Weekly (QW) epoetin alfa (EPO) in prostate cancer (PC) patients (pts) with anemia not receiving chemotherapy (CT) or radiation therapy (RT)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14634-14634
Author(s):  
D. Shasha
Keyword(s):  
Quality Of Life ◽  
Healthcare Providers ◽  
Open Label ◽  
Vascular Events ◽  
Cancer Data ◽  
Early Withdrawal ◽  
Safety Population ◽  
Study Results ◽  
The Many

14634 Background: While EPO is widely used in the management of CT-related anemia, anemia in cancer pts may stem from causes other than CT. Tumor invasion of the bone marrow and cytokine-mediated inhibition of erythropoiesis are among the many disease-related causes of anemia in cancer. Data evaluating the use of EPO in pts not receiving CT or RT, particularly in specific tumor types, would be important information to healthcare providers. Methods: An open-label, prospective, non-randomized, multicenter pilot study was conducted to evaluate the efficacy and safety of EPO 40,000 U QW in anemic (hemoglobin [Hb] ≤ 11 g/dL) cancer pts not receiving CT or RT1. (Blood 2004;104:abstract 4223.) Treatment duration was up to 12 wks with a 4-wk post-treatment observation period. Primary efficacy endpoint was hematopoietic response during the treatment period (% of pts achieving a ≥ 1 or ≥ 2 g/dL Hb increase from baseline [BL]). Secondary endpoints included change from BL in quality of life as measured by the Linear Analog Scale Assessment (LASA). This is a retrospective subset analysis of PC pts (n = 24) enrolled in the prospective study. Results: For the safety population (all pts who received ≥ 1 EPO dose, n = 23), mean age was 71.4 ± 6.8 yrs; 21 (91.3%) had ECOG status of 0 or 1; and mean BL Hb was 10.4 ± 0.8 g/dL. Of 21 pts evaluated for efficacy, 17 (81.0%) achieved Hb increase from BL ≥ 2 g/dL, while 19 (90.5%) achieved ≥ 1 g/dL by wk 17/early withdrawal. EPO dose was increased in 5 (23.8%) pts (to 60,000 U for Hb increase < 1 g/dL after 4 wks) and held in 16 (76.2%) pts (due to Hb > 13 g/dL, with dosing resumed when Hb was ≤12 g/dL, at 30,000 U from 40,000 U or at 40,000 U from 60,000 U). Both Wk 9 and 17 LASA scores increased significantly from BL in all categories (Energy Level, Daily Activities, and Quality of Life; P < 0.001). 15 of 23 pts (65.2%) had at least one adverse event (AE); 4 (17.4%) pts had at least one serious AE. No clinically relevant thrombotic vascular events were noted. No pt received transfusion. 5 pts discontinued: 2 for AEs, 1 at pt request, and 2 at study sponsor request. Conclusions: This retrospective analysis suggests that EPO 40,000 U QW is safe and effective for treating anemia in PC pts not receiving CT or RT. [Table: see text]

Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Interim safety data from the global aflibercept safety and quality-of-life program in pts pretreated with bevacizumab (B).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 556-556 ◽  
Author(s):  
David Raymond Ferry ◽  
Alberto F. Sobrero ◽  
Roberto Bordonaro ◽  
Salvatore Siena ◽  
Filippo Pietrantonio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Previously Treated ◽  
Initial Starting

556 Background: In the VELOUR study, adding Z (known as aflibercept outside the United States) to FOLFIRI resulted in improved OS, PFS, and RR in mCRC pts who had received prior oxaliplatin. Prior treatment with B (~30% of the ITT population) did not appear to impact the safety profile of Z. Results from VELOUR supported initiation of the global Aflibercept Safety and Quality-of-Life (QoL) Program composed of two clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) to capture QoL and safety data from a population similar to that of VELOUR in a real-life setting. We report early safety data from this interim analysis in pts pretreated with B. Methods: ASQoP and AFEQT are single-arm, open-label trials evaluating safety and QoL of Z in mCRC pts previously treated with an oxaliplatin-containing regimen. Eligible pts receive Z (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses and subsequent modifications are at treating physicians’ discretion. The percentage of pts with grade (G) 3/4 adverse events (AEs) in the combined safety population of ASQoP and AFEQT in B-pretreated pts is compared with that of B-pretreated pts in VELOUR. Results: At data cut-off, the safety population comprised 116 pts with ≥1 completed treatment cycle; 67 (57.8%) were pretreated with B. At least 1 G3/4 AE was experienced by 49.3% of pts vs 82.5% in VELOUR. Most G3/4 AEs were G3. There were no reports of G4 hypertension or proteinuria. Conclusions: Thisinterim safety analysis from ASQoP/AFEQT in pts pretreated with B has identified no new safety signals for Z and a trend toward decreased incidence of G3/4 events. The early analysis provides additional safety data and suggests an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Safety and quality of life (QoL) data from the Spanish subgroup of the Aflibercept Safety and Quality-of-Life Program (ASQoP).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 751-751
Author(s):  
Fernando Rivera ◽  
Eduardo Polo Marques ◽  
Enrique Aranda ◽  
Carlos Fernandez-Martos ◽  
Adelaida La Casta Munoa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Open Label ◽  
Utility Index ◽  
Real Life Setting ◽  
Safety Population ◽  
Eortc Qlq C30 ◽  
Report Data ◽  
Eortc Qlq

751 Background: In the VELOUR trial, adding Z to FOLFIRI improves OS, PFS and RR in mCRC pts progressing after oxaliplatin ±biologic agents. The ASQoP trial (NCT01571284) was designed to gather safety and QoL data from mCRC in real-life setting. We report data collected by the Spanish investigators. Methods: ASQoP is single-arm, open-label trial evaluating safety and QoL of Z in mCRC pts as 2nd line. Eligible pts received Z (4mg/kg) q2wks on day 1/cycle, followed by FOLFIRI (dosing was at physician’s discretion) until disease progression, unacceptable toxicity, death, or investigator/pt decision. The EQ-5D was used for utility index (UI) measure and the EORTC QLQ-C30 as generic cancer instrument. QoL population consisted of pts completing the questionnaire at baseline and ≥1 assessment post-baseline and received ≥1 part of 1 dose of study treatment. Results: The safety population comprised 77 pts with ≥1 completed cycle of treatment. Grade (G)3/4 AEs were reported in 72.7% of pts (vs 83.5% in VELOUR), being G3 most commonly reported. There was no G4 hypertension, stomatitis, or proteinuria. G4 Diarrhea was found in 1.3% of pts. Mean baseline UI was 0.7 (95% CI, 0.63-0.78) in 51 pts, and remained relatively stable at cycles 3 (n=39) and 7 (n=24), with a mean (±SD) change from baseline of 0.03 (±0.26) and -0.06 (±0.35), respectively. Mean baseline global health status score was 63.1 (95% CI, 55.8-70.4) in 54 pts, and remained stable up to cycle 9 with a mean (±SD) change from baseline of 4.17 (±38). Conclusions: Thisanalysis has identified no new safety signals and suggests an acceptable toxicity profile with a relatively stable UI and QoL in Spanish mCRC pts in the real-life setting. [Table: see text]

Ziv-aflibercept in combination with FOLFIRI for second-line treatment of patients with metastatic colorectal cancer (mCRC): Interim safety data from the global aflibercept safety and quality-of-life program (ASQoP and AFEQT studies) in patients ≥65.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 545-545 ◽  
Author(s):  
Roberto Bordonaro ◽  
Alberto F. Sobrero ◽  
Luca Frassineti ◽  
Libero Ciuffreda ◽  
Giuseppe Aprile ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Interim Analysis ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Real Life Setting ◽  
Safety Population ◽  
Study Results ◽  
Initial Starting

545 Background: The prespecified analysis of patients ≥65 years of age in the VELOUR study demonstrated a safety profile similar to that of ziv-aflibercept (Z) (known as aflibercept outside the United States) plus FOLFIRI in the overall VELOUR study. Results from VELOUR supported the initiation of the global Aflibercept Safety and Quality-of-Life (QoL) Program composed of two clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) to capture QoL and safety data from a target population similar to that of VELOUR in a real-life setting. We report early safety data from this interim analysis for patients ≥65 y. Methods: ASQoP and AFEQT are single-arm, open-label trials evaluating safety and QoL of Z in mCRC patients previously treated with an oxaliplatin-containing regimen. Eligible patients received Z (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/patient decision. Initial starting doses and subsequent dose modifications are at the treating physician’s discretion. The percentage of patients ≥65 y with grade (G) 3/4 adverse events (AEs) in the combined safety population of ASQoP and AFEQT are compared with that of the prespecified analysis in patients ≥65 y from VELOUR. Results: At data cut-off, the safety population comprised 116 patients with at least 1 completed cycle of treatment; 53 (45.7%) were ≥65 y. At least 1 G3/4 AE was experienced by 64.2% of patients vs 89.3% in VELOUR. Most reported G3/4 AEs were G3. There were no reports of G4 hypertension, diarrhea, stomatitis, or proteinuria. Conclusions: Thisinterim safety analysis from ASQoP and AFEQT in patients ≥65 y has identified no new safety signals. The early interim analysis provides additional safety data and suggests an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

scholarly journals Benefits of The Unforgettables: A Chorus for People With Dementia Together With Their Family Caregivers

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 784-784
Author(s):  
Mary Mittelman
Keyword(s):  
Quality Of Life ◽  
Family Caregivers ◽  
Social Engagement ◽  
Social Activity ◽  
Music Performance ◽  
Brain Health ◽  
People With Dementia ◽  
Study Results ◽  
The Many

Abstract The Unforgettables was founded in 2011 for people with dementia and their family caregivers. We hypothesized that singing and rehearsing together would providing an opportunity for people in the early and moderate stages of dementia and their family caregivers to share a normative, stimulating and social activity. Pilot study results showed that quality of life and communication with the other member of the dyad improved for people with dementia; quality of life and, social support, communication and self- esteem improved for caregivers. Moreover, people with dementia learn new songs for every performance, suggesting that this activity may slow cognitive decline. The chorus continues to rehearse and perform, and now has approximately 100 members in two locations in NYC. These findings support the recommendations of the Global Council on Brain Health by underscoring the many benefits of music performance in enhancing social engagement and providing joy to participants and the community.

Would you be more satisfied with your life if you travel more frequently?

2020 ◽  
Author(s):  
Chun-Chu Chen ◽  
Sui-Wen (Sharon) Zou ◽  
James F. Petrick
Keyword(s):  
Quality Of Life ◽  
Relevant Information ◽  
Life Domain ◽  
Travel And Tourism ◽  
Study Results ◽  
Personal Importance

This research intends to examine whether frequent travelers are more satisfied with their life as well as why these individuals travel more frequently than others. Derived from a sample of 500 Taiwanese respondents, the study results show that respondents attaching personal importance to tourism are more likely to gather travel-relevant information, resulting in more frequent travels. It is also found that frequent travelers are more satisfied with their life. These findings suggest that travel and tourism can be an important life domain affecting how people evaluate their overall quality of life.

QUALITY OF LIFE PROBLEMS OF GYNECOLOGICAL CANCER PATIENTS

2017 ◽  
Vol 63 (3) ◽  
pp. 368-374
Author(s):  
Olga Churuksaeva ◽  
Larisa Kolomiets
Keyword(s):  
Quality Of Life ◽  
Gynecological Cancer ◽  
Social Aspects ◽  
Cancer Data ◽  
Life Problems ◽  
Anticancer Treatment ◽  
Short And Long Term ◽  
The Relationship

Due to improvements in short- and long-term clinical outcomes a study of quality of life is one of the most promising trends in oncology today. This review analyzes the published literature on problems dealing with quality of life of patients with gynecological cancer. Data on quality of life with respect to the extent of anticancer treatment as well as psychological and social aspects are presented. The relationship between quality of life and survival has been estimated.

scholarly journals The Association of Sources of Support, Types of Support and Satisfaction with Support Received on Perceived Stress and Quality of Life of Cancer Patients

2021 ◽  
Vol 20 ◽  
pp. 153473542199490
Author(s):  
Iván Ruiz-Rodríguez ◽  
Isabel Hombrados-Mendieta ◽  
Anabel Melguizo-Garín ◽  
Mª José Martos-Méndez
Keyword(s):  
Quality Of Life ◽  
Social Support ◽  
Cancer Patients ◽  
Perceived Stress ◽  
Emotional Support ◽  
Multidimensional Analysis ◽  
Informational Support ◽  
Cancer Data ◽  
The Family

Introduction: The aim of the present study is to carry out a multidimensional analysis of the relationship of social support with quality of life and the stress perceived by cancer patients. Methods: The participants were 200 patients with cancer. Data was gathered on sociodemographic characteristics, health, quality of life, social support and perceived stress. Results: Frequency of and satisfaction with different sources and types of support are related positively with improvement of quality of life and negatively with perceived stress. The emotional support from the partner and the emotional and informational support from the family are significant predictors of quality of life. Emotional support from the family reduces patients’ perceived stress. Satisfaction with emotional support from the partner and with the informational support from friends and family increases quality of life. Satisfaction with emotional support from the family and with informational support from friends decreases patients’ perceived stress. Instrumental support and support provided by health professionals are not good predictors of quality of life and perceived stress. Satisfaction with the support received is more significantly related with quality of life and stress than the frequency with which the sources provide support. Conclusions: These results have important practical implications to improve cancer patients’ quality of life and reduce their perceived stress through social support. Designing intervention strategies to improve satisfaction with the support provided to patients by their closest networks results in a global benefit for the patient’s quality of life.

scholarly journals Glatiramer Acetate Treatment in Multiple Sclerosis-Associated Fatigue—Beneficial Effects on Self-Assessment Scales But Not on Molecular Markers

Biomolecules ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 393
Author(s):  
Oliver Neuhaus ◽  
Wolfgang Köhler ◽  
Florian Then Bergh ◽  
Wolfgang Kristoferitsch ◽  
Jürgen Faiss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Neurotrophic Factors ◽  
Common Symptom ◽  
Mrna Levels ◽  
Open Label ◽  
Immunological Parameters ◽  
Beneficial Effects

Although fatigue is a common symptom in multiple sclerosis (MS), its pathomechanisms are incompletely understood. Glatiramer acetate (GA), an immunomodulatory agent approved for treatment of relapsing-remitting MS (RRMS), possesses unique mechanisms of action and has been shown to exhibit beneficial effects on MS fatigue. The objective of this study was to correlate clinical, neuropsychological, and immunological parameters in RRMS patients with fatigue before and during treatment with GA. In a prospective, open-label, multicenter trial, 30 patients with RRMS and fatigue were treated with GA for 12 months. Inclusion criterion was the presence of fatigue as one of the most frequent and disabling symptoms. Before and during treatment, fatigue was assessed using the Fatigue Severity Scale (FSS), the MS-FSS, and the Modified Fatigue Impact Scale (MFIS). In addition, fatigue and quality of life were assessed using the Visual Analog Scales (VAS). Laboratory assessments included screening of 188 parameters using real-time PCR microarrays followed by further analysis of several cytokines, chemokines, and neurotrophic factors. Fatigue self-assessments were completed in 25 patients. After 12 months of treatment with GA, 13 of these patients improved in all three scales (with the most prominent effects on the MFIS), whereas 5 patients had deteriorated. The remaining 7 patients exhibited inconsistent effects within the three scales. Fatigue and overall quality of life had improved, as assessed via VAS. Laboratory assessments revealed heterogeneous mRNA levels of cytokines, chemokines, and neurotrophic factors. In conclusion, we were not able to correlate clinical and molecular effects of GA in patients with RRMS and fatigue.

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