Health-related quality of life (HRQOL) burden in patients with relapsed/refractory diffuse large B-cell lymphoma (RR-DLBCL) and non-Hodgkin’s lymphoma (RR-NHL).

e20070 Background: CAR T therapy is being investigated as 2nd line therapy in RR-DLBCL. To evaluate its impact on patients’ HRQOL, it is essential to understand the HRQOL of patients receiving current standard of care (SOC) therapy for DLBCL and NHL patients. Methods: A systematic literature review (SLR) of studies reporting HRQOL in RR-DLBCL patients was conducted in March 2019 (updated to include RR-NHL in May 2019) using EMBASE, MEDLINE, Cochrane (all from 2007), Northern Light and International Society for Quality of Life Research abstracts (both from 2017). A targeted literature review (TLR) for untreated or 1st line patients was conducted in July 2019 using PubMed. Search terms included diseases, lines of therapy and patient-reported outcome (PRO) measures. Abstracts and publications were screened for eligibility and data were extracted. Results: Of the 977 publications screened for the SLR, 26 met the inclusion criteria. Another 18 studies were included from the TLR. The most commonly used PRO measures were the SF-36 (10 studies), EORTC QLQ-C30 and FACT-Lym (8 studies each). The EORTC QLQ-C30 showed statistically significant or clinically meaningful changes in a greater number of domains (86%) than the FACT-Lym (75%) and SF-36 (62%). Additional results in table. Conclusions: While research is limited, RR-DLBCL patients receiving current SOC therapy report decreases in HRQOL and health utility. Further research is needed on how existing and future therapies may affect HRQOL among RR-DLBCL patients. [Table: see text]

Download Full-text

Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4039 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4039-4039 ◽

Cited By ~ 2

Author(s):

Scott Kopetz ◽

Axel Grothey ◽

Eric Van Cutsem ◽

Rona Yaeger ◽

Harpreet Singh Wasan ◽

...

Keyword(s):

Quality Of Life ◽

Colorectal Cancer ◽

Standard Of Care ◽

Current Standard ◽

Patient Reported ◽

Eortc Qlq C30 ◽

Euroqol 5D ◽

Eortc Qlq ◽

Triplet Regimen

4039 Background: In the BEACON CRC study, the triplet regimen of encorafenib (ENCO) + binimetinib (BINI) + cetuximab (CETUX) significantly improved overall survival (OS, HR:0.52, P < 0.0001) and objective response rates (ORR, 26% vs 2%, P < 0.0001) in patients (pts) with BRAFV600E metastatic colorectal cancer (mCRC) compared with current standard of care. This analysis focuses on the patient-reported quality of life (QOL) assessments from this study. Methods: The BEACON CRC study was a randomized, open-label, 3-arm, phase 3 global study which evaluated triplet (ENCO+BINI+CETUX) or doublet (ENCO+CETUX) vs. investigator’s choice of irinotecan + CETUX or FOLFIRI + CETUX in pts with BRAFV600E mCRC. QOL assessments (secondary endpoints in the trial) included the EORTC QOL Questionnaire (QLQ C30), Functional Assessment of Cancer Therapy Colon Cancer (FACT C), EuroQol 5D 5L, and Patient Global Impression of Change (PGIC). The primary assessment for the QOL variables was the time to definitive 10% deterioration. The study is ongoing. Results: 665 pts were randomly assigned to receive either triplet (n = 224), doublet (n = 220), or control (n = 221). Reduction in the risk of QOL deterioration was an estimated 45% (HR 0.55, 95% CI: 0.43, 0.70) and 52% (HR 0., 9485% CI: 0.38, 0.62) in EORTC QLQ C30 and FACT C assessments, respectively, in favor of the triplet regimen over control. For the doublet vs. control, reduction in risk of QOL deterioration was an estimated 46% (HR 0.54, 95% CI: 0.43, 0.69) and 54% (HR 0.46, 95% CI: 0.36, 0.59) in EORTC QLQ C30 and FACT C, respectively in favor of the doublet. Similar results were observed in EuroQol 5D 5L and PGIC assessments. There were no overall differences in QOL between triplet and doublet across the 4 instruments. Conclusions: In BEACON CRC, triplet and doublet demonstrated substantial improvement in patient-reported QOL assessments over the current standard of care in pts with BRAFV600E-mutant metastatic CRC whose disease had progressed after 1 or 2 prior regimens. Clinical trial information: NCT02928224 .

Download Full-text

Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.8 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 8-8 ◽

Cited By ~ 12

Author(s):

Scott Kopetz ◽

Axel Grothey ◽

Eric Van Cutsem ◽

Rona Yaeger ◽

Harpreet Singh Wasan ◽

...

Keyword(s):

Quality Of Life ◽

Standard Of Care ◽

Braf V600e ◽

Current Standard ◽

Patient Reported ◽

Eortc Qlq C30 ◽

Euroqol 5D ◽

Eortc Qlq ◽

Triplet Regimen

8 Background: In the BEACON CRC study, the triplet regimen of encorafenib (ENCO) + binimetinib (BINI) + cetuximab (CETUX) significantly improved overall survival (OS, HR:0.52, P < 0.0001) and objective response rates (ORR, 26% vs 2%, P < 0.0001) in patients (pts) with BRAF V600E metastatic colorectal cancer (mCRC) compared with current standard of care. This analysis focuses on the patient-reported quality of life (QOL) assessments from this study. Methods: The BEACON CRC study was a randomized, open-label, 3-arm, phase 3 global study which evaluated triplet (ENCO+BINI+CETUX) or doublet (ENCO+CETUX) vs. investigator’s choice of irinotecan + CETUX or FOLFIRI + CETUX in pts with BRAFV600E mCRC. QOL assessments (secondary endpoints in the trial) included the EORTC QOL Questionnaire (QLQ C30), Functional Assessment of Cancer Therapy Colon Cancer (FACT C), EuroQol 5D 5L, and Patient Global Impression of Change (PGIC). The primary assessment for the QOL variables was the time to definitive 10% deterioration between arms. Results: 665 pts were randomly assigned to receive either triplet (n = 224), doublet (n = 220), or control (n = 221). Reduction in the risk of QOL deterioration was an estimated 45% (HR 0.55, 95% CI: 0.43, 0.70) and 44% (HR 0.56, 95% CI: 0.44, 0.71) in EORTC QLQ C30 and FACT C assessments, respectively, in favor of the triplet regimen over control. For the doublet vs. control, reduction in risk of QOL deterioration was an estimated 46% (HR 0.54, 95% CI: 0.43, 0.69) and 43% (HR 0.57, 95% CI: 0.45, 0.72) in EORTC QLQ C30 and FACT C, respectively in favor of the doublet. Similar results were observed in EuroQol 5D 5L and PGIC assessments. There were no overall differences in QOL between triplet and doublet across the 4 instruments. Conclusions: In BEACON CRC, triplet and doublet demonstrated substantial improvement in patient-reported QOL assessments over the current standard of care in pts with BRAF V600E-mutant metastatic CRC whose disease had progressed after 1 or 2 prior regimens. Clinical trial information: NCT02928224.

Download Full-text

Long-Term Quality of Life of Acute Promyelocytic Leukemia Patients Treated with Arsenic Trioxide versus Chemotherapy

Blood Advances ◽

10.1182/bloodadvances.2021004649 ◽

2021 ◽

Author(s):

Fabio Efficace ◽

Uwe Platzbecker ◽

Massimo Breccia ◽

Francesco Cottone ◽

Paola Carluccio ◽

...

Keyword(s):

Quality Of Life ◽

Arsenic Trioxide ◽

Acute Promyelocytic Leukemia ◽

Promyelocytic Leukemia ◽

Sf 36 ◽

Patient Reported ◽

Eortc Qlq C30 ◽

Eortc Qlq

The main objective of this study was to compare the long-term health-related quality of life of patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) versus ATRA plus standard chemotherapy. Patients previously enrolled in the randomized controlled trial APL0406 were considered eligible for this follow-up study. The following patient-reported outcome measures were used: the EORTC QLQ-C30, the EORTC QLQ-CIPN20 and the SF-36. The prevalence of late comorbidities and health problems was also assessed. The clinical significance of differences was evaluated based on predefined thresholds. This study was registered at ClinicalTrials.gov (NCT03096496). One hundred sixty-one out of 232 potentially eligible patients were analyzed, of whom 83 were treated with ATRA-ATO and 78 were treated with ATRA-chemotherapy. The median time since diagnosis of the study sample was 8 years. The two largest clinically meaningful differences in the EORTC QLQ-C30 were observed for role functioning (Δ=8.4, 95% CI, 0.5 to 16.3) and dyspnea (Δ=-8.5, 95% CI, -16.4 to -0.7), favoring patients treated with ATRA-ATO. With regard to the SF-36 results, a clinically relevant better physical component score (Δ=4.6, 95% CI, 1.3 to 7.8) was observed in patients treated with ATRA-ATO, but this was not the case for the mental component score. The two groups showed similar profiles in the scores of the EORTC QLQ-CIPN20 scales and in the prevalence of late comorbidities. Overall, our findings suggest that the greater and more sustained antileukemic efficacy of ATRA-ATO is also associated with better long-term patient-reported outcomes than ATRA-chemotherapy.

Download Full-text

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

Radiotherapy and Oncology ◽

10.1016/j.radonc.2010.01.017 ◽

2010 ◽

Vol 97 (2) ◽

pp. 270-275 ◽

Cited By ~ 22

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

Download Full-text

Difficulties with Measuring the Patient's Perspective in Non Hodgkin's Lymphoma - a Review of Patient Reported Outcome Measures

Blood ◽

10.1182/blood.v120.21.4703.4703 ◽

2012 ◽

Vol 120 (21) ◽

pp. 4703-4703

Author(s):

Jyotsna Mehta ◽

Florence Joulain ◽

Peter C Trask ◽

Bonnie Teschendorf

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Clinical Benefit ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

Medical Attention ◽

Eortc Qlq C30 ◽

Eortc Qlq ◽

Pro Instruments

Abstract Abstract 4703 Aims: Patients with NHL present with a classic array of symptoms reflecting the origin of the cancer itself. Symptoms include painless swelling of lymph nodes, increased sensitivity to alcohol, weight loss which can be substantial, persistent fever, soaking night sweats, itchy skin, coughing, difficulty breathing, chest or upper back pain and persistent weakness and tiredness. The severity of symptoms alters the patient's perception of quality of life, their capacity to perform usual activities, and results in seeking medical attention. Due to profound symptoms, it is critical to use excellent measurement tools to record change and demonstrate clinical benefit in trials. The objective of the study was to describe and assess the PRO instruments used in lymphoma, summarize PROs used in ongoing clinical trials, identify gaps in existing PRO measures and evaluate the potential for labeling when using these measures for patient self-report in advanced NHL, particularly as it relates to selecting and implementing PROs. Methods: An in depth literature review was conducted. Elsevier and Medline databases were consulted using Embase platform. Studies were included if they were: published from 01/01–12/11, in English, and included terms related to lymphoma disease and PROs. A thorough review of abstracts was performed. Studies where PRO instruments were used and/or psychometric validation was performed were included. References for selected articles were used to identify other relevant sources. Clinical trials.gov was also used to search for lymphoma trials from 2001–2011. Results: Of 1278 hits, 17 articles met the search criteria. 7 PRO instruments were reported or used in NHL: 2 lymphoma specific questionnaires FACT-Lym (Functional Assessment of Cancer Therapy-Lymphoma module), FACT FLymSI-18 (FACT-Lymphoma Symptom Index), 5 cancer-specific instruments (EORTC-QLQ-C30, FACT-G, CARES (Cancer Rehabilitation Evaluation System), CARES-SF, QOL-CS (Quality of Life-Cancer Survivors), IOC (Impact Of Cancer scale). The 2 most widely used PROs were FACT-Lym and the EORTC QLQ C30. PRO instruments have been included in ongoing phase 2 and 3 clinical trials (Table 1) as secondary endpoints, including 2 in Diffuse Large B-cell lymphoma (DLBCL), 4 in Follicular lymphoma (FL), and 1 each in indolent NHL or mantle cell lymphoma (MCL). EORTC QLQ C30 was the most common instrument followed by FACT-Lym. No specific labeling claims were found in labels made to date for NHL related compounds to FDA or EMA. Conclusions: While there are some lymphoma specific measures, most ongoing trials are using only cancer specific instruments such as EORTC QLQ C30. Several instruments contain only general cancer related symptoms, but not NHL specific symptoms. To more completely understand the burden of disease and treatment effects with NHL through the eyes of patients, evaluation of existing instruments as well as potential instrument development/modification may be warranted. NHL symptom-specific measures could demonstrate therapeutic effectiveness, enhance our understanding of the impact of NHL and provide more evidence of clinical benefit for developing treatments. Disclosures: Mehta: Sanofi: Employment. Joulain:Sanofi: Employment, Equity Ownership. Trask:Sanofi: Employment.

Download Full-text

QUALITY OF LIFE OF PATIENTS WITH OVARIAN CANCER OF THE THIRD STAGE USING DIFFERENTIATED TREATMENT

EUREKA Health Sciences ◽

10.21303/2504-5679.2017.00405 ◽

2017 ◽

Vol 5 ◽

pp. 37-43

Author(s):

Andriy Rybin

Keyword(s):

Quality Of Life ◽

Ovarian Cancer ◽

Life Quality ◽

Results Of Treatment ◽

Sf 36 ◽

Third Stage ◽

Eortc Qlq C30 ◽

Eortc Qlq ◽

The Relationship

The aim of this research was to assess the quality of life in patients with stage III ovarian cancer during the treatment period, depending on the applied therapeutic approaches. A comparative analysis of the results of treatment of 350 patients with adenocarcinoma of the ovaries of III-IV stage, which have undergone suboptimal or non-optimal cytomelective surgery, was conducted. To assess the quality of life and to examine the relationship between changes in physical health and quality of life, patients in both groups were asked to complete the questionnaires EORTC QLQ-C30 and SF-36. According to the questionnaire of the EORTC QLQ-C30, the indicators of physical activity, the ability to do everyday affairs, were higher in the second group of patients who received differentiated treatment. The indicator of "social functioning" was also higher in the II group of patients. When evaluating the patients' liver on the scale of the questionnaire SF-36, it was found that the positive effect of differentiated therapy is maintained for 3 years. Life quality is an important criterion for evaluating the results of antitumor therapy, and when it is continuously monitored in patients with ovarian cancer the safety of treatment for patients could be improved, including at an advanced stage

Download Full-text

Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study

Annals of Surgical Oncology ◽

10.1245/s10434-021-09646-z ◽

2021 ◽

Author(s):

André L. Mihaljevic ◽

Keyword(s):

Quality Of Life ◽

Postoperative Complications ◽

Computerized Adaptive Testing ◽

Cancer Surgery ◽

Life Questionnaire ◽

Cancer Symptoms ◽

Patient Reported ◽

Eortc Qlq C30 ◽

Eortc Qlq

Abstract Background The patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the computerized adaptive testing (CAT) version of the EORTC quality-of-life questionnaire QLQ-C30 have been proposed as new PRO measures in oncology; however, their implementation in patients undergoing cancer surgery has not yet been evaluated. Methods Patients undergoing elective abdominal cancer surgery were enrolled in a prospective multicenter study, and postoperative complications were recorded according to the Dindo–Clavien classification. Patients reported PRO data using the CAT EORTC QLQ-C30 and the PRO-CTCAE to measure 12 core cancer symptoms. Patients were followed-up for 6 months postoperatively. The study was carried out by medical students of the CHIR-Net SIGMA study network. Results Data of 303 patients were obtained and analyzed across 15 sites. PRO-CTCAE symptoms ‘poor appetite’, ‘fatigue’, ‘exhaustion’ and ‘sleeping problems’ increased after surgery and climaxed 10–30 days postoperatively. At 3–6 months postoperatively, no PRO-CTCAE symptom differed significantly to baseline. Patients reported higher ‘social functioning’ (p = 0.021) and overall quality-of-life scores (p < 0.05) 6 months after cancer surgery compared with the baseline level. There was a lack of correlation between postoperative complications or death and any of the PRO items evaluated. Feasibility endpoints for student-led research were met. Conclusion The two novel PRO questionnaires were successfully applied in surgical oncology. Postoperative complications do not affect health-reported quality-of-life or common cancer symptoms following major cancer surgery. The feasibility of student-led multicenter clinical research was demonstrated, but might be enhanced by improved student training.

Download Full-text

Quality of life and adverse drug reaction measured in patients undergoing cancer chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.31_suppl.214 ◽

2014 ◽

Vol 32 (31_suppl) ◽

pp. 214-214

Author(s):

Harminder Singh ◽

Raja Banipal ◽

Ritu Bala

Keyword(s):

Quality Of Life ◽

Adverse Drug Reaction ◽

Drug Reaction ◽

Symptom Scale ◽

Appetite Loss ◽

Financial Difficulties ◽

Patient Reported ◽

Eortc Qlq C30 ◽

Eortc Qlq

214 Background: Cancer prevalence in India is estimated around 2.0-2.5 million, 0.7- 0.8 million new cases identified every year, and cancer deaths reported per year is 0.4-0.5 Million. The objective of this study was to analyze and compare patient-reported QoL (quality of life), and their physical/psychosocial symptom and adverse drug reaction in cancer patients. Methods: Study done by questionnaire EORTC QLQ-C30. Comparison among 3 distinctive groups (G) (varied number of Chemotherapy cycles) was done. ADR measured appropriately Results: 131 patients were recruited and QoL scoring GHS (global health status) and 4 items of symptom scale i.e. insomnia, pain, appetite loss, constipation, and financial difficulties attained a significance difference. GHS significantly improved in G3 as compared to G1, indicating that the patient overall health improved as the chemotherapy sessions progressed. Female patients had more ADR (mean 3.2/person) and G3 had more ADR (mean 3.96). Conclusions: QoL score didn’t show significant improvement in all areas (except insomnia, pain, appetite loss, constipation & financial difficulties), a judicious diagnosis with an appropriate treatment including chemotherapy may lessen the negative perception of cancer. [Table: see text]

Download Full-text

Effect of lisocabtagene maraleucel on HRQoL and symptom severity in relapsed/refractory large B-cell lymphoma

Blood Advances ◽

10.1182/bloodadvances.2020003503 ◽

2021 ◽

Vol 5 (8) ◽

pp. 2245-2255

Author(s):

Donald L. Patrick ◽

Annette Powers ◽

Monika Parisi Jun ◽

Yeonhee Kim ◽

Jacob Garcia ◽

...

Keyword(s):

Quality Of Life ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

Meaningful Improvement ◽

Large B Cell Lymphoma ◽

Car T ◽

Eortc Qlq C30 ◽

Eortc Qlq ◽

Large B Cell

Abstract CD19-directed chimeric antigen receptor (CAR) T-cell therapy has shown efficacy as a third-line or later treatment in patients with relapsed/refractory large B-cell lymphoma (LBCL). Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, we evaluated the impact of CAR T-cell treatment with lisocabtagene maraleucel (liso-cel) on health-related quality of life (HRQoL) and symptoms in patients with relapsed/refractory LBCL in the ongoing, open-label, nonrandomized TRANSCEND NHL 001 trial. Clinically meaningful improvement was observed in EORTC QLQ-C30 scores for global health status/QoL, based on a minimally important difference of 10 points at 2 to 18 months after liso-cel infusion. There were no clinically meaningful changes in physical functioning and pain, whereas clinically meaningful improvements were observed in fatigue at 2, 12, and 18 months. The proportion of patients with clinically meaningful improvement in global health status/QoL was generally higher for treatment responders than for nonresponders. A trend toward decreased mean EQ-5D-5L index scores was observed at 1 month after liso-cel infusion, followed by subsequent increases through 18 months. Mean EQ-5D-5L visual analog scale scores increased from 2 through 18 months. In summary, patients with relapsed/refractory LBCL treated with liso-cel had early, sustained, and clinically meaningful improvements in HRQoL and symptoms that correlated with antitumor activity. This study was registered at www.clinicaltrials.gov as #NCT02631044.

Download Full-text