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Health-related quality of life in cancer patients treated with immune checkpoint inhibitors: A systematic review on reporting of methods in randomized controlled trials.

ABSTRACT: OBJECTIVE:Immune checkpoint inhibitors (ICIs) have recently shown tremendous promise in the treatment of diverse cancers. The available data suggests that ICIs are well tolerated in terms of health-related quality of life (HRQOL) compared to other anticancer therapies. However, it appears that instruments currently used to evaluate HRQOL in this context may fail to capture important symptomatology unique to ICIs. This systematic review was designed to assess the adequacy of methods used to report HRQOL in cancer patients treated with ICIs and to identify the quality of life scales used. METHOD:A systematic review was performed (systematic registration number: PROSPERO: CRD42019121427). A search of the PubMed, PsycINFO, PsycARTICLES, Psychology and Behavioral Sciences collection, and SocINDEX databases was carried out for publications in English and in French. Relevant databases were searched from the earliest records through to March 2019. Publications were selected if they reported on HRQOL in patients with cancer treated by ICIs. Risk of bias was scored using the Cochrane Collaboration bias assessment tool. RESULTS:Our search identified 144 publications between 2012 and 2019, of which 15 RCTs met the inclusion criteria. The results suggest that even though the overall reporting of HRQOL was deemed to be of good quality, the data available was marred by methodological aspects such as the lack of HRQOL research hypotheses and the lack of questionnaires validated for cancer patients treated with immunotherapy. CONCLUSION:This study provides a comprehensive analysis of the current state of the art and identifies gaps in knowledge on HRQOL analysis with respect to ICIs. It also suggests avenues for further research.

SUBMITTER: Faury S

PROVIDER: S-EPMC6980610 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Health-related quality of life in cancer patients treated with immune checkpoint inhibitors: A systematic review on reporting of methods in randomized controlled trials.

Faury Stéphane S Foucaud Jérôme J

PloS one 20200124 1

<h4>Objective</h4>Immune checkpoint inhibitors (ICIs) have recently shown tremendous promise in the treatment of diverse cancers. The available data suggests that ICIs are well tolerated in terms of health-related quality of life (HRQOL) compared to other anticancer therapies. However, it appears that instruments currently used to evaluate HRQOL in this context may fail to capture important symptomatology unique to ICIs. This systematic review was designed to assess the adequacy of methods used ...[more]

PMID: 31978145

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Project description:BackgroundImmune checkpoint inhibitors (ICIs) are increasingly used to treat several types of tumors. Impact of this emerging therapy on patients' health-related quality of life (HRQoL) is usually collected in clinical trials through standard questionnaires. However, this might not fully reflect HRQoL of patients under real-world conditions. In parallel, users' narratives from social media represent a potential new source of research concerning HRQoL.ObjectiveThe aim of this study is to assess and compare coverage of ICI-treated patients' HRQoL domains and subdomains in standard questionnaires from clinical trials and in real-world setting from social media posts.MethodsA retrospective study was carried out by collecting social media posts in French language written by internet users mentioning their experiences with ICIs between January 2011 and August 2018. Automatic and manual extractions were implemented to create a corpus where domains and subdomains of HRQoL were classified. These annotations were compared with domains covered by 2 standard HRQoL questionnaires, the EORTC QLQ-C30 and the FACT-G.ResultsWe identified 150 users who described their own experience with ICI (89/150, 59.3%) or that of their relative (61/150, 40.7%), with 137 users (91.3%) reporting at least one HRQoL domain in their social media posts. A total of 8 domains and 42 subdomains of HRQoL were identified: Global health (1 subdomain; 115 patients), Symptoms (13; 76), Emotional state (10; 49), Role (7; 22), Physical activity (4; 13), Professional situation (3; 9), Cognitive state (2; 2), and Social state (2; 2). The QLQ-C30 showed a wider global coverage of social media HRQoL subdomains than the FACT-G, 45% (19/42) and 29% (12/42), respectively. For both QLQ-C30 and FACT-G questionnaires, coverage rates were particularly suboptimal for Symptoms (68/123, 55.3% and 72/123, 58.5%, respectively), Emotional state (7/49, 14% and 24/49, 49%, respectively), and Role (17/22, 77% and 15/22, 68%, respectively).ConclusionsMany patients with cancer are using social media to share their experiences with immunotherapy. Collecting and analyzing their spontaneous narratives are helpful to capture and understand their HRQoL in real-world setting. New measures of HRQoL are needed to provide more in-depth evaluation of Symptoms, Emotional state, and Role among patients with cancer treated with immunotherapy.

Project description:Introduction: Several immune checkpoint inhibitors (CPIs) are under clinical development in hepatocellular carcinoma (HCC) and the field is advancing rapidly. In this comprehensive review, we discuss published results and report on ongoing clinical trials. Methods: A literature search was carried out using PubMed and EMBASE; data reported at international meetings and clinicaltrials.gov were included as well. The search was updated 5 March 2021. We evaluated studies with monotherapy CPI's, combinations of CPI's and combinations of CPI's with other treatment modalities separately. Only studies with at least 10 included patients were considered. Results: We identified 2649 records published in the English language literature. After review, 29 studies remained, including 12 studies with preliminary data only. The obtained overall response rate of PD-1/PDL-1 monotherapy in phase II studies in the second-line setting was 15-20% with disease control in approximately 60% of patients. The responses were of long duration in a subset of patients. Furthermore, the safety profiles were manageable. However, a phase III study comparing nivolumab with sorafenib in the first-line setting and a phase III study evaluating pembrolizumab versus best supportive care in the second-line setting did not meet their prespecified endpoints. More recently, a phase I/II study of nivolumab and ipilimumab has resulted in a response rate of approximately 30% with a median OS of 22 months in the second-line setting. Multiple trials have been initiated to evaluate CPIs in combination with molecularly targeted drugs, especially anti-angiogenic drugs or local therapy. A phase III study investigating atezolizumab plus bevacizumab versus sorafenib in the first-line setting showed significantly increased survival in the combination arm. Conclusions: The combination of atezolizumab and bevacizumab represents a new standard of care in the first-line setting for fit patients with preserved liver function. CPIs can produce durable tumor remission and induce long-standing anti-tumor immunity in a subgroup of patients with advanced HCC. Although phase III trials of CPI monotherapy have been negative, the combination of PD-1/PD-L1 inhibitors with other anti-angiogenic drugs, CTLA-4 inhibitors or other modalities may result in new treatment options for patients with HCC. Research on predictive biomarkers is crucial for further development of CPIs in HCC.

Dataset Information

Health-related quality of life in cancer patients treated with immune checkpoint inhibitors: A systematic review on reporting of methods in randomized controlled trials.

Publications

Health-related quality of life in cancer patients treated with immune checkpoint inhibitors: A systematic review on reporting of methods in randomized controlled trials.

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