients were diagnosed in 1998–2002 and 25,948 patients were diagnosed in 2010–2014. Overall survival was 51% longer ( P< 0.001) in multiple myeloma patients diagnosed in 2010–2014 than in patients diagnosed in 1998–2002. Patients diagnosed in 2010–2014 had median and mean survival of 1.32 and 2.27 years longer, respectively, than patients diagnosed in 1998–2002. Conclusions: Patients diagnosed with multiple myeloma during 2010–2014 had significant improvement in survival relative to patients diagnosed in 1998–2002. This study found continued improvement in survival in multiple myeloma patients in the most recent 5-years of survival data available, demonstrating the considerable progress made since the wave of multiple myeloma innovation began in 2003.

scholarly journals Immune responses in the thyroid cancer microenvironment: making immunotherapy a possible mission

2017 ◽  
Vol 24 (12) ◽  
pp. T311-T329 ◽  
Author(s):  
Robert C Mould ◽  
Jacob P van Vloten ◽  
Amanda W K AuYeung ◽  
Khalil Karimi ◽  
Byram W Bridle
Keyword(s):  
Thyroid Cancer ◽  
Immune System ◽  
Treatment Options ◽  
Survival Rates ◽  
Standard Of Care ◽  
Cancer Microenvironment ◽  
Current Standard ◽  
Thyroid Cancers ◽  
Hormonal Modulation ◽  
Differentiated Thyroid Cancers

The incidence of thyroid cancers has been steadily increasing worldwide over the past few decades. Although five-year survival rates for differentiated thyroid cancers are upwards of 90%, clinical outcomes for patients with undifferentiated, recurrent and/or metastatic disease are often dismal despite conventional interventions. As such, there is a demand for novel treatment options. Cancer immunotherapy represents the ultimate form of personalized medicine by leveraging the specificity and potency of a patient’s immune system to kill their tumor. The thyroid cancer microenvironment is rich in immunological cells, making it a reasonable candidate for immunotherapy. This review maps out the immunological features of thyroid cancers and how these can be modulated. There are surprising immunological consequences of conventional therapies that demand attention. Also, hormonal modulation of the immune system is highlighted as a unique and confounding feature of thyroid cancers. A variety of cutting-edge immune-based therapies are discussed, with an emphasis placed on how these can be integrated with the current standard of care. Several high priority areas in need of research are also highlighted.

scholarly journals Treatment Regimens and Clinical Outcomes Among Follicular Lymphoma Patients Treated with Third-Line Therapy in the United States: A Real-World EHR Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1360-1360
Author(s):  
Dong Dai ◽  
Ji Haeng Heo ◽  
Andrew Rava ◽  
Etienne Jousseaume ◽  
Roberto Ramos ◽  
...  
Keyword(s):  
United States ◽  
Follicular Lymphoma ◽  
Median Time ◽  
Index Date ◽  
Treatment Options ◽  
The United States ◽  
Time To Progression ◽  
Publicly Traded ◽  
Treatment Regimens ◽  
Third Line

Abstract Objective: To determine treatment regimens used in clinical practice and the associated clinical outcomes among third line (3L) follicular lymphoma (FL) patients in the United States (US). Methods: This non-interventional, retrospective study used Optum electronic health records (EHR) database for FL patients in the US between 1 Jan 2007 and 31 Dec 2020. The start of this period was selected to align with the Morrison et al. 2019, with 5 years of additional data. The identification period was 1 Jan 2008 to 31 Dec 2019, to ensure at least 1 year of baseline before and 60 days of follow-up (unless death happens before) after the index date, defined as start date of 3L treatment. Adult patients (≥18 years) treated in integrated delivery networks with at least one of the 3L treatments of interest (rituximab, bendamustine and rituximab, phosphatidylinositol 3-kinase [PI3K] inhibitors [copanlisib, duvelisib, idelalisib], lenalidomide and rituximab [R2], tazemetostat, and stem cell transplant) were included. Patients with Diffuse Large B-cell Lymphoma (DLBCL) diagnosis or clinical trial enrollment on or before the index date or any other cancer diagnosis before the first FL diagnosis were excluded. All agents initiated within 90 days after the index diagnosis constituted the 1L treatment. A subsequent line of therapy (LOT) was defined as treatment initiated after ≥180 days following the runout date of all agents, or addition or substitution of a new agent in the prior LOT after 90 days. The primary endpoints were time to progression (DLBCL transformation, new LOT initiation, or supportive care), overall survival (OS) and progression-free survival (PFS), while time to next treatment (TTNT) and treatment patterns were the key secondary endpoints. The analyses were conducted for the overall cohort, patients with early progression within 24 months (POD24) after 1L treatment, patients with index date after and including year 2014, as well as for different 3L treatment regimens. The sub-group with 2014 as index date was selected based on idelalisib approval in 2014. Results: The final cohort of patients (used one of the 3L treatments of interest and met inclusion/exclusion criteria) consisted of 687 patients: mean age 62.9 years (range 18 - 86), female (46.9%), Caucasians (87.3%), non-Hispanics (92.1%), and median Charlson Comorbidity Index (CCI) 3 (range 1 - 18). Rituximab-based regimens (73.7%) were the most common 3L treatments (mono 38.4%, combo 35.2%). Obinutuzumab was used as combination 3L therapy by 6 (0.87%) patients. Bendamustine, PI3K and lenalidomide monotherapies were administered to 3.1%, 2.2% and 1.9% patients, respectively (Figure 1). Rituximab-based regimens were also the most frequently used 1L, 2L, and 4L treatment options (50.8% moved to 4L and 33.6% had rituximab-based regimens). The median time to progression, PFS, and TTNT for 3L in the overall cohort were 16.6 (95% CI 14.4, 18.1), 12.5 (95% CI 11.3, 14.4), and 18 (95% CI 15.8, 19.9) months, respectively. The 1-, 2-and 5-year OS were 83.1%, 74.8% and 61.4%, respectively. The outcomes of 3L among POD24 , non-POD24, as well as patients with index date after and including year 2014 were similar to that of the overall cohort. The median time to progression, PFS, and TTNT with rituximab treatment were 19.1 (95% CI 16.7, 21.7), 15.7 (95% CI 14.2, 17.5), and 18.8 (95% CI 17, 21.7) months respectively. The median OS with rituximab therapy was not reached while the 5-year OS was 67% (Table 1). Moreover, we did not observe statistically significant differences in time to progression, OS, PFS, and TTNT for the 3L treatment between POD24 and non-POD24 patients using a Cox regression model with adjustment for baseline characteristics (age, gender, region, and CCI). The median time to progression, PFS, and TTNT among POD24 vs. non-POD24 were 15.7 vs. 17.9, 11.6 vs. 15.2, and 18 vs. 17.9 months, respectively. Conclusion: Rituximab-based regimens were the most common 3L treatment options for FL patients. Bendamustine, PI3K, and lenalidomide monotherapies were used by a smaller proportion of patients. R2 was used by a small number of patients for 3L treatment, but it is becoming an important option for FL treatment since its approval in 2019. The majority of outcomes observed could be considered poor, newer agents undergoing clinical trials could provide additional treatment choices to physicians to balance treatment effectiveness with safety and patients' quality of life. Figure 1 Figure 1. Disclosures Dai: Novartis: Current Employment, Current equity holder in publicly-traded company. Heo: Genesis Research: Current Employment, Current equity holder in publicly-traded company. Rava: Genesis Research: Current Employment, Current equity holder in publicly-traded company. Jousseaume: Novartis: Current Employment, Current equity holder in publicly-traded company. Ramos: Novartis: Current Employment, Current equity holder in publicly-traded company. Bollu: Novartis: Current Employment, Current equity holder in publicly-traded company.

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