scholarly journals Effect of Ruxolitinib Therapy on Myelofibrosis-Related Symptoms and Other Patient-Reported Outcomes in COMFORT-I: A Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 31 (10) ◽  
pp. 1285-1292 ◽  
Author(s):  
Ruben A. Mesa ◽  
Jason Gotlib ◽  
Vikas Gupta ◽  
John V. Catalano ◽  
Michael W. Deininger ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Patient Reported Outcomes ◽  
Spleen Volume ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Purpose To assess the effects of ruxolitinib on symptom burden and quality of life (QoL) and to evaluate the ability of the modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 to measure meaningful changes in myelofibrosis-related symptoms in patients with myelofibrosis. Patients and Methods COMFORT-I (Controlled Myelofibrosis Study With Oral JAK Inhibitor Treatment–I) is a double-blind, placebo-controlled phase III study evaluating ruxolitinib in patients with intermediate-2 or high-risk myelofibrosis. Exploratory analyses were conducted on the following patient-reported outcomes (PROs) assessments: modified MFSAF v2.0 (individual symptoms and Total Symptom Score [TSS]), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale, and Patient Global Impression of Change (PGIC). Results Patients receiving ruxolitinib experienced improvements in individual myelofibrosis-related symptoms, although patients receiving placebo experienced worsening (P < .001). The majority (91%) of ruxolitinib-treated patients designated as ≥ 50% TSS responders (≥ 50% TSS improvement) self-reported their condition as either “Much improved” or “Very much improved” on the PGIC. These patients achieved significant improvements in the EORTC QLQ-C30 functional domains and Global Health Status/QoL versus patients receiving placebo, who experienced worsening on these measures (P ≤ .0135). Ruxolitinib-treated patients with a lesser degree of symptom improvement (< 50% TSS responders) also achieved improvements over placebo on these measures. The degree of spleen volume reduction with ruxolitinib correlated with improvements in TSS, PGIC, PROMIS Fatigue Scale, and EORTC Global Health Status/QoL. Ruxolitinib-treated patients who achieved a ≥ 35% reduction in spleen volume experienced the greatest improvements in these PROs. Conclusion Ruxolitinib-treated patients achieved clinically meaningful improvements in myelofibrosis-related symptoms and QoL, but patients receiving placebo reported worsening of symptoms and other PROs.

scholarly journals QOLP-35. OUTCOMES AND CORRELATIONS BETWEEN LEGACY QUALITY OF LIFE MEASURES (EORTC-C30/EORTC-BN20) AND THE ELECTRONIC QUALITY OF LIFE MEASURING SYSTEM NIH-PROMIS IN GLIOBLASTOMA PATIENTS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi205-vi205
Author(s):  
Tobias Walbert ◽  
Lonni Schultz ◽  
James Snyder ◽  
Aarushi Suneja
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Correlation Coefficients ◽  
European Organization ◽  
P Values ◽  
Gi Symptoms ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Abstract BACKGROUND Health-related quality of life (QoL) and patient reported outcomes are essential to guide patient-care. The NIH sponsored electronic Patient-Reported Outcomes Measurement Information System (PROMIS) is well established in multiple cancers but not in Glioblastoma (GBM). The aim of this study was to analyze the association of the PROMIS measures with the European Organization for Research and Treatment of Cancer core instrument (EORTC-QLQ-C30) and the brain tumor specific EORTC QLQ-BN20 questionnaire (EORTC-BN20) in GBM patients. METHODS Newly diagnosed patients with GBM were enrolled prospectively to assess association between both tools. The PROMIS modules were selected to reflect the quality of life domains assessed in the EORTC- QLQ-C30 and EORTC-BN20 questionnaires. Pearson’s correlation coefficients were computed between the PROMIS and EORTC-C30/ EORTC-BN20 measures. Due to multiple responses over time, the p-values for the correlation coefficients were adjusted. Because of the large number of correlations computed and many with p-values less than 0.05, the magnitude of the correlation was considered. Correlations greater than 0.5 or less than -0.5 were consider to be “strong” associations, while correlations between 0.3 and 0.499 (or -0.3 and -0.499) were consider to be “moderate”. RESULTS 43 patients with 124 PROMIS/EORTC responses were included in this analysis. The PROMIS measures had strong associations with the QoL functioning and fatigue measures from the EORTC-C30 and future uncertainty, communication deficit, motor dysfunction, social satisfaction and drowsiness from the EORTC-BN20 (all p< 0.001 and correlation >0.5). CONCLUSIONS There are strong and moderate correlations in the majority of PROMIS assessments and the EORTC tools. The PROMIS toolkit may be used to assess core features of the EORTC surveys. GI symptoms, seizures and itchy skin do not correlate. Given the prior documented shorter assessment time, the PROMIS toolkit may be a feasible alternative to established legacy tools to assess QoL in GBM patients.

FOENIX-CCA2 quality of life data for futibatinib-treated intrahepatic cholangiocarcinoma (iCCA) patients with FGFR2 fusions/rearrangements.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4097-4097
Author(s):  
Juan W. Valle ◽  
Antoine Hollebecque ◽  
Junji Furuse ◽  
Lipika Goyal ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Global Health Status ◽  
Phase 2 ◽  
Life Data ◽  
Eortc Qlq C30 ◽  
Eortc Qlq ◽  
Eq Vas

4097 Background: In FOENIX-CCA2 (NCT02052778), a pivotal phase 2 study among iCCA patients (pts) with FGFR2 fusions/rearrangements, the highly selective, irreversible FGFR1–4 inhibitor futibatinib demonstrated a confirmed objective response rate of 41.7%, with a 9.7-month median duration of response. Adverse events were manageable with dosing modifications that did not adversely impact on response. We report outcomes for the preplanned analysis of Patient-Reported Outcomes (PROs) during futibatinib treatment as a secondary objective of FOENIX-CCA2. Methods: Pts enrolled in FOENIX-CCA2 had locally advanced/metastatic unresectable iCCA with FGFR2 fusions/rearrangements, ≥1 prior line of therapy (including gemcitabine/cisplatin) and ECOG PS 0-1. Pts received oral futibatinib 20 mg continuous QD dosing per 21-day cycle. PRO measures included EORTC-QLQ-C30 (1 global health, 5 functional, 9 symptom scales), EQ-5D-3L, and EQ visual analogue scale (VAS). PROs were collected at screening, cycles 2 and 4, every 3 cycles thereafter, and end of treatment. PRO data were evaluated up to cycle 13, the last visit before data were missing for >50% of the PRO population (PRO primary assessment time point). Results: 92/103 (89.3%) pts enrolled had PRO completion data at baseline and a minimum of 1 follow-up assessment (median age 58 y, 56.5% female), with 48 pts having PRO data at cycle 13. At baseline, mean (SD) EORTC QLQ-C30 global health status score was 70.1 (19.4) and EQ VAS score 71.7 (20.3). Mean EORTC QLQ-C30 global health status scores were maintained from baseline to cycle 13, corresponding to 9.0 months on treatment, with no clinically meaningful (≥10-point) changes in individual functional measures (Table). EORTC QLQ-C30 scores across individual symptom measures were also stable from baseline through cycle 13; only constipation showed an average of 10.0-point worsening at only cycle 4. Mean EQ VAS scores were sustained from baseline to cycle 13 (mean change ranging -1.8 to +4.8 across cycles), with values maintained within the population norm range from across 20 countries. Conclusions: Quality of life data from the phase 2 FOENIX-CCA2 trial show that physical, cognitive and emotional functioning, and overall health status were maintained among pts with advanced iCCA receiving futibatinib. Clinical trial information: NCT02052778. [Table: see text]

scholarly journals Quality of Life in Patients with Primary CNS Lymphoma - a Pooled Analysis from Three Prospective Multicentre Trials

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5385-5385
Author(s):  
Benjamin Kasenda ◽  
Gabriele Ihorst ◽  
Heidi Fricker ◽  
Elke Valk ◽  
Elisabeth Schorb ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Multivariable Analysis ◽  
Newly Diagnosed ◽  
Eortc Qlq C30 ◽  
Beta Coefficient ◽  
Relapsed Disease ◽  
Eortc Qlq ◽  
Over Time

Abstract Background Primary CNS lymphoma (PCNSL) is a rare extra nodal non-Hodgkin lymphoma. High-dose methotrexate (HD-MTX) based treatment has improved prognosis, but little is known about the development of quality of life (QoL) during treatment and follow-up from prospective trials. Methods We pooled data from three prospective trials including 225 immunocompetent patients with PCNSL (186 [83%] with newly diagnosed and 39 [17%] with relapsed disease) - all received HD-MTX based polychemotherapy with rituximab. QoL was a pre-specified secondary endpoint in all trials and evaluated using the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaire at start of treatment, after completion of treatment and during follow-up. We used descriptive statistics to summarize QoL over time. To investigate the development of QoL over time adjusted for age and Karnofsky performance status (KPS), we used multivariable linear regression models with a random effect to account for repeat measurements. We also did two separate analyses for patients with newly diagnosed PCNSL and relapsed disease. Multiple imputations were applied for missing values within a questionnaire, but we did not impute values of questionnaires that were missing completely. We herein report results on the global health status (GHS, item 30 of EORTC QLQ-C30, higher values represent better QoL) and the predominant item of the EORTC QLQ-BN20 (future uncertainty, higher values represent worse QoL). A change of 10% on the respective scale was considered as a clinically meaningful difference (Osoba et al, Eur J Cancer. 2005 Jan;41(2):280-7 and Maringwa et al, Ann Oncol. 2011 Sep;22(9):2107-12). Results The median age and KPS was 62 years (range 20 to 85) and 80% (30% to 100%), respectively, 119 (52%) were female. Before treatment, the median GHS of the EORTC QLQ-C30 was 50 (interquartile range [IQR] 33 to 67) reflecting substantial impaired QoL. After completion of treatment, the median GHS significantly increased by 17 points to a median of 67 (IQR 50 to 71) (P<0.001), which reflects a clinically meaningful difference. This positive effect was consistent in multivariable analysis (beta coefficient 0.37, p<0.001). Patient with a better KPS before starting treatment had a higher chance that their QoL improved over time (beta coefficient 0.26, p=0.0029). There was no difference regarding GHS between patients with newly diagnosed PCNSL or patients with relapsed disease before starting treatment (median GHS both 50). However, in patients with relapsed disease, numerical increase of GHS over time did not reach statistical significance (beta coefficient 0.36, p=0.2185) likely to limited power in the multivariable analysis. The overall development of GHS over time is shown in Figure 1. The dip at months 17 and 18 area is associated with disease relapse. Regarding the EORTC QLQ-BN20 questionnaire, the predominant issue for patients was future uncertainty (median 42, IQR 17 to 67) before starting treatment, which significantly improved after treatment to 25 (IQR 8 to 33) (p<0.001). In multivariable analysis, future uncertainty also improved significantly in separate analyses for patients with newly diagnosed PCNSL (beta coefficient -0.45, p=0.005) and relapsed disease (beta coefficient -0.89, p=0.0049). The overall development of future uncertainty over time is shown in Figure 2. The increase at months 17 and 18 area is associated with disease relapse. Conclusions Patients with newly diagnosed or relapsed PCNSL reported substantial impaired QoL before starting treatment. However, after treatment with HD-MTX based chemotherapy, QoL significantly improved over time and patients were also more confident regarding their future. Results from our analyses provide a reference for future studies on this important issue in the care of patients with PCNSL. At the meeting we will present further analyses and results from all domains of the EORTC QLQ-C30 and EORTC QLQ-BN20 questionnaires. Figure 1 Global Health Status development from the EORTC QLQ-C30 questionnaire (higher values denote better quality of life) Figure 1. Global Health Status development from the EORTC QLQ-C30 questionnaire (higher values denote better quality of life) Figure 2 Future uncertainty from the EORTC QLQ-BN20 questionnaire (lower values denote better quality of life) Figure 2. Future uncertainty from the EORTC QLQ-BN20 questionnaire (lower values denote better quality of life) Disclosures Kasenda: Riemser: Other: Travel Support. Illerhaus:Riemser, Amgen: Honoraria.

scholarly journals Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non–Small-Cell Lung Cancer

2020 ◽  
Vol 38 (22) ◽  
pp. 2530-2542 ◽  
Author(s):  
Martin Reck ◽  
Thomas Wehler ◽  
Francisco Orlandi ◽  
Naoyuki Nogami ◽  
Carlo Barone ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Patient Reported Outcomes ◽  
Small Cell ◽  
Small Cell Lung ◽  
Patient Reported ◽  
Eortc Qlq ◽  
Nonsquamous Nsclc

PURPOSE Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non–small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC. METHODS Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13. RESULTS Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5% v 8.2%; ABCP, 48.6% v 21.2%; BCP, 44.7% v 11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly. CONCLUSION ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.

Comparison of patient-reported late treatment toxicity (LENT–SOMA) with quality of life (EORTC QLQ-C30 and QLQ-H&N35) assessment after head and neck radiotherapy

2010 ◽  
Vol 97 (2) ◽  
pp. 270-275 ◽  
Author(s):  
Kean Fatt Ho ◽  
Damien J.J. Farnell ◽  
Jacqueline A. Routledge ◽  
Meriel P. Burns ◽  
Andrew J. Sykes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Treatment Toxicity ◽  
Patient Reported ◽  
Eortc Qlq C30 ◽  
Late Treatment ◽  
Eortc Qlq ◽  
Head And Neck Radiotherapy

Measuring the Quality of Life of Patients with Cancer

2014 ◽  
Vol 10 (01) ◽  
pp. 10
Author(s):  
Efstathios Zikos ◽  
Corneel Coens ◽  
John Bean ◽  
Divine Ediebah ◽  
Andrew Bottomley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Patient Reported Outcomes ◽  
Patient Perspective ◽  
Meta Analysis ◽  
Randomised Clinical Trial ◽  
The United States ◽  
Prognostic Indicators ◽  
Patient Reported ◽  
Eortc Qlq

What is quality of life? Clinical trials have long been dominated by clinically based endpoints, but research has proved that health-related quality of life (HRQoL) can only be captured accurately by patients themselves using patient-reported outcomes (PROs). The United States Food and Drug Administration defines PROs as the measurement of any aspect of a patient’s health status that comes directly from the patient, that is, a measurement taken without interpretation of the patient’s responses by a physician or anyone else. The EORTC QLQ-C30 is the most widely cancer specific HRQoL questionnaire used for PROs in the world. Developed in 1991 by the EORTC Quality of Life Group, it has been translated into more than 60 languages and has over 40 developed or under development cancer-specific modules. One of the key challenges faced is pooling data and performing meta-analyses of the results of closed trials. The EORTC Patient Reported Outcomes and Behavioural Evidence (PROBE) team is dedicated to the meta-analysis of EORTC randomised clinical trial quality of life results. During the last 5 years, pooled data have revealed important results, such as prognostic indicators of survival, which have informed clinical practice. This research shows how the patient perspective in palliative and curative EORTC trials has been considered of major importance. The inclusion of patient perspective in drug development shows that a more comprehensive HRQoL assessment has taken place over time as better instruments have become available. As clinicians, regulatory bodies and industry acknowledge the value of the patient perspective, we expect that EORTC will continue including HRQoL endpoints where appropriate.

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