QLQ-C30 Functional Scales Research Articles

Long-Term Follow-Up of Computer-Assisted Microvascular Mandibular Reconstruction: A Retrospective Study.

Background: Virtual surgical planning has become a well-established practice in head and neck surgery. In oncological surgery, it permits the achievement of safe margins resections and ensures functional reconstructions and optimal esthetic outcomes. This study aimed to evaluate the long-term outcomes after virtually planned mandibular microvascular reconstruction, focusing on functional and esthetic results, as well as health-related quality of life. Methods: A long-term retrospective evaluation of 17 patients with oral cavity malignancy who underwent computer-assisted mandibular resection and reconstruction was performed. Functional and esthetic outcomes were analyzed using the EORTC, QLQ-C30, H&N35, and FACE-Q questionnaires. Results: Time since reconstruction ranged from 7 to 14 years. Patients reported high functional levels on the QLQ-C30 functional scales but lower scores on H&N35. On FACE-Q, patients demonstrated higher appraisal and satisfaction with their smiles compared to their overall facial appearance. Conclusions: In this retrospective case series, patients undergoing computer-assisted mandibular reconstruction for oral malignancies achieved good long-term functional and esthetic outcomes. Although limited by the small sample size, these results support the enduring benefits of virtual planning for mandibular reconstruction. To minimize declines in function and appearance, considerations should include immediate dental implants, enhanced reconstruction of the temporomandibular joint, newer methods of radiotherapy to minimize xerostomia, and oral exercises to prevent trismus.

Effects of sintilimab plus chemotherapy as first-line treatment on health-related quality of life in patients with advanced esophageal squamous cell carcinoma: results from the randomized phase 3 ORIENT-15 study

In ORIENT-15 study, sintilimab plus chemotherapy demonstrated significant improvement on overall survival (OS) versus placebo plus chemotherapy in first-line treatment of advanced esophageal squamous cell carcinoma (ESCC). Here, we report effect of sintilimab plus chemotherapy on health-related quality of life (HRQoL) in patients with advanced ESCC. From December 14, 2018 to August 28, 2022, HRQoL was evaluated in all randomized patients using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30), EORTC Quality of Life Questionnaire Oesophageal Cancer Module 18 items (QLQ-OES18), and visual analogue scale (VAS) of the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L). Mean scores of each scale were described by treatment group through week 60. Least-squares mean (LSM) score change from baseline through week 24 were analyzed using the mixed-model repeated-measures method. Time to the first onset of deterioration (TTD) and OS for each scale were estimated. Clinical Trials Registration: NCT03748134. As of August 28, 2022, 689 of 690 enrolled patients were assessed for HRQoL analysis (sintilimab group: 340, placebo group: 349). Median follow-up was 32.2 months. Differences in LSM favored sintilimab over placebo for QLQ-C30 social functioning (LSM difference: 3.06, 95% CI: 0.55 to 5.57; P=0.0170), pain (-2.24, 95% CI:-4.30 to-0.17; P=0.0337), fatigue (-2.24, 95% CI:-4.46 to-0.02; P=0.0479), constipation (-3.27, 95% CI-5.49 to-1.05; P=0.0039), QLQ-OES18 pain (-1.77, 95% CI-3.11 to-0.43; P=0.0097), trouble swallowing saliva (-2.09, 95% CI:-3.77 to-0.42; P=0.0146), and choked when swallowing (-3.23, 95% CI:-5.60 to-0.86; P=0.0076). TTD favored sintilimab over placebo for QLQ-OES18 dysphagia (Hazard ratio [HR]: 0.76, 95% CI: 0.61-0.94, P=0.0104), and trouble swallowing saliva (HR: 0.48, 95% CI: 0.35-0.67, P<0.0001). Improved OS were observed in patients with better performance in several functioning and symptom scales of QLQ-C30 and QLQ-QES18. The statistically significant differences of several HRQoL scales and improvements in delayed deterioration observed in our study further support the use of sintilimab plus chemotherapy as first-line treatment for advanced ESCC. This study was funded by Innovent Biologics and was co-funded by Eli Lilly.

Impact of pembrolizumab versus chemotherapy on health-related quality of life in patients with metastatic triple-negative breast cancer: results from the phase 3 randomised KEYNOTE-119 study

In KEYNOTE-119 (ClinicalTrials.gov, NCT02555657), overall survival (primary end-point) was similar between pembrolizumab and chemotherapy in patients with previously treated metastatic triple-negative breast cancer (TNBC), although the pembrolizumab treatment effect increased with tumour PD-L1 expression. We report results of prespecified health-related quality of life (HRQoL) analyses from KEYNOTE-119. Eligible patients were randomised 1:1 to pembrolizumab 200mg Q3W intravenously for up to 35 cycles or treatment of physician's choice per local/country guidelines. Prespecified exploratory end-points were the change from baseline in HRQoL (EORTC QLQ-C30, QLQ-BR23) and to characterise utilities (EQ-5D-3L). Time to deterioration (TTD) was the time from start of treatment to first onset of a ≥10-point worsening from baseline. HRQoL analyses included 187 patients with tumour PD-L1 combined positive score (CPS) ≥10. Changes from baseline at 6 weeks (primary analysis time point) were directionally better with pembrolizumab versus chemotherapy for QLQ-C30 GHS/QoL (between-group difference in least-squares mean scores of 4.21 [95% CI, -1.38 to 9.80]), QLQ-C30 functional scales (physical, role, cognitive, social), QLQ-C30 symptom scales/items (fatigue, nausea/vomiting, dyspnoea, appetite loss), and QLQ-BR23 symptom scales/items (systemic therapy side-effects, upset by hair loss). Median TTD was directionally longer for pembrolizumab versus chemotherapy for QLQ-C30 QHS/QoL (4.3 versus 1.7 months), QLQ-C30 nausea/vomiting (7.7 versus 4.8 months), and QLQ-BR23 systemic therapy side-effects (6.1 versus 3.4 months). Minimal treatment differences were observed for other HRQoL end-points. HRQoL results were consistent with clinical outcomes and appeared to be driven by results for patients with tumour PD-L1 CPS ≥10.

ASSESSMENT OF QUALITY OF LIFE IN PATIENTS WITH GASTRIC CANCER IN UKRAINE.

The aim: To identify the main problems in the quality of life of patients with gastric cancer to optimize health care for them. Materials and methods: The sociological study was performed by surveying 404 patients with gastric cancer usage questionnaires EORTC QLQ-C30 and QLQ-STO22. Calculations were performed according to the EORTC QLQ-C30 Scoring Manual and QLQ-STO22. The analysis of three main indicators was performed: functional scale, symptom scale and quality of life scale. Results: The quality of life of gastric cancer patients amounted to 51.80±11.35 on a 100-point scale. According to the QLQ-C30 functional scale, the psy¬cho-emotional sphere (59.62±12.91), social functioning (66.42±13.48) are the most impressive in patients. According to the results obtained in the QLQ-C30 symptoms scale, gastric cancer patients were most concerned about financial difficulties (57.18±12.45) and fatigue with a score of 50.12±10.86 on a 100-point scale. According to the QLQ-STO22 symptom scale in the study of patients, anxiety (59.07±12.46) and hair loss (56.97±11.78) amounted to the highest scores. Conclusions: Given the low quality of life of gastric cancer patients, they need psychological support, which is aimed at adapting to the manifestations of the disease and should be a mandatory component in the development of models or strategies for providing medical care to cancer patients. Standardized psychological care should be organized at all stages of diagnosis, treatment and rehabilitation in all institutions that provide treatment to gastric cancer pa¬tients. It is also important to develop and implement a comprehensive program to support gastric cancer patients in interaction with society, family and work.

Real-world patient-reported outcomes and physician satisfaction with poly (ADP-ribose) polymerase inhibitors versus chemotherapy in patients with germline BRCA1/2-mutated human epidermal growth factor receptor 2–negative advanced breast cancer from the United States, Europe, and Israel

BackgroundIn clinical trials, poly (ADP-ribose) polymerase inhibitors (PARPi) versus chemotherapy resulted in significantly improved progression-free survival, manageable adverse event profiles, and favorable patient-reported outcomes (PROs) in patients with human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC) and germline BRCA1/2 mutations (gBRCA1/2mut). The objective of this study was to evaluate PROs and physician satisfaction with treatment in patients with gBRCA1/2mut HER2− ABC receiving PARPi or physician’s choice of chemotherapy in a multi-country, real-world setting.MethodsThis retrospective analysis used data from the Adelphi Real World ABC Disease Specific Programmes in the United States, European Union, and Israel. PROs were assessed at a single timepoint using the EuroQol 5-Dimensions 5-Level (EQ-5D-5L) scale, Cancer Therapy Satisfaction Questionnaire (CTSQ), and European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) and the breast cancer−specific module (QLQ-BR23). Baseline PROs were not assessed. Physician satisfaction with treatment scores was dichotomized to a 0/1 variable (0 = very dissatisfied/dissatisfied/moderately satisfied; 1 = satisfied/very satisfied). Scores were compared using inverse-probability−weighted regression adjustment, controlling for multiple confounding factors.ResultsThe study included 96 patients (PARPi, n = 38; platinum/non–platinum-based chemotherapy, n = 58). Patients receiving PARPi versus chemotherapy reported significantly better scores on the EQ-5D-5L Health Utility Index. On the EORTC QLQ-C30 functional scales, patients receiving PARPi reported significantly better scores (mean ± SE) for physical functioning (80.0 ± 2.4 vs 71.9 ± 3.4; p < 0.05) and social functioning (82.0 ± 6.2 vs 63.6 ± 3.7; p < 0.05) and, on the symptom scales, reported significantly better scores for constipation (1.9 ± 1.8 vs 18.7 ± 3.2; p < 0.001), breast symptoms (0.4 ± 3.9 vs 13.3 ± 2.6; p < 0.01), arm symptoms (2.6 ± 1.3 vs 11.4 ± 2.4; p = 0.001), and systemic therapy side effects (13.5 ± 1.8 vs 29.4 ± 2.3; p < 0.001). In contrast, patients receiving chemotherapy scored significantly better on the nausea/vomiting scale (18.3 ± 2.8 vs 34.5 ± 5.1; p < 0.01). Patients receiving PARPi reported numerically better satisfaction scores on the CTSQ scales. Physicians were more likely to be satisfied/very satisfied with PARPi versus chemotherapy (95.4% ± 7.3% vs 40.8% ± 6.2%; p < 0.001).ConclusionsThe PRO findings in this real-world population of patients with gBRCA1/2mut HER2− ABC complement those from the pivotal clinical trials, providing further support for treatment with PARPi in these patients.

Quality of life, distress, anxiety and depression of ambulatory cancer patients receiving chemotherapy.

Cancer and its treatment have substantial physical and psychological consequences that severely affect the patients' quality of life (QoL) and emotional status. This study aimed to investigate the relationship between distress, anxiety, depression, and QoL of ambulatory cancer patients undergoing chemotherapy. A descriptive, cross-sectional study of 150 cancer patients who were receiving chemotherapy in the outpatient unit of a central anticancer hospital in Athens. The data were collected through convenience sampling between November 2017 and January 2018, using a demographic and clinical characteristics questionnaire, the Distress Thermometer (DT) and Problem List (PL), the Hospital Anxiety and Depression Scale (HADS) and the European Organization for Research and Treatment for Cancer QoL assessment Questionnaire (EORTC QLQ-C30). Variability characterized the sample's demographic and clinical characteristics. The majority of patients were women (64%), married (66%), high school graduates (43%), had breast cancer (35%), with a mean age of 60.07 ± 11.42. 83% reported anxiety, 75% reported fear, 51% nervousness and sadness, 34% depression and 84.7% fatigue. The DT was positively correlated with HADS (p<0.001) and with almost all EORTC QLQ-C30 functional subscales and symptoms (p<0.001). The HADS-Anxiety was significantly correlated with overall QoL and with almost all the EORTC QLQ-C30 functional scales and symptoms (p<0.001). HADS-Depression was significantly correlated with overall QoL and all the EORTC QLQ-C30 functional scales and symptoms (p<0.001). Women tended to have higher level of distress (p=0.003). There was a statistically significant relationship between educational level, the cognitive functioning scale (p=0.017) and financial difficulties (p=0.026). Ambulatory cancer patients undergoing chemotherapy are at risk of facing distress in all aspects of daily living, along with anxiety and depression, which decreases their QoL. Oncology nurses as members of multidisciplinary teams should assess the affected aspects of patients' QoL and appropriate interventions should be implemented at community level.

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.

Effect Evaluation of Comfort Nursing Materials Assisted Nursing for Patients with Advanced Malignant Tumor.

In order to explore the effect of comfort care on patients with advanced malignant tumors assisted by bioceramics, 82 patients with advanced malignant tumors admitted to a cancer hospital were selected as the research object control group: 26 males and 15 females and the observation group: 25 males and 16 females. The control group was given routine care, and the observation group was given comfort care on the basis of the control group. The quality of life (QLQ-C30 functional scale) and nursing satisfaction before and after nursing were compared between the two groups. The results of the study indicate that after care, the physical, role, emotional, cognitive, social, general health, and symptom scores of the observation group were significantly higher than those of the control group, the nursing satisfaction degree of the observation group was 97.56%, which was significantly higher than that of the control group of 82.93%, and the difference was statistically significant (P < 0.05). Comfortable care has a definite effect on the care of patients with advanced malignant tumors; it can improve the overall comfort and satisfaction of patients, effectively reduce adverse events, and improve the quality of life of patients.

Altered cancer care delivery during COVID-19: Evaluating the impact of virtual clinics and treatment changes on oncology patient outcomes, quality of life, and satisfaction.

e18618 Background: The coronavirus disease (COVID-19) pandemic has created unprecedented strain on healthcare systems across the world. COVID-19 has thought to have significant impacts on the oncology patient population and has affected their care. Additional research is needed to ascertain the impact of the COVID-19 pandemic at the patient level. We sought to evaluate whether the delivery of cancer care, quality of life (QoL) and treatment outcomes of oncology patients at Mount Sinai Hospital (MSH), Toronto, Canada was impacted by the COVID-19 pandemic. Methods: A 3-part longitudinal questionnaire study including 138 oncology patients receiving active treatment or in active follow-up at MSH was conducted between June 15, 2020 and August 25, 2021. The questionnaire consisted of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer QoL Questionnaire Version 3) and satisfaction with virtual healthcare questionnaire. The questionnaire was completed at baseline (Jun 15-Sep 8, 2020), 1 month follow-up (Jul 15-Oct 8, 2020), and 12 months follow-up (Aug 4-Aug 25, 2021). Repeated measures analysis of variance tests were performed to evaluate EORTC QLQ-C30 subscale score changes and satisfaction with virtual care question scores over time. Results: Overall, the mean EORTC QLQ-C30 QoL scores were seen to improve in oncology patients from 65.1 (SD±22.3) at baseline to 69.1 (SD±16.9) at 12 months follow-up (p = 0.2). Within the EORTC QLQ-C30 functional scales, mean role functioning and mean social functioning scores were observed to increase over 12 months of follow-up, 66.4 to 79.2 (p &lt; 0.05) and 67.7 to 76.4 (p = 0.17), respectively. Little change was observed within other EORTC QLQ-C30 functional scales and individual symptom scales during follow-up. Over 12 months of follow-up, mean agreement (0 = strongly disagree to 6 = strongly agree) to the questionnaire statement regarding avoiding going to the hospital during COVID-19 pandemic had declined, from 4.6 (SD±2.0) at baseline to 3.9 (SD±2.2) at 12 months follow-up (p = 0.09). Although not significant, virtual care satisfaction generally decreased over the follow-up time period. 97% of 48 patients who completed the survey at 12 months of follow-up reported feeling more safe coming into the hospital when considering the current increased vaccination rates in Ontario. Conclusions: As the COVID-19 pandemic has evolved, there has been increased knowledge of disease transmission, along with the introduction of health care measures such as vaccination and treatment. During this time, cancer outpatients at MSH became more comfortable as demonstrated by improvements in both QoL and virtual care scores. Prospective studies should still be considered to assess the efficacy of different methods of improving oncology patient care and QoL during the COVID-19 pandemic.

The prevalence, distribution and impact of peripheral neuropathy among Danish patients with cancer – a population-based cross-sectional study

Background Prevalence of peripheral neuropathy (PN) has been studied in patients undergoing treatment with taxanes, platinums and vinca alkaloids. The prevalence is unknown in the general oncological cancer population, characterized by advanced age, comorbidities and heterogeneous treatments. Material and Methods A cross-sectional survey was administered to all adult patients, attending outpatient services at three Danish departments of oncology. The survey contained the EORTC-CIPN20, the EORTC-QLQ-C30, the GAD7 and PHQ9 questionnaires. A high PN symptom score was defined as a summary score ≥30 points on the CIPN20. P-values were adjusted for multiple testing. Results With an overall response rate of 83% (2839 patients), prevalence of PN was 17% overall, varying from 6 to 33% between diagnosis groups. A high score was more common among females (19 vs. 14%, p = .008), smokers (21 vs. 15%, p = .04), patients living alone (21 vs. 15%, p = .002) and patients using cannabis (29 vs. 15%, p < .001), as well as patients suffering from diabetes (26 vs. 16%, p < .001), cardiac heart disease (27 vs. 16%, p < .001), arthritis (32 vs. 15%, p < .001) or chronic obstructive pulmonary disease (25 vs. 16%, p = .01). High score patients were also older (69ys vs 67ys, p = .048) and more likely experiencing polypharmacy (OR = 3.38 [95% CI, 2.64;4.35]). Patients with a high CIPN20 symptom score scored worse on all EORTC QLQ-C30 function and symptom scales. The mean adjusted C30 SumScore difference was −18.66 ([95% CI, −20.31; −17.02], p < .001). Conclusion Symptoms of PN are experienced widely across cancer groups in the oncology setting. PN symptoms were associated with clinically relevant worse health-related quality of life and with patient-related factors as living alone, various comorbidities, polypharmacy, and cannabis use.

Real-world quality of life (QoL) in black, indigenous and people of color (BIPOC) treated with palbociclib (PAL) and endocrine therapy for hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): A subgroup analysis from POLARIS.

1071 Background: Racial disparities in breast cancer incidence, mortality, and care are well documented. PAL plus endocrine therapy is indicated for patients (pts) with HR+/HER2− ABC. Findings from the PALOMA clinical trials have shown that pts receiving PAL maintained stable QoL; however, limited QoL data are available from real-world settings for BIPOC receiving PAL. Methods: POLARIS is a noninterventional, prospective, primarily US-based study in pts with HR+/HER2– ABC receiving PAL. QoL was assessed with the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline, monthly for the first 3 mo of treatment (Tx) with PAL, and then every 3 mo. In this interim analysis, we report Tx patterns and QoL assessments at baseline and at 6 mo and 12 mo in BIPOC from POLARIS. Results: Of 1280 pts treated with PAL as November 10, 2020, 233 were included in the BIPOC subgroup of whom 159 (68.2%) completed PAL Tx for ≥6 mo and 112 (48.1%) for ≥12 mo. In the BIPOC cohort, 59.2% of pts were black, 35.2% Hispanic, 3.4% American Indian or Alaskan native, 2.1% Pacific Islander. PAL in combination with letrozole/anastrozole was received by 116 pts, 94 received PAL plus fulvestrant, 13 received PAL plus exemestane, and 10 received PAL plus another Tx; 175 pts (75.1%) received PAL as first-line Tx. Mean EORTC QLQ-C30 global health QoL and functional scales scores remained stable over the first 12 mo of PAL Tx, without any changes at or above the 10-point threshold considered clinically meaningful, and were similar to those previously reported in an earlier analysis of the entire POLARIS population (Table and Rocque et al SABCS 2019). Symptom scales scores, including nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea, also remained stable over 12 mo. Conclusions: In this subgroup analysis, PAL had no significant adverse impact on QOL in BIPOC with HR+/HER2– ABC, consistent with previous findings from the total POLARIS study population. Pfizer (NCT03280303). Clinical trial information: NCT03280303 .[Table: see text]

Health-related quality of life in the randomized phase III trial of brigatinib vs crizotinib in advanced ALK inhibitor–naive ALK + non−small cell lung cancer (ALTA-1L)

ObjectiveIn ALTA-1 L, first-line brigatinib versus crizotinib significantly prolonged progression-free survival in advanced ALK-positive (ALK+) non–small cell lung cancer (NSCLC). We report health-related quality of life (HRQOL) outcomes from ALTA-1 L. Materials and MethodsHRQOL was assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 (EORTC QLQ-C30) and lung cancer–specific module (QLQ-LC13). HRQOL time to worsening, change from baseline, and duration of improvement were analyzed. ResultsEORTC QLQ-C30 and QLQ-LC13 compliance was >90 % for both groups (n = 131 each). Brigatinib versus crizotinib significantly delayed time to worsening in the EORTC QLQ-C30 global health status (GHS)/QOL (median: 26.74 vs 8.31 months; hazard ratio [HR]: 0.70; 95 % CI: 0.49, 1.00; log-rank P = 0.0485); emotional functioning, social functioning, fatigue, nausea and vomiting, appetite loss, and constipation scales (log-rank P < 0.05); delays in time to worsening for the physical, role, and cognitive functioning scales were not statistically significant. Mean change from baseline showed greater improvement in GHS/QOL and most EORTC QLQ-C30 functional and symptom scales with brigatinib versus crizotinib. Among patients with GHS/QOL improvement, brigatinib had longer duration of improvement versus crizotinib (median: not reached vs 11.99 months); similar results were seen in the physical, role, emotional, and social functioning; fatigue; nausea and vomiting; and appetite loss scales. Median time to worsening in dyspnea (QLQ-LC13) was 23.98 versus 8.25 months (brigatinib vs crizotinib; HR: 0.64; 95 % CI: 0.39, 1.05). ConclusionBrigatinib significantly delayed time to worsening and prolonged duration of improvement in GHS/QOL versus crizotinib, supported by improvement in functional and symptom scores. These preliminary analyses suggest brigatinib is the first ALK inhibitor with better HRQOL versus another ALK inhibitor in ALK inhibitor–naive advanced ALK + NSCLC.

Relationship Between Nutritional Status and Quality of Life in Patients with Lung Cancer.

IntroductionMalnutrition is often co-occur in patients with advanced cancer and are associated with poorer response to treatment therapy and decrease significantly the quality of life (QoL). There is little evidence regarding the relationship between nutritional status and QoL in this patient group.Purpose of the StudyTo assess the relationship between nutritional status and QoL in patients with lung cancer.MethodsOur cross-sectional, descriptive study included 310 patients. Only standardized instruments were used to perform the study: Mini Nutritional Assessment (MNA) to assess nutritional status and The European Organization for Research and Treatment of Cancer Quality of Life Core-30 (EORTC-QLQ-C30) and Lung Cancer-13 (LC-13) to assess the QoL.ResultsThe mean age in the study group was 63.77±9.43. 18.71% of patients were malnourished 44.19% at risk of malnutrition and 37.1% of patients had normal nutritional status. Clinical characteristics showed that 75% of respondents had been diagnosed with non-small-cell lung carcinoma, with an average duration of illness of 1–2 years. Nearly all patients received symptomatic treatment, and one in two had undergone surgery. At subsequent stages, QoL was analyzed in three groups depending on nutritional status risk. Malnourished patients had a lower quality of life and greater severity of cancer symptoms than those with a normal nutritional status (p<0.001). In regression analysis, nutritional status has a significant impact on all QLQ-C30 functional scales. Regression parameters are positive, indicating that better nutritional status is associated with better functioning in specific QLQ domains.ConclusionA considerable proportion of lung cancer patients are either malnourished or at risk of malnutrition. Malnutrition correlates negatively with QoL and increases symptom severity. Malnutrition is an independent determinant of lower QoL.Implications for PracticeNutritional assessment should be accompanied by QoL evaluation, so that nutritional interventions can be optimized based on a patient’s individual requirements.

Dose fusion and efficacy evaluation of different radical radiotherapy doses for cervical cancer

BackgroundThe recommended external beam radiotherapy (EBRT) dose for cervical cancer is 40–50 Gy, but there is no consensus. In this study, 45-Gy and 50.4-Gy treatment groups were compared for fused doses to target tumor areas and organs at risk (OARs), clinical efficacy, and quality of life. MethodsSeventy-nine cases receiving radical radiotherapy within the past 3 years were retrospectively analyzed. EBRT and three-dimensional brachytherapy dose fusion values were calculated for target areas and OARs using Elastix V5.0. Clinical efficacy was assessed using Response Evaluation Criteria in Solid Tumors (RECIST), adverse events using Common Terminology Criteria for Adverse Events v4.03 (CTCAE4.03), and quality of life using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). ResultsMinimum fused dose delivered to 90% of the high-risk clinical target volume (HRCTV D90) did not differ significantly between 45-Gy and 50.4-Gy groups, whereas D2cc values of rectum and bladder (OARs) were significantly lower in the 45-Gy group (both p < 0.05). Further analysis showed that these D2cc differences resulted primarily from EBRT. No grade III–IV adverse events were observed in either group during follow up. Short-term clinical efficacy, adverse events, and EORTC QLQ-C30 functional and symptom scales also did not differ significantly between groups (all p > 0.05). However, quality of life was markedly higher in the 45-Gy group (p < 0.05). ConclusionAppropriate EBRT dose reduction can reduce OAR irradiation without compromising total target area dose or clinical efficacy. Dose fusion can facilitate the judicious choice of EBRT to limit OAR exposure, reduce adverse events, and enhance the quality of life.

Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS) questionnaire: translation, cultural adaptation and validation to Brazilian Portuguese

IntroductionConstitutional symptoms and thrombohemorrhagic events are common in patients with myeloproliferative neoplasms (MPNs). Hence, the treatment’s primary goal is to control symptoms and improve the quality of life (QoL). In order to assess response to therapy, symptom burden, and QoL among patients with MPN, the “Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS)” questionnaire was developed in the USA in 2012. Herein, we translated and validated the MPN-SAF TSS questionnaire to Brazilian Portuguese. MethodsThe ten-item questionnaire was translated from the English language and its psychometric properties (reliability, convergent and construct validities) were evaluated in 101 MPN patients. ResultsThere were 41 patients with essential thrombocythemia, 39 with myelofibrosis and 21 with polycythemia vera. The median age of all patients at diagnosis was 68 years and 59% were female. The Cronbach's alpha coefficient for the overall questionnaire was 0.78, ranging from 0.73 to 0.79, if each item was deleted. Validity analyses showed that the strongest item-item correlation were between early satiety and abdominal discomfort. Strong correlations were also found between physician and patient perceptions of itching (r=0.81) and fatigue (r=0.70). The Pearson coefficient correlation between the MPN-SAF TSS global score and the EORTC QLQ-C30 functional scales ranged from 0.51 to 0.64. The exploratory factor analysis showed that seven of the ten symptoms loaded into one single factor. ConclusionThe Brazilian Portuguese version of the MPN-SAF-TSS showed good psychometric properties and can be an available tool to assess symptom burden in this group of patients.

Validation of the Moroccan arabic version of the low anterior resection syndrome score

BackgroundSphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome. The aim of this observational study is to translate this tool into arabic and test its psychometric properties in rectal cancer patients, in order to ease its use in clinical practice and future research.MethodsThe LARS questionnaire was translated to arabic and administered to a total of 143 patients. A subgroup of 42 patients took the test twice for test-retest reliability. Internal consistency was examined through cronbach’s alpha. The score results were correlated to the EORTC QLQ-C30 questionnaire for convergent validity assessment, while discriminant validity was established through the ability of the LARS score to differentiate patients with different clinical and pathological criteria.ResultsThe Moroccan Arabic version of the LARS score was completed by 143 patients. The internal consistency was demonstrated through a cronbach alpha score of 0.66. The agreement between the test and retest was established by a Bland Altman plot with 95% limits of agreement. 85.6% of patients remained in the same LARS category. The LARS score showed negative correlation with all five of the QLQ-C30 functional scales as well as positive correlation to the diarrhea symptom scale. The questionnaire score differed between patients according to their tumor location, chemoradiotherapy, type of mesorectal excision and anastomosis.ConclusionThe Moroccan Arabic version of the LARS score shows good psychometric properties and can be used for bowel dysfunction assessment in clinical and research settings.

Evaluation of the performance of algorithms mapping EORTC QLQ-C30 onto the EQ-5D index in a metastatic colorectal cancer cost-effectiveness model

BackgroundCost-effectiveness models require quality of life utilities calculated from generic preference-based questionnaires, such as EQ-5D. We evaluated the performance of available algorithms for QLQ-C30 conversion into EQ-5D-3L based utilities in a metastatic colorectal cancer (mCRC) patient population and subsequently developed a mCRC specific algorithm. Influence of mapping on cost-effectiveness was evaluated.MethodsThree available algorithms were compared with observed utilities from the CAIRO3 study. Six models were developed using 5-fold cross-validation: predicting EQ-5D-3L tariffs from QLQ-C30 functional scale scores, continuous QLQ-C30 scores or dummy levels with a random effects model (RE), a most likely probability method on EQ-5D-3L functional scale scores, a beta regression model on QLQ-C30 functional scale scores and a separate equations subgroup approach on QLQ-C30 functional scale scores. Performance was assessed, and algorithms were tested on incomplete QLQ-C30 questionnaires. Influence of utility mapping on incremental cost/QALY gained (ICER) was evaluated in an existing Dutch mCRC cost-effectiveness model.ResultsThe available algorithms yielded mean utilities of 1: 0.87 ± sd:0.14,2: 0.81 ± 0.15 (both Dutch tariff) and 3: 0.81 ± sd:0.19. Algorithm 1 and 3 were significantly different from the mean observed utility (0.83 ± 0.17 with Dutch tariff, 0.80 ± 0.20 with U.K. tariff). All new models yielded predicted utilities drawing close to observed utilities; differences were not statistically significant. The existing algorithms resulted in an ICER difference of €10,140 less and €1765 more compared to the observed EQ-5D-3L based ICER (€168,048). The preferred newly developed algorithm was €5094 higher than the observed EQ-5D-3L based ICER. Disparity was explained by minimal diffences in incremental QALYs between models.ConclusionAvailable mapping algorithms sufficiently accurately predict utilities. With the commonly used statistical methods, we did not succeed in developping an improved mapping algorithm. Importantly, cost-effectiveness outcomes in this study were comparable to the original model outcomes between different mapping algorithms. Therefore, mapping can be an adequate solution for cost-effectiveness studies using either a previously designed and validated algorithm or an algorithm developed in this study.

The neurocognitive function change criteria after whole-brain radiation therapy for brain metastasis, in reference to health-related quality of life changes: a prospective observation study

BackgroundWe sought to construct the optimal neurocognitive function (NCF) change criteria sensitive to health-related quality of life (HR-QOL) in patients who have undergone whole-brain radiation therapy (WBRT) for brain metastasis.MethodsWe categorized the patients by the changes of NCF into groups of improvement versus deterioration if at least one domain showed changes that exceeded the cut-off while other domains remained stable. The remaining patients were categorized as stable, and the patients who showed both significant improvement and deterioration were categorized as ‘both.’ We examined the clinical meaning of NCF changes using the cut-off values 1.0, 1.5, and 2.0 SD based on the percentage of patients whose HR-QOL changes were ≥ 10 points.ResultsBaseline, 4-month and 8-month data were available in 78, 41 (compliance; 85%), and 29 (81%) patients, respectively. At 4 months, improvement/stable/deterioration/both was seen in 15%/12%/41%/32% of the patients when 1.0 SD was used; 19%/22%/37%/22% with 1.5 SD, and 17%/37%/37%/9% with 2.0 SD. The HR-QOL scores on the QLQ-C30 functional scale were significantly worse in the deterioration group versus the others with 1.0 SD (p = 0.013) and 1.5 SD (p = 0.015). With 1.5 SD, the HR-QOL scores on the QLQ-BN20 was significantly better in the improvement group versus the others (p = 0.033). However, when ‘both’ was included in ‘improvement’ or ‘deterioration,’ no significant difference in HR-QOL was detected.ConclusionsThe NCF cut-off of 1.5 SD and the exclusion of ‘both’ patients from the ‘deterioration’ and ‘improvement’ groups best reflects HR-QOL changes.

Perceived social support and associations with health-related quality of life in young versus older adult patients with haematological malignancies

BackgroundThis study compared the perceived social support of young and older adult cancer patients, examining possible influencing factors as well as associations with health-related quality of life.MethodsA total of 179 young patients (18–39 years) and 200 older adult patients (> 70 years) with haematological malignancies completed questionnaires on their perceived social support (ISSS-8, scales: Positive Support and Detrimental Interactions, range 0–16) and health-related quality of life (EORTC QLQ-C30). Tests for mean differences, correlations and regression analyses to determine associated variables of social support were performed.ResultsNo difference was reported between young (M = 13.40, SD = 2.81) and older adult patients (M = 13.04, SD = 3.82; p = .313) for Positive Support. However, young patients (M = 4.16, SD = 3.10) reported having had more Detrimental Interactions than older patients did (M = 1.63, SD = 2.42; p < .001, Cohen’s d = .910). Comparison of the EORTC QLQ-C30 Function scales showed poorer outcomes for young patients on Emotional, Cognitive and Social Functions and a higher outcome on Physical Function compared with older adult patients. Regression analyses indicated that age (young vs. older adult patients) significantly explained proportions of variance in all models, with young age having a negative impact on Emotional, Cognitive and Social Functions and a positive impact on Physical and Role Functions compared with old age. Significant associations between Detrimental Interactions and all the scales examined except Cognitive Function were found.ConclusionsThe difference in negative perceptions of social support in young vs. older adult patients and its impact on health-related quality of life emphasises the necessity of differentiating between positive and negative social support. Negative interactions should be addressed through psychosocial care, particularly with young cancer patients.

Health-related quality of life after oncological resection and reconstruction of the chest wall

There is limited information of the health-related quality of life (HRQoL) after surgical treatment of chest wall tumors. This cross-sectional study aimed to assess long-term HRQoL after chest wall reconstruction following oncological resection. Seventy-eight patients having undergone chest wall tumor resection and reconstruction during 1997-2015 were invited to complete the 15D and QLQ-C30 HRQoL instruments. Altogether, 55 patients (17 men and 38 women), with a mean (SD) age of 68 (14) years, completed the questionnaires (response rate 71%). Patients had been operated due to soft tissue sarcoma (n = 16), advanced breast cancer (n = 15), osteo- or chondrosarcoma (n = 14), or other tumor (n = 10). Median time after primary surgery was 66 (IQR 38, 141) months. The resection was full thickness in 29/55 cases and partial thickness in 26/55 cases. Chest wall reconstruction was required for 47/55 cases (85%). Reconstruction was performed using soft-tissue flap in eight cases, skeletal stabilizations with mesh or mesh-cement-mesh (sandwich method) in 15 cases, and skeletal stabilizations and soft-tissue flap in 24 cases. Patients' mean 15D score (0.878, SD 0.111) was comparable to that of the age- and gender-standardized general population (0.891, SD 0.041). Limitations in breathing and usual activities were noted. The QLQ-C30 cancer-specific HRQoL was 72 points (maximum 100). Scores in the QLQ-C30 Functional scales ranged from 78 (Physical) to 91 (Social). Long-term HRQoL in patients after chest wall reconstruction following oncological resection is fair and comparable to that of the general population. Limitations in breathing and usual activities can occur.