Mastication, swallowing, and salivary flow in patients with head and neck cancer: objective tests versus patient-reported outcomes

Abstract Purpose Before and after treatment for head and neck cancer (HNC), many patients have problems with mastication, swallowing, and salivary flow. The aim of this study was to investigate the association between objective test outcomes of mastication, swallowing, and salivary flow versus patient-reported outcomes (PROs) measuring mastication-, swallowing-, and salivary flow–related quality of life. Methods Data of the prospective cohort “Netherlands Quality of Life and Biomedical Cohort Study” was used as collected before treatment, and 3 and 6 months after treatment. Spearman’s rho was used to test the association between objective test outcomes of the mixing ability test (MAT) for masticatory performance, the water-swallowing test (WST) for swallowing performance, and the salivary flow test versus PROs (subscales of the EORTC QLQ-H&N35, Swallow Quality of Life questionnaire (SWAL-QoL-NL) and Groningen Radiation-Induced Xerostomia (GRIX)). Results Data of 142 patients were used, and in total, 285 measurements were performed. No significant correlations were found between the MAT or WST and subscales of the EORTC QLQ-H&N35. Significant but weak correlations were found between the MAT or WST and 4 subscales of the SWAL-QoL-NL. Weak to moderate correlations were found between the salivary flow test and GRIX at 3 and 6 months after treatment, with the highest correlation between salivary flow and xerostomia during the day (Spearman’s rho = − 0.441, p = 0.001). Conclusion The association between objective test outcomes and PROs is weak, indicating that these outcome measures provide different information about masticatory performance, swallowing, and salivary flow in patients with HNC.

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

Journal of Clinical Oncology ◽

10.1200/jco.19.03158 ◽

2020 ◽

Vol 38 (22) ◽

pp. 2530-2542 ◽

Cited By ~ 1

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.

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Measuring the Quality of Life of Patients with Cancer

European Oncology & Haematology ◽

10.17925/eoh.2014.10.1.10 ◽

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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Patient-reported outcomes from a phase III multicenter, randomized, double-blind, placebo-controlled trial of gefitinib versus placebo in esophageal cancer progressing after chemotherapy: Cancer Oesophagus Gefitinib (COG).

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.4_suppl.6 ◽

2013 ◽

Vol 31 (4_suppl) ◽

pp. 6-6

Author(s):

Susan J. Dutton ◽

Jane M. Blazeby ◽

Russell D. Petty ◽

Wasat Mansoor ◽

Joyce Thompson ◽

...

Keyword(s):

Quality Of Life ◽

Overall Survival ◽

Esophageal Cancer ◽

Patient Reported Outcomes ◽

Predictive Biomarkers ◽

Phase Iii ◽

Patient Reported ◽

Global Quality Of Life ◽

Eortc Qlq

6 Background: There are no randomised trials of 2nd line chemotherapy for esophageal cancer. The phase III COG trial of gefitinib versus placebo in patients with esophageal cancer progressing after chemotherapy did not show significant overall survival (OS) benefit, however the trial incorporated patient reported outcomes (PRO) using validated tools. The PRO data are therefore critical to inform practice and the initial results are presented here. Methods: Adults with measurable/evaluable metastatic esophageal or types I/II junctional adeno or squamous cell carcinoma progressing after prior chemotherapy, with performance status 0-2 were randomised 1:1 to 500mg gefitinib (G) or placebo (P), treated until progression. Primary outcome: OS. Secondary outcomes include safety, PFS, PRO (assessed by EORTC QLQ-C30 and EORTC QLQ-OG25 at baseline 4, 8 and 12 weeks until progression) and predictive biomarkers. Pre-specified PRO domains were global quality of life, dysphagia, eating and odynophagia. Analysis by ANCOVA of change in PRO at 4 weeks adjusted for baseline. Results: 450 patients were recruited from 51 UK centres and no difference in OS was detected. There was evidence that PFS was better in the intervention arm (P 35 days, G 49 days; HR=0.795, 95%CI 0.66, 0.96, p=0.017). Questionnaire compliance rates were excellent at baseline (94%) and at 4 weeks (77%). Patients in the gefitinib arm reported significantly better social function (9.26; 95%CI 1.94 to 16.58; p=0.013) and significantly fewer problems with odynophagia (-8.61; 95%CI -14.49 to -2.73; p=0.004), constipation (-15.24; 95%CI -22.83 to -7.65; p=0.0001) and speech (-10.40; 95%CI -16.13 to -4.67; p=0.0004) than patients receiving placebo but more problems with diarrhoea (19.23; 95%CI 11.79 to 26.27; p<0.0001). All other PRO domains were similar between the two groups. Conclusions: Gefitinib did not improve overall survival in esophageal cancer patients after chemotherapy however there was significant PFS improvement and improvement in quality of life and palliation of symptoms albeit with an excess of diarrhoea. Clinical trial information: 29580179.

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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

Neuro-Oncology ◽

10.1093/neuonc/noz175.855 ◽

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.

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1.5T MR-guided and daily adapted SBRT for prostate cancer: feasibility, preliminary clinical tolerability, quality of life and patient-reported outcomes during treatment

10.21203/rs.2.24255/v1 ◽

2020 ◽

Author(s):

Filippo Alongi ◽

Michele Rigo ◽

Vanessa Figlia ◽

Francesco Cuccia ◽

Niccolò Giaj-Levra ◽

...

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

Patient Reported Outcomes ◽

Adaptive Strategy ◽

Localized Prostate Cancer ◽

Rectal Pain ◽

Genitourinary Toxicity ◽

Patient Reported ◽

Eortc Qlq

Abstract Background Unity Elekta is a unique magnetic resonance (MR)-linac that conjugates a 1.5 Tesla MR unit with a 7 MV flattening filter free accelerator.A prospective observational study for the clinical use of Elekta Unity is currently ongoing in our department. Herein, we present our preliminary report on the feasibility, quality of life, and patient-reported outcomes measures (PROMs) for localized prostate cancer (PC) treated with stereotactic body radiotherapy (SBRT). Methods The SBRT protocol consisted of a 35 Gy schedule delivered in 5 fractions within two weeks. Toxicity and quality of life (QoL) were assessed at baseline and after treatment using the Common Terminology Criteria for Adverse Events v5.0, International Prostatic Symptoms Score (IPSS), ICIQ-SF, IIEF-5, and EORTC-QLQ-C30 and PR-25 questionnaires. Results Between October 2019 and January 2020, 25 patients with localized PC were recruited. The median age was 68 years (range, 54-82); 4 were low risk, 11 favorable intermediate risk (IR) and 10 unfavorable IR. Median iPSA was 6.8 ng/ml (range, 1-19), and 9 of these patients (36%) received concurrent androgen deprivation therapy. Median prostate volume was 36 cc (range, 20-61); median baseline IPSS was 5 (range, 0-10). Median time for fraction was 53 minutes (range, 34-86); adaptive strategy with daily critical structure and target re-contouring and daily replanning (adapt to shape) was performed in all cases. No grade ≥ 3 adverse event was observed, three patients (12%) reported grade 2 acute genitourinary toxicity (urinary frequency, urinary tract pain and urinary retention), while only one patient reported mild rectal pain. No relevant deteriorations were reported in PROMs. Conclusion To the best of our knowledge, this is the first experience reporting feasibility, clinician-reported outcome measurements, and PROMs for 1.5T MR-guided adaptive SBRT for localized prostate cancer. The preliminary data collected here report optimal safety and excellent tolerability, as also confirmed by PROMs questionnaires. Moreover, the data on technical feasibility and timing of online daily adapted planning and delivery are promising. More mature data are warranted.

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

Journal of Clinical Oncology ◽

10.1200/jco.2012.44.4489 ◽

2013 ◽

Vol 31 (10) ◽

pp. 1285-1292 ◽

Cited By ~ 114

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.

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