Health-related quality-of-life (HRQoL) results from the FAST study: A phase II trial of epirubicin, oxaliplatin, and capecitabine with or without IMAB362 in patients with advanced CLDN18.2+ gastric and gastroesophageal junction adenocarcinoma.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 54-54 ◽  
Author(s):  
Robert Morlock ◽  
James Turnbull ◽  
Steven Blahut ◽  
Michelle R Krukas-Hampel ◽  
Emily Hawryluk ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Repeated Measures ◽  
Mixed Model ◽  
Gastroesophageal Junction ◽  
Global Health Status ◽  
Minimally Clinically Important Difference ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Related Quality ◽  
Health Related

54 Background: In the FAST study, IMAB362 (loading dose 800 mg/m2 then 600 mg/m2 d1 qd21) plus EOX (epirubicin 50 mg/m2 and oxaliplatin 130 mg/m2 d1, and capecitabine 625 mg/m2 bid) was compared with EOX alone in patients with advanced/metastatic gastric (GA), gastroesophageal (GE), and gastroesophageal junction (GEJ) adenocarcinoma. The FAST study exhibited a clinically relevant benefit in PFS and OS with a manageable safety profile in patients treated with IMAB362. Here we present the HRQoL results from the FAST study. Methods: CLDN18.2-positive patients (intermediate/strong membrane staining in ≥40% of cells) with advanced/metastatic GA/GE/GEJ adenocarcinoma were randomized 1:1 to first-line EOX for a maximum of 8 cycles with or without 600 mg/m2 q3w IMAB362, which after 8 cycles could be continued as monotherapy until disease progression (DP). The EORTC QLQC30 and a gastric cancer specific measure EORTC STO22 were collected at baseline (BL), Cycle 5, end of EOX therapy (EOT) and post-EOT every 12 weeks until DP. Change from BL in EORTC scores over 8 cycles of EOX treatment were analyzed using mixed model repeated measures. Time to deterioration in HRQoL was defined as time from randomization to first minimally clinically important difference (MCID) decline in each HRQoL domain. Results: The HRQoL analysis included 74 EOX and 68 IMAB362 + EOX per protocol patients. There were no significant differences in mean changes from BL in EORTC QLQC30 Global Health Status/QoL Score and STO22 Total Score across the 8 cycles of treatment with EOX. The QLQC30 Nausea and Vomiting domain showed a statistical difference (p = 0.0108) in favor of EOX-only. The median time to first HRQoL MCID deterioration for the QLQC30 Global Health Status was 8.6 mo for EOX + IMAB362 and 6.0 mo for EOX alone (p = 0.008). For patients who remained on IMAB362 post EOT, HRQoL improved from BL. Conclusions: HRQoL was maintained for a longer duration in pts with advanced/metastatic GA/GE/GEJ adenocarcinoma who received EOX + IMAB362 therapy vs EOX alone. HRQoL post EOT was improved for EOX + IMAB362 therapy vs EOX alone. Clinical trial information: NCT01630083.

scholarly journals Deterioration of Health-Related Quality of Life Scores under Treatment Predicts Longer Survival

2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Maike Jörling ◽  
Sandra Rutzner ◽  
Markus Hecht ◽  
Rainer Fietkau ◽  
Luitpold V. Distel
Keyword(s):  
Quality Of Life ◽  
Overall Survival ◽  
Health Status ◽  
Global Health ◽  
Cox Regression ◽  
Global Health Status ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Objectives. Baseline health-related quality of life (HRQoL) scores predict survival, which has already been demonstrated in various studies. However, we were interested in whether changes in baseline scores during treatment are also significant predictors of survival. Methods and Materials. We analysed the data of 400 consecutive cancer patients receiving radiochemotherapy. Leading diagnoses were head and neck cancer (34.5%), rectal cancer (24.5%), and lung cancer (13%). HRQoL was studied at baseline, six weeks after therapy and after each completed year after the start of therapy until drop out of the study using the EORTC QLQ-C30 questionnaire. The change score was calculated as the baseline score subtracted from the score after therapy. Statistics included Kaplan-Meier estimates and Cox regression. Results. High global health status (p=0.005) and low pain scores (p=0.040) at baseline were related to favourable overall survival. Change scores of role functioning (p=0.027), global health status (p<0.018), and pain (p<0.001) were predictive of overall survival. Pain was the superior predictor of survival (p=0.001) among all variables and QoL scores studied by multivariate analysis. A deterioration in pain was associated with a 2.8 times higher chance of survival (HR 0.36). Conclusions. Deterioration of HRQoL baseline pain score by cancer treatment is a favourable and superior prognostic factor for survival.

Health-related quality-of-life results from JCOG0912: A phase III noninferiority trial comparing open and laparoscopy-assisted distal gastrectomy for stage I gastric cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 293-293
Author(s):  
Takaki Yoshikawa ◽  
Masahiko Ando ◽  
Junki Mizusawa ◽  
Hitoshi Katai ◽  
Takanobu Yamada ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Health Status ◽  
Global Health ◽  
Distal Gastrectomy ◽  
Stage I ◽  
Global Health Status ◽  
Related Quality ◽  
Health Related ◽  
Hrqol Assessment

293 Background: Laparoscopy-assisted distal gastrectomy (LADG) was non-inferior to open (ODG) in patients with stage I gastric cancer in randomized phase 3 non-inferiority trial (JCOG0912). Here, we present the results of health-related quality of life (HRQoL) which was a secondary endpoint in JCOG0912. Methods: Among 33 institutions participated in JCOG0912, 4 major cancer centers were selected for HRQOL assessment. HRQoL was assessed using EORTC QLQ-C30 and the EORTC-STO22 before (baseline) and at 1, 3, 12, and 36 months after surgery. The primary HRQOL scale was QLQ-C30 global health status. We defined clinically meaningful decrease of HRQoL as decrease in 10 points or more from the baseline. Missing data were regarded as decrease. Assuming that expected %decrease of global health status at 3 months was 61% in ODG and 45% in LADG with 80% power and two-sided alpha of 0.05, sample size for HRQOL assessment was calculated to be 304. When this hypothesis at 3 months was confirmed, statistical comparison was tested in turn at 12 and 36 months. Results: Among 921 enrolled patients in JCOG0912 from Mar 2010 to Nov 2013, 592 were enrolled from the 4 centers in this HRQoL study. The %decrease of global health status at 3 months was different between ODG and LADG (37.2% (109/293) in ODG vs 29.2% (86/295) in LADG, odds ratio [OR] 0.65 (95% CI: 0.45-0.93, p = 0.020)), but was not different in 1 month (56.0% (164/293) vs 55.3% (163/295), OR 0.92 (0.61-1.32)), 12 months (26.3% (77/293) vs 27.8% (82/295) (OR 1.07 (0.73-1.56))and 36 months (31.4% (91/293)vs 30.8% (91/295) (odds ratio, 0.96 (0.67-1.37))). Among the other subscales, LADG had significantly better symptom scores for pain at 1 and 3 months, constipation at 3 and 12 months, and eating restrictions at 3 months. Conclusions: Decrease of HRQoL was less frequently observed in LADG than ODG especially in the early phase after surgery. Considering non-inferiority and better HRQoL of LADG, LADG is strongly recommended for stage I gastric cancer. However, we have to be careful to expand the indication of LADG for advanced gastric cancer until a solid evidence is obtained. Clinical trial information: UMIN000003319.

scholarly journals Prophylactic Cranial Irradiation in Extensive Disease Small-Cell Lung Cancer: Short-Term Health-Related Quality of Life and Patient Reported Symptoms—Results of an International Phase III Randomized Controlled Trial by the EORTC Radiation Oncology and Lung Cancer Groups

2009 ◽  
Vol 27 (1) ◽  
pp. 78-84 ◽  
Author(s):  
Berend J. Slotman ◽  
Murielle E. Mauer ◽  
Andrew Bottomley ◽  
Corinne Faivre-Finn ◽  
Gijs W.P.M. Kramer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Health Status ◽  
Global Health ◽  
Global Health Status ◽  
Life Questionnaire ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Purpose Prophylactic cranial irradiation (PCI) in patients with extensive-disease small-cell lung cancer (ED-SCLC) leads to significantly fewer symptomatic brain metastases and improved survival. Detailed effects of PCI on health-related quality of life (HRQOL) are reported here. Patients and Methods Patients (age, 18 to 75 years; WHO ≤ 2) with ED-SCLC, and any response to chemotherapy, were randomly assigned to either observation or PCI. Health-related quality of life (HRQOL) and patient-reported symptoms were secondary end points. The European Organisation for the Research and Treatment of Cancer core HRQOL tool (Quality of Life Questionnaire C30) and brain module (Quality of Life Questionnaire Brain Cancer Module) were used to collect self-reported patient data. Six HRQOL scales were selected as primary HRQOL end points: global health status; hair loss; fatigue; and role, cognitive and emotional functioning. Assessments were performed at random assignment, 6 weeks, 3 months, and then 3-monthly up to 1 year and 6-monthly thereafter. Results Compliance with the HRQOL assessment was 93.7% at baseline and dropped to 60% at 6 weeks. Short-term results up to 3 months showed that there was a negative impact of PCI on selected HRQOL scales. The largest mean difference between the two arms was observed for fatigue and hair loss. The impact of PCI on global health status as well as on functioning scores was more limited. For global health status, the observed mean difference was eight points on a scale 0 to 100 at 6 weeks (P = .018) and 3 months (P = .055). Conclusion PCI should be offered to all responding ED SCLC patients. Patients should be informed of the potential adverse effects from PCI. Clinicians should be alert to these; monitor their patients; and offer appropriate support, clinical, and psychosocial care.

Patient-reported outcomes (PROs) with first-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic NSCLC: Results from MYSTIC.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9048-9048
Author(s):  
Edward B. Garon ◽  
Byoung Chul Cho ◽  
Niels Reinmuth ◽  
Ki Hyeong Lee ◽  
Alexander Luft ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Repeated Measures ◽  
Mixed Model ◽  
Global Health Status ◽  
First Line ◽  
Primary Analysis ◽  
Open Label ◽  
Appetite Loss ◽  
Patient Reported

9048 Background: MYSTIC, an open-label, Phase 3 trial of first-line D (anti-PD-L1) ± T (anti-CTLA-4) vs platinum CT in mNSCLC, showed an improvement in overall survival (OS) with D vs CT in pts with tumor cell PD-L1 expression ≥25% (TC ≥25% [primary analysis population]; D vs CT, HR 0.76 [97.54% CI 0.56–1.02], p = 0.036; D+T vs CT, HR 0.85 [98.77% CI 0.61–1.17], p = 0.202). Here we summarize PROs from MYSTIC. Methods: Immunotherapy/CT-naïve mNSCLC pts were randomized (1:1:1) to D, D+T, or CT. Symptoms, function, and global health status/quality of life (QoL) were assessed using the EORTC QLQ-C30 v3 questionnaire and its lung cancer module, QLQ-LC13. A change in score from baseline ≥10 points was predefined as clinically meaningful (CM). Mean changes from baseline (over 12 mos) for prespecified symptoms were analyzed using a mixed model for repeated measures (MMRM). Time from randomization to the first CM deterioration (TTD) was analyzed. Results: Among pts with PD-L1 TC ≥25% (n = 488), there were no differences between arms in symptoms, function, or global health status/QoL at baseline. Compliance with completing the questionnaires was ≥60% to wk 120 in the D±T arms, and to wk 40 (C30) and wk 44 (LC13) in the CT arm. MMRM analysis showed significant between-arm differences in changes from baseline in favor of D for fatigue (difference vs CT −9.5) and appetite loss (−11.9; CM), and D+T for fatigue (−11.7; CM). Significantly longer TTD (median, mos) was seen with D and D+T vs CT for appetite loss (12.8 and 5.6 vs 4.5), constipation (14.6 and 9.0 vs 5.5), nausea/vomiting (16.7 and 9.7 vs 4.5), and dyspnea (10.6 and 7.4 vs 5.6); D vs CT for diarrhea (16.3 vs 9.0), insomnia (9.3 vs 6.2), and hemoptysis (not reached vs 10.3); and D+T vs CT for fatigue (5.6 vs 2.0). Significantly longer TTD (median, mos) was also seen with D and D+T vs CT for function (cognitive [9.1 and 6.6 vs 5.2], physical [9.0 and 7.4 vs 4.2], role [D vs CT only; 7.3 vs 3.7], social [12.9 and 5.4 vs 5.2]), and global health status/QoL (5.9 and 6.8 vs 5.5). Conclusions: Pts with PD-L1 TC ≥25% treated with D±T had a reduced symptom burden over time and longer TTD for symptoms, function, and global health status/QoL compared to pts receiving CT. Clinical trial information: NCT02453282.

Health-related quality of life in the early-access phase IIIb study of trifluridine/tipiracil in pretreated metastatic colorectal cancer (mCRC): Results from PRECONNECT study.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 638-638 ◽  
Author(s):  
Julien Taieb ◽  
Timothy Jay Price ◽  
Fortunato Ciardiello ◽  
Marc Peeters ◽  
Lucjan Wyrwicz ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Utility Score ◽  
Global Health Status ◽  
Early Access ◽  
Related Quality ◽  
Eortc Qlq C30 ◽  
Health Related ◽  
Eortc Qlq ◽  
Ecog Ps

638 Background: Pivotal RECOURSE trial assessed efficacy and safety of trifluridine/tipiracil (FTD/TPI) in mCRC patients (pts) without collecting QoL data. Here we describe a preliminary analysis of QoL in mCRC pts treated with FTD/TPI in the ongoing phase 3b PRECONNECT study (NCT03306394). Methods: Eligible pts had histologically mCRC previously treated with available therapies and an ECOG-PS of 0/1. Pts received FTD/TPI (35 mg/m2 twice daily) orally on days 1–5 and 8–12 of each 28-day cycle. ECOG-PS and QoL were assessed at baseline, every 4 weeks on FTD/TPI and at discontinuation. QoL was measured with EORTC QLQ-C30, EQ-5D index and VAS questionnaires. Utility score was based on EQ-5D index and values from Germany, UK and Spain. For QLQ-C30, clinical relevance was assessed using a 10 point threshold. Changes in utility score and VAS were deemed clinically relevant if ≥ 9 and ≥ 7, respectively. Only results where ≥ 10% of the initial cohort completed the questionnaires were assessed, corresponding to 7 cycles of treatment. Results: 464 pts were included at cutoff (1 November 2017). Median FTD/TPI treatment duration was 2.96 months (range 0.4–14.7). Median time to ECOG-PS ≥ 2 was 8.7 months with 74.3% of pts remaining at ECOG-PS 0/1 at discontinuation. At baseline mean QLQ-C30 global health status was 62.75 (SD = 20.50; median 66.67) with values for all scales in line with EuroQoL reference for mCRC (variation < 10 points on function and < 5 on symptom scales). Baseline EQ-5D VAS was 65.55 (SD = 20.11; median 70.00) and utility score 73.11 (SD = 20.71; median 75.27). There was no clinically relevant difference in mean change from baseline at any time point on global health status score nor any of functional or symptom scales. Similar results were obtained for utility score and VAS. QoL was maintained on FTD/TPI in all subgroups based on age and ECOG-PS for all scales except for appetite loss increase at cycle 5 in pts ≥ 65 and in ECOG-PS 0 in whom the score increased by 12.2 and 10.4, respectively. Conclusions: The first prospective data on QoL suggest that mCRC pts can maintain their QoL while on FTD/TPI treatment. Clinical trial information: NCT03306394.

TPExtreme randomized trial: Quality of Life (QoL) and survival according to second-line treatments in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6507-6507 ◽  
Author(s):  
Joel Guigay ◽  
Jerome Fayette ◽  
Ricard Mesia ◽  
Esma Saada-Bouzid ◽  
Cedrik Lafond ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Global Health Status ◽  
Open Label ◽  
Trial Quality ◽  
Significant Difference ◽  
Health Status Score

6507 Background: TPExtreme trial comparing EXTREME regimen to the taxane-based TPEx confirmed the encouraging survival results of the TPEx regimen, despite lack of significant overall survival (OS) increase, with a significantly lower toxicity than the EXTREME regimen. Herein, the QoL and exploratory analyses of survival according to 2nd line treatments focusing on immunotherapy (IO) are presented. Methods: Randomized (1:1), open-label trial. Main inclusion criteria were R/M HNSCC not suitable for loco-regional treatment, age 18-70 years, PS < 2, creatinin clearance > 60ml/min, prior cisplatin < 300 mg/m². 539 pts were enrolled over a period of 37 months (mo). QoL was evaluated with QLQ-C30 questionnaire at baseline, week(W)12, W18, W26 and analyzed by linear mixed model. The primary QoL endpoint was the Global Health Status score. 2nd line treatments were collected for 501 (93%) patients (pts), 256 in the EXTREME arm and 245 in the TPEx arm. Results: The percentage of QLQ-C30 questionnaires filled at baseline, W12, W18 and W26 were similar in the 2 arms, 89%, 52%, 43%, and 39% in the EXTREME arm and 91%, 59%, 40%, and 37% in the TPEx arm, respectively.. Higher scores of Global Health Status (p = 0.02), physical functioning (p = 0.009) and role functioning (p = 0.013) and lower scores of appetite loss (p = 0.041) were observed in the TPEx arm than in the EXTREME arm. No significant difference was observed for the other scores. In 2nd line treatment, 120 (47%) pts in the EXTREME arm and 109 (44%) in the TPEx arm received chemotherapy +/- cetuximab (CT); 41 (16%) pts in the EXTREME arm and 41 (17%) in the TPEx arm received IO, mainly anti-PD-1/PD-L1. 79% and 85% of these 2nd line treatments were given after progression in EXTREME and TPEx arms respectively. Median OS (95%CI) since randomization was 17.6 (15.2 – 19.5) mo with CT and 19.4 (13.4 – 22.3) mo with IO in the EXTREME arm vs 14.9 (13.0 – 16.3) and 21.9 (15.9 – 35.0) mo in the TPEx arm (interaction test p = 0.077) respectively. Median OS since start of 2nd line was 9.3 mo with CT and 8.3 mo with IO in the EXTREME arm, and 7.1 and 11.6 mo respectively in the TPEx arm. Conclusions: An improvement in the QoL of patients was observed in the TPEx arm compared to that of the EXTREME arm. Exploratory analysis showed that the taxane-based TPEx regimen followed by IO in 2nd line could provide interesting median OS for pts who need CT in 1st line, with less toxicity than EXTREME. This sequential treatment deserves to be compared to a strategy that starts with Platinum+5FU+pembrolizumab. Clinical trial information: NCT02268695 .

scholarly journals Effects of Qigong Training on Health-Related Quality of Life, Functioning, and Cancer-Related Symptoms in Survivors of Nasopharyngeal Cancer: A Pilot Study

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Shirley S. M. Fong ◽  
Shamay S. M. Ng ◽  
W. S. Luk ◽  
Louisa M. Y. Chung ◽  
Janet Y. H. Wong ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Nasopharyngeal Cancer ◽  
Global Health Status ◽  
Control Group ◽  
European Organization ◽  
Health Related ◽  
Experimental Group

This study aimed to investigate the effects of Qigong intervention on quality of life (QOL), health-related functioning, and cancer-related symptoms in survivors of nasopharyngeal cancer (NPC). Twenty-five survivors of NPC were included in the experimental group (mean age ± SD: 55.4 ± 7.5 years) and 27 in the control group (mean age ± SD: 58.7 ± 9.5 years). The experimental group underwent a weekly 1.5-hour Qigong training program and an identical home program (three times/week) for six months. The control group received no training. Global health status/QOL, functioning, and cancer-related symptoms were assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35 questionnaires before training began, after three months of Qigong training, at the end of the six-month Qigong intervention (i.e., posttest), and six months posttest. Intention-to-treat analysis revealed no statistically (P>0.05) or clinically significant improvement in global health status/QOL, functioning, or symptoms in either group. The experimental group had 45.8% fewer sense-related (smell and taste) problems (P<0.05) but 98.6% more speech-related problems (P<0.05) than the control group after the Qigong intervention. Qigong training resulted in no apparent improvement in health-related QOL, functionality, or cancer-related symptoms in cancer-free survivors of NPC, except for a possible reduction in smell- and taste-related problems.

Association of Changes in Transfusion Status with Changes in Health-Related Quality of Life of Real-World Patients with MDS Across Six Months of Treatment with Azacitidine

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2796-2796
Author(s):  
Chris L. Pashos ◽  
David L. Grinblatt ◽  
Mikkael A. Sekeres ◽  
Rami S. Komrokji ◽  
Mohit Narang ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Board Of Directors ◽  
Global Health Status ◽  
Employment Equity ◽  
Advisory Committees ◽  
Transfusion Independence ◽  
Related Quality ◽  
Equity Ownership ◽  
Rbc Transfusion

Abstract Abstract 2796 Introduction: The health-related quality of life (HRQOL) of patients with myelodysplastic syndromes (MDS) is worse if they are red blood cell transfusion dependent (RBC TD) than if they are RBC transfusion independent (TI). Little is known whether a change in status from RBC TD to RBC TI is associated with improved HRQOL. This analysis characterized the HRQOL of real-world patients with MDS across 6 months of treatment with Azacitidine (AZA) by their RBC TD/TI status. Methods: Data were collected from AVIDA®, a prospective, US, community-based registry of patients treated with AZA. Patients with MDS who were originally RBC TD at baseline, and who received 56 days or more of AZA were analyzed. RBC TD, defined as having received > 1 RBC transfusion within 56 consecutive days, was determined and verified centrally. Clinicians provided data on patient demographics and clinical characteristics, including RBC transfusions. Patients reported HRQOL by completing the EORTC-QLQ-C30 instrument at baseline and quarterly thereafter. Summary statistics (e.g., mean scores and changes in scores) on global health status, five functional scales, and nine symptom/other scales were analyzed. Statistical significance was ascertained by ANOVA using SAS 9.1. Results: In the full AVIDA cohort, 328 MDS patients received at least 56 days of treatment with AZA, of whom 153 reported HRQOL data at baseline and at six months. At baseline, 85 of the 153 were RBC TD, while the rest were RBC TI. At six months, 41 of the 85 had become RBC TI, while 44 remained RBC TD. Global health status improved among those who became RBC TI, but declined among those who stayed RBC TD. Statistically significant and clinically meaningful (i.e., greater than 7 points) differences in change between baseline and 6 months also were seen in physical and role function, but not in emotional, cognitive or social function. Fatigue was the only symptom score in which changes were statistically significantly different between groups, with RBC TI patients reporting less fatigue, and RBC TD patients reporting more. Conclusions: Findings from AVIDA® indicate that HRQOL among RBC TD MDS patients treated with AZA improves significantly overall and on certain domains if they achieve RBC transfusion independence. The improved global health status; better physical and role functioning; and less fatigue associated with RBC TD patients achieving RBC transfusion independence should be recognized by US clinicians as they manage patients with MDS. Disclosures: Pashos: Celgene: Membership on an entity's Board of Directors or advisory committees. Grinblatt:Celgene: Membership on an entity's Board of Directors or advisory committees. Sekeres:Celgene: Consultancy, Honoraria, Speakers Bureau. Komrokji:Celgene: Honoraria, Research Funding, Speakers Bureau. Narang:Celgene: Membership on an entity's Board of Directors or advisory committees. Swern:Celgene Corporation: Employment, Equity Ownership. Street:Celgene: Employment, Equity Ownership. Sullivan:Celgene: Employment, Equity Ownership. Khan:Celgene: Employment, Equity Ownership.

Health-related quality of life (HRQoL) and symptom burden in patients (Pts) with myelofibrosis (MF) in the COMFORT-II study.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6626-6626 ◽  
Author(s):  
Jean-Jacques Kiladjian ◽  
Heinz Gisslinger ◽  
Francesco Passamonti ◽  
Dietger Niederwieser ◽  
Estella Mendelson ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Severe Disease ◽  
Symptom Burden ◽  
Global Health Status ◽  
Open Label ◽  
Phase 3 ◽  
Related Quality ◽  
Night Sweats ◽  
Eortc Qlq

6626^ Background: Ruxolitinib has demonstrated rapid and durable reductions in splenomegaly and improved disease-related symptoms and QoL in 2 phase 3 studies (COMFORT-I and -II) in pts with primary MF (PMF), post-polycythemia vera-MF (PPV-MF), or post-essential thrombocythemia-MF (PET-MF). The prevalence of individual symptoms among these pts has not been defined. We evaluated the baseline HRQoL and symptoms among pts enrolled in COMFORT-II. Methods: COMFORT-II is a randomized, open-label, multicenter, phase 3 study comparing ruxolitinib with best available therapy. HRQoL and symptoms were assessed at baseline using the European Organisation for the Research and Treatment of Cancer QoL Questionnaire–Core 30 (EORTC QLQ‑C30) and Functional Assessment of Cancer Therapy–Lymphoma (FACT‑Lym); this analysis summarizes these scores for all pts, regardless of assigned treatment. Results: In COMFORT-II (N = 219), 52% of pts were aged > 65 years and 57% were male. By IPSS criteria (Cervantes et al. 2009), 40% had intermediate-2 and 60% had high-risk MF. Mean (95% CI) EORTC global health status/QoL (53.7 [50.6-56.7]; median, 50.0) and FACT-General total scores (73.0 [70.8-75.2]) were comparable to those for pts of similar age with other cancers (Oliva et al. 2011: median global health status score of 50 for acute myeloid leukemia [AML]). The most frequent symptoms (reported as “quite a bit” or “very much”) were fatigue (54%), dyspnea (30%), insomnia (30%), pain (29%), night sweats (23%), and itching (21%), and there were differences in baseline symptoms across MF subtypes (Table). Conclusions: This analysis shows that pts with MF experience severe disease-related symptoms and have diminished HRQoL similar to pts with AML, but because pts with MF have a longer life expectancy (an average of 2.3 to 4 years for high and intermediate-2 risk pts, respectively), they may suffer with a reduced QoL for many years. [Table: see text]

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