A prospective comparison of the FACT-e and EORTC-QLQC30 and OG25 questionnaires for evaluating changes in health-related quality of life in patients with esophageal cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 130-130
Author(s):  
Gail Darling

130 Background: The FACT-E (Functional Assessment of Cancer Therapy– Esophageal) and the EORTC QLQ-C30 (European Organization for Research on Treatment of Cancer Quality of Life Questionnaire) and its cancer-specific module (OG25) are two validated instruments used to assess quality-of-life (QOL) in patients with esophageal cancer. This study investigates the differences between these two instruments. Methods: This is a prospective study of 22 consecutive patients treated with chemoradiation followed by surgery. Questionnaires were self-administered at each of the following: baseline (prior to treatment), 6-8 weeks and 12-14 weeks following start of chemoradiation, and 1, 3, 6, 9, 12, and 18 months following esophagectomy. Mixed model regression was applied to model the repeated measures of the two questionnaires to compare slopes. Results: Of the 22 patients, 20 proceeded to surgery. Overall survival and disease-free survival at 18 months were 59% and 55% respectively. Comparison of the QOL domains over time showed good correlation for physical and functional well-being, with an apparent variation in the magnitude of the changes over time for the latter. The questionnaires were discordant with respect to social and total well-being. Social well-being showed a return to baseline by 1 month post-op using the FACT, but never recovered to baseline for the EORTC. FACT Total well-being recovered to baseline by 9 months, while the EORTC only approached baseline values by 18 months. The disease-specific modules showed post-operative symptom improvement with the FACT and a deterioration with the EORTC. There was also discordance in emotional well being. Conclusions: Domain comparisons of the EORTC and FACT questionnaires showed differing results. Discordance was seen for emotional, social and overall QOL, as well as symptomatology. The EORTC total and physical well-being domains showed a similar pattern of change over time. These findings might result from the overall tendency of the EORTC to emphasize physical aspects of QOL. Thus these two instruments appear to measure different aspects of QOL, which may affect their clinical utility.

1999 ◽  
Vol 17 (11) ◽  
pp. 3612-3620 ◽  
Author(s):  
Hans Heinzer ◽  
Thomas S. Mir ◽  
Edith Huland ◽  
Hartwig Huland

PURPOSE: We conducted both a subjective and objective, prospective quality-of-life analysis during high-dose (36 × 106 immunizing units/d) inhalational interleukin (IL)-2 treatment (mean treatment time, 13.4 months) of 15 patients with metastatic renal cell carcinoma (mRCC). Additionally, quality of life for 10 patients with mRCC receiving low-dose (9 × 106 IU/m2/d for 5 days) intravenous IL-2 treatment also was evaluated. PATIENTS AND METHODS: Patients responded to the European Organization for Research and Treatment of Cancer quality-of-life questionnaire QLQ-C30 before and during inhalational IL-2 treatment at 1, 3, 6, 9, and 12 months and before and once during intravenous IL-2 treatment. A clinician assessed patient well-being using the Quality of Well-Being scale to calculate once weekly quality-adjusted life-years (QALYs) during inhalational IL-2 treatment. RESULTS: Patients completed 103 questionnaires and clinicians performed 892 QALY calculations. For patients treated with inhalational IL-2, the mean quality-of-life score deteriorated modestly but significantly 1 month after treatment initiation (15.1%, P = .01) but did not differ significantly from pretreatment scores after 3, 6, 9, and 12 months of treatment. Inhalational IL-2 therapy stabilized patient quality of life for a mean of 13.4 months. The resulting QALY calculation for patients on inhalation IL-2 was 70.1% of 13.4 months, representing 9.4 months of QALY. In comparison, patients who received intravenous IL-2 showed a more marked, statistically significant deterioration in mean quality-of-life score during treatment (27%, P = .006); moreover, three of these 10 patients experienced treatment-related toxicity that prevented questionnaire completion. CONCLUSION: Quality-of-life analysis during immunotherapy provides valuable information regarding cancer treatment outcomes.


1999 ◽  
Vol 17 (10) ◽  
pp. 3270-3275 ◽  
Author(s):  
David H. Ilson ◽  
Leonard Saltz ◽  
Peter Enzinger ◽  
Ying Huang ◽  
Alice Kornblith ◽  
...  

PURPOSE: To evaluate the response, toxicity, survival, and quality of life in patients with unresectable or metastatic esophageal cancer treated with weekly irinotecan and cisplatin. PATIENTS AND METHODS: Thirty-five patients with metastatic or unresectable esophageal adenocarcinoma (23 patients) or squamous cell carcinoma (12 patients) were treated. No prior chemotherapy was allowed. The majority of patients had metastatic and bidimensionally measurable disease (34 patients each [97%]). Patients were treated with cisplatin 30 mg/m2 and irinotecan 65 mg/m2, repeated weekly for 4 weeks, followed by a 2-week rest period. Treatment was recycled every 6 weeks. Degree of dysphagia relief was monitored, and quality of life was measured prospectively using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 and Functional Assessment of Cancer Therapy–General instruments. RESULTS: Thirty-five patients were assessable for response and toxicity. Major objective responses were observed in 20 patients (57%; 95% confidence interval, 41% to 73%), including two complete responses (6%). Similar response rates were observed for adenocarcinoma (12 of 23 patients; 52%) and squamous carcinoma (eight of 12 patients; 66%). The median duration of response was 4.2 months (range, 1 to 8.8+ months). Median actuarial survival was 14.6 months (range, 1 to 15.2+ months). In 20 patients with dysphagia assessable at baseline, 18 (90%) noted either improvement or resolution of dysphagia on chemotherapy. Global quality of life improved in responding patients, primarily because of improvements in pain, emotional state, and relationships with family and friends. Toxicity was relatively mild and included only three patients (9%) with grade 4 neutropenia and four (11%) with grade 3 diarrhea. There were no treatment-related deaths. CONCLUSION: The combination of weekly cisplatin plus irinotecan had significant activity in metastatic esophageal carcinoma and resulted in significant relief of dysphagia. The regimen was well tolerated, with acceptable myelosuppression and rare treatment-related diarrhea. Further evaluation of the combination of weekly irinotecan and cisplatin, including the addition of other agents to this regimen, is indicated.


2021 ◽  
Author(s):  
Jeffrey S Wefel ◽  
Terri S Armstrong ◽  
Stephanie L Pugh ◽  
Mark R Gilbert ◽  
Merideth M Wendland ◽  
...  

Abstract Background Results of NRG Oncology RTOG 0825 reported adding bevacizumab to standard chemoradiation did not significantly improve survival endpoints and resulted in greater decline in neurocognitive function (NCF) and patient reported outcomes (PRO) over time in bevacizumab treated patients. The present report provides additional results of patient centered outcomes over time and their prognostic association with survival endpoints. Methods NCF tests, MD Anderson Symptom Inventory brain tumor module (MDASI-BT), and European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire with brain-cancer module (QLQ-C30/BN20) were completed in a subset of progression-free patients at baseline and longitudinally. The prognostic value of baseline and early changes in NCF and PROs and differences between treatments from baseline to follow-up assessments was evaluated. Results 508 randomized patients participated. Baseline/early changes in NCF and PROs were prognostic for OS and PFS. No between arm differences in time to deterioration was found. At week 6, patients treated with bevacizumab evidenced greater improvement on NCF tests of executive function and the MDASI-BT Cognitive Function scale, but simultaneously reported greater decline on the EORTC Cognitive Function Scale. At later time points (week 22, 34, and 46), patients treated with bevacizumab had greater worsening on NCF tests as well as PRO measures of cognitive, communication, social function, motor symptoms, general symptoms and interference. Conclusion The collection of patient centered clinical outcome assessments in this phase III trial revealed greater deterioration in NCF, symptoms and QOL in patients treated with bevacizumab. Baseline and early change in NCF and PROs were prognostic for survival endpoints.


Author(s):  
Conor F Murphy ◽  
Michelle Fanning ◽  
Nicola Raftery ◽  
Jessie A Elliott ◽  
Neil G Docherty ◽  
...  

Summary Improved cure rates in esophageal cancer care have increased focus on health-related quality of life (HRQL) in survivorship. To optimize recovery after esophagectomy, particularly nutritional well-being, a personalized multidisciplinary survivorship clinic was established at this center. Assessments at 6 and 12 months postoperatively include validated European Organization for the Research and Treatment of Cancer (EORTC) symptom and health-related quality of life (HRQL) questionnaires, functional status review, anthropometry, and biochemical screening for micronutrient deficiencies. 75 patients, at a mean age of 63 years, 84% male, 85% with adenocarcinoma, and 73% receiving multimodal therapy were included. Mean preoperative body mass index (BMI) was 27.5 (4.3) kg m −2. 6- and 12-month assessments were completed by 66 (88%) and 37 (93%) recurrence-free patients, respectively. Mean body weight loss at 6 months was 8.5 ± 6.6% and at 12 months 8.8 ± 7.3%. Of the 12-month cohort, micronutrient deficiency was present in 27 (79.4%) preoperatively and 29 (80.6%) after 1 year (P = 0.727), most commonly iron deficiency (preoperative: 16 [43.2%] and postoperative: 17 [45.9%] patients, P = 0.100). 26 (70.3%) of these patients also had clinically significant dumping syndrome persisting to 12 months after surgery. We describe a novel follow-up support structure for esophageal cancer patients in the first year of survivorship. This may serve as an exemplar model with parallel application across oncological care.


Author(s):  
Karamveer Singh ◽  
Navneet Jain ◽  
Sunil Saini

Background: Oesophageal cancer is sixth most common cause of cancer related deaths worldwide. Despite complete resections, overall survival remained low. To improve the existing treatment combination of chemotherapy and radiotherapy in both neoadjuvant and adjuvant settings was introduced. Impact of treatment on quality of life, morbidities and toxicities associated with multimodality treatment in patients of carcinoma oesophagus was studied prospectively and retrospectively.Methods: A total of 40 patients histologically proven carcinoma of the oesophagus were enrolled in the study. Study included assessment of clinical features, risk factors, biopsy, multimodality treatment and associated morbidities and toxicities. Quality of Life (QOL) in patients of multimodality treatment assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Core 18 before, immediate post treatment and 6 months after completion of the planned treatment.Results: In 40 patients, male to female ratio was 1.10:1. Dysphagia was the leading complain. 3 patients were treated using neoadjuvant therapy (chemotherapy and radiotherapy followed by surgery) among them 2 patients expired, 1 patient is under regular follow up. 6 patients underwent upfront surgery followed by adjuvant therapy out of which 3 patients expired,15 patients were treated with curative intent by definitive chemotherapy and radiotherapy out of which only 7 patients survived for >1 year. 16 patients were treated with palliative intent (radiotherapy, chemotherapy, oesophageal stenting and feeding procedures) in which only 1 patient survived for 1 year.Conclusions: The present study demonstrates that patients over all QOL was reduced after treatment and in the follow up period which was due to the treatment related toxicities but in contrast symptom improvement was observed simultaneously.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21004-e21004
Author(s):  
Richard Wayne Joseph ◽  
Frank Xiaoqing Liu ◽  
Alicia C. Shillington ◽  
Cynthia Macahilig ◽  
Scott J. Diede ◽  
...  

e21004 Background: Pembrolizumab (PEMBRO) and combination ipilimumab + nivolumab (IPI+NIVO) are FDA-approved immunotherapies for advanced melanoma (AM). HRQoL was better maintained with PEMBRO vs IPI in KEYNOTE-006. CheckMate-067 reported no clinically meaningful HRQoL differences with IPI+NIVO vs IPI. As randomized trial data are lacking, we compared HRQoL outcomes in AM between PEMBRO and IPI+NIVO in real-world clinical settings. Methods: A prospective, observational study was conducted with sponsor blinded to sites, and sites blinded to sponsor; nine oncologists from 9 US academic centers and affiliated satellite clinics enrolled AM patients (pts) age ≥18 years initiating first-line PEMBRO or IPI+NIVO between June 2017 – March 2018. The European Organization for the Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ C30) and EQ-5D-5L were administered at baseline and weeks 6, 12, 18, and 24 following therapy. Least squared (LS) mean changes in HRQoL scores from baseline were compared using mixed-effects models for repeated measures, adjusting for baseline covariates. Results: A total of 225 PEMBRO and 187 IPI+NIVO pts were enrolled, with > 95% questionnaire completion rates through week 24. At baseline, PEMBRO pts were more likely > age 65 (49% vs 37%, p = .011), stage IV disease (92% vs 85%; p = .002), and higher comorbidity index (1.0 vs 0.6; p < .001) compared with IPI+NIVO pts. Adjusted EORTC global health status/quality of life (GHS) LS mean changes from baseline showed greater improvement with PEMBRO vs. IPI+NIVO at 12, 18 and 24 weeks. At week 24, PEMBRO pts achieved a 3.3-point improvement (95% CI = 0.8, 5.7) and IPI+NIVO pts had no significant change (1.0, 95% CI = -1.6, 3.5), with a LS mean difference of 2.3 points (p = .037; 95% CI = 0.14, 4.51). At week 24, the EQ-5D visual analogue scale increased 1.0 (95% CI, -1.2, 3.2) for PEMBRO vs IPI+NIVO which decreased 0.9 (95% CI = -3.2, 1.3), with a statistically significant LS mean difference of 2.0 (95% CI = 0.4, 3.9; p = .045). Conclusions: Results from 2 measures suggest HRQoL was maintained vs. baseline in both PEMBRO and IPI+NIVO pts, with a significant between-group difference favoring PEMBRO in GHS over 24 weeks.


2019 ◽  
Vol 17 (6) ◽  
pp. 677-685
Author(s):  
Piera Cote Robson ◽  
Mithat Gonen ◽  
Ai Ni ◽  
Lynn Brody ◽  
Karen T. Brown ◽  
...  

AbstractObjectivePercutaneous tunneled drainage catheter (PTDC) placement is a palliative alternative to serial paracenteses in patients with end-stage cancer and refractory ascites. The impact of PTDC on quality of life (QoL) and long-term outcomes has not been prospectively described. The objective was to evaluate changes in QoL after PTDC.MethodEligible adult patients with end-stage cancer undergoing PTDC placement for refractory ascites completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and McGill Quality of Life instruments before PTDC placement and at 2 to 7 days and 2 to 4 weeks after PTDC. Catheter function, complications, and laboratory values were assessed. Analysis of QoL data was evaluated with a stratified Wilcoxon signed-rank test.ResultFifty patients enrolled. Survey completion ranged from 65% to 100% (median 88%) across timepoints. All patients had a Tenckhoff catheter, with 98% technical success. Median survival after PTDC was 38 days (95% confidence interval = 32, 57 days). European Organization for Research and Treatment of Cancer scores showed improvement in global QoL (p = 0.03) at 1 week postprocedure (PP). Significant symptom improvement was reported for fatigue, nausea/vomiting, pain, dyspnea, insomnia, and appetite at 1 week PP and was sustained at 3 weeks PP for dyspnea (p < 0.01), insomnia (p < 0.01), and appetite loss (p = 0.03). McGill Quality of Life demonstrated overall QoL improvement at 1 (p = 0.03) and 3 weeks (p = 0.04) PP. Decline in sodium and albumin values pre- and post-PTDC slowed significantly (albumin slope –0.43 to –0.26, p = 0.055; sodium slope –2.50 to 1.31, p = 0.04). Creatinine values increased at an accelerated pace post-PTDC (0.040 to 0.21, p < 0.01). Thirty-eight catheter-related complications occurred in 24 of 45 patients (53%).Significance of resultsQoL and symptoms improved after PTDC placement for refractory ascites in patients with end-stage malignancy. Decline in sodium and albumin values slowed postplacement. This study supports the use of a PTDC for palliation of refractory ascites in cancer patients.


1999 ◽  
Vol 17 (9) ◽  
pp. 2932-2932 ◽  
Author(s):  
Georg Kemmler ◽  
Bernhard Holzner ◽  
Martin Kopp ◽  
Martina Dünser ◽  
Raimund Margreiter ◽  
...  

PURPOSE: To compare two quality-of-life (QOL) questionnaires for cancer patients, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (Fact-G), on the basis of empirical data. PATIENTS AND METHODS: Two hundred forty-four patients with a diagnosis of breast cancer or Hodgkin's disease completed both the EORTC QLQ-C30 and the FACT-G (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis, canonical correlation, and multiple linear regression. RESULTS: Correlations between corresponding subscales of the FACT-G and the EORTC QLQ-C30 ranged from r = .14 for the social domain (very poor agreement) to r = .66 for the physical domain (good agreement), with r values for the other domains lying between these extremes. Canonical correlation analysis for the two sets of subscales revealed that overall agreement between the two instruments was only moderate (first canonical correlation coefficient r = .85, but overall redundancy less than 40%). Of the five FACT-G subscales, only one, physical well-being, was well represented by the EORTC QLQ-C30 subscales (multiple linear regression, R2 = .67). Only three of eight EORTC QLQ-C30 subscales (physical functioning, global QOL, general symptoms) were represented fairly well by FACT-G subscales (R2 = .43 to .60). The lowest R2 values (< .15; ie, virtually no representation by the other instrument) were found for the FACT-G social well-being and relation with doctors and EORTC QLQ-C30 cognitive functioning subscales. CONCLUSION: For the sample investigated, the EORTC QLQ-C30 and the FACT-G were found to measure markedly different aspects of QOL, despite considerable overlap. Replicability provided, this implies that neither of the two QOL instruments can be replaced by the other and that a direct comparison of results obtained with the two instruments is not possible.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19519-e19519
Author(s):  
Michael B. Dabrow ◽  
Christine E. Szarka ◽  
Joanne Moore ◽  
Michael R Chernick

e19519 Background: Breast cancer therapy related neurocognitive dysfunction, such as memory impairment and “chemo-brain”, has been reported by many women during and after receiving adjuvant chemotherapy. Studies evaluating this effect have had mixed results regarding its validity. No study has evaluated a specific regimen and none have examined dose dense therapy. We have serially evaluated the cognitive and quality of life changes in patients receiving dose dense adjuvant adriamycin/cyclophosphamide followed by pactitaxel (DD AT-P) chemotherapy. Methods: Patients with early stage breast cancer (Stages I, II) who were treated at a single community hospital cancer center and were given dose dense AC-P adjuvant chemotherapy were asked to participate in this trial. 45 patients were enrolled and 43 were eligible for evaluation with the following instruments: FACT-F, FAS test, MMSE, MNA and BDI. Tests were administered at the start of chemotherapy, at the completion of chemotherapy, at 6 months and 12 months after completing chemotherapy. The tests were administered by oncology nurses. Scores were evaluated using repeated measures analysis of variance testing whether or not the change from baseline test scores had a trend over time. Results: 43 patients were evaluated. Age range was 34-72 years with a median age of 52. 34 patients completed 4 evaluations, 6 completed 3 evaluations, 3 completed 2 evaluations. The only measures demonstrating significant trends were the FAS test (p=0.022) and the Functional Well-Being (p=0.002) and Physical Well-Being (p<0.0001) portions of the FACT-F. The changes over time for these measures all indicated improved performance over baseline at the completion of the trial. The remainder of the tests showed no significant change over time. Conclusions: Dose dense adjuvant chemotherapy with AC-P for breast cancer does not result in decreased cognitive or quality of life measures over time. Patients can be reassured that this specific program of therapy will not lead to long term decreases in mental function and quality of life.


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