Patient-Reported Fatigue Scores in Cancer Patients with Chemotherapy-Induced Anemia Treated with Erythropoietic-Stimulating Agents (ESAs).

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1304-1304
Author(s):  
Tanya Burton ◽  
David Hoaglin ◽  
Kay Larholt ◽  
Elizabeth Apgar ◽  
Chris Pashos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Repeated Measures ◽  
Prospective Observational Study ◽  
Positive Trend ◽  
Significant Positive Trend ◽  
Repeated Measures Analysis ◽  
Patient Reported ◽  
Clinical Trial Evidence ◽  
Outcomes Study ◽  
Trial Evidence

Abstract Background: Clinical trial evidence has demonstrated greater anemia-related fatigue at lower hemoglobin (Hb) levels in ESA-treated patients with chemotherapy-induced anemia (CIA). To understand these patient-reported outcomes (PROs), during ESA treatment in a real-world setting, data were analyzed from the Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (D.O.S.E.) Registry, an ongoing, prospective, observational study. Methods: Patients included for analysis were required to have a baseline Hb prior to ESA administration and at least two ESA administrations. PROs were measured using the Functional Assessment of Cancer Therapy: Fatigue subscale (FACT-F), a 13-question measure of anemia-associated fatigue with lower scores indicating greater fatigue in patients with CIA. Patients were to have completed up to three FACT-F questionnaires within seven days of a post-baseline Hb level. If multiple Hb values were identified, the Hb value closest to the FACT-F assessment was reported. The association between FACT-F scores and Hb levels was tested in a repeated-measures analysis. Mean FACT-F scores were calculated for specified Hb ranges. Results: 740 CIA patients from 63 sites were identified between 12/03 and 7/08. 1088 concurrent FACT-F and Hb level assessments were available during ESA treatment. Mean FACT-F scores were lower when patients had lower Hb levels (table). The association between FACT-F scores and Hb levels showed a significant positive trend (p<.0001). Hb ≤ 8.0 g/dL 8.01–9.0 g/dL 9.01–10.0 g/dL 10.01–11.0 g/dL 11.01–12.0 g/dL n (concurrent FACT-F and Hb assessments) 19 63 212 336 458 Mean FACT-F score (SD) 21.26 (11.01) 22.95 (12.44) 25.64 (12.40) 26.84 (11.70) 29.34 (12.04) Conclusions: This analysis of FACT-F assessments in CIA patients suggests that lower Hb levels were associated with greater anemia-related fatigue. These findings are consistent with clinical trial evidence and provide observational PRO data to patients and providers regarding anemia-related fatigue during ESA treatment.

scholarly journals Sulfonylureas at the Glomerular Battlefield

2018 ◽  
Vol 14 (2) ◽  
pp. 15
Author(s):  
Sanjay Kalra ◽  
Deepak Khandelwal ◽  
Sarita Bajaj ◽  
Ashok Kumar Das
Keyword(s):  
Clinical Trial ◽  
Glucose Homeostasis ◽  
Diabetes Complications ◽  
Cardiovascular Health ◽  
Glucose Lowering ◽  
Meeting Point ◽  
Normal Glucose ◽  
Clinical Trial Evidence ◽  
Trial Evidence

The kidney is important in the context of diabetes not only because it is involved in normal glucose homeostasis, but also because it is one of the most important end organs to be involved in diabetes complications. Glomeruli are the meeting point of both microvascular, or renal; and macrovascular, or cardiovascular, health in diabetes. Sulfonylureas are effective glucose-lowering drugs. While a sulfonylurea-based glucose-lowering strategy is nephro-safe and nephro-protective, this aspect of sulfonylurea pharmaco-biology has not been highlighted earlier. In this editorial, we discuss current preclinical and clinical trial evidence regarding the performance of modern sulfonylureas at the glomerular battlefield.

Checkmate 577:Health-related quality of life (HRQoL) in a randomized, double-blind phase III study of nivolumab (NIVO) versus placebo (PBO) as adjuvant treatment in patients (pts) with resected esophageal or gastroesophageal junction cancer (EC/GEJC).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 167-167
Author(s):  
Eric Van Cutsem ◽  
Prianka Singh ◽  
James M. Cleary ◽  
Ronan Joseph Kelly ◽  
Markus H. Moehler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Visual Analogue Scale ◽  
Repeated Measures ◽  
Analogue Scale ◽  
Gastroesophageal Junction ◽  
Neoadjuvant Chemoradiotherapy ◽  
Phase Iii ◽  
Meaningful Improvement ◽  
Utility Index ◽  
Patient Reported

167 Background: NIVO is the first adjuvant therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus PBO in resected EC/GEJC following neoadjuvant chemoradiotherapy as demonstrated by CheckMate 577. NIVO was well tolerated with an acceptable safety profile. This analysis provides additional information on the exploratory HRQoL endpoints in this clinical trial. Methods: The effect of NIVO versus PBO on HRQoL, including general and disease-related symptoms, functioning, disease burden, and overall QoL, was assessed using FACT-E and EQ-5D-3L patient-reported outcome (PRO) questionnaires administered at baseline (BL), every 4 weeks during the 12-month treatment period, and at post-treatment follow-up visits (up to 2 years after last dose). Longitudinal change from BL in PRO scores over 12 months was assessed using descriptive statistics. Additionally, mixed model for repeated measures and time to deterioration analyses evaluated the difference between treatment with NIVO and PBO (data not shown). Results: 794 pts with EC/GEJC were randomized 2:1 to NIVO (n = 532) or PBO (n = 262). PRO completion rates were ≥ 95% at BL and ~ 90% at 12 months on treatment. Mean (SD) BL HRQoL scores were similar between treatment arms for the FACT-E total score (NIVO: 133.40 [20.97]; PBO: 134.03 [20.40]); esophageal cancer subscale (ECS; NIVO: 50.2 [9.3]; PBO: 50.1 [8.9]); EQ-5D Visual Analogue Scale (NIVO: 70.4 [22.3]; PBO: 69.1 [24.1]); and EQ-5D Utility Index (NIVO: 0.820 [0.179]; PBO: 0.831 [0.163]) based on the UK value set. Descriptive analyses showed a trend for increases from baseline at most time points through week 49 for both NIVO and PBO treatment groups for FACT-E total score, ECS, and EQ-5D Visual Analogue Scale and Utility Index. Conclusions: Preliminary results from CheckMate 577 demonstrated that pts on NIVO treatment showed trends of improvement in both esophageal-specific and general HRQoL. Similar trends were also observed in pts treated with PBO over 1 year. Pts treated with NIVO did not experience a reduction in HRQoL, further supporting clinical data to demonstrate treatment benefit and tolerability for adjuvant NIVO in pts with resected EC/GEJC. Clinical trial information: NCT02743494.

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