Functional Assessment Of Cancer Therapy-General Research Articles

Changes in Functional Assessment of Cancer Therapy: General (FACT-G) to predict treatment response and survival outcomes in patients with metastatic gastrointestinal (GI) cancer.

6570 Background: The FACT-G contains 27 questions within 4 subscale domains [Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being] related to health-related quality of life (QOL) in the past 7 days, with higher scoring indicating better QOL. In this prospective cohort study, we assessed longitudinal FACT-G data with treatment response and survival outcomes among patients with metastatic GI cancer. Methods: From 5/2019-11/2021, we enrolled patients at Massachusetts General Hospital with metastatic GI cancer to study before their treatment start. We collected the FACT-G survey at baseline (start of treatment) and 1-month later. We then used regression models to assess associations of 1-month changes in FACT-G with treatment response and survival outcomes (progression-free survival [PFS] and overall survival [OS]). For treatment response, clinical benefit was defined as decreased or stable tumor burden versus progressive disease at the time of first scan. All models were adjusted for baseline values of each respective variable. Results: We enrolled 203 of 262 patients approached (77.5% enrollment); 160 had 1-month follow-up data (median age = 63.0 years [range: 28.0-84.0 years], 66.3% male, 45.6% pancreaticobiliary cancer). For treatment response, 66.3% experienced a clinical benefit and 33.8% had progressive disease at the time of first scan (mean time to first scan = 2.7 months). Increases in FACT-G Total were predictors for treatment response (OR = 1.05, p = 0.0028), and improved PFS (HR = 0.98, p = 0.026) and OS (HR = 0.98, p = 0.038). Increases in FACT-G Emotional were associated with clinical benefit at the time of first scan (OR = 1.18, p = 0.0024), improved PFS (HR = 0.94, p = 0.023), and improved OS (HR = 0.93, p = 0.012). Improvement in FACT-G Physical were predictors for clinical benefit at time of first scan (OR = 1.08, p = 0.038) and better PFS (HR = 0.96, p = 0.038), while increases in FACT-G Functional were associated with improved PFS (HR = 0.96, p = 0.034) and OS (HR = 0.96, p = 0.019). Finally, changes in FACT-G Social were only associated with treatment response (OR = 1.16, p = 0.011). Conclusions: We found that 1-month increases in FACT-G can predict for treatment response and improved survival outcomes in patients with metastatic GI cancers. Notably, the FACT-G Total and FACT-G Emotional subscore predicted for all three outcomes of interest, while the FACT-G Social only predicted for clinical benefit at first scan. These data support previous findings indicating the possible use of early changes in patient-reported outcomes as a biomarker for early treatment response while emphasizing the growing need to integrate more patient-centric interventions into clinical care for cancer patients. Clinical trial information: NCT04776837.

Association of illness mindsets with health-related quality of life in cancer survivors.

This study aimed to examine the association between mindsets-established, but mutable beliefs that a person holds-and health-related quality of life in survivors of breast and gynecologic cancer. A cross-sectional survey study was conducted with breast and gynecologic cancer survivors. Measures included the Illness Mindset Questionnaire and Functional Assessment of Cancer Therapy-General (FACT-G). Two hundred seventy-three survivors (74% breast/26% gynecologic) who were on average 3.9 years post-diagnosis (SD = 4.2), Mage 55 (SD = 12) completed the survey (response rate 80%). Of the survivors, 20.1% (N = 55) endorsed ("agree" or "strongly agree") that Cancer is a Catastrophe, 52.4% (N = 143) endorsed that Cancer is Manageable, and 65.9% (N = 180) endorsed that Cancer can be an Opportunity (not mutually exclusive). Those who endorsed a maladaptive mindset (Cancer is a Catastrophe) reported lower health-related quality of life (HRQOL) compared with those who did not hold this belief (p < .001). Alternatively, those who endorsed more adaptive mindsets (Cancer is Manageable or Cancer can be an Opportunity) reported better HRQOL compared with those who disagreed (all p-values < .05). All three mindsets were independent correlates of HRQOL, explaining 6-15% unique variance in HRQOL, even after accounting for demographic and medical factors. Mindsets about illness are significantly associated with HRQOL in cancer survivors. Our data come from a one-time evaluation of cancer survivors at a single clinic and provide a foundation for future longitudinal studies and RCTs on the relationship between mindsets and psychosocial outcomes in cancer survivors. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Temporal evolution in quality of life following melphalan percutaneous hepatic perfusion for patients with metastatic uveal melanoma.

e21520 Background: Recent studies have demonstrated a clear survival benefit of melphalan percutaneous hepatic perfusion (M-PHP) for liver metastases from ocular melanoma (mUM). Importantly, the survival benefit relating to each treatment cycle must be carefully balanced with changes in patient Quality of Life. We contribute our single centre findings on the temporal change in the quality of life after M-PHP therapy. Methods: We performed a retrospective analysis of the change in quality of life (QoL) using the Functional Assessment of Cancer Therapy - General (FACT-G) with mUM patients receiving M‐PHP at our institutions (n = 13). The FACT-G score which comprises physical (PWB), social (SWB), emotional (EWB) and functional (FWB) wellbeing were measured pre-procedure and at day 1, day of discharge, 7, 14 and 28 days after M-PHP therapy. Paired t-test was used to assess for any significant change in each QoL domain. Results: The baseline FACT-G score was 93.4 out of 108 +/- 14.7 (mean +/- std). Quality of life scoring significantly decreased immediately after the procedure (day 1; 84.8 +/- 13.1, p = 0.01) and gradually improved over time, with no significant difference in total score by the day of discharge; 88.7 +/- 13.7, c.f baseline p = 0.22). By day 28, there was a trend for overall improved QoL (96.6 +/-9.3, p = 0.25). Sub-score analysis revealed that by day 28 there was a statistically significant improvement in EWB (p = 0.02), a trend towards improved scores in PWB and SWB domains. FWB was slightly below baseline by day 28 (23.8 vs 23.2). Conclusions: Quality of life following M-PHP decreases immediately after therapy and is not significantly different from baseline by the day of discharge. By day 28 there is a trend towards improved overall quality of life. This study could provide the basis for determining the optimal time between treatment cycles.

Health-related quality of life in patients with resectable undifferentiated pleomorphic sarcoma treated with neoadjuvant checkpoint blockade in a single institution randomized phase II clinical trial.

11544 Background: In SARC028, patients with undifferentiated pleomorphic sarcoma (UPS) had a 40% overall response rate to pembrolizumab. Based on this, we conducted a randomized, phase II, non-comparative trial of combination nivolumab (nivo/RT) and ipilimumab (ipi/nivo/RT) and demonstrated an 89% major pathologic response. Here, we report the health-related quality of life (HRQoL) metrics. Methods: In this study (NCT03307616), patients with resectable UPS were randomized (1:1) to receive one dose of nivo (3mg/kg) or one dose of combination nivo (3 mg/kg) and ipi (1 mg/kg), followed by combination of nivo (3 doses, 3mg/kg every 2 weeks) plus 50 Gy in 25 fractions (both arms). HRQoL was assessed using the MD Anderson Symptom Inventory (MDASI), European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30, and the Functional Assessment of Cancer Therapy – General (FACT-G) questionnaires. Questionnaire completion rates were calculated using the number of patients with at least one baseline and post-baseline assessment. Analyses included mean change from baseline scores to week 11 (preoperative) and week 54 (postoperative). Results: Ten patients were randomized from October 2017 to February 2020. HRQoL were collected at baseline (n = 10) and at week 11 for five (83%) nivo/RT and three (60%) ipi/nivo/RT patients. Three (60%) nivo/RT and three (100%) ipi/nivo/RT patients had week 54 assessments. MDASI scores indicative of symptom severity and interference of daily life both decreased for patients undergoing ipi/nivo/RT (0.8→0.67 and 0.9→0.46, respectively) while both increased in the nivo/RT group (1.6→2.22 and 1.9→3.33, respectively). Both arms had similar increases at 54 weeks. Patients undergoing ipi/nivo/RT experienced a greater decline in EORTC-QLC global health status at 54 weeks than those undergoing single agent therapy (-22.92 vs -8.33). The mean change in total FACT-G score did not differ between the two arms at 11 weeks (-4.0 vs -4.5), however, there was a significant decline for patients undergoing ipi/nivo/RT at 54 weeks (-20.3 vs -5.7). Conclusions: For patients with resectable UPS, combination immune checkpoint blockade with ipi/nivo/RT is associated with an improvement in short term HRQoL compared to single-agent nivo/RT. This finding warrants further study with more patients, controlling for baseline symptom scores. Combination therapy was associated with a slower recovery to baseline function, with ongoing decline in HRQoL at 54 weeks post treatment. Our study demonstrates the feasibility of collecting HRQoL metrics, which can be key factors in guiding patient management decisions. Clinical trial information: NCT03307616.

A Case Report on Opioid-Induced Constipation in a Patient with Cancer Treated by &lt;italic&gt;Jowiseunggi-tang&lt;/italic&gt;

Objective: &lt;i&gt;Jowiseunggi-tang&lt;/i&gt; (JWSGT) is a traditional herbal medicine commonly used for purgative activity in constipation. This study evaluates JWSGT for the treatment of opioid-induced constipation (OIC), the most common and debilitating gastrointestinal effect of opioid use.Methods: A 64-year-old man with floor of mouth cancer was hospitalized for OIC, and JWSGT was administered orally twice a day for 10 days, along with acupuncture, moxibustion, and cupping. The primary outcome measures were defecation type according to the Bristol Stool Form Scale (BSFS) and the frequency of bowel movements. The Brief Fatigue Inventory (BFI) and the Functional Assessment of Cancer Therapy-General (FACT-G) were used as secondary measures.Results: After three days of JWSGT administration, spontaneous bowel movements were observed two to three times per week with improved BSFS from type 2 to 4. A reduction in BFI score (8.7 to 2.0) and an increase in FACT-G score (44.3 to 59.0) suggested an improvement in fatigue level and quality of life.Conclusion: This is the first report to assess the efficacy of JWSGT for the management of OIC in patients with cancer, and JWSGT may be an effective option to improve symptoms and quality of life in this group.

Long-Term Health-Related Quality of Life of Autologous Hematopoietic Cell Transplantation Patients and Nontransplant Patients With Aggressive Lymphoma: A Prospective Cohort Analysis.

This study assessed the long-term quality of life (QOL) of patients with aggressive lymphoma subtypes treated with autologous hematopoietic cell transplant (autoHCT) compared with those without history of transplant. Patient-reported QOL measures were prospectively gathered from patients enrolled in the Iowa/Mayo Specialized Program of Research Excellence Molecular Epidemiology Resource cohort with aggressive lymphoma subtypes. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G), Functional Assessment of Chronic Illness Therapy-Fatigue Scale, State-Trait Anxiety Inventory (STAI), and Profile of Mood States instruments and with a numeric rating scale for overall QOL and spiritual QOL. The autoHCT group and no HCT groups were compared at 3 years (FU3) and 6 years (FU6) after lymphoma diagnosis. In total, 980 patients with lymphoma (106 autoHCT and 874 no HCT) diagnosed between 2002 and 2013 were included for analysis. The mean FACT-G total score was similar in the autoHCT and no HCT groups at FU3 (89.9 v 90.1, P = .64) and also at FU6 (91.5 v 89.6, P = .44). No differences between the autoHCT and no HCT groups were identified in the FACT subscales. The STAI identified lower anxiety in the autoHCT group by mean STAI1 (state) at FU3 (30.1 v 33.4, P < .01) and by mean STAI2 (trait) at FU6 (30.1 v 33.5, P = .02). No other clinically meaningful differences were identified between the two groups using the other QOL instruments. Patients remaining in remission at 3 and 6 years after diagnosis had a high level of QOL with no significant differences associated with history of treatment with autoHCT.

Effect of an anti-inflammatory dietary intervention on quality of life among breast cancer survivors.

Behavioral interventions have been used with breast cancer survivors (BCS) in cancer pain management and post-treatment quality of life (QOL) studies. We studied the effects of an anti-inflammatory dietary intervention on QOL in BCS. One hundred fifty-three overweight and obese (body mass index [BMI] ≥ 25kg/m2), early stage (0-III), English-speaking BCS who had completed all cancer treatment 2 or more months prior to enrollment were recruited into a two-arm randomized controlled trial with a 2 (group) by 3 (time) repeated measures design. Intervention components included six monthly food-preparation workshops and twelve motivational interviewing telephone calls. Endpoints included the Perceived Stress Scale (PSS), the Functional Assessment of Cancer Therapy-General (FACT-G) and Breast Cancer (FACT-B), and the Center for Epidemiologic Studies Depression Scale (CES-D). Repeated measures analysis using PROC MIXED in SAS version 9.4 was used. On repeated measures analysis (intent to treat), there were no differences between groups on any of the QOL outcomes except the PSS total scores. These were significantly different in the intervention group (IG; n = 76) compared to control group (CG; n = 77), showing a main effect of assignment but no effect of time and no interaction effects. There was an impact on QOL as measured by the PSS between groups. The intervention reduced perceived stress at 6-month follow-up, but the effects dissipated by 12months. Sources and stress and stress reduction should be a focus of future studies. Future research should also identify appropriate QOL measures that are sensitive to changes brought about by behavioral interventions.

Abstract OT2-13-01: Supervised training exercise program during chemotherapy for breast cancer (STRENGTH) trial

Abstract Background: Chemotherapy for breast cancer can have a detrimental effect on cardiorespiratory fitness. VO2max (maximal oxygen consumption measured during exercise) is a key predictor of cardiovascular risk and has been found to be lower in women with a history of breast cancer compared with healthy women. Chemotherapy is associated with a decrease in VO2max but these decreases may be attenuated with exercise training, such as resistance, aerobic and high-intensity interval training programs. Physical activity may reduce the risk of mortality for breast cancer patients, improve quality of life (QoL) and reduce weight. All gyms and fitness studios had to close due to the COVID-19 pandemic, and while some have re-opened, many patients are not comfortable returning to an exercise facility now and are incorporating virtual exercise into their routine. Prior studies have demonstrated the safety, feasibility and potential benefits of home-based exercise programs for breast cancer patients receiving chemotherapy. However, many of these programs are self-reported, which can create bias and to our knowledge, there is no existing data on the effect of home-based exercise programs for breast cancer patients receiving neoadjuvant chemotherapy. The goal of the STRENGTH Trial is to evaluate the effect of a 12-week virtual supervised exercise program in breast cancer patients receiving chemotherapy on cardiorespiratory fitness. Study Description: This is a single-center, prospective, single-arm study designed to evaluate the effect of a virtual supervised exercise training program in breast cancer patients receiving chemotherapy on cardiorespiratory fitness. All participants are assigned to a 12-week virtual supervised exercise program and asked to complete a total of 150 minutes of moderate intensity physical activity per week, as a combination of a weekly virtual personal training session and workout classes streamed from the Peloton®Digital platform (i.e. walking, running, cardio, yoga, strength training, and cycling classes). Due to the ongoing COVID-19 pandemic, cardiorespiratory fitness cannot be assessed using a cardiopulmonary exercise test. As such, the co-primary endpoints are resting blood pressure and heart rate and distance walked during a Six-Minute Walk Test (6MWT), which is measured at the start and completion of the 12-week supervised exercise program. Secondary endpoints are QoL as assessed by the Functional Assessment of Cancer Therapy - General (FACT-G) and symptom management assessment by the MD Anderson Symptom Inventory (MDASI). Several exploratory clinical endpoints will be collected including adherence to the program, type of fitness classes completed, and treatment toxicities. Eligibility Criteria: Patients aged ≥18 years with stage I to IV breast cancer who are planned to receive at least 12 weeks of chemotherapy of investigator’s choice are eligible for inclusion. Patients who have an ejection fraction on echocardiogram &amp;lt;40%, symptomatic heart failure, myocarditis, myocardial infarction, cerebrovascular accident, pulmonary embolism or COVID-19 infection within past 3 months, severe, uncorrected valvular disease, uncontrolled hypertension and/or uncontrolled arrhythmias are excluded. Statistical Methods: Continuous and categorical variables measured in this study will be summarized. The distributions of the data collected in the study participants from the 6MWT, FACT-G and MDASI will be evaluated. Based upon the findings, either paired t-tests or nonparametric Wilcoxon signed-rank tests will be performed to analyze the differences observed between the pre-exercise intervention data and the post-exercise intervention data. P values &amp;lt;= 0.05 will be considered statistically significant. . Accrual: At this time, 20 patients have enrolled out of a planned 30 participants. Citation Format: Eleonora Teplinsky, Amanda Podolski, Benita Burke, Kasey Bessada, Laura Klein, Moira Christoudias, Kariann Abbate. Supervised training exercise program during chemotherapy for breast cancer (STRENGTH) trial [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT2-13-01.

Abstract PD5-11: Pilot study to assess prolonged nightly fasting in breast cancer survivors (LONGFAST)

Abstract Background: Prior, retrospective analysis of nightly fasting among women with breast cancer suggests that fasting less than 13 hours per night may be associated with higher risk of breast cancer recurrence. Small studies suggest that fasting duration can influence inflammation, obesity, sleep, and other potential mediators of breast cancer recurrence risk. Prolonged overnight fasting is a simple, nonpharmacological behavioral intervention strategy that may be doable for most patients. We designed this pilot study to prospectively evaluate the feasibility of prolonged overnight fasting among breast cancer survivors. Methods: We designed a single-arm, pilot study to evaluate the feasibility of fasting for 13 hours overnight for a 12-week period among women with a history of early stage breast cancer (I to III) who had completed initial cancer therapy at least 6 months prior. Baseline and end of study assessments included measurements of body mass index (BMI), quality of life (QOL) (Functional Assessment of Cancer Therapy - General (FACT-G)), mood (Hospital Anxiety and Depression Scale (HADS)), fatigue (Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue), levels of physical activity (Godin Leisure-Time Exercise Questionnaire), and blood biomarkers (expanded lipid profile, hemoglobin A1c, C-reactive protein, interleukin-6, tumor necrosis factor alpha, leptin, adiponectin). Patient-reported outcome (PRO) surveys were also administered at 6 weeks. Feasibility was defined as ≥ 60% of participants documenting fasting in the food diary for 13 hours on at least 70% of nights during the study period. Changes in study measures from baseline were evaluated using Wilcoxon signed-rank tests. Results: Between July 2020 and January 2021, we enrolled 40 women with a history of breast cancer. Participants had a median age of 59.9 (range 34.9-76.3) and median time since diagnosis was 4.5 years (range 0.8-20.7). At baseline, BMI was normal (18.5-24.9) in 40.0%, overweight (25-29.9) in 37.5%, and obese (≥30) in 22.5%. Forty-two and a half percent had Stage I cancer, 42.5% stage II, and 15.0% stage III. Sixty-five percent were on hormonal therapy. Ninety-five percent of participants fasted ≥ 13 hours for at least 70% of study days (95% CI 83%-99%). At 6 weeks, there was a statistically significant improvement in anxiety (p=.0007). No other significant changes were seen in PROs. At 12 weeks, there were statistically significant improvements in BMI (p=.0072), anxiety (p=.0141), depression (p=.0048), and fatigue (p=.0105). There was no association between change in BMI during the study and baseline BMI category, age, or endocrine therapy. There was no significant change in overall QOL, physical activity levels, or blood biomarkers at 12 weeks. Conclusions: Prolonged overnight fasting is feasible in the breast cancer population and may improve BMI, mood, and fatigue without a detrimental effect on overall QOL. The data from this study support the need for a larger, longer randomized study of prolonged overnight fasting in the breast cancer population to further evaluate the effects on body composition, mood, QOL, metabolic markers, and risk of recurrence. Table 1.Impact of Prolonged Overnight Fasting among Breast Cancer SurvivorsStudy AssessmentMedian at baselineMedian at 12 weeksMedian within-participant changep-valueBody Mass Index (kg/m2)26.4225.80-0.380.0072HADS - Depression1.001.00-1.000.0048HADS - Anxiety4.504.00-0.500.0141FACIT - Fatigue47.5049.821.000.0105FACT-G - Quality of Life95.2096.840.910.4933Physical Activity Level40.5039.000.000.3340Hemoglobin A1c (mg/dL)5.455.400.000.2758High-density lipoprotein (mg/dL)72.0073.00-2.000.4688Low-density lipoprotein (mg/dL)92.0099.001.000.5626Total Cholesterol (mg/dL)193.00192.003.000.6569C-reactive protein (mg/L)1.500.90-0.100.1043Interleukin-6 (pg/mL)2.001.90-0.300.1213Tumor Necrosis Factor α (pg/mL)0.740.74-0.050.2898Adiponectin (ug/mL)12.0012.000.000.0682Leptin (ng/mL)7.158.30-0.100.8418 Citation Format: Elizabeth K. O'Donnell, Yael N. Shapiro, Amy Comander, Steven J. Isakoff, Beverly Moy, Laura Spring, Seth Wander, Irene Kuter, Jennifer Shin, Jerry Younger, Michelle Specht, Chryssanthi Kourniotis, Carol Sullivan, Loren Winters, Nora Horick, Jeffrey Peppercorn. Pilot study to assess prolonged nightly fasting in breast cancer survivors (LONGFAST) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD5-11.

Abstract PD5-10: Consequent job loss, return to work and multidimensional well-being after breast cancer treatment in working-age black and white women

Abstract Background: Few studies have assessed relationships between job loss due to breast cancer and well-being. These relationships may vary by race, work type, and functional difficulties.Methods: In the Carolina Breast Cancer Study, 1,646 women with primary breast cancer who worked prior to diagnosis were longitudinally evaluated for post-diagnosis job loss and well-being using the Functional Assessment of Cancer Therapy General (FACT-G) measure. Women were classified as having ‘sustained work’ (working at baseline and 25 months); ‘returned to work’ (not working at baseline, working at 25 months); ‘consequent job loss’ (working at baseline, not working at 25 months); or ‘persistent non-employment’ (not working at either timepoint). Analysis of covariance was used to evaluate associations between work status and well-being (physical, functional, social, emotional).Results: Women who had sustained work or returned to work had higher FACT-G scores than women with consequent job loss and persistent non-employment in all well-being domains (p&amp;lt;.05). Consequent job loss and persistent non-employment were associated with higher frequency of service/laborer job types, lower education and income, later stage at diagnosis, longer treatment duration, non-private insurance, and greater disability. Consequent job loss was more common among Black than White women (adjusted odds ratio [aOR]=3.44; 95% confidence interval [CI] 2.37-4.99). Black versus White women with job loss reported lower well-being in all domains (p&amp;lt;.05) and greater disability (mean score 42.8 vs. 29.3) and work-related difficulties (aORs=10.3, 95% CI 5.9-18.2 vs. 5.7, 95% CI 2.9-11.2).Conclusions: Work status is an indicator of multidimensional well-being after breast cancer. Citation Format: Marc A Emerson, Bryce B Reeve, Melissa B. Gilkey, Shekinah N Elmore, Cathy J Bradley, Melissa A Troester. Consequent job loss, return to work and multidimensional well-being after breast cancer treatment in working-age black and white women [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD5-10.

Validity of a single-item indicator of treatment side effect bother in a diverse sample of cancer patients

PurposeWith higher efficacy of cancer therapies, the numbers and types of side effects experienced by patients have also increased, evidencing a need for brief assessments of side effect bother. The Functional Assessment of Cancer Therapy-General (FACT-G) includes the item “I am bothered by side effects of treatment” (GP5). This study aimed to confirm GP5’s validity in a large, diverse, real-world patient sample.MethodsReal-world data were drawn from 10 Adelphi Disease Specific Programmes (DSP™) conducted between 2015 and 2019 in France, Germany, Italy, Spain, the UK and the USA, covering 10 cancer sites. We examined correlations between GP5 responses and varied measures of patient-reported global health and the number of side effects experienced. We explored whether more advanced patients and those with worse Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) reported greater side effect bother. Finally, we conducted differential item functioning (DIF) assessment using the Mantel–Haenszel approach.ResultsThe sample included 6755 advanced cancer patients. GP5 responses were distributed similarly across most cancer sites. A moderate, negative correlation (rpolyserial = − 0.43) between GP5 responses and global health evidenced convergent validity. Known groups validity was evidenced by dichotomised distributions of GP5, showing expected results between cancer stage 2 vs. 3 and 4 and with ECOG PSR (p < 0.001). Little evidence of DIF was found.ConclusionGP5 exhibited evidence of validity across cancer sites and countries and appeared to measure the same construct across these countries. GP5 has significant promise as a summary indicator of side effect bother.

Therapeutic Efficacy of Traditional Chinese Medicine Syndrome-Based Formulae to Neuropathic Pain Caused by Chemotherapy.

Objective:Chemotherapy-induced neuropathic pain (CINP) is a troublesome complication of anti-cancer treatment. The aim of this retrospective study was to investigate the effectiveness of classic Chinese herbal formulae (CHF) Huang Qi Gui Zhi Wu Wu Tang (HQGZWWT) and Dang Gui Si Ni Tang (DGSNT) in the treatment of CINP.Materials and Methods:Douleur Neuropathique 4 (DN4) and Functional Assessment of Cancer Therapy-General (FACT-G) questionnaires were rated at baseline and after 3-monthly CHF treatment.Results:By searching through our medical records of all the CIPN patients from 2018 to 2019, we identified and enrolled 37 patients with Deficiency-Cold syndrome in the study, for whom the treatment of neuropathic pain by regular pharmacotherapies had failed or intolerable. At the third month evaluation with the DN4 questionnaire, 13 patients had symptomatic remission, 15 patients remained stable, and 9 patients had no response to CHF. The 3-month mean DN4 score was significantly higher than that at the baseline (P < .001). After CHF treatment, significant differences in quality of life were noted in the physical, social, emotional, and functional well-being subscales, and in the total score, of the FACT-G (P < .001). No adverse events or instances of disease progression were observed.Conclusions:The results of our small study are the first in the literature to show the clinical effectiveness of CHF for CINP. Combination of HQGZWWT and DGSNT is well tolerated and may offer the possibility to ameliorate CINP more than conventional care can. It merits further investigation.

POSB186 Global Clinical, Economic, and Humanistic Burden of Marginal Zone Lymphoma: A Systematic Literature Review

Marginal zone lymphoma (MZL) is a rare, indolent non-Hodgkin lymphoma (NHL) with orphan disease designation. This study aimed to review the global disease burden of MZL and identify current evidence gaps. A systematic literature review was conducted using PubMed, Embase, and selected congress proceedings to identify full-text and conference abstracts between 2016 and 2021. English language studies with an abstract were extracted. Studies were screened and summarized for clinical (incidence, prevalence, mortality, and survival), economic (costs and healthcare resource utilization [HRU]), or humanistic (quality of life, utility, and symptom impact) data. A total of 48 unique studies (42 clinical, 4 economic, and 2 humanistic) were identified. MZL incidence rate was low in the 2 countries reported with a range of: 0.30 in France to 0.91 in the US (per 100,000 patient-years). Survival and mortality were reported across different MZL subtypes at different disease stages and treatment status in limited countries. 5-year overall survival ranged from 41% (splenic MZL) to 99% (extranodal MZL). Overall rituximab +/- chemotherapy was the most common treatment reported. There is no MZL-related economic burden reported in Europe. In the US, Medicare data suggests HRU increases as the line of therapy advanced. Hospitalization rates ranged from 73% to 86% throughout observed disease course. Two studies (US, Korea) reported humanistic burden of indolent NHL that included MZL. The median Functional Assessment of Cancer Therapy – General (FACT-G) for MZL patients was reported to be 83.3. There are limited data focusing specifically on MZL, with the majority reported with other NHL. Epidemiology and clinical burden data skews towards selected developed countries. The economic and humanistic burden of MZL is also vastly underreported globally. Future research is warranted to bridge the evidence gap and understand the impact of heterogenous MZL subtypes on patient outcomes.

Effect of Narrative Nursing Intervention Based on Targeted Nursing Intervention on Anxiety and Nursing Satisfaction of Patients with Malignant Tumors Undergoing Chemotherapy.

Objective To explore the effect of narrative nursing intervention based on targeted nursing intervention on anxiety and nursing satisfaction of patients with malignant tumors undergoing chemotherapy. Methods 120 malignant tumor patients treated with chemotherapy in our hospital from January 2019 to January 2020 were selected as the research objects and randomly divided into group A and group B, with 60 cases in each group. The targeted nursing intervention was performed to group B, and the targeted nursing intervention centering on narrative nursing was performed to group A, so as to compare their distress thermometer (DT) scale scores, depression and anxiety scale scores, Medical Coping Modes Questionnaire (MCMQ) scores, Functional Assessment of Cancer Therapy-General (FACT-G) scores for quality of life, and nursing satisfaction. Results After nursing intervention, group A obtained 5.00 ± 1.20 points in the DT score, which were significantly lower than group B (P < 0.05); and group A achieved significantly lower depression and anxiety scale scores (P < 0.001), better MCMQ scores (P < 0.05), and higher FACT-G scores (P < 0.05) and nursing satisfaction (P < 0.05) than group B. Conclusion The targeted nursing intervention based primarily on narrative nursing can greatly reduce negative emotions, alleviate anxiety, and improve confidence in treatment and quality of life for malignant tumor patients undergoing chemotherapy, with higher nursing satisfaction, which should be promoted and applied in the practice.

Clinical outcome and quality of life in octogenarian patients with muscle-invasive urothelial carcinoma of the bladder treated with radical cystectomy or transurethral resection of the bladder tumor: a retrospective analysis of 143 patients

PurposeTo compare clinical outcome and quality of life (QoL) in octogenarian patients with muscle-invasive urothelial carcinoma (MIBC) either treated by radical cystectomy (RC) or transurethral resection of the tumor (TURBT).MethodsWe identified octogenarian patients with MIBC in our institutions since 2005. Clinical treatment outcomes and QoL were analyzed. Uni- and multivariable Cox regression analyses, two-tailed Wilcoxon test, Mann–Whitney test and Fisher’s exact test were assessed as appropriate. QoL was evaluated using FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire.Results143 patients were identified (RC: 51 cases, TURBT: 92 cases). Mean follow-up was 14 months (0–100 months). Median overall survival (OS) was 12 months in the RC group and 7 months in the TURBT group. TURBT and low preoperative hemoglobin were independent risk factors for reduced cancer-specific survival (CSS) (TURBT: p = 0.019, Hb: p = 0.008) and OS (TURBT: p = 0.026, Hb: p = 0.013) in multivariable analyses. Baseline QoL was low throughout the whole cohort. There was no difference in baseline FACT-G scoring comparing RC and TURBT (FACT-G total score (median): RC 43.7/108 vs. TURBT 44.0/108, p = 0.7144). Increased FACT-G questionnaire scoring was assessed for RC patients (median percentage score change RC 22.9%, TURBT 2.3%, p < 0.0001).ConclusionRC and TURBT are feasible treatment options for MIBC in octogenarian patients. In our cohort, RC was associated with increased CSS, OS and QoL. QoL in general was low throughout the whole cohort. Interdisciplinary decision-making has to be improved for these critically ill patients.

Effects of yoga in men with prostate cancer on quality of life and immune response: a pilot randomized controlled trial

BackgroundDiagnosis and treatment of prostate cancer is associated with anxiety, fear, and depression in up to one-third of men. Yoga improves health-related quality of life (QoL) in patients with several types of cancer, but evidence of its efficacy in enhancing QoL is lacking in prostate cancer.MethodsIn this randomized controlled study, 29 men newly diagnosed with localized prostate cancer were randomized to yoga for 6 weeks (n = 14) or standard-of-care (n = 15) before radical prostatectomy. The primary outcome was self-reported QoL, assessed by the Expanded Prostate Index Composite (EPIC), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT–F), Functional Assessment of Cancer Therapy-General (FACT-G) at baseline, preoperatively, and 6 weeks postoperatively. Secondary outcomes were changes in immune cell status and cytokine levels with yoga.ResultsThe greatest benefit of yoga on QoL was seen in EPIC-sexual (mean difference, 8.5 points), FACIT-F (6.3 points), FACT-Functional wellbeing (8.6 points), FACT-physical wellbeing (5.5 points), and FACT-Social wellbeing (14.6 points). The yoga group showed increased numbers of circulating CD4+ and CD8+ T-cells, more production of interferon-gamma by natural killer cells, and increased Fc receptor III expression in natural killer cells. The yoga group also showed decreased numbers of regulatory T-cells, myeloid-derived suppressor cells, indicating antitumor activity, and reduction in inflammatory cytokine levels (granulocyte colony-stimulating factor [0.55 (0.05–1.05), p = 0.03], monocyte chemoattractant protein [0.22 (0.01–0.43), p = 0.04], and FMS-like tyrosine kinase-3 ligand [0.91 (−0.01, 1.82), p = 0.053].ConclusionsPerioperative yoga exercise improved QoL, promoted an immune response, and attenuated inflammation in men with prostate cancer. Yoga is feasible in this setting and has benefits that require further investigation.Trial registrationclinicaltrials.org (NCT02620033).

Health-Related Quality of Life in a Biologic Assignment Trial of Reduced Intensity Hematopoietic Cell Transplantation Based on Donor Availability in Patients Aged 50-75 with Advanced Myelodysplastic Syndrome

Health-Related Quality of Life in a Biologic Assignment Trial of Reduced Intensity Hematopoietic Cell Transplantation Based on Donor Availability in Patients Aged 50-75 with Advanced Myelodysplastic Syndrome

Utility Estimation of Rituximab Versus Bendamustine-Rituximab Induction in Indolent Non-Hodgkin Lymphomas Using Patient-Reported Quality of Life Survey Data

BackgroundRituximab induction (RI) and bendamustine-rituximab (BR) induction are both options for the frontline management of indolent non-Hodgkin lymphomas (NHLs). Although BR induces longer progression-free survival than RI, BR confers more toxicity and a longer duration of initial induction than RI. The effects of RI versus BR on health-related quality of life (HRQoL) after induction treatment, and the implications on patient utility and quality-adjusted life-years (QALYs), have not been previously studied. We conducted a cost-utility analysis of RI versus BR utilizing patient-reported HRQoL survey data.MethodsPatient-reported utility data were collected from the Hoogland Lymphoma Biobank, which enrolls patients with lymphoma at the University of Chicago and prospectively administers serial patient-level HRQoL surveys utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Lymphoma (FACT-LYM) instruments. Patients with indolent NHLs (follicular lymphoma, marginal zone lymphoma, and lymphoplasmacytic lymphoma) who were treated with frontline RI (4 doses of weekly rituximab) or BR (6 months of monthly BR) and who had completed HRQoL surveys at both of the following timepoints were included: within 6 months of treatment completion (timepoint 1) and 6-12 months after treatment completion (timepoint 2). Individual FACT-G scores were converted into EQ-5D utility index scores using a United States-based validated mapping algorithm (Teckle et al., Health Qual Life Outcomes, 2013). Cost-utility analysis was performed by trial-based methodology in which patient-level QALYs are estimated using area-under-the-curve (AUC) between timepoints 1 and 2. Incremental cost utility ratio (ICUR) was calculated utilizing cost and life years gained inputs of RI and BR from previous cost-effectiveness literature. All HRQoL scores for RI versus BR at both timepoints were compared with unpaired two-tailed t-tests.ResultsThere were 19 patients treated with RI and 13 patients treated with BR (Table 1). At timepoint 1, the BR cohort had significantly worse physical and emotional wellbeing on the FACT-G compared to the RI cohort, with emotional wellbeing significantly worse in the BR cohort at timepoint 2 (Table 2). EQ-5D utility index was stable at both timepoints for the RI cohort, and was initially lower in the BR cohort at timepoint 1 compared to RI but improved by timepoint 2 (Table 2). During the initial 12-month observation period after treatment completion, quality of life was higher for RI compared to BR (+0.02); however, when accounting for life years gained, the BR cohort had more QALYs (+1.53) (Table 3). Compared with RI, BR had an ICUR of $37,442.ConclusionsAlthough HRQoL was inferior in the BR cohort in the first year after treatment completion, particularly in the emotional wellbeing domain on FACT-G, BR induction conferred higher QALYs owing to more life years gained as compared to RI induction. Given a cost-effectiveness threshold of $100,000 in the United States (Vanness et al., Ann Intern Med, 2021), BR induction is likely to be cost effective when considering patient-reported HRQoL over the first year after treatment completion. The present analysis is limited by the small number of patients from which utility values at each timepoint were derived; however, calculation of QALYs using a database of prospectively-collected HRQoL data is feasible. Further incorporation of patient-reported outcomes into cost-utility analysis is warranted, particularly with larger datasets. [Display omitted] DisclosuresSmith: Alexion, AstraZeneca Rare Disease: Other: Study investigator; Celgene, Genetech, AbbVie: Consultancy.

Quality of Life in Patients

Quality of Life in Patients <=70 Years of Age with Chronic Lymphocytic Leukemia Treated Frontline with Ibrutinib-Rituximab Versus Fludarabine Cyclophosphamide Rituximab: Analysis from ECOG-ACRIN E1912

Quality of Life Outcomes Following Stereotactic Body Radiotherapy in Patients with Oligo-Metastatic Disease: A Systematic Review and Meta-Analysis

<h3>Purpose/Objective(s)</h3> The management of oligo-metastatic disease (OMD) is evolving, with increasing data supporting the use of stereotactic body radiotherapy. The aim of this systematic review and meta-analysis is to analyses health related quality of life (HRQOL) outcomes and the side-effects of SBRT in patients with OMD. <h3>Materials/Methods</h3> We searched MEDLINE, Epub Ahead of Print, EMBASE, Cochrane CT, Cochrane SR, Emcare, and PsycInfo databases (from inception to March 2020). Randomized clinical trials (RCTs) or observational studies were included if HRQOL outcomes were reported from patients with defined OMD (£5 metastases) who received SBRT as metastasis-directed therapy, and who completed validated HRQOL questionnaires at baseline and 12-months. Meta-analysis using weighted mean difference was performed to estimate a difference between baseline and 12-month scores. Secondary outcome, calculated by the pooled incidence rate approach using the inverse variance method, was the estimated event rate of clinically significant Common Terminology Criteria for Adverse Events (CTCAE) grade 2-4 and grade 5 toxicity, expressed per person-time of follow-up. Authors of studies included were contacted to obtain additional information. Methods adhered to PRISMA guidelines. <h3>Results</h3> Four of 7,545 studies screened were eligible for inclusion. Two studies were phase II RCTs and two were prospective single arm studies. Among 277 patients who received SBRT, median follow-up was 31 months (range 24–41 months). Two studies included only prostate cancer patients and two studies included mixed histologies. Two studies measured European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and two measured Functional Assessment of Cancer Therapy – General (FACT-G) scores. Using a fixed effects model, the mean change in 12-month EORTC QLQ-C30 global health QOL score from baseline demonstrated a statistically significant decline (pooled weighted mean difference -5.2, 95% CI -9.3 to -1.2, both prostate cancer studies, 57 patients total). Meta-analysis of total FACT-G scores in the other two studies was not possible as mean difference results for one study were unavailable. For the available multi-histology study, no statistically significant difference was seen in baseline to 12-month mean FACT-G total scores in the SBRT arm. We estimated an event rate of 0.06 (95% CI: 0.024, 0.15) CTCAE grade 2-4 toxicities per person-year and 0.008 (95% CI: 0.002, 0.031) grade 5 toxicities per person-year. <h3>Conclusion</h3> Although a statistically significant decline in the EORTC QLQ C30 global health/QOL measure was seen, it was small and unlikely to be of clinical importance. Rates of SBRT-related clinical toxicities are low. There is limited QOL data published for patients with OMD, with varying HRQOL tools used.