scholarly journals Molecular Profiling-Selected Therapy for Treatment of Advanced Pancreaticobiliary Cancer: A Retrospective Multicenter Study

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Ron Epelbaum ◽  
Einat Shacham-Shmueli ◽  
Baruch Klein ◽  
Abed Agbarya ◽  
Baruch Brenner ◽  
...  
Keyword(s):  
Null Hypothesis ◽  
Impact Analysis ◽  
Treatment Decision ◽  
Treatment Decisions ◽  
Molecular Profiling ◽  
Outcome Analysis ◽  
Multicenter Cohort Study ◽  
Pancreaticobiliary Cancer ◽  
The Impact ◽  
Guided Therapy

This multicenter cohort study assessed the impact of molecular profiling (MP) on advanced pancreaticobiliary cancer (PBC). The study included 30 patients treated with MP-guided therapy after failing ≥1 therapy for advanced PBC. Treatment was considered as having benefit for the patient if the ratio between the longest progression-free survival (PFS) on MP-guided therapy and the PFS on the last therapy before MP was ≥1.3. The null hypothesis was that ≤15% of patients gain such benefit. Overall, ≥1 actionable (i.e., predictive of response to specific therapies) biomarker was identified/patient. Immunohistochemistry (the most commonly used method for guiding treatment decisions) identified 1–6 (median: 4) actionable biomarkers per patient. After MP, patients received 1–4 (median: 1) regimens/patient (most commonly, FOLFIRI/XELIRI). In a decision-impact analysis, of the 27 patients for whom treatment decisions before MP were available, 74.1% experienced a treatment decision change in the first line after MP. Twenty-four patients were evaluable for clinical outcome analysis; in 37.5%, the PFS ratio was ≥1.3. In one-sided exact binomial test versus the null hypothesis,P= 0.0015; therefore, the null hypothesis was rejected. In conclusion, our analysis demonstrated the feasibility, clinical decision impact, and potential clinical benefits of MP-guided therapy in advanced PBC.

Molecular profiling (MP)-selected therapy for the treatment of patients with advanced pancreaticobiliary cancer (PBC).

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 195-195
Author(s):  
Ron Epelbaum ◽  
Einat Shacham-Shmueli ◽  
Ravit Geva ◽  
Ayala Hubert
Keyword(s):  
Retrospective Analysis ◽  
Null Hypothesis ◽  
Impact Analysis ◽  
Treatment Decision ◽  
Treatment Selection ◽  
Outcome Analysis ◽  
Sequencing Analysis ◽  
Tissue Samples ◽  
Treatment Regimens ◽  
Guided Therapy

195 Background: For patients (pts) with advanced PBC who are able to pursue additional therapy, treatment selection is often empiric and clinical benefits are usually modest. Our goal was to study clinical outcomes of MP-guided treatment in advanced PBC. Methods: This retrospective analysis included pts with advanced PBC whose tissue samples underwent MP (IHC, microarray [MA], and sequencing analyses) using Target Now (Caris Life Sciences, Irving, TX). These pts received ≥1 lines of therapy for advanced PBC before their treatment was guided by MP. The MP-guided therapy was considered to have clinical benefit if the TTP ratio between the longest TTP on MP-guided therapy and the TTP on the last therapy pre-MP was ≥1.3. Results: Out of 20 pts included in the analysis, 16 had advanced cancer of the pancreas. Median age was 59 yrs (range: 30-81), 85% were male, and 60% had PS of 1. Pts had 1-4 treatment regimens (median: 1) prior to MP. MP identified 1-7 (median: 4) actionable targets per pt. The most commonly identified targets by IHC were: negative or low TS (80%), high TOPO1 (70%), negative or low ERCC1 (52%), and high SPARC (40%). In all 14 pts that had MA results, multiple actionable targets were identified. Of 14 pts with KRAS sequencing analysis, 10 pts (71%) had mutations. Post-MP, pts had 1-4 (median: 1) treatment regimens, most commonly FOLFIRI/XELIRI, FOLFOX/XELOX, capecitabine, and nab-paclitaxel. The total number of regimens post-MP was 33, of which 29 were evaluable for decision impact analysis. In 24 (83%) of cases, treatment decision was modified due to the MP results. Out of the 20 pts, 4 received ≤1 cycle of MP-guided therapy during rapidly progressing disease and were excluded from the clinical outcome analysis. Of the 16 evaluable pts, 6 (37.5%) had a TTP ratio of ≥1.3 (one-sided exact binomial test vs a null hypothesis of ≤15% with TTP ratio ≥1.3, P=0.0056; therefore the null hypothesis is rejected). Conclusions: In our retrospective analysis of a small, yet well-defined, cohort of pts with advanced PBC, MP often influenced treatment decisions and over a third of pts experienced a longer TTP (compared to the last regimen pre-MP), highlighting the promise in MP for treatment selection.

scholarly journals INNV-11. GLIOBLASTOMA IN THE OLDER PERSON – HOW DO WE DECIDE ON TREATMENT?

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii118-ii118
Author(s):  
Cressida Lorimer ◽  
Anthony Chalmers ◽  
Margaret Johnson ◽  
Juliet Brock
Keyword(s):  
Screening Test ◽  
Older Patients ◽  
Performance Status ◽  
Treatment Options ◽  
Treatment Decision ◽  
Treatment Decisions ◽  
Clinical Factor ◽  
Cross Sectional ◽  
Multiple Treatment ◽  
The Impact

Abstract The incidence of glioblastoma (GBM) peaks in the 7th and 8th decades of life. Multiple treatment options exist for older patients with GBM however, the assessment of older patients prior to treatment decisions is poorly researched and lacks standardization. In order to address this issue we performed a cross-sectional electronic survey distributed to all full members of the Society for Neuro-Oncology. There were 116 respondents from a total of 1515 recipients (8% response rate). The survey was distributed during the peak of COVID-19 which undoubtedly affected response rates. 97% of respondents were clinicians with 86% academic. 72% had been in practice > 10 years and the majority saw 5–10 new GBM cases per month. 95% of respondents were from the USA, with involvement from Japan, Australia, Canada and Italy. 37% of respondents routinely perform a cognitive or frailty screening test. Of these, MMSE and MoCA were the most commonly used. Of those who performed a screening test, the majority reported that the results changed their treatment decision in approximately 50% of cases. 50% of respondents have access to a multidisciplinary team during their clinic, with physical therapy being the most available. When making treatment decisions, participants ranked performance status as the most important clinical factor. Considering the heterogeneity of this patient population, we argue that performance status is a crude measure of vulnerability within this cohort. In the first survey of this kind, we have shown a disparity in assessment techniques across the international neuro-oncology field and the impact performing a cognitive screen has on decision making. Older patients with GBM represent a unique clinical scenario because of the complexity of distinguishing neuro- oncology related symptoms from general frailty. There is a need for specific geriatric assessment models tailored to the older neuro-oncology population in order to facilitate treatment decisions.

Impact of CCP test on personalizing treatment decisions: Results from a prospective registry of newly diagnosed prostate cancer patients.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 63-63
Author(s):  
Neal D. Shore ◽  
Judd Boczko ◽  
Naveen Kella ◽  
Brian Joseph Moran ◽  
E. David Crawford ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Treatment Decision ◽  
Treatment Decisions ◽  
Patient Treatment ◽  
Treatment Recommendation ◽  
Interventional Treatment ◽  
Newly Diagnosed ◽  
Actual Treatment ◽  
Therapy Recommendation ◽  
The Impact

63 Background: The cell cycle progression (CCP) test is a validated molecular assay that assesses risk of prostate cancer−specific disease progression and mortality when combined with standard clinicopathologic parameters. PROCEDE−1000 is the largest prospective registry to evaluate CCP test impact on personalizing prostate cancer treatment. Results of an interim analysis are presented. Methods: Untreated patients with newly diagnosed (≤6 months), clinically localized prostate adenocarcinoma were enrolled (n=816). The physician’s initial therapy recommendation (pre−CCP) was recorded on the first questionnaire. The CCP test was then conducted on prostate biopsy tissue. Three post−CCP questionnaires recorded the physician’s revised treatment recommendation, physician/patient treatment decision, and actual treatment administered. Changes in treatments between the pre-CCP and post−CCP questionnaires demonstrated the impact of CCP testing on treatment decisions at each stage. Results: Visual analog scale measurements indicated a significant increase (p=0.0125) in the physician’s likelihood of recommending non−interventional treatment post−CCP test; there was an increase in active surveillance from the initial interventional therapy recommendation. From pre−CCP therapy recommendation, the CCP score caused a change in actual treatment administered in 44% of patients; 72% of changes were reductions in treatment. Reductions occurred in radical prostatectomy (27%), radiation therapy (44% primary; 56% adjuvant), brachytherapy (46% interstitial; 66% HDR) and hormonal therapy (33% neoadjuvant; 68% concurrent) treatments. While 35.9% of patients were recommended for conservative management pre−CCP testing, there was a 6.5% increase in non−interventional treatments during actual follow−up. Overall, there was a significant reduction in the number of treatment options at each successive evaluation (p<0.0001). Conclusions: The CCP risk assessment score has a significant impact in helping physicians and patients reach consensus on an appropriate personalized treatment decision, often with major reductions in interventional treatment burden. Clinical trial information: NCT01954004.

Molecular profiling-selected treatment in metastatic gastric and oesophageal cancer: Real-life clinical experience.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15537-e15537 ◽  
Author(s):  
Ofer Purim ◽  
Alexander Beny ◽  
Moshe J. Inbar ◽  
Baruch Brenner ◽  
Elizabeth Dudnik ◽  
...  
Keyword(s):  
Clinical Experience ◽  
Oesophageal Cancer ◽  
Null Hypothesis ◽  
Real Life ◽  
Progression Free Survival ◽  
Molecular Profiling ◽  
Considerable Proportion ◽  
Free Survival ◽  
Poorly Differentiated ◽  
Guided Therapy

e15537 Background: We evaluated real-life clinical experience with molecular profiling (MP)-guided therapy in metastatic gastric and oesophageal cancer in Israel Methods: This multicenter retrospective cohort study included patients with metastatic gastric or oesophageal cancer who were treated in the participating institutions and underwent MP (Caris Molecular Intelligence). Treatment was considered as having benefit if the ratio between the longest progression-free survival (PFS) post MP and the last PFS pre MP was ≥1.3. The null hypothesis was that ≤15% of patients gain such benefit. Results: The analysis included 46 patients (61% males; median age, 58 years; 57% with poorly-differentiated tumours). At least one actionable (i.e., predictive of response to a specific therapy) biomarker was identified per patient. Immunohistochemistry was performed on all samples and identified 1-8 (median: 3) biomarkers per patient (most commonly: low TS, high TOPO1, high TOP2A). Twenty-eight patients received therapy post MP (1-4 lines). In the 1st-line post MP, 5 patients (18%) achieved partial response and 5 (18%) stable disease; the median (range) PFS was 4.3 (0.4-38.5) months. Twenty-four patients were evaluable for PFS ratio analysis; in 7 (29.2%), the ratio was ≥1.3. In one-sided exact binomial test vs. the null hypothesis, P = 0.019; therefore, the null hypothesis was rejected. Conclusions: Our findings demonstrated that implementing MP is feasible and that MP could provide clinical benefit for a considerable proportion (~30%) of patients with metastatic gastric or oesophageal cancer.

scholarly journals U SO CARE—The Impact of Cardiac Ultrasound during Cardiopulmonary Resuscitation: A Prospective Randomized Simulator-Based Trial

2021 ◽  
Vol 10 (22) ◽  
pp. 5218
Author(s):  
Karim Zöllner ◽  
Timur Sellmann ◽  
Dietmar Wetzchewald ◽  
Heidrun Schwager ◽  
Corvin Cleff ◽  
...  
Keyword(s):  
Cardiopulmonary Resuscitation ◽  
Diagnostic Accuracy ◽  
Treatment Decision ◽  
Treatment Decisions ◽  
Point Of Care Ultrasound ◽  
Correct Treatment ◽  
Inappropriate Treatment ◽  
Hands On ◽  
Rhythm Analysis ◽  
The Impact

Background: Actual cardiopulmonary resuscitation (CPR) guidelines recommend point-of-care ultrasound (POCUS); however, data on POCUS during CPR are sparse and conflicting. This randomized trial investigated the effects of POCUS during CPR on team performance and diagnostic accuracy. Methods: Intensive Care and Emergency Medicine residents performed CPR with or without available POCUS in simulated cardiac arrests. The primary endpoint was hands-on time. Data analysis was performed using video recordings. Results: Hands-on time was 89% (87–91) in the POCUS and 92% (89–94) in the control group (difference 3, 95% CI for difference 2–4, p < 0.001). POCUS teams had delayed defibrillator attachments (33 vs. 26 sec, p = 0.017) and first rhythm analysis (74 vs. 52 sec, p = 0.001). Available POCUS was used in 71%. Of the POCUS teams, 3 stated a POCUS-derived diagnosis, with 49 being correct and 42 followed by a correct treatment decision. Four teams made a wrong diagnosis and two made an inappropriate treatment decision. Conclusions: POCUS during CPR resulted in lower hands-on times and delayed rhythm analysis. Correct POCUS diagnoses occurred in 52%, correct treatment decisions in 44%, and inappropriate treatment decisions in 2%. Training on POCUS during CPR should focus on diagnostic accuracy and maintenance of high-quality CPR.

Improving the quality of breast cancer surgical treatment decisions.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6024-6024
Author(s):  
Steven J. Katz ◽  
Jennifer J. Griggs ◽  
Nancy K. Janz ◽  
Sarah T. Hawley
Keyword(s):  
Breast Cancer ◽  
Surgical Treatment ◽  
Early Stage ◽  
Treatment Decision ◽  
Treatment Decisions ◽  
Breast Cancer Patients ◽  
Chi Square ◽  
Treatment Decision Making ◽  
Strongly Agree ◽  
The Impact

6024 Background: Ensuring breast cancer treatment decisions are high quality (i.e., informed and preference-concordant) is a key component of patient centered care. Methods: A web-based decision tool, including an interactive preference clarification exercise, was developed over a one-year period with input from health communication experts, clinicians, and women with breast cancer. Newly diagnosed early stage breast cancer patients from two cancer centers were recruited and randomized to view the tool before or after completing a survey. Mean scores for key outcome measures, including surgical treatment knowledge (4 true/false questions), decision satisfaction (12 questions each with a 5-point Likert scale from strongly agree to strongly disagree), and preference-concordant decisions, were compared between the groups using t-tests. Concordance between preferences and surgical choices was evaluated using the chi-square test. Results: 110 subjects were recruited and 105 completed the study. Their mean age was 57 years, 60% had a college degree or more, and 81% were white. Those viewing the website first had higher scores on several decision outcomes than those taking the survey first (Table). Knowledge scores were also higher among those viewing the website before the survey (3.0 vs. 2.61, p=.23). The risk of recurrence was the most important treatment attribute, followed by retaining the natural breast, in both groups. Concordance between treatment choice and computer generated treatment was 65% for website first and 61% for survey first groups. Conclusions: A tool focused on improving knowledge and preference-concordant decisions produced positive results on breast cancer surgical treatment decision making. Further work should assess the impact of the tool in larger and more diverse populations. [Table: see text]

Molecular profiling with the 92-gene assay and decision-impact on cancer treatment: Interim results from a prospective, multidisciplinary study.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 249-249
Author(s):  
Sachdev P. Thomas ◽  
Fadi S. Braiteh ◽  
Karen Ann Cherkis ◽  
Theresa N. Operana ◽  
Nichole Renee Blatner ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Metastatic Cancer ◽  
Clinical Care ◽  
Significant Proportion ◽  
Treatment Decision ◽  
Molecular Classification ◽  
Treatment Decisions ◽  
Molecular Profiling ◽  
Medical Oncologists ◽  
Gene Assay

249 Background: Metastatic lesions with unknown (CUP), unclear, or differential diagnoses pose significant challenges, particularly when presenting in the GI tract, leading to suboptimal treatment and outcomes. In clinical studies, molecular classification with the 92-gene assay demonstrated improved diagnostic accuracy compared to standard pathology techniques and improved survival in patients treated based on assay results. The current study assessed the utility of the 92-gene assay in diagnoses and treatment decision-making in clinical practice. Methods: Cases in which the 92-gene assay was ordered as part of routine clinical care were submitted into a study database via web-based, standardized, discipline-specific questionnaires. Utilization and impact of the assay were characterized for medical oncologists and pathologists. Physician-reported results from medical oncologists are included in this interim analysis of 134 cases. Results: Results from this registry-based reporting study showed that molecular profiling impacted treatment decisions in 53% of cases. Significantly, 46% of these cases reported a change in treatment regimen associated with integration of 92-gene assay results. Clinical scope included 18 tumor types with 52% having a molecular diagnosis of GI origin. The top 3 diagnoses were pancreaticobiliary, intestine, and gastroesophageal adenocarcinoma. The pre-assay working diagnosis was unknown in 41%, a differential diagnosis in 26%, and a single suspected site in 33% of cases. Conclusions: Findings from this study demonstrate that use of the 92-gene assay impacted treatment decisions and selection in a significant proportion of patients, and further define its role in clinical practice in the diagnosis and treatment planning of diagnostically-challenging metastatic cancer. [Table: see text]

scholarly journals The impact of a multidisciplinary small renal mass clinic on patient treatment decisions

2021 ◽  
Vol 16 (2) ◽  
Author(s):  
Danielle Earis ◽  
Chris Wall ◽  
Nicolette Sinclair ◽  
Trustin Domes ◽  
Kunal Jana
Keyword(s):  
Decision Making ◽  
Watchful Waiting ◽  
Irreversible Electroporation ◽  
Treatment Decision ◽  
Treatment Decisions ◽  
Patient Treatment ◽  
Control Group ◽  
Treatment Decision Making ◽  
The Impact ◽  
Historic Cohort

Introduction: Small renal masses (SRMs) are managed with active surveillance (AS), thermal ablation (TA), irreversible electroporation (IRE), or surgery, depending on patient and tumor factors. A novel SRM multidisciplinary clinic (SRMC), involving urologists and interventional radiologists, was established to provide patients with information on treatments options. The objective of this study was to evaluate the impact of the SRMC on treatment decision-making Methods: Demographics, tumor characteristics, and treatment decisions were prospectively collected on patients (n=216) attending the SRMC between 2016 and 2019. A retrospective historic cohort (n=238) seen by urologists was used as a control group. Key variables were analyzed and compared. Patient satisfaction (n=27) was surveyed and responses were summarized and explored. Results: Mean age, tumor size, and pathology was similar between groups; however, the SRMC cohort had more male patients (65.7% vs. 53.8%, p=0.009). Chosen treatment modality differed significantly between cohorts (p<0.0001). Patients in the historic cohort were treated by AS (41.5%), surgery (37.9%), TA (11.9%), watchful waiting (7.9%), and IRE (0.8%). SRMC patients were treated by TA (42.2%), AS (26.7%), surgery (21.3%), IRE (7.6%), and watchful waiting (2.2%). Post-hoc analysis revealed statistically significant differences in proportions of AS, TA, IRE, and surgery between cohorts. Patients reported high satisfaction with the collaborative approach. Conclusions: A multidisciplinary approach may have an impact on patient treatment decision-making for SRMs. Consultations involving a urologist and an interventional radiologist resulted in more TA and IRE and less AS and surgery. Future studies should evaluate if these findings occur in other centers.

Molecular profiling-guided therapy in gastroesophageal carcinoma: A single-institution experience.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15582-e15582
Author(s):  
Lionel Aurelien Kankeu Fonkoua ◽  
Jason Liao ◽  
Nelson S. Yee
Keyword(s):  
Targeted Therapy ◽  
Tyrosine Kinases ◽  
Clonal Evolution ◽  
Gastroesophageal Junction ◽  
Resistance Mechanism ◽  
Molecular Profiling ◽  
Molecular Profile ◽  
Limited Efficacy ◽  
The Impact ◽  
Guided Therapy

e15582 Background: Gastroesophageal carcinoma (GEC) including carcinoma of stomach (GC), gastroesophageal junction (GEJ), and esophagus (EC) is the 2nd leading cause of cancer death worldwide. Chemotherapy and HER2-targeted therapy (trastuzumab) have shown limited efficacy. We aim to assess the impact of molecular profile (MP)-guided therapy (MPgt) by correlating expression of select biomarkers in GEC patients (pts) with survival. Methods: 27 GEC (11 GC, 9 GEJ, 7 EC) submitted to Caris Life Sciences for molecular profiling between 2011 and 2016 were analyzed and correlated with pt survival. The impact of MPgt was assessed by calculating the ratio of progression-free survival (PFS) on MPgt to PFS on the preceding empiric therapy. MPgt was deemed beneficial if PFS ratio ≥1.3. Results: In-situ hybridization indicated amplification of HER2 (15.4%) and c-MET (7.4%). Immunohistochemistry revealed increased expression of TOPO1 (57.7%), TOP2A (38.5%), HER2 (15.4%) and c-MET (6.9%), as well as decreased expression of TS (69.2%), ERCC1 (42.3%), and PGP (15.4%). These data suggest sensitivity to topoisomerase inhibitors, anthracyclines, trastuzumab, MET-targeted therapy, fluoropyrimidine, platinums, and taxanes, respectively. Expression of these markers was heterogeneous among pts, and a trend toward improved PFS was noted in pts with low/absent ERCC1 expression on platinum-based therapy ( P= 0.06). Of the 13 pts who had sufficient data to assess the benefit of MPgt, 5 (38%) achieved a PFS ratio ≥1.3. One pt with metastatic HER2-amplified EC who had initially demonstrated clinical benefit from trastuzumab-containing chemotherapy, developed a new HER2 and c-MET co-amplified lung metastasis. Conclusions: While MPgt was beneficial in 38% of pts, tumor-associated plasticity, clonal evolution, and adaptive resistance may have limited efficacy. The emergence of HER2 and c-MET co-amplified clones is a potential resistance mechanism in HER2-amplified GEC, and highlights combined inhibition of receptor tyrosine kinases as a therapeutic strategy. Further studies with expanded data sets will be needed to test the hypothesis that actionable targets can be used independently to predict treatment response in GEC pts.

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