QLQ-C30 Scores Research Articles

Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types

IntroductionEarly guidelines for minimally important differences (MIDs) for the EORTC QLQ-C30 proposed ≥10 points change as clinically meaningful for all scales. Increasing evidence that MIDs can vary by scale, direction of change, cancer type and estimation method has raised doubt about a single global standard. This paper identifies MID patterns for interpreting group-level change in EORTC QLQ-C30 scores across nine cancer types. MethodsData were obtained from 21 published EORTC Phase III trials that enroled 13,015 patients across nine cancer types (brain, colorectal, advanced breast, head/neck, lung, mesothelioma, melanoma, ovarian, and prostate). Anchor-based MIDs for within-group change and between-group differences in change over time were obtained via mean change method and linear regression, respectively. Separate MIDs were estimated for improvements and deteriorations. Distribution-based estimates were derived and compared with anchor-based MIDs. ResultsAnchor-based MIDs mostly ranged from 5 to 10 points. Differences in MIDs for improvement vs deterioration, for both within-group and between-group, were mostly within a 2-points range. Larger differences between within-group and between-group MIDs were observed for several scales in ovarian, lung and head/neck cancer. Most anchor-based MIDs ranged between 0.3 SD and 0.5 SD distribution-based estimates. ConclusionsOur results reinforce recent claims that no single MID can be applied to all EORTC QLQ-C30 scales and disease settings. MIDs varied by scale, improvement/deterioration, within/between comparisons and by cancer type. Researchers applying commonly used rules of thumb must be aware of the risk of dismissing changes that are clinically meaningful or underpowering analyses when smaller MIDs apply.

The role of integrated psychological support in breast cancer patients: a randomized monocentric prospective study evaluating the Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) program

PurposeThis study examined the effects of Fil-Rouge Integrated Psycho-Oncological Support (FRIPOS) in a group of women with breast cancer compared with a group receiving treatment as usual (TAU).MethodsThe research design was a randomized, monocentric, prospective study with three time points of data collection: after the preoperative phase (T0), in the initial phase of treatments (T1), and 3 months after the start of treatments (T2). The FRIPOS group (N = 103) and the TAU group (N = 79) completed a sociodemographic questionnaire, the Symptom Checklist-90-R (SCL-90-R) at T0; the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and EORTC QLQ-BR23 at T1; and SCL-90-R, EORTC QLQ-C30, and EORTC QLQ-BR23 at T2.ResultsA series of independent and paired t tests showed that patients in the FRIPOS group performed better on all scales related to symptomatic manifestations and on some quality of life scales (fatigue, dyspnea, and sleep disturbances) at T2. In addition, a series of ten multiple regressions were performed to predict each SCL subscale at T2 from the SCL score at T0 and the EORTC QLQ-C30 scores at T2. In nine of ten regression models (all except somatization), both FRIPOS group membership and QoL subscale contributed significantly to prediction.ConclusionsThis study suggests that patients in the FRIPOS group have more benefits in emotional, psychological, and collateral symptoms than patients in the TAU group and that these improvements are due to integrated psycho-oncology care.

Functional decline and resilience in older adults over the age of 70 receiving radiotherapy for breast cancer: A pilot study

IntroductionRadiotherapy (RT) as an adjuvant, post-lumpectomy treatment has been shown to improve local control and survival in people with breast cancer. While adverse events because of cancer treatments are common, many older adults have demonstrated the ability to return to their baseline levels of physical functioning. There are limited reports on the functional decline and recovery of older patients undergoing RT. The primary objective of this study was to investigate physical function at various time points during RT in people with breast cancer over age 70 and their ability to recover post-decline. Materials and MethodsSeventy-nine patients with breast cancer aged 70+ undergoing adjuvant RT at Sunnybrook Health Science Centre, Toronto, Ontario, Canada were enrolled for a prospective observational study. Participants completed the EORTC QLQ-C30 quality of life questionnaire before their first RT, after their final RT, and at three- and six-months post-RT to assess changes in physical function. Descriptive statistics were utilized to evaluate EORTC QLQ-C30 scores. A higher score was indicative of poorer physical function. Physical decline was a 10+ point increase in EORTC QLQ-C30 score from baseline to the last RT, and resilience was a return to <10 points from the baseline score within six months post-RT. Resistance was a post-RT change from the baseline score by fewer than 10 points. ResultsNine patients (11%) experienced physical decline following their last RT, and two of them (22%) displayed resilience within six months. There were no demographic or symptom variables associated with functional decline from the baseline to post-RT, nor with resilience. Nausea, pain, and diarrhea post-RT were associated with functional decline at six months post-RT (P = 0.0185, P = 0.0449, P = 0.0007, respectively). Nausea and diarrhea at baseline were associated with resistance to decline (P = 0.0055, P = 0.019, respectively), and with decline at the six-month follow-up (P ≤0.0001, P = 0.0235, respectively). DiscussionThis study highlights the incidence of physical decline in patients over age 70 receiving RT for breast cancer and identifies risk factors for decline. Future research with a larger sample, longer follow-up period, and incorporating geriatric assessments pre-RT is warranted to better understand functional decline and resilience in this population.

Effect of Postoperative Adjuvant Radiotherapy on Quality of Life, Anxiety, and Depression in Adult Female Breast Cancer Patients.

This study aims to identify anxiety and depression caused by adjuvant radiotherapy in breast cancer cases to determine the deterioration in the quality of life and investigate the effect of early treatment. In this study, the Beck Depression Inventory, Beck Anxiety Inventory, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) Turkish 3.0 forms were evaluated in 63 breast cancer patients before the start of radiotherapy treatment (T1) and at six weeks after the end of radiotherapy treatment (T2). A high level of anxiety was detected in 77.8% of patients, and depression was found in 25.4% of patients in T1. When depressive cases were evaluated with EORTC QLQ-C30 scores, the general health status (p = 0.043), role function (p = 0.027), emotional (p < 0.002), cognitive (p < 0.001), and social (p < 0.0001) scales were statistically lower in T1, whereas pain (p = 0.045) and insomnia (p < 0.0001) symptoms were higher in T1. Anxiety and EORTC QLQ-C30 scores in terms of emotional function (p = 0.015), social function (p < 0.003), and symptoms of insomnia (p = 0.027) were found to be statistically higher in T1 anxious cases. However, anxiety was detected in only 3% of T2 cases, and no depression was found in any of the cases. Anxiety and EORTC QLQ-C30 scores and symptom scales were evaluated in terms of role function (p < 0.0001), emotional (p = 0.041) and social scales (p = 0.014), fatigue (p = 0.028), pain (p = 0.033), insomnia (p = 0.011), and constipation (p < 0.0001); these were found to be statistically significant in T2. This study revealed that early diagnosis and treatment of anxiety before initiating adjuvant radiotherapy reduces the development of long-term anxiety-related depression in the future. Therefore, it is recommended that patients be evaluated for anxiety and depression before starting adjuvant radiotherapy.

Abstract P1-10-18: Impact of Adjuvant Chemoradiation on cardiopulmonary function and Quality of Life in Breast Cancer

Abstract Aims and Objectives – To evaluate the safety of adjuvant chemo-radiation (CTRT) for breast cancer. We report the cardio-pulmonary safety and quality of life outcome of this regimen. Methods – Stage II-III invasive breast cancer patients planned for adjuvant taxane-based chemotherapy and adjuvant radiotherapy (RT) between April 2019 to December 2020 were eligible irrespective of prior neo-adjuvant therapy. Patients received standard 3D conformal radiotherapy (40 Gy in 15 fractions over 3 weeks ± boost for breast conservation) along with the third cycle of adjuvant taxanes in a 3- weekly schedule or the eighth cycle in a weekly schedule. Troponin T, echo cardiography and pulmonary function test were done pre-RT and repeated at 6 months from RT conclusion while quality of life was evaluated pre-RT, at RT conclusion and after 6 months using EORTC QLQ C30 and BR23. Results – Sixty patients were analysed. The median ejection fraction pre and post CTRT was 60% (p=0.177). The median value of Troponin T at baseline was 37 which decreased to 20 post CTRT (p=0.009). Of the 54 patients who underwent the PFT, the functional vital capacity (FCV) was 2.29 litres at baseline which was 2.2 litres post CTRT (p=0.375). No significant difference was seen for forced expiratory volume (FEV) at 1 second (1.86 vs. 1.82: p=0.365), FEV1/FVC (81.5 vs. 81.43; p=0.9) and diffusing capacity for carbon monoxide (DLCO) (88.3 vs. 87.6; p=0.62) at baseline and post CTRT respectively. There was a significant improvement in QOL scores for nausea, vomiting, pain, constipation, loss of appetite and hair loss post RT 6 months. Conclusion- Patients treated with taxane-based adjuvant CTRT had stable cardio-pulmonary profile at 6 months compared to pre-RT. Quality of life scores improved after treatment for most of the domains compared to the pre-RT scores. Table 1. Calculated scores of EORTC QLQ-C30 and BR23 scales for breast cancer patients at baseline, post CTRT and at first follow up of six months. Citation Format: AKANKSHA ANUP, Tabassum Wadasadawala, CARLTON JOHNNY, RAJIV SARIN, RIMA PATHAK, REVATHY KRISHNAMURTHY, Sudeep Gupta, VANI PARMAR, Jaya Ghosh, JYOTI BAJPAI, SEEMA GULIA. Impact of Adjuvant Chemoradiation on cardiopulmonary function and Quality of Life in Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-10-18.

Association of patient activity bio-profiles with health-related quality of life in patients with newly diagnosed multiple myeloma: a prospective observational cohort study.

Due to the nature of their disease, patients with multiple myeloma (MM) often have bone disease-related pain that limits physical activity and diminishes health-related quality of life (HRQOL). Digital health technology with wearables and electronic patient reported outcome (ePRO) tools can provide insights into MM HRQoL. In this prospective observational cohort study conducted at Memorial Sloan Kettering Cancer in NY, NY, USA, patients with newly diagnosed MM (n=40) in two cohorts (Cohort A - patients <65 years; Cohort B - patients ≥65 years) were passively remote-monitored for physical activity at baseline and continuously for up to 6 cycles of induction therapy from Feb 20, 2017 to Sep 10, 2019. The primary endpoint of the study was to determine feasibility of continuous data capture, defined as 13 or more patients of each 20-patient cohort compliant with capturing data for ≥16h of a 24-hr period in ≥60% of days of ≥4 induction cycles. Secondary aims explored activity trends with treatment and association to ePRO outcomes. Patients completed ePRO surveys (EORTC - QLQC30 and MY20) at baseline and after each cycle. Associations between physical activity measurements, QLQC30 and MY20 scores, and time from the start of treatment were estimated using a linear mixed model with a random intercept. Forty patients were enrolled onto study, and activity bioprofiles were compiled among 24/40 (60%) wearable user participants (wearing the device for at least one cycle). In an intention to treat feasibility analysis, 21/40 (53%) patients [12/20 (60%) Cohort A; 9/20 (45%) Cohort B] had continuous data capture. Among data captured, overall activity trended upward cycle over cycle for the entire study cohort (+179 steps/24h per cycle; p=0.0014, 95% CI: 68-289). Older patients (age ≥65 years) had higher increases in activity (+260 steps/24h per cycle; p<0.0001, 95% CI:-154 to 366) compared to younger patients (+116 steps/24h per cycle; p=0.21, 95% CI:-60 to 293). Activity trends associated with improvement of ePRO domains, including physical functioning scores (p<0.0001), global health scores (p=0.02), and declining disease burden symptom scores (p=0.042). Our study demonstrates that feasibility of passive wearable monitoring is challenging in a newly diagnosed MM patient population due to patient use. However, overall continuous data capture monitoring remains high among willing user participants. As therapy is initiated, we show improving activity trends, mainly in older patients, and that activity bioprofiles correlate with traditional HRQOL measurements. Grants -National Institutes of HealthP30 CA 008748, Awards - Kroll Award2019.

Real-world treatment and quality of life (QOL) in locally advanced or metastatic urothelial carcinoma (la/mUC) in Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.

462 Background: Little is known about treatment and QOL of la/mUC in Saudi Arabia, South Korea, Turkey, and Taiwan. Therefore, this study assessed patient (pt), tumor, and disease characteristics; treatment sequencing; and QOL in pts with la/mUC treated in these countries. Methods: Data were drawn from the Adelphi mUC Disease-Specific Programme, a real-world, multinational, point-in-time study using validated methodology (Anderson et al. Curr Med Res Opin. 2008;24:3063-72) and included physician surveys, chart reviews, and pt questionnaires (Saudi Arabia, Turkey, and Taiwan only). Data were collected (12/2021–3/2022) from oncologists and urologists and adult pts with confirmed la/mUC. EQ-5D visual analogue scale (VAS; scores: 0 [worst health] to 100 [best health]) and the global health status (QL2) from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (scores: 0 [low functioning] to 100 [high functioning]) questionnaires were used to assess QOL. Results: Data were provided by 175 physicians for 988 pts (Turkey, n=300; Saudi Arabia, n=240; South Korea, n=298; Taiwan, n=150) with la/mUC. Mean pt age was 66.3 y; 77% were men. Most (77%) pts had no family history of urothelial carcinoma (UC); 30% recorded no risk factors (eg, genetic risk, smoking, occupational exposure). At initial UC diagnosis, the bladder was the initial tumor location in 82% of pts, of whom 67% had la/mUC, and 83% of pts had an Eastern Cooperative Oncology Group performance status 0–2. At data collection, the most common metastatic sites were the lymph nodes (53%), lungs (29%), liver (27%), and bone (21%). Biomarker/tumor testing was not done in 45% of pts. In pts initially diagnosed with nonmetastatic UC (n=346), 28% received neoadjuvant and 31% received adjuvant therapy. Of pts receiving ≥1 line of therapy (LOT) for la/mUC (n=988), 74% received gemcitabine, 60% received cisplatin, 18% received carboplatin, 17% received a programmed cell death protein 1/ligand 1 (PD-1/L1) inhibitor, and 4% received best supportive care (BSC) in the first-line (1L) setting; mean duration of therapy (DOT) in 1L was 5.7 mo. Of pts receiving ≥2 LOTs for la/mUC (n=290), 63% received a PD-1/L1 inhibitor and 35% received chemotherapy in the second-line (2L) setting; mean DOT in 2L was 4.9 mo. Of pts receiving ≥3 LOTs for la/mUC (n=87), 59% received chemotherapy (most often cisplatin [46%] or gemcitabine [38%]), 34% received a PD-1/L1 inhibitor, and 10% received BSC only in the third-line (3L) setting; mean DOT in 3L was 4.3 mo. Questionnaires were available for 319 pts. Mean (SD) EQ-5D VAS score was 51.8 (15.6); EORTC QL2 score was 44.6 (19.9). Conclusions: Pts with la/mUC in this multinational study generally received 1L platinum-based and 2L PD-1/L1 inhibitor therapies. These results highlight the need for therapies that improve clinical and QOL outcomes.

Effect of combined application of apatinib and perioperative quality nursing based on Orem’s self-care theory in patients undergoing cholangiocarcinoma resection

Purpose: To investigate the effect of application of perioperative quality nursing based on Orem’s self-care theory, in combination with apatinib in patients who underwent cholangiocarcinoma resection.&#x0D; Methods: Ninety patients who underwent cholangiocarcinoma resection in The Fourth Hospital of Hebei Medical University from Feb. 2019 to Feb. 2020 were assigned to control group (CG) and study group (SG) based on their order of admission, with 45 patients in each group. Conventional nursing in combination with conventional treatment was applied to CG, while perioperative quality nursing based on Orem’s self-care theory was used in combination with apatinib therapy in SG patients. Comparison was made between CG and SG regarding clinical efficacy, self-care ability and quality of life (QoL, based on QLQ-C30 score).&#x0D; Results : Disease control rate (DCR) and Barthel index (BI) score were higher in SG than in CG (p &lt; 0.05). After treatment, QoL score was higher in SG than in CG (p &lt; 0.001).&#x0D; Conclusion: Implementation of perioperative quality nursing along with apatinib therapy in patients undergoing cholangiocarcinoma resection improves their QoL and enhances their self-care ability. Thus, this treatment modality has high utility and treatment potential.

Health-related quality of life (HRQoL) associated with fruquintinib in the global phase 3, placebo-controlled, double-blind FRESCO-2 study.

67 Background: The global phase 3 FRESCO-2 study, (NCT04322539) demonstrated that fruquintinib (F) vs placebo (P) significantly improved OS (HR=0.66 [95% CI: 0.55-0.80]; p&lt;0.001) and PFS (HR=0.32 [95% CI: 0.27-0.39]; p&lt;0.001) in heavily pre-treated patients (pts) with refractory metastatic colorectal cancer (mCRC). F safety profile was consistent with the established monotherapy profile. Here we report the HRQoL and tolerability results. Methods: Pts were randomized 2:1 to F + BSC or P + BSC. EORTC QLQ-C30 and EQ-5D-5L were assessed at baseline and on Day (D) 1 of each Cycle (C) until treatment discontinuation, and ECOG PS was assessed at baseline, D1 of each C, and D21 of C1 to C3. Least-squares mean (LSM) change from baseline to post-baseline visits and the difference between F and P in QLQ-C30 scale scores (e.g. global health status [GHS]/QoL) and EQ-5D-5L scale scores (e.g. visual analog scale [VAS]) were calculated using mixed model repeated measures approach. For each scale, the appropriate minimally important difference (MID) thresholds were determined to evaluate the improvement or deterioration. Time to deterioration (TTD), defined as worsening from baseline in scale-specific MID or death, was analyzed using Kaplan-Meier method, adjusted log-rank test, and stratified Cox PH model. QLQ-C30 and EQ-5D-5L analyses were conducted on the ITT population, and ECOG PS was on the safety population. Results: 691 pts were randomized (F: 461 vs P: 230) and 686 pts received study drug (F: 456 vs P: 230). Median treatment Cycles received (range) were 3 (1, 20) for F vs 2 (1, 13) for P. More than 79% of pts on both arms had a baseline and ≥1 post-baseline assessment for QLQ-C30, EQ-5D-5L, and ECOG PS. GHS/QoL was similar between F and P at baseline; the LSM differences between F and P were 1.7 (95% CI: -1.7, 5.0) for C2 and 1.6 (95% CI: -3.2, 6.4) for C3. At C4, &lt;30 P patients were available. The % of patients who remained stable (MID -6.38 to &lt;8.43) or improved (≥8.43) was numerically higher for F vs P (C2: 61.5% vs 57.1%; C3: 56.4% vs 50.9%). Median TTD was 2.1 months in F and 1.8 months in P (HR=0.9; 95% CI: 0.7-1.0; P=0.098). EQ-5D VAS was similar between F and P at baseline; the LSM differences between F and P were 0.6 (95% CI: -2.3, 3.5) for C2 and 1.4 (95% CI: -2.8, 5.6) for C3. The % of patients who remained stable (MID -7 to &lt;7) or improved (≥7) was similar for F and P (C2: 64.6% vs 58.3%; C3: 64.2% vs 64.8%). Median TTD was 2.6 months in F and 1.9 months in P (HR=0.8; 95% CI: 0.6-0.9; P=0.001). The % of patients with ≥1-point increase from baseline in ECOG PS was 52.1% in F vs 54.0% in P. Conclusions: HRQoL is not negatively impacted by treatment with F. TTD in health utility instrument EQ-5D is improved for patients receiving F. These results, along with improved OS and PFS and favorable toxicity profile, further support F as a potential new treatment option for patients with refractory mCRC. Clinical trial information: NCT04322539 .

Comparing the Influence of Surgical and Conservative Therapy on Quality of Life in Patients with Early-Stage Medication-Related Osteonecrosis of the Jaw-A Prospective Longitudinal Study.

Background and Objectives: The purpose of this study was to evaluate the impact of surgical and conservative, non-surgical treatment on general health-related (QoL) and oral health-related quality of life (OHRQoL) in patients suffering from AAOMS stage I MRONJ. Materials and Methods: In the course of this prospective clinical study, QoL and OHRQoL using QLQ-C30 and QHIP G14 questionnaire were longitudinally assessed in N = 174 prospectively enrolled patients with indication of treatment of MRONJ stage I over a period of 12 months. Patients received conservative or surgical treatment. The measurement time points were preoperatively (T0), 12 weeks (T1), 6 months (T2) and 1 year after operation (T3). Results: For OHRQoL, no significant (p > 0.05) differences were found between both treatment groups for all timepoints (T0-T3). In the surgical treatment group, OHIP scores of T1, T2 and T3 were significantly lower than baseline measures (T0) (T0-T1 (2.99, p = 0.024), T0-T2 (5.20, p < 0.001), T0-T3 (7.44, p < 0.001)). For conservative treatment group OHIP, scores of T2 and T3 were significantly lower than baseline measures (T0) (T0-T2 (9.09, p = 0.013), T0-T3 (12.79, p < 0.001)). There was no statistically significant effect of time on QLQ-C30 scores in both groups (surgical treatment: F(3, 174) = 1.542, p < 0.205, partial η2 = 0.026; conservative treatment: F(3, 30) = 0.528, p = 0.667, partial η2 = 0.050). QLQ-C30 scores turned out to be significantly lower in the non-surgical group at T1 (p = 0.036) and T3 (p = 0.047) compared to the surgical treatment group. Conclusions: Surgical and conservative treatment of MRONJ stage I significantly improves patients' OHRQoL. Surgical treatment is superior to conservative treatment of MRONJ stage I regarding general QoL. Therefore, surgical treatment of MRONJ stage I should not be omitted for QoL reasons.

Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial

Robot-assisted lobectomy (RAL) is increasingly used as an alternative to video-assisted lobectomy (VAL) for resectable non-small cell lung cancer (NSCLC). However, there is little evidence of any difference in postoperative health-related quality of life (HRQoL) between these two approaches. Is RAL superior to VAL in improving quality of life in patients with resectable NSCLC? We performed a single-center, open-label randomized clinical trial from May 2017 to May 2020 with 320 enrolled patients undergoing RAL or VAL for resectable NSCLC (RVlob trial; NCT03134534). Postoperative pain was evaluated by visual analog score or numeric rating score on postoperative day 1 and at weeks 4, 24, and 48. The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30), EORTC Quality of Life Questionnaire in Lung Cancer (QLQ-LC13), and the European Quality of Life 5 Dimensions (EQ-5D) questionnaire were also administered at weeks 4, 24, and 48 after surgery. One hundred and fifty-seven patients underwent RAL and 163 underwent VAL. The mean pain score of patients after RAL was significantly lower at week 4 (2.097 ± 0.111 vs2.431 ± 0.108; P= .032). QLQ-C30 and QLQ-LC13 summary scores (P > .05) were similar for both RAL and VAL during the first 48weeks of follow-up. HRQoL scores assessed with the EQ-5D questionnaire were also comparable between the two groups (P > .05) during the whole study period. Both RAL and VAL showed satisfactory and comparable HRQoL and postoperative pain up to 48weeks after surgery, despite some minor statistical differences at week4. ClinicalTrials.gov; No.: NCT03134534; URL: www. gov.

Prevalence and Factors Associated With Post-Cholecystectomy Syndrome in Saudi Arabia.

Post-cholecystectomy syndrome (PCS) refers to the continuation or recurrence of biliary colic and any other gastrointestinal symptoms present prior to cholecystectomy. Given that PCS is rare and underestimated in Saudi Arabia, this study aimed to determine the prevalence of PCS among Saudis. This cross-sectional study included randomly gathered subjects who self-administered the validated European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire from September 6 to October 7, 2022. A total of 518 participants who underwent cholecystectomies were included; most were female (73.6%), 153 (29.5%) were 19 to 25 years old, and the vast majority were Saudi Arabian (91.1%). The average preoperative weight was 71 ± 20.7 kg (range 20 to 258), and the mean current weight was 69 ± 19.4 kg (range 30 to 257). About 137 (26.4%) had a chronic disease, most frequently hypertension (37.2%). In the past week, most participants experienced some trouble doing strenuous activities (42.9%), slight pain (37.6%), fatigue (32.2%), insomnia (37.5%), and weakness (38.2%). There were no significant associations between age, nationality, or residence with the QLQ-C30 score (P-value = 0.152, 0.262, 0.071, respectively). A significant association was observed between gender and QLQ-C30 score (P-value < 0.001), with females scoring higher than their male counterparts. Females also reported having a higher quality of life than males. The prevalence of PCS was higher than reported elsewhere.

An exercise prescription for patients with lung cancer improves the quality of life, depression, and anxiety.

Lung cancer has the highest rates of morbidity and mortality among all cancers. Patients with lung cancer inevitably confront psychosocial discomforts and progressively experience depression and anxiety that potentially impact the clinical outcomes [e.g., quality of life (QoL)]. These mental disorders in patients with lung cancer may effectively be alleviated with prescribed Chinese traditional mind-body exercises. This study aimed to determine the effect of the exercise prescription containing Chinese traditional mind-body exercise on QoL, depression, and anxiety in patients with lung cancer. In this study, 52 patients with non-small cell lung cancer (NSCLC) recruited from the China-Japan Friendship Hospital were divided into two groups, namely, the experimental group (N = 26) and the control group (N = 26). The experimental group was treated with an 8-week exercise prescription containing aerobic and resistance training. The control group received the usual care during the study period. The QoL, depression, and anxiety were separately investigated using EORTC QLQ-C30, EORTC QLQ-LC13, the Self-Rating Depression Scale (SDS), and the Self-Rating Anxiety Scale (SAS) at baseline and post-intervention. The scores of questionnaires were analyzed using the paired sample and independent sample t-tests to explore the intragroup and intergroup differences, respectively. The EORTC QLQ-C30 scores for physical functioning, role functioning, emotional functioning, and global QoL in the experimental group at post-intervention were significantly higher than those at baseline. The EORTC QLQ-C30 scores for fatigue, pain, dyspnea, and insomnia in the experimental group at post-intervention were significantly lower than those at the baseline. The SDS scores (baseline: 57.74 ± 8.77 vs. post-intervention: 51.42 ± 7.31, p < 0.05) and the SAS scores (baseline: 56.63 ± 9.39 vs. post-intervention: 49.16 ± 7.83, p < 0.05) in the experimental group at post-intervention were significantly lower than those at baseline. The 8-week exercise prescription containing moderate-intensity Baduanjin (5 days per week) can effectively alleviate QoL, depression, and anxiety in patients with NSCLC. Our exercise prescription is an effective supportive treatment for lung cancer patients with depression and anxiety. Chinese Clinical Trial Registry (ChiCTR1900025121).

Cancer-related fatigue: Identification of hallmarks to enable refined treatment approaches.

Recommendations for fatigue management are commonly given in an undifferentiated manner without further evaluation of patient's specific symptomatology. Thus, we aimed to identify hallmarks of potential fatigue subgroups which might guide more refined treatment. The FiX study assessed fatigue with the EORTC QLQ-FA12 in patients around 2years after cancer diagnosis (T0) including 15 different entities. After 2years, a follow-up survey (T1) was conducted. The analyses comprised all patients with prevalent fatigue at T0 (N=1023). Hierarchical cluster analysis was performed using the Ward method and including the dichotomized factors emotional distress, pain, insomnia, and obesity. Emotional distress, that is, depressive symptoms and anxiety, was assessed by the PHQ-4. Pain and insomnia were based on the according symptom scores of the EORTC QLQ-C30. Analysis of covariance was conducted to investigate the association of the fatigue clusters at T0 with subsequent fatigue at T1. Four hierarchical clusters were identified. The first cluster comprised patients with moderate-to-severe distress. The remaining fatigue cases were differentiated by obesity and then by pain. Fatigue cases without any of these three symptoms formed the last cluster. Physical, emotional and cognitive fatigue were highest in the distress cluster. Additionally, this cluster was associated with higher physical, emotional and cognitive fatigue at T1 compared to the other clusters. Fatigue in conjunction with emotional distress had worse impact, persisted longer, and may require other treatment approaches than fatigue in patients without emotional distress. Obesity and pain may be further distinguishing hallmarks for refined fatigue management.

Cost-utility analysis of brigatinib compared to alectinib in the treatment of ALK-positive NSCLC in patients previously not treated with an ALK inhibitor

Objective: The aim of this economic evaluation was to assess the cost-utility of brigatinib versus alectinib in the treatment of naïve patients to anaplastic lymphoma kinase-positive advanced non-small cell lung cancer (ALK-positive aNSCLC) from the perspective of the Italian National Health Service (INHS). Methods: A partitioned survival model with four health states (progression-free [PFS], no central nervous system progression [CNS-PFS], central nervous system progression [CNS-PD] and death) was used. The clinical data (progression-free survival, overall survival and time to progression) was based on the ALTA-1L trial for brigatinib and on ALEX trial for alectinib. Utility values were derived from EORTC QLQ-C30 scores evaluated in the ALTA-1L trial and literature. Costs included frontline therapies, subsequent therapies, best supportive care (BSC), administration, concomitant medications, adverse events and health states. Direct medical costs and benefits (quality-adjusted life-years, QALYs) were discounted at a 3.0% annual rate. Uncertainty was assessed using deterministic (DSA) and probabilistic sensitivity analyses (PSA). Results: The analysis showed that brigatinib was dominant versus alectinib; brigatinib led to a gain of 0.216 QALYs and to a treatment cost reduction of € 85,635. The results of the DSA showed that no parameters of the model significantly modified the base case result. Conclusions: This economic evaluation suggested that, compared with alectinib, brigatinib can be considered a valid cost-utility option from the perspective of INHS in the treatment of patients with ALK-positive aNSCLC.

Evaluating the Safety and Quality of Life of Colorectal Cancer Patients Treated by Autologous Immune Enhancement Therapy (AIET) in Vinmec International Hospitals.

(1) Colorectal cancer (CRC) is an increasingly prevalent disease with a high mortality rate in recent years. Immune cell-based therapies have received massive attention among scientists, as they have been proven effective as low-toxicity treatments. This study evaluated the safety and effectiveness of autologous immune enhancement therapy (AIET) for CRC. (2) An open-label, single-group study, including twelve patients diagnosed with stages III and IV CRC, was conducted from January 2016 to December 2021. Twelve CRC patients received one to seven infusions of natural killer (NK)-cell and cytotoxic T-lymphocyte (CTL). Multivariate modelling was used to identify factors associated with health-related quality-of-life (HRQoL) scores. (3) After 20–21 days of culture, the NK cells increased 3535-fold, accounting for 85% of the cultured cell population. Likewise, CTLs accounted for 62.4% of the cultured cell population, which was a 1220-fold increase. Furthermore, the QoL improved with increased EORTC QLQ-C30 scores, decreased symptom severity, and reduced impairment in daily living caused by these symptoms (MDASI-GI report). Finally, a 14.3 ± 14.1-month increase in mean survival time was observed at study completion. (4) AIET demonstrated safety and improved survival time and HRQoL for CRC patients in Vietnam.

657MO Effectiveness of geriatric assessment-driven interventions on quality of life for 2 years in older patients with head and neck cancer: Results from the EGeSOR trial

About 30% of Head and Neck Cancer (HNC) cases are diagnosed in patients aged 70 years and older. Due to their location, HNC and the toxicity of associated treatments may have consequences on quality of life. The aim of this study was to assess the effectiveness of Geriatric Assessment (GA)-driven interventions on quality of life for 2 years in older patients with HNC. The EGeSOR study was a two parallel group, multicenter, randomized, controlled and open-label trial, including HNC patients aged 65 years and over between 2013 and 2018. Patients were randomized 1 :1 to receive either a pre-therapeutic GA, a standardized geriatric intervention and follow-up (intervention group) or standard of care (control group). The main outcome was quality of life measures through the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30/100) and HNC questionnaire (QLQ-HN35/100) at 6, 12 and 24 months. Linear mixed models were performed. Among the 475 patients included (238 in the intervention group and 237 in the control group), the median age was 75.3 years, 31% were women, 44% with oral cancer and 21% metastasis. At baseline, the median score of global health status was 66.7 [50-83.3]. There were no statistically significant differences in evolution between the two groups in either the QLQ-C30 (15 dimensions) or HN35 scores (18 dimensions) over the 24-month period. The evolution of global health status followed a J-shape between M0 and M24 (median gain : 8 points). In the intervention group, 74% of patients did not receive the complete intervention as planned. Statistical analyses regarding age, tumor site and metastasis status are ongoing. Baseline GA did not improve quality of life for 2 years in older patients with HNC. Difficulties in implementation of complete interventions may have contributed to this result. Alternative models to implement GA-driven interventions could be explored.

Traditional Chinese medicine formula 01 for nasopharyngeal carcinoma (NPC01) for head & neck cancer and health-related quality of life: a retrospective study

BackgroundThe traditional Chinese medicine (TCM) formula 01 for nasopharyngeal carcinoma (NPC01) is used in the management of head and neck cancers (HNCs), but whether NPC01 has an impact on the HR-QOL of patients with HNCs is unknown.MethodsThis was a retrospective study of patients with HNCs who were treated between January 2019 and January 2020 at the Head & Neck Cancer Center of Tianjin Medical University Cancer Institute & Hospital. The patients were grouped according to whether they received NPC01 or not (controls). All patients routinely completed the EORTC QLQ-C30 and QLQ-H&N35 modules before and after 3 months of systemic treatment. Health economics were collected.ResultsThe patients who received NPC01 were older than the controls (48.6 ± 11.4 vs. 43.4 ± 8.8 years, P = 0.004). All other characteristics were comparable between the two groups (all P > 0.05). In EORTC QLQ-C30, physical functioning (P = 0.03), fatigue (P = 0.04), pain (P = 0.02), appetite loss (P = 0.02), and constipation (P = 0.01) scores were improved more in the NPC01 group than in controls. In EORTC H&N35, the scores for pain (P = 0.02), swallowing (P = 0.01), and dry mouth (P = 0.02) were better in the NPC01 group than in controls. The NPC01 cost was 38.94 RMB/patient compared with 12.81 RMB/patient for regular follow-up, but considering insurance coverage, the financial burden was not higher.ConclusionsThe results suggest that NPC01 improves HNCs-related symptoms and HR-QOL.

S303: EFFECT OF PEGCETACOPLAN ON QUALITY OF LIFE IN COMPLEMENT-INHIBITOR NAÏVE PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA: RESULTS FROM THE PHASE 3 PRINCE STUDY

Background: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening disease characterized by complement-mediated hemolysis and thrombosis. Historically, PNH was treated with C5 inhibitors (eculizumab [ECU)/ravulizumab). Despite their proven efficacy in the control of intravascular hemolysis (IVH), up to 72% of patients experience persistent hemolysis leading to suboptimal hemoglobin (Hb) levels and 36% require transfusions despite ECU treatment which results in a significant impact on the quality of life (QoL), including persistent fatigue. Pegcetacoplan (PEG) is an FDA/EMA-approved C3 complement-inhibitor that provides broad hemolysis control (including IVH and extravascular hemolysis) in patients with PNH. Aims: This analysis evaluates QoL measures in the Phase 3 PRINCE study (NCT04085601), a multicenter, randomized, open-label, controlled study evaluating the efficacy and safety of PEG compared to control treatment (CTRL; excluding complement-inhibitors) in complement-inhibitor naïve patients with PNH. Methods: PRINCE has been described previously and was superior for the coprimary endpoints of hemoglobin (Hb) stabilization (avoidance of >1 g/dL decrease in Hb from baseline), change from baseline in lactate dehydrogenase at 26 weeks and PEG-treated patients saw clinically meaningful increases in the FACIT-Fatigue scores (Wong SR, et al. Blood 2021; 138 [Supplement 1]: 606). Secondary endpoints specific to QoL measures included the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Scale (EORTC QLQ-C30), Linear Analog Scale Assessment (LASA) and The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). The EORTC QLQ-C30 contains 30 questions comprising 5 functional, 9 individual symptoms, and one global health status/QoL item(s), where a ≥10-point change in score is considered clinically meaningful. The LASA consists of 3 sections asking to rate the perceived level of functioning (scale 0-100, where a higher score corresponds to a better QoL) and contains specific domains for activity level, ability to carry out daily activities, and overall QoL. The FACIT-Fatigue is a 13-item Likert scaled instrument (scale 0-51), where a ≥3-point increase is considered clinically meaningful. Results: Relevant baseline characteristics for PRINCE are reported in Table A. Mean baseline scores of the EORTC QLQ-C30 functional and symptom scales were generally similar between groups (except for role and cognitive functioning and insomnia; Table B). After 26 weeks of PEG-treatment, patients displayed clinically meaningful improvements in most of the functional scales and the global health status/QoL at Week 26 as indicated by a ≥10-point score increase from baseline (Table B). Improvements in the symptom scales, including fatigue and dyspnea scales, were also observed in the PEG group at Week 26 as indicated by a reduction in the symptom score close to the general population norms (general population norm: fatigue: 24.1, dyspnea: 10.9). Mean total LASA scores increased in the patients receiving PEG treatment for 26 weeks (Table B). FACIT-Fatigue scores increased for PEG-treated patients to near the general population norm [43.6], supporting the gains shown in the EORTC QLQ-C30-Fatigue scale. Image:Summary/Conclusion: Substantial and clinically relevant improvements in QoL were consistently observed with PEG across both EORTC QLQ-C30, total LASA and FACIT-Fatigue scores and clinically significant improvements in fatigue and dyspnea are highly relevant to the symptomology of PNH.

S211: CLINICAL AND PATIENT-REPORTED OUTCOMES IN A PHASE 3 STUDY OF AXICABTAGENE CILOLEUCEL (AXI-CEL) VS STANDARD-OF-CARE IN ELDERLY PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (ZUMA-7)

Background: The median age at large B-cell lymphoma (LBCL) diagnosis is 66 years, and older patients with relapsed/refractory (R/R) LBCL are at risk of inferior outcomes, increased toxicity, and inability to tolerate second-line standard-of-care (SOC) treatment (Di M, et al. Oncologist. 2021). Further, second-line SOC treatment is often associated with poor health-related quality of life (Lin V, et al. J Clin Oncol. 2020;38:e20070). In the global Phase 3, randomized ZUMA-7 study, axi-cel, an autologous anti-CD19 CAR T-cell therapy, significantly improved event-free survival (EFS; hazard ratio [HR], 0.398, P<0.0001; median 8.3 vs 2 months, respectively) compared with second-line SOC in R/R LBCL (Locke FL, et al. N Engl J Med. 2022;386:640-654). Aims: Here we report results of a planned subgroup analysis of the ZUMA-7 study assessing outcomes, including patient-reported outcomes (PROs), of second-line axi-cel vs SOC in patients aged ≥65 years. Methods: Patients with ECOG performance status 0-1 and R/R LBCL ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axi-cel or SOC (2-3 cycles of platinum-based chemoimmunotherapy; patients with partial or complete response [CR] proceeded to high-dose therapy with autologous stem cell transplantation). PRO instruments, including the EORTC QLQ-C30 (Global Health and Physical Functioning) and the EQ-5D-5L visual analog scale (VAS), were administered at baseline (prior to treatment), Day 50, Day 100, Day 150, and Month 9, then every 3 months up to 24 months or time of EFS event, whichever occurred first. The quality-of-life analysis set included all patients who had a baseline PRO and ≥1 completed measure at Day 50, 100, or 150. A clinically meaningful change was defined as 10 points for each EORTC QLQ-C30 score and 7 points for EQ-5D-5L VAS score. Results: The data cutoff for this analysis was March 18, 2021 and included 51 axi-cel and 58 SOC patients with median ages of 70 years (range, 65-80) and 69 years (range, 65-81), respectively. At baseline, more axi-cel vs SOC patients had high-risk features, including second-line age-adjusted International Prognostic Index 2-3 (53% vs 31%) and elevated lactate dehydrogenase (61% vs 41%). EFS was superior with axi-cel vs SOC (HR, 0.276, P<0.0001), with higher CR rates (75% vs 33%). Grade ≥3 treatment-emergent adverse events (AEs) occurred in 94% and 82% of axi-cel and SOC patients, respectively, and Grade 5 treatment-related AEs occurred in 0 and 1 patient. In the quality-of-life analysis set comprising 46 axi-cel and 42 SOC patients, there were statistically significant and clinically meaningful differences in mean change of scores from baseline at Day 100 favoring axi-cel for EORTC QLQ-C30 Global Health (P<0.0001) and Physical Functioning (P=0.0019) and EQ-5D-5L VAS (P<0.0001). For all 3 domains, scores also favored (P<0.05) axi-cel over SOC at Day 150. The mean estimated scores numerically returned to or exceeded baseline scores earlier in the axi-cel arm (by Day 150) but never equaled or exceeded baseline scores by Month 15 in the SOC arm. Summary/Conclusion: Axi-cel demonstrated superiority over second-line SOC in patients ≥65 years with significantly improved EFS and a manageable safety profile. Axi-cel also showed meaningful improvement in quality of life over SOC, measured by multiple validated PRO instruments, with suggested faster recovery to pretreatment quality of life. The superior clinical outcomes and patient experience with axi-cel over SOC should help inform treatment choices in second-line R/R LBCL for patients ≥65 years.