scholarly journals Impact of the timing of tumor assessments on median progression-free survival in clinical trials in advanced cancer patients

ESMO Open ◽  
2022 ◽  
Vol 7 (1) ◽  
pp. 100366
Author(s):  
T. Samaille ◽  
C. Moreau Bachelard ◽  
E. Coquan ◽  
P. du Rusquec ◽  
X. Paoletti ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Progression Free Survival ◽  
Advanced Cancer Patients ◽  
Free Survival ◽  
Median Progression Free Survival

scholarly journals Treatment with therapeutic anticoagulation is not associated with immunotherapy response in advanced cancer patients

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Paul Johannet ◽  
Amelia Sawyers ◽  
Nicholas Gulati ◽  
Douglas Donnelly ◽  
Samuel Kozloff ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Advanced Cancer ◽  
Immune Checkpoint ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Progression Free Survival ◽  
Immune Checkpoint Blockade ◽  
Coagulation Cascade ◽  
Advanced Cancer Patients ◽  
Clinical Endpoints

Abstract Background Recent preclinical data suggest that there may be therapeutic synergy between immune checkpoint blockade and inhibition of the coagulation cascade. Here, we investigate whether patients who received immune checkpoint inhibitors (ICI) and were on concomitant anticoagulation (AC) experienced better treatment outcomes than individuals not on AC.Affiliation: Kindly confirm if corresponding authors affiliation is identified correctly.The corresponding author's affiliation is correct. Methods We studied a cohort of 728 advanced cancer patients who received 948 lines of ICI at NYU (2010–2020). Patients were classified based on whether they did (n = 120) or did not (n = 828) receive therapeutic AC at any point during their treatment with ICI. We investigated the relationship between AC status and multiple clinical endpoints including best overall response (BOR), objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), overall survival (OS), and the incidence of bleeding complications.Affiliations: Journal instruction requires a country for affiliations; however, this is missing in affiliations 1 to 5. Please verify if the provided country is correct and amend if necessary.The country is correct for all affiliations (1 - 5). Results Treatment with AC was not associated with significantly different BOR (P = 0.80), ORR (P =0.60), DCR (P =0.77), PFS (P = 0.59), or OS (P =0.64). Patients who received AC were significantly more likely to suffer a major or clinically relevant minor bleed (P = 0.05). Conclusion AC does not appear to impact the activity or efficacy of ICI in advanced cancer patients. On the basis of our findings, we caution that there is insufficient evidence to support prospectively evaluating the combination of AC and immunotherapy.

scholarly journals Prognostic Value of CD133 and SOX2 in Advanced Cancer

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Susu Han ◽  
Tao Huang ◽  
Xing Wu ◽  
Xiyu Wang ◽  
Shanshan Liu ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Advanced Cancer ◽  
Prognostic Value ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Molecular Therapy ◽  
Chinese Patients ◽  
Advanced Cancer Patients ◽  
Free Survival ◽  
Stratified Analysis

Background. The prognostic value of CD133 and SOX2 expression in advanced cancer remains unclear. This study was first conducted to investigate the association between CD133 or SOX2 positivity and clinical outcomes for advanced cancer patients.Methods. Hazard ratios (HRs) with 95% confidence intervals (95% CIs) were calculated to evaluate the correlation between CD133 or SOX2 positivity and overall survival (OS), disease-free survival (DFS), progression-free survival (PFS), cancer-specific survival (CSS), or recurrence-free survival (RFS) from multivariable analysis. Trial sequential analysis (TSA) was also performed.Results. 13 studies with 1358 cases (CD133) and five studies with 433 cases (SOX2) were identified. CD133 positivity was correlated with worse CSS and OS, but there was no correlation between CD133 positivity and DFS. SOX2 positivity was associated with poor DFS and RFS but was not linked to PFS. Stratified analysis by study source showed that only CD133 positivity can decrease OS for Chinese patients. Stratified analysis by treatment regimens indicated that CD133 positivity was linked to poor OS in patients treated with adjuvant therapy. TSA showed that additional studies were necessary.Conclusions. CD133 and SOX2 might be associated with worse prognosis in advanced cancer. More prospective studies are strongly needed.Impact. CD133 and SOX2 may be promising targeted molecular therapy for advanced cancer patients.

Individual Meaning-Centered Psychotherapy for Advanced Cancer Patients

2017 ◽  
Author(s):  
William Breitbart ◽  
Wendy G. Lichtenthal ◽  
Allison J. Applebaum ◽  
Melissa Masterson
Keyword(s):  
Clinical Trials ◽  
End Of Life ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Therapeutic Intervention ◽  
Well Being ◽  
Existential Psychology ◽  
Advanced Cancer Patients ◽  
Spiritual Well Being ◽  
Existential Concerns

Among the advanced cancer population, existential concerns are major issues that promote significant distress. For patients who are facing death, meaning and the preservation of meaning are not only clinically and existentially important but also central concepts to a therapeutic intervention. Based on Viktor Frankl’s logotherapy and the principles of existential psychology and philosophy, “meaning-centered psychotherapy” was developed to help patients with advanced cancer sustain or enhance a sense of meaning, peace, and purpose in their lives. This chapter provides an overview of work developing and testing individual meaning-centered psychotherapy (IMCP). It provides an overview of the session content in the IMCP intervention. It also presents findings from clinical trials, which support the efficacy of IMCP as an intervention to increase a sense of meaning, spiritual well-being, and hope while decreasing end-of-life despair. Furthermore, it presents difficult scenarios that may arise when delivering IMCP for clinicians interested in this work.

scholarly journals The prognostic value of hypoxia-inducible factor-1α in advanced cancer survivors: a meta-analysis with trial sequential analysis

2019 ◽  
Vol 11 ◽  
pp. 175883591987585 ◽  
Author(s):  
Susu Han ◽  
Tao Huang ◽  
Fenggang Hou ◽  
Liting Yao ◽  
Xiyu Wang ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Sequential Analysis ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Progression Free Survival ◽  
Trial Sequential Analysis ◽  
Advanced Cancer Patients ◽  
Cancer Specific Survival ◽  
Study Region ◽  
Free Survival

Background: Expression of hypoxia-inducible factors (HIFs) has been observed, but their prognostic role in advanced cancers remains uncertain. We conducted a meta-analysis to establish the prognostic effect of HIFs and to better guide treatment planning for advanced cancers. Methods: Pooled hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated. Trial sequential analysis (TSA) was also performed. The clinical outcomes included overall survival (OS), disease-free survival (DFS), progression-free survival (PFS), cancer-specific survival (CSS), relapse/recurrence-free survival (RFS), and metastasis-free survival (MFS) in patients with advanced tumors according to multivariate analysis. Results: A total of 31 studies including 3453 cases who received chemotherapy, radiotherapy, or chemoradiotherapy were identified. Pooled analyses revealed that HIF-1α expression was correlated with worse OS (HR = 1.61, p < 0.001), DFS (HR = 1.61, p < 0.001), PFS (HR = 1.49, p = 0.01), CSS (HR = 1.65, p = 0.056), RFS (HR = 2.10, p = 0.015), or MFS (HR = 2.36, p = 0.002) in advanced cancers. HIF-1α expression was linked to shorter OS in the digestive tract, epithelial ovarian, breast, non-small cell lung, and clear cell renal cell carcinomas. Subgroup analysis by study region showed that HIF-1α expression was correlated with poor OS in Europeans and Asians, while an analysis by histologic subtypes found that HIF-1α expression was not associated with OS in squamous cell carcinoma. No relationship was found between HIF-2α expression and OS, DFS, PFS, or CSS. Conclusions: Targeting HIF-1α may be a useful therapeutic approach to improve survival for advanced cancer patients. Based on TSA, more randomized controlled trials are strongly suggested.

Placebo and nocebo effects in randomized double-blind clinical trials for fatigue in advanced cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9640-9640
Author(s):  
M. de la Cruz ◽  
D. Hui ◽  
H. A. Parsons ◽  
P. Lynn ◽  
C. Parker ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Randomized Clinical Trials ◽  
Placebo Response ◽  
Well Being ◽  
Advanced Cancer Patients ◽  
Edmonton Symptom Assessment Scale ◽  
Nocebo Effects

9640 Background: We have previously reported significant placebo response in randomized controlled treatment trials for cancer related fatigue (CRF). We conducted a retrospective study to determine the frequency and predictors of response to placebo and nocebo effect in patients with CRF. Methods: We reviewed patients that received placebo in two previous randomized clinical trials conducted by our group and determined the proportion of patients who demonstrated clinical response to fatigue using an increase (ΔFACIT-F score) > 7 from baseline to day 8, and those with nocebo response as those who reported side effects. Baseline patient characteristics and symptoms recorded from the Edmonton Symptom Assessment Scale (ESAS) were analyzed to determine their association with placebo and nocebo effects. Results: A total of 105 advanced cancer patients received placebo. 59 (56%) patients responded to placebo (median Δ FACIT-F score of 22). Worse baseline anxiety and well-being subscale score (univariate) and well-being (multivariate, MR) were significantly associated with placebo response. Common side effects reported were insomnia (79%), anorexia (53%), nausea (38%) and restlessness (34%). MR analysis showed that worse baseline (ESAS) sleep, appetite, nausea, and restless are associated with increased reporting of these side effects ( Table ). Conclusions: Nearly half of advanced cancer patients enrolled in the fatigue trials responded to placebo. Worse physical well-being score was associated with placebo response. Patients experiencing specific symptoms at baseline were more likely to report these as side effects of the medication. These findings should be considered in fatigue clinical trial design. [Table: see text] No significant financial relationships to disclose.

Development, and Evaluation of a Decision Aid to Support Patients’ Participa-tory Decision-making on Tumor-specific and Palliative Therapy in Advanced Cancer Patients: A Study Protocol. (Preprint)

2020 ◽  
Author(s):  
Katsiaryna Laryionava ◽  
Jan Schildmann ◽  
Michael Wensing ◽  
Ullrich Wedding ◽  
Bastian Surmann ◽  
...  
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Health Care Providers ◽  
Study Protocol ◽  
Care Providers ◽  
Advanced Cancer Patients ◽  
Design Study

BACKGROUND To support advanced cancer patients, for whom standard therapy is no longer avail-able, and their oncologists in therapy decisions, we aim to develop a decision-making aid (DA) in a multi-phased bicentric study. The DA aims to help patients to better un-derstand risks and benefits of available treatment options including the options of standard palliative care, off-label drug use within an individual treatment plan and involvement in clinical trials. OBJECTIVE This study protocol outlines the development and testing of a DA in a pre-post design study targeting at a heterogeneous population of advanced cancer patients. METHODS In phase I, The DA will be developed after of decisional needs of patients and views of health care providers based on face-to face interviews and focus groups discus-sions. Subsequently, the DA will be alpha-tested and redrafted, as necessary, in phase II. In phase III, the DA will be (1) beta-tested with patients and oncologists and (2) assessed by experts. In the last project phase, we will run a pre-post design study with n= 70 doctor-patient-encounters to access improvements on primary study outcome, i.e. patients’ level of decisional conflict. In addition, the user ac-ceptance will be tested. RESULTS Interviews with cancer patients, oncologists and health care providers have been completed. CONCLUSIONS A unique feature of this study is the development of a DA for patients with different types of advanced cancer, which covers a wide range of topics relevant for patients near the end of life such as forgoing cancer-specific therapy and patients’ inclusion in clinical trials. CLINICALTRIAL NCT04606238 https://clinicaltrials.gov/ct2/show/NCT04606238

Phase II clinical trial of mutant Ras peptide vaccine in combination with GM-CSF and IL-2 in advanced cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 3067-3067 ◽  
Author(s):  
M. S. Achtar ◽  
A. Toubaji ◽  
V. Herrin ◽  
B. Gause ◽  
M. Hamilton ◽  
...  
Keyword(s):  
Immune Responses ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Phase Ii ◽  
Peptide Vaccine ◽  
Progression Free Survival ◽  
Advanced Cancer Patients ◽  
Gm Csf ◽  
Therapeutic Modalities ◽  
Novel Proteins

3067 Background: Mutant ras oncogenes produce novel proteins that are processed and displayed through HLA molecules on tumor cells. Therefore, mutant ras is an attractive target for vaccine therapy. We have shown in a previous phase I trial that vaccination with mutant ras peptides produced specific immune responses (IR). Here we tested in a phase II trial the use of specific mutant ras peptides in combination with GM-CSF and IL-2 in advanced cancer patients carrying the ras mutation in their tumors. Methods: We treated 17 patients with advanced cancers (14 CRC, 1 NSCLC and 2 pancreatic) with 5000μg of the corresponding mutant ras peptide given SQ along with GM-CSF and IL-2. GM-CSF was given SQ on days -1,0,1,2 followed by ten days of low dose SQ IL-2. Vaccines were repeated every 5 weeks for a maximum of 15 cycles or until disease progression. Results: 11 patients who received 3 or more vaccinations were tested for immune response by measuring IFN-γ mRNA copies in PBMCs pre and post vaccination. 6/11 patients generated specific IR to the corresponding mutant ras vaccine. The median overall survival and the median progression-free survival for all patients were 25.8 and 13.1 months respectively. However, in the 6 patients with positive IR, it was 39.9 and 17.9 months compared to 18.5 and 15.6 months in the 5 patients who showed no IR. No grade IV toxicity occurred. Most adverse events were Grade I-II toxicities and resolved spontaneously. Grade III toxicities led to IL-2 dose reduction in 3/17 patients (18%). Conclusions: The study showed that vaccination of advanced cancer patients with mutant ras peptides in combination with GM-CSF and IL-2 is safe and can induce specific immune responses. Furthermore, those patients who generated IR showed better clinical outcome, as reflected by PFS and OS. So we believe that this vaccine may form a potentially promising approach in combination with other therapeutic modalities in advanced solid tumors. No significant financial relationships to disclose.

Incidence of thromboembolism in patients receiving vorinostat: Clinical trial and post-marketing data from more than 1,800 patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e14547-e14547
Author(s):  
S. Rizvi ◽  
J. Lis ◽  
K. Boileau ◽  
J. Garcia-Vargas
Keyword(s):  
Clinical Trials ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Advanced Cancer Patients ◽  
Serious Adverse Events ◽  
Cutaneous Manifestations ◽  
Post Marketing Surveillance ◽  
The Usa ◽  
Post Marketing ◽  
Marketing Data

e14547 Background: Thromboembolic events (TEEs) occur in approximately 10–15% of advanced cancer patients. Risk factors include cancer therapy and extent and type of malignancy. Vorinostat, a histone deacetylase inhibitor, has been licensed in the USA for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease on or following two systemic therapies. TEEs were observed in 6/86 patients (7.0%) enrolled in vorinostat CTCL clinical trials at licensure. To gain further insight into the association between TEEs and vorinostat treatment, we analyzed data from vorinostat clinical trials and post-marketing surveillance (PMS) reports. Methods: Serious adverse events (SAEs) reported through November 3, 2008, among patients receiving vorinostat in completed and ongoing clinical trials, PMS reports, and published literature were reviewed for terms consistent with TEEs. A committee of independent (non-Merck employees) academic experts evaluated these reports. Although no safety signals were observed, the committee recommended that d-dimer and/or plasmin-antiplasmin assays should be conducted. This recommendation has been implemented in three ongoing studies ( NCT00486720 , NCT00632931 , NCT006429542) and will provide further information on clotting parameters among patients being treated with vorinostat. Results: During the reporting period, data from >1,845 cancer patients who received vorinostat were reviewed. Irrespective of causality, 107 patients (<5.8%) reported TEE SAEs (Table). Of these, 47 (<2.6%) had TEE SAEs that were rated as related to vorinostat, four of which were fatal. As of the data cut off, review of the special assays in the three studies did not result in any conclusive correlation. Conclusions: The incidence rate of TEEs observed in vorinostat studies is similar to reported rates of TEEs for advanced cancer patients. [Table: see text] [Table: see text]

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