Differences in health‐related quality of life between European and Asian patients with hepatocellular carcinoma

Chie, Wei‐Chu; Blazeby, Jane M; Hsiao, Chin‐Fu; Chiu, Herng‐Chia; Poon, Ronnie Tung Ping; Mikoshiba, Naoko; Al-Kadhim, Gillian; Heaton, Nigel; Calara, Jozer; Collins, Peter L.; Caddick, Katharine; Costantini, Anna; Vilgrain, Valérie

doi:10.1111/ajco.12464

Cited by 11 publications

(6 citation statements)

References 27 publications

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“…Also, significant changes in QoL have been observed across different cultures. 129 Defining and evaluating reliable QoL assessment tools has been established as one of the unmet needs in HCC research by international guidelines. 4 In summary, health-related QoL measures are not ready to support, as single tools, regulatory approval for drugs in HCC.…”

Section: Key Pointmentioning

confidence: 99%

Randomized trials and endpoints in advanced HCC: Role of PFS as a surrogate of survival

Llovet

Montal

Villanueva

2019

Journal of Hepatology

174

167

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Hepatocellular carcinoma (HCC) is a major cause of cancer-related mortality worldwide. Around half of patients with HCC will receive systemic therapies during their life span. The pivotal positive sorafenib trial and regulatory approval in 2007 was followed by a decade of negative studies with drugs leading to marginal antitumoral efficacy, toxicity, or trials with a lack of enrichment strategies. This trend has changed over the last 2 years with several compounds, such as lenvatinib (in first-line) and regorafenib, cabozantinib, ramucirumab and nivolumab (in second-line), showing clinical benefit. These successes came at a cost of increasing the complexity of decision-making, and ultimately, impacting the design of future clinical trials. Nowadays, life expectancy with single active agents has surpassed the threshold of 1 year and sequential strategies have provided encouraging outcomes. Overall survival (OS) remains the main endpoint in phase III investigations, but as in other solid tumours, there is a clear need to define surrogate endpoints that both reliably recapitulate survival benefits and can be assessed before additional efficacious drugs are administered. A thorough analysis of 21 phase III trials published in advanced HCC demonstrated a moderate correlation between progression-free survival (PFS) or time to progression (TTP) and OS (R = 0.84 and R = 0.83, respectively). Nonetheless, the significant differences in PFS identified in 7 phase III studies only correlated with differences in OS in 3 cases. In these cases, the hazard ratio (HR) for PFS was ≤0.6. Thus, this threshold is herein proposed as a potential surrogate endpoint of OS in advanced HCC. Conversely, PFS with an HR between 0.6-0.7, despite significance, was not associated with better survival, and thus these magnitudes are considered uncertain surrogates. In the current review, we discuss the reasons for positive or negative phase III trials in advanced HCC, and the strengths and limitations of surrogate endpoints (PFS, TTP and objective response rate [ORR]) to predict survival.

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Section: Key Pointmentioning

confidence: 99%

Randomized trials and endpoints in advanced HCC: Role of PFS as a surrogate of survival

Llovet

Montal

Villanueva

2019

Journal of Hepatology

174

167

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“…Many studies showed a marked discrepancy between reported HRQoL data in the results section and the frequency of HRQoL data assessment specified in the methods section. Eight studies reported only baseline HRQoL data although these trials specified in their methods section to have assessed HRQoL also during follow-up [ 38 , 41 , 42 , 58 , 80 , 94 , 98 , 139 ]. The other 18 studies lacked reporting of HRQoL data altogether in their results section, although assessment had been announced in the methods section (supplement 3) [ 25 , 28 , 31 , 44 , 50 , 53 , 56 , 66 , 71 , 74 , 75 , 80 , 95 , 97 , 112 , 134 , 136 , 139 ].…”

Section: Resultsmentioning

confidence: 99%

“…Finally, nine publications combined patient groups undergoing different treatment options (surgery/medical therapy/interventional treatment) for the reporting of HRQoL outcomes. In these cases, assignment of HRQoL outcomes to a specific treatment (surgery vs. medical therapy vs interventional treatment) was impossible [ 28 , 42 , 56 , 58 , 87 , 88 , 120 , 127 , 132 ]. In summary, only three studies remained for quantitative analyses (Fig.…”

Section: Resultsmentioning

confidence: 99%

Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies

et al. 2021

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Purpose Patient-reported outcomes including health-related quality of life (HRQoL) are important oncological outcome measures. The validation of HRQoL instruments for patients with hepatocellular and cholangiocellular carcinoma is lacking. Furthermore, studies comparing different treatment options in respect to HRQoL are sparse. The objective of the systematic review and meta-analysis was, therefore, to identify all available HRQoL tools regarding primary liver cancer, to assess the methodological quality of these HRQoL instruments and to compare surgical, interventional and medical treatments with regard to HRQoL. Methods A systematic literature search was conducted in MEDLINE, the Cochrane library, PsycINFO, CINAHL and EMBASE. The methodological quality of all identified HRQoL instruments was performed according to the COnsensus-based Standards for the selection of health status Measurements INstruments (COSMIN) standard. Consequently, the quality of reporting of HRQoL data was assessed. Finally, wherever possible HRQoL data were extracted and quantitative analyses were performed. Results A total of 124 studies using 29 different HRQoL instruments were identified. After the methodological assessment, only 10 instruments fulfilled the psychometric criteria and could be included in subsequent analyses. However, quality of reporting of HRQoL data was insufficient, precluding meta-analyses for 9 instruments. Conclusion Using a standardized methodological assessment, specific HRQoL instruments are recommended for use in patients with hepatocellular and cholangiocellular carcinoma. HRQoL data of patients undergoing treatment of primary liver cancers are sparse and reporting falls short of published standards. Meaningful comparison of established treatment options with regard to HRQoL was impossible indicating the need for future research.

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“…This hypothesis was driven by findings reported by previous studies that demonstrate geographic areas effect HRQoL in HCC. Specifically, Asian patients with HCC report significantly better scores in HCC18 scales (sexual interest, fatigue) than European patients [ 31 ]. It has been posited that these differences in scores stem from variability in management practices between Europe and Asia (i.e., active surveillance programs implemented in Asia) [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

Psychometric validation of the EORTC QLQ-HCC18 in patients with previously treated unresectable hepatocellular carcinoma

Serrano

Podger

Barnes³

et al. 2021

Qual Life Res

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To demonstrate the measurement properties of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18-question module (EORTC QLQ-HCC18) within a previously treated, unresectable hepatocellular carcinoma (HCC) clinical trial population that was distinct from the published QLQ-HCC18 validation population. Analyses were conducted using data from BGB-A317-208, an open label, international, clinical trial assessing efficacy and safety of the monoclonal antibody tislelizumab in adult HCC patients. The EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-HCC18 instruments were assessed at baseline and weeks 3 and 9 follow-up visits. Per US Food and Drug Administration guidance, psychometric validation of the QLQ-HCC18 included reliability (internal consistency and test–retest), construct validity (convergent and discriminant validity and known-groups validity), ability to detect change, and meaningful within-patient change (MWPC). Known-groups validity and MWPC analyses were also stratified on several pre-defined subgroups. A total of 248 patients were included. Only the QLQ-HCC18 fatigue, nutrition, and index domains demonstrated acceptable internal consistency; acceptable test–retest reliability was found for fatigue, body image, nutrition, pain, sexual interest, and index domains. The QLQ-HCC18 fatigue domain achieved the pre-specified criterion defining acceptable convergent and discriminant validity for 13 of 16 correlations, whereas the index domain achieved the pre-specified criterion for 14 of 16 correlations. Clear differentiation of the QLQ-HCC18 change scores between improvement and maintenance anchor groups were observed for body image, fatigue, pain, and index domains, whereas differentiation between deterioration and maintenance anchor groups were observed for fever and fatigue domains. MWPC point estimates defining improvement for the QLQ-HCC18 fatigue and index domains were −7.18 and −4.07, respectively; MWPC point estimates defining deterioration were 5.34 and 3.16, respectively. The EORTC QLQ-HCC18 fatigue and index domains consistently demonstrated robust psychometric properties, supporting the use of these domains as suitable patient-reported endpoints within a previously treated, unresectable HCC patient population.

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Differences in health‐related quality of life between European and Asian patients with hepatocellular carcinoma

Abstract: Both clinical characteristics and geographic areas affected the HRQoL in with hepatocellular carcinoma. Cultural differences and clinical differences in the pattern of disease due to active surveillance of Asian countries may explain the results.

Cited by 11 publications

References 27 publications

Randomized trials and endpoints in advanced HCC: Role of PFS as a surrogate of survival

Randomized trials and endpoints in advanced HCC: Role of PFS as a surrogate of survival

Health-related quality of life in primary hepatic cancer: a systematic review assessing the methodological properties of instruments and a meta-analysis comparing treatment strategies

Psychometric validation of the EORTC QLQ-HCC18 in patients with previously treated unresectable hepatocellular carcinoma

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