Functional Assessment Of Cancer Therapy-Hepatobiliary Research Articles

Role of Radiotherapy in Improving Quality of Life in Patients with Hepatocellular Carcinoma and Liver Metastasis

Background: Hepatocellular carcinoma (HCC) and liver metastases (LM) are often associated with significant symptoms such as pain and abdominal discomfort, impacting the quality of life (QoL) of affected patients. Current treatments vary in effectiveness and often leave a substantial unmet medical need in symptom management. Objective: This study aimed to assess the efficacy of external radiation therapy (ERT) in alleviating symptoms and improving the QoL in patients with HCC and LM, focusing on those presenting primarily with pain or abdominal discomfort. Methods: After institutional review board approval, patients with HCC or painful LM, not previously treated with tumor resection, radiofrequency ablation, or systemic therapy, were included. Eligible participants exhibited symptoms such as pain, nausea, and fatigue, and had a performance status of 0-2. A single fraction dose of ERT was administered, and symptom relief was evaluated using the Brief Pain Inventory (BPI) and QoL using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30). Completion rates of these questionnaires were tracked at baseline, one week, and one month post-treatment. Results: Of the 43 patients enrolled (23 HCC, 20 LM), significant improvement in the FACT-G TOI was observed in 34% of patients at one month post-ERT. When focusing on those with pain or abdominal discomfort, 59% reported clinically significant symptom relief. However, QoL improvement was noted in only about one quarter of patients, with one third experiencing worsening QoL at one month. Questionnaire completion rates were high initially but decreased over time, reflecting the challenging nature of the patient population. Conclusion: ERT demonstrated potential benefits in symptom relief, particularly for pain and abdominal discomfort in patients with HCC and LM. Nonetheless, the impact on overall QoL was mixed, highlighting the need for further research into optimizing therapeutic strategies for this patient group.

Efficacy of ginseng-based Renshenguben oral solution for cancer-related fatigue among patients with advanced-stage hepatocellular carcinoma: A prospective multicenter cohort study

BackgroundCancer-related fatigue (CRF) is a common and debilitating symptom experienced by patients with advanced-stage cancer, especially those undergoing antitumor therapy. This study aimed to evaluate the efficacy and safety of Renshenguben (RSGB) oral solution, a ginseng-based traditional Chinese medicine, in alleviating CRF in patients with advanced hepatocellular carcinoma (HCC) receiving antitumor treatment. MethodsIn this prospective, open-label, controlled, multicenter study, patients with advanced HCC at BCLC stage C and a brief fatigue inventory (BFI) score of ≥ 4 were enrolled. Participants were assigned to the RSGB group (RSGB, 10 mL twice daily) or the control group (with supportive care). Primary and secondary endpoints were the change in multidimensional fatigue inventory (MFI) score, and BFI and functional assessment of cancer therapy-hepatobiliary (FACT-Hep) scores at weeks 4 and 8 after enrollment. Adverse events (AEs) and toxicities were assessed. ResultsA total of 409 participants were enrolled, with 206 assigned to the RSGB group. At week 4, there was a trend towards improvement, but the differences were not statistically significant. At week 8, the RSGB group exhibited a significantly lower MFI score (P < 0.05) compared to the control group, indicating improved fatigue levels. Additionally, the RSGB group showed significantly greater decrease in BFI and FACT-Hep scores at week 8 (P < 0.05). Subgroup analyses among patients receiving various antitumor treatments showed similar results. Multivariate linear regression analyses revealed that the RSGB group experienced a significantly substantial decrease in MFI, BFI, and FACT-Hep scores at week 8. No serious drug-related AEs or toxicities were observed. ConclusionsRSGB oral solution effectively reduced CRF in patients with advanced HCC undergoing antitumor therapy over an eight-week period, with no discernible toxicities. These findings support the potential of RSGB oral solution as an adjunctive treatment for managing CRF in this patient population.

Relationship of Hepatocellular Carcinoma Stage and Hepatic Function to Health-Related Quality of Life: A Single Center Analysis.

Health-related quality of life (HRQoL) is known to be an important prognostic indicator and clinical endpoint for patients with hepatocellular carcinoma (HCC). However, the correlation of the Barcelona Clinic Liver Cancer (BCLC) stage with HRQoL in HCC has not been previously studied. We examined the relationship between BCLC stage, Child-Pugh (CP) score, and Eastern Cooperative Oncology Group (ECOG) performance status on HRQoL for patients who presented at a multidisciplinary liver cancer clinic. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. Fifty-one patients met our inclusion criteria. The FACT-Hep total and subscales showed no significant association with BCLC stages (p = 0.224). Patients with CP B had significantly more impairment in FACT-Hep than patients with CP A. These data indicate that in patients with HCC, impaired liver function is associated with reduced quality of life, whereas the BCLC stage poorly correlates with quality of life metrics. Impairment of quality of life is common in HCC patients and further studies are warranted to determine the impact of early supportive interventions on HRQoL and survival outcomes.

Real world impact of hepatocellular carcinoma stage and hepatic function on health-related quality of life.

e16215 Background: Health-Related Quality of Life (HRQoL) is an important prognostic indicator and clinical endpoint for patients with hepatocellular carcinoma (HCC). The relationship between cancer stage, liver function, performance status, and HRQoL in HCC in a real-world clinical setting is not well defined. Methods: A retrospective chart review was undertaken of consecutive patients with HCC treated at our institution's liver multidisciplinary clinic between February 2020 and August 2022. We examined the relationship between Barcelona Clinic Liver Cancer (BCLC) stage, Child Pugh (CP) score, and Eastern Cooperative Oncology Group (ECOG) performance status on HRQoL at diagnosis. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. Results: Fifty-one patients met our inclusion criteria. The median age was 69 and the mean FACT-Hep score was 130.3 ± 20.3. FACT-Hep total and subscales showed no significant association with BCLC stages A, B, and C (p =0.224), except in the Emotional Well Being (EWB) subscale (p =0.001). There was no impact of ECOG performance status on the FACT-Hep scores, except for the Functional Well Being (FWB) subscale (p=0.006). Patients with a CP B had significantly more impairment in FACT-Hep than patients with CP A, including FACT-Hep total score (118.5 ±27.3 versus 134.3 ±23.8; p =0.021) and subscales including the Physical Well Being (p =0.018), FWB (p =0.030), Hepatobiliary Cancer Subscale (p &lt;0.001), and FACT-Hep Trial Outcome Index score (p =0.003). Conclusions: Cancer stage poorly correlates with HRQoL at diagnosis in HCC patients. Impaired liver function reduces overall quality of life in HCC patients. Further large-scale prospective studies should be undertaken which incorporate validated HRQoL tools in the routine assessment of HCC patients. [Table: see text]

Canadian Cancer Trials Group HE.1: A phase III study of palliative radiotherapy for symptomatic hepatocellular carcinoma and liver metastases.

LBA492 Purpose: To determine if more patients (pts) with painful liver cancer have improved pain 1 month following radiation therapy (RT), compared to best supportive care (BSC). Methods: This multi-centre, phase III trial randomized pts with painful hepatocellular carcinoma (HCC) or liver metastases (LM) 1:1 to BSC alone or with single fraction RT (8 Gy). Eligible pts had end-stage disease unsuitable for local, regional or systemic therapies, &gt; 4 weeks since chemotherapy or TACE, &gt; 2 weeks since targeted therapy or immunotherapy, and no planned systemic therapy. The primary objective was to determine if the proportion of pts with improved liver cancer pain "intensity at worst" on Brief Pain Inventory (BPI) by ≥2 points from baseline to 1 month was higher following RT vs. BSC alone. Secondary endpoints included proportion of pts 1) alive at 3 months, 2) with improvement ≥2 points in BPI at 1 and 3 months, 3) with a 25% reduction in opioids at 1 month and 4) with improved quality of life (QOL): Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) hepatobiliary subscale (HBS) change score ≥5 and Trial Outcome Index ≥7 at 1 month. Results: Sixty-six pts were randomized, 43 with LM (12 colorectal, 5 breast, 4 pancreas, 3 lung, 19 other), 23 with HCC. 59% had ECOG performance status 2 or 3, 64% Child Pugh (CP) score A vs. 36% CP B or C. The clinical target volume irradiated was the whole liver or near whole liver (median 2013 cc). Forty-two pts (24 on RT and 18 on BSC) completed baseline and 1-month assessments. The average baseline pain at worst score was 7/10. A significant improvement in the primary endpoint, ‘worst’ pain score on BPI, from baseline to 1 month was seen in 67% of pts on RT and 22% on BSC (p = 0.004). The proportion of pts with improved ‘worst’ pain at 1 month, with no increase in opioid use was 21% on RT vs 0% with BSC (p = 0.07). From baseline to 1 month, the proportion of pts with a significant improvement in BPI “pain at its least” was higher for pts on RT vs. BSC (63% vs. 28%, p = 0.03), as was BPI “percentage relief in pain by treatment” (59% vs. 25%, p = 0.04). A sensitivity analysis of all pts, treating those with no 1 month assessment as having ‘no improvement’, found improvements in BPI ‘worst’ pain in 49% of pts on RT and 12% for BSC alone (p = 0.002). Eleven patients on the BSC arm crossed over to receive RT at 1 month. A trend to improvement in FACT HBS post RT vs BSC was seen at 1 month (p = 0.07), with no statistically significant difference in other FACT-Hep subscales. The proportion of pts with grade ≥2 AE (CTCAEv4.0) at day 30 was 58% on RT vs 33% on BSC (p = 0.05). Grade ≥3 AE were uncommon. There was a trend for improved 3 month survival with RT (51% vs. 33% for BSC alone, p = 0.07). Conclusions: Single fraction RT (8 Gy) improves hepatic pain in the majority of patients with end-stage HCC or liver metastases, with a trend to improved survival. This research is funded by the Canadian Cancer Society (Grant #703547). Clinical trial information: NCT02511522 .

Validation of the Thai Version of the Memorial Symptom Assessment Scaled - Short Form Among Cholangiocarcinoma Patients.

The Memorial Symptom Assessment Scale-Short Form (MSAS-SF), a standard instrument for assessing cancer patients' symptoms, has been validated in numerous languages. However, it has not been validated in Thai. The purpose of this study was to translate the MSAS-SF into Thai and determine its psychometric properties in Cholangiocarcinoma (CCA) patients. The MSAS-SF was translated into Thai, and 231 CCA patients completed the questionnaires, which included baseline characteristics, T-MSAS-SF, Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep), and the Hospital Anxiety and Depression Scale (HADS). Cronbach's alpha coefficient was used to assess reliability for internal consistency. For convergent validity, Pearson's correlation coefficient was used to calculate the relationship between the T-MSAS-SF and the T-CaSUN, HADS, and FACT-Hep subscales. Subscale and total T-MSAS-SF internal consistency reliability was moderately high, with Cronbach alpha coefficients ranging from 0.76 to 0.87. For convergent validity, the majority of T-MSAS-SF scores had moderate to low inverse correlation with FACT-Hep, HADS T-CaSUN subscales with the correlation coefficients-0.10 to -0.68 (p<0.05), reflecting that they were measuring a similar construct. Our findings showed that the T-MSAS-SF has acceptable validity and reliability to assess the psychometric properties of early to advance stage CCA patients during treatment and early post-treatment stage.

Comparison of psychological distress and quality of life in patients with advanced liver cancer before and after transformation therapy

To analyze the changes in psychological distress and quality of life of patients with advanced liver cancer after transformation therapy. This study was conducted among 60 patients with advanced liver cancer undergoing transformation therapy from July, 2019 to March, 2022. Before and after 2-10 cycles of treatment, the patients were assessed for psychological distress and quality of life using a psychological stress thermometer and the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep). The patients showed significantly lowered scores for psychological distress after transformation therapy (P < 0.01) with decreased psychological stress, emotional factors, tension, worry, sleep problems, memory decline and inattention, physical factors, pain, fatigue, eating problems and dyspepsia (P < 0.05). The total score of quality of life and the scores for physical status, social and family status, emotional status, functional status and hepatobiliary-specific items were all significantly lowered after the treatment (P < 0.05). In patients with advanced liver cancer, the psychological distress involves mainly the emotional factors and physical factors. Transformation therapy can significantly relieve psychological distress of the patients and improve their quality of life.

Physician- and patient-reported symptom concordance and association with quality of life in hepatocellular carcinoma.

Aim: To investigate the association of discordance in patient- and physician-reported symptoms on health-related quality of life (HRQoL) in hepatocellular carcinoma (HCC). Patients & methods: Data were drawn from a point-in-time survey of physicians and patients conducted in Germany, Italy and Spain (October 2018- January 2019). Physicians and their consulting patients independently reported baseline characteristics, symptoms, treatment history and satisfaction, and HRQoL derived using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. Results: Of 486 patients analysed, tiredness (73.3%, 73.7%), pain/aches (67.7%, 66.9%) and weight/appetite loss (54.3%, 53.7%) were the most common and concordant patient and physician-reported symptom domains, respectively. The symptom domains showing the largest discordance were reflux/indigestion (14.6%, 5.1%), neurological (11.9%, 5.6%), dermatological (9.3%, 6.2%) symptomsand jaundice (4.7%, 10.3%). Reduced HRQoL was observed with increasing symptom-reporting discordance. Conclusion: Further studies should investigate how symptom-reporting discordance influences patient satisfaction and HRQoL.

Long-term efficacy of percutaneous transhepatic cholangioscopy-guided photodynamic therapy for postoperative recurrent extrahepatic cholangiocarcinoma

BackgroundCholangiocarcinoma recurs frequently following excision surgery and is usually inoperable, while radiotherapy, chemotherapy, and immunotherapy are of limited benefit. As palliative care, percutaneous transhepatic cholangial drainage (PTCD) can relieve biliary obstruction, prevent jaundice, and maintain quality of life (QOL), but does not improve overall survival. In contrast, photodynamic therapy (PDT) has been demonstrated to prolong the survival of inoperable cancer patients. ObjectiveThis study evaluated the clinical efficacy of percutaneous transhepatic cholangioscopy (PTCS)-guided PDT following PTCD versus PTCD alone for recurrent inoperable cholangiocarcinoma. MethodsThe case files of 39 patients with postoperative recurrence were retrospectively analyzed, including 18 receiving PTCS-guided PDT (PTCS-PDT group) and 21 receiving PTCD only as a control (PTCD group). Survival time was compared by Kaplan-Meier analysis and log-rank test, and QOL by the Functional Assessment of Cancer Therapy–Hepatobiliary (FACT-HEP) questionnaire. Clinicodemographic factors, including serum bilirubin and adverse reaction rates, were compared by Student's t-test or Fisher's exact test. The maximum follow-up period was 71 months. ResultsMedian survival time was significantly longer in the PTCS-PDT group than the PTCD group (23 months vs. 10 months, P = 0.00001). At 6 and 12 months post-treatment, total FACT-HEP score was lower in the PTCS-PDT group (P < 0.05), indicating improved QOL. There was no significant difference in total adverse events incidence between groups (19 [51.4%] vs. 15 [71.4%]; P = 0.131). ConclusionPTCS-guided PDT can prolong survival and improve the QOL of patients with postoperative cholangiocarcinoma recurrence without increasing complications. Significant and/or new findingsCompared to PTCD alone, PTCS-guided PDT significantly prolonged the survival time of patients with postoperative recurrent extrahepatic cholangiocarcinoma. Photodynamic therapy also improved patient quality of life by facilitating timely removal of the PTCD drainage tube. PTCS-guided PDT did not increase surgery-related complications except for skin phototoxicity, which can be easy avoided and treated.

RETRACTED ARTICLE: Percutaneous Transhepatic Biliary Drainage Improves Quality of Life in Advanced Gallbladder Cancer with Obstructive Jaundice: a Holistic Assessment.

Advanced gallbladder cancers (GBC) with jaundice are mostly inoperable with poor outcomes. Palliation of jaundice by biliary drainage is the mainstay of treatment. This study aims to assess the improvement in quality of life (QOL) after PTBD in inoperable GBC with jaundice. We included 97 patients with advanced GBC and jaundice who underwent successful PTBD. Two validated hepatobiliary-specific QOL indices, namely European Organization for Research and Treatment of Cancer Quality of Life BIL21 (EORTC QLQ BIL21) and Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-HEP) version 4, were used. QOL scores were assessed at baseline and 1 and 3 months post-drainage. The changes in QOL indices between various time periods were objectively analyzed. Mean FACT-HEP overall scores improved from 69 ± 7.5 before intervention to 121 ± 11.4 at 1 month (p < 0.001) and 132.35 ± 12.0 at 3 months (p < 0.001). Physical and functional well-being domains of FACT-HEP showed maximum improvement at 1 month (p < 0.001). Mean EORTC QLQ BIL21 overall scores improved from 55.3 ± 6.8 1 at baseline to 35.0 ± 5.2 at 1 month (p < 0.001) and 28.5 ± 4.1 at 3 months (p < .001). Pain (p = 0.069) and anxiety symptoms (p = 0.09) did not show any significant change. In both scales, no significant improvements of scores were noted between 1 and 3 months. In advanced gallbladder cancer with jaundice, PTBD significantly enhances the quality of life, but this effect is short-lived, not beyond 1 month.

Quality of life after pancreatic resection for malignant and benign disease - a cross-sectional study

Introduction: To investigate QOL trajectories following pancreatic resection for malignant or benign disease. Methods: Consecutive patients of six upper gastrointestinal surgeons who underwent pancreatic resection at one of six hospitals in Sydney, Australia between Apr-2014 and Apr-2019 were invited to participate. The main outcome was self-reported QOL using the Short Form 36 (SF-36v2) expressed as mental (MCS) and physical component scores (PCS) with values ranging from 0-100 and the Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep) expressed as a total score, with values ranging from 0-180. Higher scores indicate better QOL. QOL outcomes were measured at < 12, 12-23, 24-35, 36-47 and ≥48 months post-surgery. Differences at each timepoint were compared with ANOVA and multiple pairwise comparisons were made using the Bonferroni correction. Results: Of 224 invited patients, 121 (54%) responded. Mean (SD) age was 68.0 (11.9) years and 52% (n=63) were male. Malignancy was the indication for surgery in 78% (n=94), 63% (n=74) of participants underwent pancreaticoduodenectomy and 57% (n=69) were between 12 and 35 months from surgery. No difference in the PCS and total FACT-Hep score was observed for the studied period. A significant increase on the MCS was observed from < 12 month to 12-23 months postoperatively (mean difference: 9.4; 95%CI: 1.1to17.1); No difference on MCS was noted on any other time points (Figure 1). Conclusions: MCS improved significantly from < 12 months to 12-23 months. No further significant changes were observed in MCS, PCS and total FACT-Hep scores over time compared to baseline.

Patient-Reported Quality of Life Before and After Chemoradiation for Intact Pancreas Cancer: A Prospective Registry Study

PurposeOur purpose was to determine the effect of chemoradiotherapy (CRT) on patient-reported quality of life (QOL) for patients with intact pancreas cancer. Methods and MaterialsWe reviewed a prospective QOL registry for patients with intact, clinically localized pancreatic ductal adenocarcinoma treated with CRT between June 2015 and November 2018. QOL was assessed pre-CRT (immediately before CRT, after neoadjuvant chemotherapy) and at the completion of CRT with the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) and its component parts: FACT-General (FACT-G) and hepatobiliary cancer subscore (HCS). A minimally important difference from pre-CRT was defined as ≥ 6, 5, and 8 points for FACT-G, HCS, and FACT-Hep, respectively. ResultsOf 157 patients who underwent CRT, 100 completed both pre- and post-CRT surveys and were included in the primary analysis. Median age at diagnosis was 65 years (range, 23-90). National Comprehensive Cancer Network resectability status was resectable (3%), borderline resectable (40%), or locally advanced (57%). Folinic acid, 5-fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) (75%) or gemcitabine and nab-paclitaxel (42%) were given for a median of 6 cycles (range, 0-42) before CRT. Radiation therapy techniques included 3-dimensional conformal (22%), intensity modulated photon (55%), and intensity modulated proton (23%) radiation therapy to a median dose of 50 Gy (range, 36-62.5). Concurrent chemotherapy was most commonly capecitabine (82%). Sixty-three patients (63%) had surgery after CRT. The mean decline in FACT-G, HCS subscale, and FACT-Hep from pre- to post-CRT was 3.5 (standard deviation [SD], 13.7), 1.7 (SD 7.8), and 5.2 (SD 19.4), respectively. Each of these changes were statistically significant, but did not meet the minimally important difference threshold. Pancreatic head tumor location was associated with decline in FACT-Hep. Nausea was the toxicity with the greatest increase from pre- to post-CRT by both physician-assessment and patient-reported QOL. ConclusionsFor patients with intact pancreatic adenocarcinoma, modern CRT is well tolerated with minimal decline in QOL during treatment.

A Standard Set of Value-Based Patient-Centered Outcomes for Pancreatic Carcinoma: An International Delphi Survey.

Global health systems are shifting toward value-based health care to improve patient outcomes in the face of rising health care costs. The challenge is to identify standardized outcome measurements that allow optimal quality-of-care monitoring and comparison to optimize medical practices and patient pathways. A common outcomes definition is required, including medical results (Clinical Reported Outcomes Measurements [CROMs]) and quality-of-life components that matter most to patients (Patient-Reported Outcomes Measurements [PROMs]), which are particularly important for severe pathologies with short life expectancy such as pancreatic cancer. This study aimed to create standardized metrics that could be used for outcomes analysis of pancreatic cancer care. A multidisciplinary working group (WG) was assembled. A systematic review was performed to collect the most used outcomes in clinical studies of pancreatic cancers. The study reviewed 570 studies published in the last 10years. From these studies, 3370 outcomes, including CROMs, and PROMs, were listed and prioritized. The WG reached a consensus on key outcomes, proposed groupings for CROMs and PROMs, identified existing questionnaires that could be used for PROMs collection, and set the timeline for data collection. To refine and validate the final outcomes set, an international external committee completed a Delphi process (two rounds for both CROMS and PROMs). After the systematic literature review, the WG selected 102 outcomes (92 CROMs and 10 PROMs) for submission to the international Delphi vote committee. The committee retrained 89 outcomes (78 CROMs and 11 PROMs). For the PROMs, the WG and the international external committee chose a validated questionnaire, the Functional Assessment of Cancer Therapy-Hepatobiliary, which covers all of the 11 selected PROMs. A standardized set of outcome measures that need to be validated through international health outcome comparisons and quality-of-care assessments was built. Pilot projects are underway to test and optimize the approach in real-life conditions.

1083 Health-Related Quality of Life Decreases With Disease Progression From Chronic Liver Disease to Cirrhosis and Hepatocellular Carcinoma

INTRODUCTION: Health-related quality of life (HRQOL), an important outcome for cancer patients, is reliably measured by the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep). FACT-Hep predicts disease progression, treatment response and survival in HCC patients. This study aimed to evaluate HRQOL in diverse HCC patients compared to patients with chronic liver disease (CLD) and cirrhosis. METHODS: Since 2018, we have enrolled patients with CLD, cirrhosis and HCC from the University of Miami and Jackson Memorial Hospitals into an observational longitudinal cohort. Clinical data is extracted from the electronic medical record. Participants complete various surveys, including the FACT-Hep version 4.0. Descriptive statistics were used for demographics and disease-specific characteristics. Each FACT-HEP subscale was prorated and combined, if valid. Disease subgroups were compared using Pearson’s chi-squared or Kruskal-Wallis tests. In a subset of participants who completed the Perceived Stress Scale (PSS-10), stress was correlated with HRQOL. RESULTS: From 1/2018 to 3/2019, 333 patients enrolled; 103 have CLD, 131 have cirrhosis and, 99 have HCC (91 cirrhotic HCC and 8 noncirrhotic HCC). The sample is 4% Asian, 16% Black, 34% White and 42% Hispanic. Median age of the CLD group was 54 years vs. 58 years for cirrhotics and 65 years for HCC patients, P &lt; 0.001. Table 1. The FACT-Hep was completed by 223; the prorated score was valid in 211. There were no significant differences in physical, social, or emotional well-being when comparing disease groups. In contrast, participants with cirrhosis or cirrhotic HCC had significantly worse functional well-being compared to those with CLD or noncirrhotic HCC, P 0.001. Patients with cirrhosis with or without HCC scored lowest (worst) on the hepatobiliary subscale. HRQOL was best in non-cirrhotic HCC patients, then CLD patients, then cirrhotic patients followed by cirrhotic-HCC patients, P 0.004. Table 2. The PSS-10 was administered to 38 participants who completed the FACT-Hep. There was a correlation between stress and HRQOL; as stress increased from low to moderate to high, HRQOL decreased significantly, P 0.003. Significant racial differences in HRQOL, P 0.05, disappeared when stratified by disease group. CONCLUSION: Low HRQOL in HCC patients is likely driven by cirrhosis; non-cirrhotic HCC patients had the highest HRQOL. Therefore, alleviation of cirrhosis symptoms may improve HRQOL for most HCC patients.

A Prospective Evaluation of the Reliability and Utility of Quality of Life Measures in Patients With Hepatocellular Carcinoma.

Little is known about how quality of life (QOL) can assist clinical decision-making for patients with hepatocellular carcinoma (HCC). This study aimed to investigate the reliability and validity of QOL as well as its prognostic value and utility. A prospective cohort of 300 HCC patients at various stages was recruited from 2015 to 2017 in Korea. The subjects answered the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30) and QLQ-HCC18 and the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. Prognostic nomograms including the QOL scales were developed. The prediction performance of the Barcelona Clinic Liver Cancer (BCLC) and the American Joint Committee on Cancer (AJCC) staging systems when they were incorporated with QOL was investigated. The EORTC QLQ-C30 and QLQ-HCC18 subscales showed higher reliability than FACT-Hep subscales. With regard to the validity, both questionnaires discriminated the patients by stages, treatment modalities, and performance status effectively. Multivariable analysis revealed that EORTC role functioning and EORTC appetite loss subscales were statistically associated with overall survival and disease progression. The developed nomograms accurately estimated the 1-year overall survival and disease progression-free rates. Incorporating the EORTC role functioning subscale or Hepatobiliary Cancer Subscale of FACT-Hep with the BCLC and AJCC systems improved the prognostic classification. Incorporating QOL into the AJCC system showed better predictive accuracy than incorporating performance status into it did. The findings suggest that QOL data can serve as a reliable predictive factor and assist prognostic calculation for HCC patients.

Preoperative Health-Related Quality of Life Predicts Minimal Clinically Important Difference and Survival after Surgical Resection of Hepatocellular Carcinoma.

Despite the growing use of minimal clinically important difference (MCID) as a cancer outcome measure, no study has reported clinically significant outcomes in cancer patients. We defined MCID and evaluated the use of preoperative HRQoL for predicting MCID and survival after surgical resection of hepatocellular carcinoma (HCC). In total, 369 patients completed the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) and the SF-36 at baseline and at two years post-operative at three tertiary academic hospitals. The corresponding MCID values were 3.6 (SF-36 physical component summary), 4.2 (SF-36 mental component summary), 5.4 (FACT-General total score), and 6.7 (FACT-Hep total score). The predictors of achieving postoperative MCID were significantly higher in patients who had low preoperative HRQoL score, advanced age, high education level, and high BMI (p < 0.05). However, patients with a high preoperative HRQoL score, high education level, high BMI, and low Charlson comorbidity index score were significantly associated with survival (p < 0.05). Preoperative HRQoL scores were predictive of MCID and overall survival after surgical resection of HCC. The findings of this study may be useful for managing the preoperative expectations of candidates for HCC resection and for developing shared decision-making procedures for patients undergoing surgical resection of HCC.

Impact of preoperative anxiety and depression on quality of life before and after resection of hepatocellular carcinoma.

The impact of anxiety and depression symptoms (ADS) is often estimated in terms of clinical endpoints such as the risk of complications and probabilities of readmission and survival. The purpose of this study was to provide a benchmark for capturing the negative effects of ADS on quality of life after hepatocellular carcinoma (HCC) surgery and to provide an evidence base for future research and clinical interventions aimed at understanding and remediating these effects. This prospective study analyzed 410 HCC patients at three tertiary academic hospitals. The Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Functional Assessment of Cancer Therapy- Hepatobiliary (FACT-H) were administered before HCC surgery and at 6 months, 1 year, and 2 years after HCC surgery. Generalized estimating equations were used to estimate differences-in-differences models for examining the effects of ADS. At baseline, 9.0% of the participants had anxiety symptom (BAI > 10), 17.1% had depression symptom (BDI > 13), and 7.1% had ADS. Throughout the study period, anxiety and depression (differences-in-differences value) had significant (P < 0.001) negative net effects on mean scores for all FACT-H dimensions, and the differences gradually increased over time. From baseline through all follow-up years, the two groups significantly (P < 0.001) differed in scores for all FACT-H dimensions, and the differences increased over time. For healthcare providers, this study highlights the need for continued monitoring for ADS in patients who have undergone hepatic resection and the need for timely and appropriate psychological care for these patients.

Clinical assessment of palliative radiotherapy for pancreatic cancer

PurposeTo evaluate the feasibility and response to radiotherapy for improving the symptoms and quality of life in patients with pancreatic cancer. Patients and methodsWe enrolled 31 eligible patients (20 men, 11 women) with pancreatic cancer who were receiving radiotherapy from February 2012 to February 2014. The prescribed dose was 40 to 42Gy delivered to the planning target volume in seven to ten fractions of 4 to 6Gy. Patients completed Brief Pain Inventory (BPI), Functional Assessment Of Cancer Therapy-Hepatobiliary (FACT-Hep), and European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire C30 (EORTC QLQ-C30) one week prior to radiotherapy, and one and three months after treatment. The main outcome was the evaluation of the proportion of patients with less pain and reduced clinical symptoms after one month of radiotherapy compared to before treatment according to the BPI, FACT-Hep and EORTC QLQ-C30 scales. ResultsOf 31 patients, 28 completed the questionnaires. According to BPI evaluation, symptoms were improved in 57% of patients; the FACT-General (FACT-G) and liver function subscales revealed that there was symptom improvement in 89% and 7.1% of patients, respectively. Six items in the EORTC QLQ-C30 were improved. ConclusionsFollowing treatment, pain and clinical symptoms were improved in a considerable proportion of patients with pancreatic cancer, proving that palliative radiotherapy is feasible for pancreatic cancer.

Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes

PurposePencil-beam scanning intensity modulated proton therapy (IMPT) may allow for an improvement in the therapeutic ratio compared with conventional techniques of radiation therapy delivery for pancreatic cancer. The purpose of this study was to describe the clinical implementation of IMPT for intact and clinically localized pancreatic cancer, perform a matched dosimetric comparison with volumetric modulated arc therapy (VMAT), and report acute adverse event (AE) rates and patient-reported outcomes (PROs) of health-related quality of life. Methods and materialsBetween July 2016 and March 2017, 13 patients with localized pancreatic cancer underwent concurrent capecitabine or 5-fluorouracil-based chemoradiation therapy (CRT) utilizing IMPT to a dose of 50 Gy (radiobiological effectiveness: 1.1). A VMAT plan was generated for each patient to use for dosimetric comparison. Patients were assessed prospectively for AEs and completed PRO questionnaires utilizing the Functional Assessment of Cancer Therapy-Hepatobiliary at baseline and upon completion of CRT. ResultsThere was no difference in mean target coverage between IMPT and VMAT (P > .05). IMPT offered significant reductions in dose to organs at risk, including the small bowel, duodenum, stomach, large bowel, liver, and kidneys (P < .05). All patients completed treatment without radiation therapy breaks. The median weight loss during treatment was 1.6 kg (range, 0.1-5.7 kg). No patients experienced grade ≥3 treatment-related AEs. The median Functional Assessment of Cancer Therapy-Hepatobiliary scores prior to versus at the end of CRT were 142 (range, 113-163) versus 136 (range, 107-173; P = .18). ConclusionsPencil-beam scanning IMPT was feasible and offered significant reductions in radiation exposure to multiple gastrointestinal organs at risk. IMPT was associated with no grade ≥3 gastrointestinal AEs and no change in baseline PROs, but the conclusions are limited due to the patient sample size. Further clinical studies are warranted to evaluate whether these dosimetric advantages translate into clinically meaningful benefits.

Health-Related Quality of Life before and after Surgical Resection of Hepatocellular Carcinoma: A Prospective Study

Background and Objectives:This large-scale prospective cohort study of a Taiwan population applied generalized estimating equations (GEEs) to evaluate changing trends in health-related quality of life (HRQoL) and to compare predictors of HRQoL before and after surgical resection of hepatocellular carcinoma (HCC) performed during 2011-2014.Materials and Methods:The Short Form-36 Health Survey (SF-36) and Functional Assessment of Cancer Therapy-Hepatobiliary were used in a preoperative assessment and in 3- and 6-month postoperative assessments of 332 HCC patients.Results:The HRQoL was signficantly (p<0.05) improved at 3 months after surgical resection of HCC and plateaued at 6 months after surgery. Scores for both the SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) were significantly higher at the third month after surgery (p<0.05) compared to the preoperative period. Both scores also exceeded the norms after hepatic resection of HCC. However, PCS scores were generally higher than MCS scores throughout the study period. After adjusting for time effects and baseline predictors, GEE approaches revealed the following explanatory variables for HRQoL: time of HRQoL assessment, gender, age, education, coresidence with family, chemotherapy, average length of hospital stay, and preoperative functional status.Conclusions:Hepatic resection significantly increased HRQoL in patients with HCC (p<0.05). However, an evaluation of HRQoL after hepatic resection should consider several factors other than outcomes of the surgery itself. Additionally, patients should be advised that their HRQoL improvement after surgery might depend not only on the success of surgery, but also on their preoperative functional status.