Malignant gastrointestinal stromal tumors treated with imatinib in France: Results in unselected patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e22177-e22177
Author(s):  
A. Mathieu-Boue ◽  
O. Bouché ◽  
A. Cioffi ◽  
M. Rios ◽  
F. Duffaud ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Onset ◽  
Initial Dosage ◽  
Real Life ◽  
Published Data ◽  
Case Report Form ◽  
Primary Tumors ◽  
Real Life Setting

e22177 Background: GISTs are rare tumors of the GI tract. In France, their incidence is estimated to be 9- 12/106 inhabitants/year. Imatinib (IM) has been approved to treat unresectable and/or metastatic Kit-positive GISTs since 2002 but information on routine use, safety and efficacy in unselected “real life” setting is lacking. An observational cohort (EPIGIST) in France was designed to provide data on survival, safety and treatment patterns and quality of life. Methods: EPIGIST is a nationwide multi-center, observational study on GIST patients (pts) treated with IM for the first time between the availability on the French Market and the end of the 2008. Centers were randomly selected in national files of oncologists, gastrointestinal surgeons and gastrointestinal specialists. The planned follow-up duration was three years. A case report form (CRF) had to be completed at inclusion and during each follow-up visits. Quality of life was assessed using QLQ-C30 and SF36 questionnaires. Results: 29 on 51 selected centers enrolled at least one pt and 127 pts were included (as of 12/2008), The median age of disease onset was 59 years (range 29 - 85) with 48% pts>50 years. 63% were symptomatic at diagnosis; 69% were fully active (grade 0 on the ECOG index). Primary tumors were most often gastric (34%), or from jejunum/ileum (24%). At diagnosis 84% of pts had a tumor size over 5cm. 64% of patients had surgery of the primary tumor before starting IM. For 86% of the pts, IM was given at an in initial dosage of 400 mg, 8% at 300 mg and 6% at 800mg. Compliance was superior to 90% for all pts. With a median follow-up of 1.72 years (CI95%: [1.08;1.95]), two-years overall survival from first treatment with IM was 88.1% (CI95%: [65.3%-96.3%]). Conclusions: EPIGIST is still an ongoing survey. Current results confirm previous published data on survival in GIST treated with IM in an unselected cohort of patients outside of a clinical trial. [Table: see text]

Pulmonary lymphangitis and cancer: Prospective series of 37 patients in palliative care

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18600-18600 ◽  
Author(s):  
A. A. Dettino ◽  
E. M. Negri ◽  
T. Pagano
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Short Form ◽  
Primary Tumors ◽  
Patients With Cancer ◽  
The Moment ◽  
In The Beginning ◽  
Minor Criteria

18600 Background: Lymphangitis of the lungs is an uncommon type of metastasis, mainly in breast, lung and gastric cancers, and has major impact in quality of life and an unfavorable prognosis. Survival is very poor: 50% in 3 and 15% in 6 months. Our objective was to evaluate prospectively quality of life in cancer patients with pulmonary lymphangitis, under palliative care. Methods: Patients with pulmonary lymphangitis, diagnosed either by lung biopsy (major criteria) or 3 minor criteria (cyto or histotologically proven cancer, clinical picture and image exam) were followed in 3 tertiary services, in a cohort series study. Primary end point was quality of life (QoL), measured with questionnaires in the beginning of the study and monthly afterwards (Saint George Respiratory Questionnaire -SGRQ- and Medical Outcomes Study 36-Item Short-Form Health Survey -SF36). Clinical and complementary aspects were also followed, in addition to treatment and outcome. Results: Thirty-seven patients were included from Aug/2004 to Jan/2006 - 23 female and 14 male; age from 41 to 84 (mean: 62) years. Primary tumors were: lung (20), breast (11), esophagus (2), pancreas, rectum and bone. Of those patients, 33 were able to respond QoL questionnaires in the beginning of follow-up and monthly thereafter. Median follow-up was of one month (range: 0–13); at the moment, 9 patients are still alive. Median survival was 2.5 months (range: 0,1–33), with 38% with a survival of at least 6 months. In general, QoL was poor, but improved after palliative care. Notice that values get higher as QoL improves in SF-36; however, they get lower as QoL improves in SGRQ - values were 61.5, 50.5, 61.7, and 47.5% for SGRQ and 38.1, 32.1, 32.8, 61.6 for SF36 in 0, 1, 3 and 6 months, respectively. Palliative care included: corticosteroids (65%), oxygen (51%), opioids (51%), diuretics (47%), inhalations with beta2-agonists and/or ipatropium (57%), chemo and/or hormonotherapy (51%), physical therapy (43%), antidepressants and benzodiazepines (37% each), thoracocentesis (35%), and blood transfusions. Conclusions: Even though QoL is poor and survival is short for patients with cancer lymphangitis in lungs, some improvement is possible with active palliative care. No significant financial relationships to disclose.

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]

scholarly journals Does long-term GH replacement therapy in hypopituitary adults with GH deficiency normalise quality of life?

2006 ◽  
Vol 155 (1) ◽  
pp. 109-119 ◽  
Author(s):  
Maria Koltowska-Häggström ◽  
Anders F Mattsson ◽  
John P Monson ◽  
Paul Kind ◽  
Xavier Badia ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Gh Deficiency ◽  
Disease Onset ◽  
Life Assessment ◽  
Hormone Deficiency ◽  
Gh Replacement ◽  
Country Specific

Objective: To determine whether impaired quality of life (QoL) in adults with GH deficiency (GHD) is reversible with long-term GH therapy and whether the responses in QoL dimensions differ from each other. Methods: QoL was measured by the Quality of Life–Assessment for Growth Hormone Deficiency in Adults (QoL-AGHDA) in general population samples in England & Wales, The Netherlands, Spain and Sweden (n = 892, 1038, 868 and 1682 respectively) and compared with corresponding patients’ data from KIMS (Pfizer International Metabolic Database) (n = 758, 247, 197 and 484 respectively) for 4–6 years a follow-up. The subsets of patients from England and Wales, and Sweden with longitudinal data for 5 years’ follow-up were also analysed. The change of the total QoL-AGHDA scores and responses within dimensions were evaluated. Subanalyses were performed to identify any specificity in response pattern for gender, age, disease-onset and aetiology. Results: Irrespective of the degree of impairment, overall QoL improved dramatically in the first 12 months, with steady progress thereafter towards the country-specific population mean. Problems with memory and tiredness were the most serious burden for untreated patients, followed by tenseness, self-confidence and problems with socialising. With treatment, these improved in the reverse order, normalising for the latter three. Conclusions: Long-term GH replacement results in sustained improvements towards the normative country-specific values in overall QoL and in most impaired dimensions. The lasting improvement and almost identical pattern of response in each patient subgroup and independent of the level of QoL impairment support the hypothesis that GHD may cause these patients’ psychological problems.

Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

2016 ◽  
Vol 123 (5) ◽  
pp. 533-540 ◽  
Author(s):  
Katja Kollewe ◽  
Claus M. Escher ◽  
Dirk U. Wulff ◽  
Davood Fathi ◽  
Lejla Paracka ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Real Life ◽  
Term Treatment ◽  
Real Life Setting ◽  
Long Term Treatment

scholarly journals The Use of HSQoL-24 in an Assessment of Quality-of-Life Impairment among Hidradenitis Suppurativa Patients: First Look at Real-Life Data

2021 ◽  
Vol 10 (22) ◽  
pp. 5446
Author(s):  
Piotr K. Krajewski ◽  
Servando E. Marrón ◽  
Manuel Gomez-Barrera ◽  
Lucía Tomas-Aragones ◽  
Yolanda Gilaberte-Calzada ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Hidradenitis Suppurativa ◽  
Disease Onset ◽  
Real Life ◽  
Clinical Settings ◽  
Life Data ◽  
Real Life Data ◽  
Inflammatory Skin Disorder ◽  
Family House

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder with well-documented effects on patients’ quality of life (QoL). The aim of this study was to evaluate the QoL of patients with HS via the use of a newly developed questionnaire: Hidradenitis Suppurativa Quality of Life-24 (HSQoL-24). This study was performed on a population of 342 HS patients. Their QoL was assessed via the HSQoL-24 questionnaire. The perceived impairment of QoL due to HS in the studied group was considered to be serious (mean HSQoL-24 score: 58.3 ± 21.0 points). Women tended to experience a significantly higher impact from the disease than men (61.6 ± 19.2 points vs. 51.1 ± 23.1 points, p < 0.001). The HS severity had an effect on the perceived QoL, with statistically significant differences being evident between the self-assessed HS severity groups. The level of QoL impairment correlated positively with the number of affected body areas (r = 0.285, p < 0.001) and the duration of the disease (r = 0.173, p = 0.001), while the patients’ age at disease onset correlated negatively with the HSQoL-24 global score (r = −0.182, p = 0.001). Patients living in their family house scored higher than other groups. The least affected were patients who lived alone. The study shows that the HSQoL-24 questionnaire is a reliable, HS-specific tool for measuring the QoL among patients with HS in real-life clinical settings.

scholarly journals AN OPD BASED PROSPECTIVE EXPLORATORY STUDY OF DERMATOPHYTOSIS - FOCUS ON TREATMENT OUTCOMES, MEDICATION ADHERENCE, AND QUALITY OF LIFE

2021 ◽  
pp. 109-112
Author(s):  
SOUGATA MUKHERJEE ◽  
CHIRANJIB BAGCHI ◽  
KINGSHUK CHATTERJEE ◽  
AVIK DAS ◽  
SANTANU KUMAR TRIPATHI
Keyword(s):  
Quality Of Life ◽  
Medication Adherence ◽  
Rating Scale ◽  
Life Quality ◽  
Tinea Corporis ◽  
Case Report Form ◽  
Treatment Regimens ◽  
Predominant Symptom

Objective: The study was planned primarily to judge the effectiveness, safety, and adherence of the prescribed treatments in dermatophytosis along with the effect on the Quality of Life (QoL) of the affected individuals. Methods: In this prospective observational study, spanning over 5 months, participants (dermatophytosis patients) were assessed at baseline and 6 week-follow-up at study site. Information about their clinical presentation, QoL (Quality of Life) parameters, medication adherence, and adverse drug reaction (ADR) were entered in the Case Report Form (CRF) prepared by utilizing global standard tools such as 5D-itch scale, Dermatology Life Quality Index (DLQI), Medication Adherence Rating Scale (MARS), and WHO-ADR reporting form respectively. Results: Total 60 subjects (33 males and 27 females) had completed the study. Overall, tinea cruris (40%) was the most common variety followed by combination of tinea corporis and cruris (35%), tinea corporis (20%), and tinea incognito (3%). Pruritus was the predominant symptom. There was a significant (p<0.001) improvement of both 5D-itch & DLQI scores from baseline to follow-up stage (after 6 weeks). Treatment regimens were well tolerated (only eight subjects reported any adverse event such as gastric irritation and sedation). Medication adherence to the prescribed treatment was good; (mean MARS score 7.588±1.82). Mostly prescribed regimen was a combination of antifungal (oral plus topical) and antihistamine tablet (58/60, 96.66%). The most common drug combination was capsule itraconazole, luliconazole cream, and cetirizine or levocetirizine tablet with or without ketoconazole soap (35/60, 58.33%). Conclusion: Prescribed treatment regimen for dermatophytosis was effective, tolerable, acceptable with high medication adherence and also improved the QoL of the study subjects.

scholarly journals A French Multicentric Prospective Cohort of 6000 Patients with Integrative Epidemiological, Clinical, Biological and Treatment Data to Improve Knowledge on Outcome of Lymphoma Patients: Pilot Phase Results of the Real World Data in Lymphoma and Survival in Adults (REALYSA) Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4762-4762
Author(s):  
Herve Ghesquieres ◽  
Cedric Rossi ◽  
Fanny Cherblanc ◽  
Sandra Le Guyader ◽  
Fontanet Bijou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Board Of Directors ◽  
Real World ◽  
Biological Samples ◽  
Real Life ◽  
Pilot Phase ◽  
Real World Data ◽  
Advisory Committees

Introduction: Lymphoma incidence continues to rise in France since early 80', although differently among subtypes. Recent improvements in patient survival in major lymphoma subtypes at populational level raise new questions about patient outcome (in specific subgroups) and survivorship (i.e. quality of life, long term sequelae). Numerous epidemiological studies have investigated factors related to lymphoma risk, but far fewer have addressed the extent to which socioeconomic status, social institutional context (i.e. healthcare system), social relationships, environmental context (exposures), individual behaviours (lifestyle) or genetic determinants influence lymphoma outcomes, especially in the general population. Moreover, the knowledge of the disease behaviour achieved from clinical trials data is partly biased because of patient selection. Study Design and Methods: The REALYSA ("REal world dAta in LYmphoma and Survival in Adults") study is a real-life multicentric cohort set in France areas mostly covered by population-based cancer registries to study the prognostic value of epidemiological, clinical and biological factors with a prospective 9-year follow up. ClinicalTrials.gov identifier is NCT03869619. We aim to include 6000 patients over 4 years. Adult patients without lymphoma history and newly diagnosed of one of the following 7 lymphoma subtypes (diffuse large B cell (DLBCL), follicular (FL), marginal zone (MZL), mantle cell (MCL), Burkitt, Hodgkin (HL), T-cell (T-NHL)) are offered to participate during a medical consultation with their hematologist. Exclusion criteria are: having already received anti-lymphoma treatment (except pre-phase) and having a documented HIV infection. After having given signed informed consent, participants fill in three auto-questionnaires regarding lifelong history of residences and occupations, quality of life (QoL / QLQ-C30 questionnaire) and social support (SS / SSQ6 questionnaire). Patients are then interviewed to collect their sociodemographic characteristics, medical and familial history, professional and domestic exposures to major chemicals and pesticides, lifestyle and women health. Clinical data are obtained using patients medical records, including care pathway, medical history, concomitant treatments, initial diagnosis characteristics, nodal/extra-nodal involvement, exams performed, staging, laboratory data, serologic tests, geriatric screening (G8 questionnaire), treatments received (including pre-phase, detailed treatment phases and molecules, reasons for treatment discontinuation), progressions, and treatment response evaluation. Biological samples at baseline and during treatment are collected including plasma and peripheral mononuclear cells. Additionally, a virtual tumor biobank is constituted for baseline tumor samples. The diagnosis will be ensured thanks to the review of French Lymphopath network. Follow-up, including clinical outcomes, new morbidities, lifestyle, professional situation, QoL, SS, fertility, health behavior, are collected every 6 months in the first 3 years and every year thereafter. Results: A pilot phase was implemented between November 2018 and June 2019 in 7 French hospitals/clinics. By June 30, 328 patients were recruited. Biological samples at baseline were obtained for 81% of included patients (n=265). 52% were male and 48% were female. The median age was 62 years (range: 18-95). The histological subtypes were the following (n=308 patients with complete data): 132 DLBCL (42.8%); 59 FL (19.5%); 52 HL (16.9%); 29 MCL (9.4%); 22 MZL (7.1%); 13 T-NHL (4.2%); 1 other (0.3%). We observed a good adherence to clinical research process despite the complexity of data collection. An extension phase with 10 additional centres will be launched during the last 2019 trimester. Discussion: The pilot phase of REALYSA study showed a good compliance to study guidelines and a good quality of data collected at baseline. Consequently, the study design is prospectively feasible in real-life setting. This cohort will constitute an innovative platform for clinical, biological, epidemiological and socio-economical research projects. Disclosures Oberic: Takeda: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria; Roche: Membership on an entity's Board of Directors or advisory committees. Salles:Amgen: Honoraria, Other: Educational events; Novartis, Servier, AbbVie, Karyopharm, Kite, MorphoSys: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Educational events; BMS: Honoraria; Roche, Janssen, Gilead, Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Educational events; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Educational events; Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Autolus: Consultancy, Membership on an entity's Board of Directors or advisory committees; Epizyme: Consultancy, Honoraria.

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]

scholarly journals Effects of lower limb prosthesis on activity, participation, and quality of life: a systematic review

2012 ◽  
Vol 36 (2) ◽  
pp. 145-158 ◽  
Author(s):  
Kersti AM Samuelsson ◽  
Outi Töytäri ◽  
Anna-Liisa Salminen ◽  
Åse Brandt
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Lower Limb ◽  
User Satisfaction ◽  
Real Life ◽  
Assistive Devices ◽  
Activity Participation ◽  
High Quality Research

Background: Effects presented on the use of assistive devices such as prosthesis are often based on laboratory findings (i.e. efficacy). Objectives: To summarise and evaluate findings from studies on effectiveness of lower limb prostheses for adults in real life contexts, primarily in terms of activity, participation, and quality of life (QoL) and secondarily in terms of user satisfaction, use/non-use, and/or cost-effectiveness. Study Design: Systematic review. Methods: We included controlled studies and non-controlled follow-up studies including both baseline and follow-up data. Using 14 different databases supplemented with manual searches, we searched for studies published from 1998 until June 2009. Results: Out of an initial 818 identified publications, eight met the inclusion criteria. Four studies reported on the effectiveness of a microprocessor-controlled knee (MP-knee) compared to a non-microprocessor-controlled knee (NMP-knee). Results were inconsistent except for quality of life and use/non-use, where the authors reported an improvement with the MP-knee compared to the NMP-knee. The remaining four studies included a diversity of prosthetic intervention measures and types of endpoints. Conclusions: Overall, there was an inconsistency in results and study quality. This review highlights the need for high-quality research studies that reflect the effectiveness of different prosthesis interventions in terms of users’ daily living and QoL. Clinical relevance Clinical guidelines are important to every practitioner. Information on expected effectiveness from assistive devices should be well founded and contain both facts about the device quality and its contribution to users’ daily lives. Thus, studies based on users’ experiences from prosthetic use in everyday life activities are of great importance.

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