scholarly journals Clinical Course of Oxaliplatin-Induced Neuropathy: Results From the Randomized Phase III Trial N08CB (Alliance)

2015 ◽  
Vol 33 (30) ◽  
pp. 3416-3422 ◽  
Author(s):  
Deirdre R. Pachman ◽  
Rui Qin ◽  
Drew K. Seisler ◽  
Ellen M.L. Smith ◽  
Andreas S. Beutler ◽  
...  
Keyword(s):  
Clinical Course ◽  
Severe Symptom ◽  
Phase Iii ◽  
Life Questionnaire ◽  
North Central ◽  
Phase Iii Trial ◽  
Quality Of Life Questionnaire ◽  
Acute Neuropathy ◽  
Chronic Neuropathy

Purpose Given that the clinical course of oxaliplatin-induced neuropathy is not well defined, the current study was performed to better understand clinical parameters associated with its presentation. Methods Acute and chronic neuropathy was evaluated in patients receiving adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) on study N08CB (North Central Cancer Treatment Group, Alliance). Acute neuropathy was assessed by having patients complete daily questionnaires for 6 days with each cycle of FOLFOX. Before each dose of FOLFOX and as long as 18 months after chemotherapy cessation, chronic neurotoxicity was assessed with use of the 20-item, European Organisation for Research and Treatment of Cancer quality-of-life questionnaire for patients with chemotherapy-induced peripheral neuropathy. Results Three hundred eight (89%) of the 346 patients had at least one symptom of acute neuropathy with the first cycle of FOLFOX; these symptoms included sensitivity to touching cold items (71%), sensitivity to swallowing cold items (71%), throat discomfort (63%), or muscle cramps (42%). Acute symptoms peaked at day 3 and improved, although they did not always resolve completely between treatments. These symptoms were about twice as severe in cycles 2 through 12 as they were in cycle 1. For chronic neurotoxicity, tingling was the most severe symptom, followed by numbness and then pain. During chemotherapy, symptoms in the hands were more prominent than they were in the feet; by 18 months, symptoms were more severe in the feet than they were in the hands. Patients with more severe acute neuropathy during the first cycle of therapy experienced more chronic sensory neurotoxicity (P < .0001). Conclusion Acute oxaliplatin-induced neuropathy symptoms do not always completely resolve between treatment cycles and are only half as severe on the first cycle as compared with subsequent cycles. There is a correlation between the severities of acute and chronic neuropathies.

scholarly journals Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial

2020 ◽  
pp. JCO.20.01370
Author(s):  
Aurore Perrot ◽  
Thierry Facon ◽  
Torben Plesner ◽  
Saad Z. Usmani ◽  
Shaji Kumar ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Myeloma ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Newly Diagnosed ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Depth Of Response ◽  
Descriptive System

PURPOSE To evaluate the effects of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) on patient-reported outcomes (PROs) in the phase III MAIA study. PATIENTS AND METHODS PROs were assessed on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item and the EuroQol 5-dimensional descriptive system at baseline and every 3 months during treatment. By mixed-effects model, changes from baseline are presented as least squares means with 95% CIs. RESULTS A total of 737 transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma were randomly assigned to D-Rd (n = 368) or Rd (n = 369). Compliance with PRO assessments was high at baseline (> 90%) through month 12 (> 78%) for both groups. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item global health status scores improved from baseline in both groups and were consistently greater with D-Rd at all time points. A global health status benefit was achieved with D-Rd, regardless of age (< 75 and ≥ 75 years), baseline Eastern Cooperative Oncology Group (ECOG) performance status score, or depth of response. D-Rd treatment resulted in significantly greater reduction in pain scores as early as cycle 3 ( P = .0007 v Rd); the magnitude of change was sustained through cycle 12. Reductions in pain with D-Rd were clinically meaningful in patients regardless of age, ECOG status, or depth of response. Similarly, PRO improvements were observed with D-Rd and Rd on the EuroQol 5-dimensional descriptive system visual analog scale score. CONCLUSION D-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in PROs, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.

Quality of Life With Docetaxel Plus Cisplatin and Fluorouracil Compared With Cisplatin and Fluorouracil From a Phase III Trial for Advanced Gastric or Gastroesophageal Adenocarcinoma: The V-325 Study Group

2007 ◽  
Vol 25 (22) ◽  
pp. 3210-3216 ◽  
Author(s):  
Jaffer A. Ajani ◽  
Vladimir M. Moiseyenko ◽  
Sergei Tjulandin ◽  
Alejandro Majlis ◽  
Manuel Constenla ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Continuous Infusion ◽  
Gastroesophageal Junction ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Phase Iii Trial ◽  
Gastroesophageal Junction Cancer ◽  
Eortc Qlq C30 ◽  
Eortc Qlq

Purpose Therapy of patients with advanced gastric or gastroesophageal junction cancer should provide symptom relief and improve quality of life (QOL) because most patients are symptomatic at baseline. Using validated instruments, we prospectively assessed QOL (even after completion of protocol treatment) as one of the secondary end points of the V325 phase III trial. Patients and Methods Four hundred forty-five patients randomly received either docetaxel 75 mg/m2 and cisplatin 75 mg/m2 each on day 1 plus fluorouracil 750 mg/m2/d continuous infusion on days 1 to 5 every 3 weeks (DCF) or cisplatin 100 mg/m2 on day 1 plus fluorouracil 1,000 mg/m2/d continuous infusion on days 1 to 5 every 4 weeks (CF). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and, where available, the EuroQOL EQ-5D questionnaire were administered every 8 weeks from baseline until progression and then every 3 months. Time to definitive deterioration of QOL parameters was analyzed. Results The proportions of patients having assessable EORTC QLQ-C30 and EQ-5D questionnaires at baseline were 86.0% and 78.7% with DCF, respectively, and 89.7% and 92.8% with CF, respectively. Time to 5% deterioration of global health status (primary end point) significantly favored DCF over CF (log-rank test, P = .01). QOL was preserved longer for patients on DCF than those on CF for all time to deterioration analyses, demonstrating the statistical superiority of DCF compared with CF. Conclusion V325 represents the largest trial with the longest prospectively controlled evaluations of QOL during protocol chemotherapy and follow-up in patients with advanced gastric or gastroesophageal junction cancer. In V325, advanced gastric or gastroesophageal junction cancer patients receiving DCF not only had statistically improved overall survival and time to tumor-progression, but they also had better preservation of QOL compared with patients receiving CF.

scholarly journals A disease-specific Quality of Life questionnaire for primary aldosteronism

2019 ◽  
Vol 8 (4) ◽  
pp. 389-397 ◽  
Author(s):  
Marieke Stientje Velema ◽  
Aline de Nooijer ◽  
Ad R M M Hermus ◽  
Henri J L M Timmers ◽  
Jacques W M Lenders ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Primary Aldosteronism ◽  
Phase Iii ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire ◽  
Hrqol Questionnaire ◽  
Disease Specific ◽  
Selection Of

Objective To develop a primary aldosteronism (PA) disease-specific Health-Related Quality of Life (HRQoL) questionnaire. Methods We included newly diagnosed patients with PA (n = 26), and patients with PA after adrenalectomy (n = 25) or treated with mineralocorticoid receptor antagonists (n = 25). According to the guidelines for developing HRQoL questionnaires from the European Organization for Research and Treatment of Cancer (EORTC): Phase I: systematic literature review followed by focus group meetings with patients (n = 13) resulting in a list of 94 HRQoL issues. Relevance of issues was rated by 18 other patients and by health care professionals (n = 15), resulting in 30 remaining issues. Phase II: selected issues were converted into questions. Phase III: the provisional questionnaire was pre-tested by a third group of patients (n = 45) who also completed the EORTC core Quality of Life questionnaire (QLQ-C30). Psychometric testing resulted in a final selection of questions with their scale structure. Results After the collection and selection of HRQoL issues a provisional questionnaire consisting of 30 items was formed. Of these items, 26 could be assigned to one of the four scales ‘physical and mental fatigue’, ‘anxiety and stress’, ‘fluid balance’ and ‘other complaints’ cumulatively accounting for 68% of variation in all items. All scales had good reliability and validity. There was a significant correlation of all four scales with the QLQ-C30 in most cases. Conclusions We developed the first PA-specific HRQoL questionnaire (PA-QoL) using standard, methodologically proven guidelines. After completion of the final validation (phase IV, international field testing), the questionnaire can be implemented into clinical practice.

Alexithyme Patientenmerkmale und Lebensqualität – Eine Querschnittsstudie an 79 ambulanten Patienten mit Angststörungen

2013 ◽  
Vol 61 (1) ◽  
pp. 17-26 ◽  
Author(s):  
Katrin Leenen ◽  
Michael Rufer ◽  
Hanspeter Moergeli ◽  
Hans-Jörgen Grabe ◽  
Josef Jenewein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
World Health ◽  
Life Questionnaire ◽  
World Health Organization Quality ◽  
Fand Sich ◽  
Quality Of Life Questionnaire ◽  
Organization Quality ◽  
Health Organization ◽  
Tas 20

Aus Untersuchungen in der Normalbevölkerung ist bekannt, dass Menschen mit erhöhten Alexithymiewerten eine verminderte Lebensqualität (LQ) aufweisen. Für Patienten mit psychischen Störungen wurde dieser Zusammenhang jedoch kaum untersucht. Ziel dieser Studie war es, den möglichen Zusammenhang zwischen alexithymen Patientenmerkmalen und der LQ bei Patienten mit Angststörungen zu überprüfen. Bei 79 ambulanten Patienten mit Angststörungen wurden alexithyme Charakteristika mit der Toronto Alexithymia Scale (TAS-20), die LQ mit der Kurzversion des World Health Organization Quality of Life Questionnaire 100 (WHOQOL-BREF) erfasst. Darüber hinaus fand eine Erhebung der psychischen Symptombelastung (SCL-90-R) und depressiven Symptomatik (MADRS) statt. Mittels hierarchischer Regressionsanalysen wurde der Zusammenhang zwischen der alexithymen Charakteristika und den unterschiedlichen LQ-Domänen berechnet. Die Patienten zeigten eine im Vergleich zur Normalbevölkerung deutlich verminderte LQ. Als Hauptergebnis fand sich, auch nach Kontrolle von Depression, Ängstlichkeit und Geschlecht, ein signifikanter Zusammenhang zwischen den beiden TAS-20 Subskalen Schwierigkeiten, Gefühle zu identifizieren und zu beschreiben und vor allem der psychischen LQ. Unsere Ergebnisse sprechen dafür, bei der Diagnostik und Therapieplanung von Patienten mit Angststörungen alexithyme Merkmale einzubeziehen. Im Falle von ausgeprägten alexithymen Merkmalen sollten psychotherapeutische Interventionen zur Verbesserung der Schwierigkeiten Gefühle wahrzunehmen und zu kommunizieren in Betracht gezogen werden.

Nursing Home Vision-Targeted Health-Related Quality of Life Questionnaire

2007 ◽  
Author(s):  
Laura E. Dreer ◽  
G. McGwin ◽  
K. Scilley ◽  
G. C. Meek ◽  
A. Dyer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Nursing Home ◽  
Life Questionnaire ◽  
Health Related Quality ◽  
Quality Of Life Questionnaire ◽  
Related Quality ◽  
Health Related

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-ELD14--Spanish Version

2019 ◽  
Author(s):  
Juan Ignacio Arraras ◽  
Gemma Asin ◽  
José Juan Illarramendi ◽  
Ana Manterola ◽  
Esteban Salgado ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spanish Version ◽  
Life Questionnaire ◽  
European Organization ◽  
Quality Of Life Questionnaire
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