Impact of Clinical Trial Participation on Survival of Patients with Metastatic Non-Small Cell Lung Cancer

Merkhofer, Cristina; Eaton, Keith D.; Martins, Renato; Ramsey, Scott D.; Goulart, Bernardo H. L.

doi:10.1016/j.cllc.2021.04.003

Cited by 8 publications

(4 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In this retrospective cohort study, after balancing the baseline characteristics, we demonstrated that participating or not participating in clinical trials appeared to result in similar survival outcomes in advanced NSCLC patients. This finding was consistent with two recent studies among patients with advanced NSCLC [ 12 , 18 ]. In a multi-center retrospective study conducted in China, after adjusting the baseline characteristics, there was no statistically significant difference in the PFS and OS of patients with advanced NSCLC who were treated with PD-1/PD-L1 inhibitors, either in the real world or in clinical studies [ 18 ].…”

Section: Discussionsupporting

confidence: 94%

“…Whether participation in a clinical trial benefits survival outcomes is important information for both physicians and patients when making decisions on the enrollment. It is generally believed that participation in clinical trials may benefit the patients in a variety of ways, such as early access to novel therapies or medications, improved observations, or adjustments in the behaviors of patients or investigators as a consequence of being observed [ 12 ]. Several studies have shown that participation in clinical trials prolonged survival time in various advanced cancers such as glioblastoma, melanoma, and gastric carcinoma [ [13] , [14] , [15] ].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Comparison of survival outcomes between clinical trial participants and non-participants of patients with advanced non-small cell lung cancer: A retrospective cohort study

Jiang,

Yue,

Lei

et al. 2023

Heliyon

View full text Add to dashboard Cite

Section: Discussionsupporting

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Comparison of survival outcomes between clinical trial participants and non-participants of patients with advanced non-small cell lung cancer: A retrospective cohort study

Jiang,

Yue,

Lei

et al. 2023

Heliyon

View full text Add to dashboard Cite

“…Therefore, one should consider the impact of this extra care when evaluating the CoPPO cohort’s survival outcomes. However, trial inclusion has not impacted survival within other disease areas (Merkhofer et al 2021 ).…”

Section: Discussionmentioning

confidence: 99%

Similar genetic profile in early and late stage urothelial tract cancer

Stormoen,

Rohrberg,

Mouw

et al. 2024

J Cancer Res Clin Oncol

View full text Add to dashboard Cite

Introduction Urothelial tract cancer (UTC) ranks as the tenth most prevalent cancer and holds the seventh position in terms of mortality worldwide. Despite its prevalence and mortality ranking, there are still gaps in the knowledge of the mutational landscape in patients with advanced disease who have limited therapeutic options after multiple lines of prior treatment. This study compares the genomic and transcriptomic landscape, and targeted treatment options between metastatic UTC (mUTC) patients treated with multiple lines of therapy compared to newly diagnosed, untreated Muscle Invasive Bladder Cancer (MIBC). Methods We compared genomic and clinical data from two cohorts: mUTC patients who received multiple lines of therapy and were referred to the Copenhagen Prospective Personalized Oncology (CoPPO) project at Rigshospitalet, University of Copenhagen. Data for MIBC UTC patients were acquired from the Cancer Genome Atlas Bladder Cancer (TCGA BLCA) cohort. Biopsies in CoPPO were performed at the time of enrollment. 523 highly important cancer-related genes (TrueSight Oncology-500 targeted sequencing panel) were used from both cohorts for comparative analysis. Analyses included RNA count data to compare predicted molecular subtypes in each cohort separately. Results Patients from the CoPPO cohort had a lower median age at first-line treatment than the TCGA BLCA cohort, with no significant gender disparity. The predominant histology was urothelial cell carcinoma in both cohorts. Genomic analysis revealed no significant difference between the top mutated genes in the two cohorts, specifically looking into DNA damage repair genes. Molecular subtyping indicated a higher frequency of neuroendocrine differentiation in the CoPPO cohort. 13% of patients in the CoPPO cohort received targeted therapy based on genomic findings, and 16% received non-targeted treatment, totaling 29% receiving CoPPO treatment (9 patients). The remaining 71% received best supportive care. Kaplan-Meier analysis showed a non-significant survival benefit for the intervention group in the CoPPO cohort. Conclusion When focusing on 523 highly relevant cancer genes, the mutational profile of mUTC patients who have undergone numerous treatment lines resembles that of newly diagnosed MIBC. These alterations can be targeted, indicating the potential advantage of early genomic testing for personalized treatment within clinical trials.

show abstract

“…1 Indeed, later phase clinical trials are perceived by oncology healthcare professionals and patients to offer the best treatment available despite limited evidence to suggest that trial participation prolongs survival. 2–4 Patients who are not able to access or who progress through these later phase clinical trials may opt to participate in Phase 1 clinical trials. 5 As part of new drug development in a first-in-human setting, the objectives of Phase 1 clinical trials are primarily safety and dosing, with minimal or no therapeutic intent, especially in the early stages when the dose has not been determined.…”

Section: Introductionmentioning

confidence: 99%

Motivations and experiences of patients with advanced cancer participating in Phase 1 clinical trials: A qualitative study

et al. 2022

View full text Add to dashboard Cite

Background: Persons with advanced cancer may participate in Phase 1 clinical trials – first-in-human trials that are conducted with the main objectives of safety and dosing. The motivations for participation are not well understood and may include hope for cure. Aim: To explore the perspectives of persons with advanced cancer in order to understand the motivations for participating in Phase 1 clinical trials, experiences while being on trial and views on palliative care provision. Design: Qualitative study with a constructivist stance, using thematic analysis based upon the grounded theory approach. Setting/participants: 20 persons with advanced cancer who were participating in a Phase 1 clinical trial. Results: Many participants described how Phase 1 clinical trial participation was their last hope, as they were cognisant of their advanced disease. Information-seeking needs differed – some needed comprehensive information while others relied on the doctor’s recommendation. Participants experienced varied negative and positive physical and psycho-emotional concerns, and needed to draw on multiple sources of support such as family, friends and healthcare professionals. Some could list potential benefits of palliative care but felt they did not require it yet. The overarching theme was hope and positive thinking as a way of coping. Conclusions: The concepts of hope as a way of coping and the supportive presence of healthcare professionals could be weaved into a future model of palliative care to improve the illness journey for patients considering Phase 1 clinical trial participation and other persons with advanced cancer.

show abstract

Impact of Clinical Trial Participation on Survival of Patients with Metastatic Non-Small Cell Lung Cancer

Cited by 8 publications

References 23 publications

Comparison of survival outcomes between clinical trial participants and non-participants of patients with advanced non-small cell lung cancer: A retrospective cohort study

Comparison of survival outcomes between clinical trial participants and non-participants of patients with advanced non-small cell lung cancer: A retrospective cohort study

Similar genetic profile in early and late stage urothelial tract cancer

Motivations and experiences of patients with advanced cancer participating in Phase 1 clinical trials: A qualitative study

Contact Info

Product

Resources

About