Patient-reported quality of life (QOL) analysis of radium-223 dichloride (Ra-223) evaluating pain relief from the phase 3 ALSYMPCA study.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 5069-5069 ◽  
Author(s):  
Sten Nilsson ◽  
Michael Tomblyn ◽  
Paul Cislo ◽  
Jonathan Reuning-Scherer ◽  
Chris Parker
2020 ◽  
Vol 125 (5) ◽  
pp. S22
Author(s):  
D. Johnston ◽  
A. Banerji ◽  
M. Riedl ◽  
D. Soteres ◽  
J. Bernstein ◽  
...  

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 63-63
Author(s):  
Seungyeon Kim ◽  
Henriette Breunis ◽  
Narhari Timilshina ◽  
Helen Yang ◽  
Shabbir M.H. Alibhai

63 Background: As the arsenal of therapeutic agents for mCRPC expands, frailty-informed care is emerging as a strategy for tailoring management decisions. Yet, data to guide this approach and to ascertain its impact on the mood, fatigue, pain, and quality of life (QoL) experienced by older men with mCRPC remain lacking. We examined patient-reported outcomes, stratified by a validated frailty index (FI), for mCRPC treatment with docetaxel chemotherapy (CHEMO), abiraterone (ABI), enzalutamide (ENZA), or radium 223 (RAD). Methods: Older (aged 65+) men starting one of four approved therapies for mCRPC were enrolled in a multicenter prospective cohort study. Assessing their mood, fatigue, pain, and QoL with PHQ-9, ESAS tiredness, ESAS pain, and FACT-G total as well as subscale scores, we used linear mixed effect models to determine change in each outcome over time (0, 3, 6 months). At end of treatment, we administered the Decisional Regret Scale. We then constructed a FI from 34 variables that span laboratory abnormalities, geriatric syndromes, instrumental activities of daily living, social support, as well as emotional, cognitive, and physical deficits. Following established cut-offs, we categorized patients as non-, pre-, and frail, then performed stratified linear mixed effects regression analyses to identify differences in outcomes by frailty status. Results: A total of 198 men (mean age 75.1) starting CHEMO (n = 70), ABI (n = 38), ENZA (n = 67), and RAD (n = 29) were included, of which 9.6%, 1.5%, 5.6%, and 2.5%, respectively, were determined frail. Frailty correlated only modestly with age (Pearson r = 0.27). Independent of frailty status, patients across treatment cohorts were similar in terms of baseline QoL-related measures, with the exceptions of mood (p = 0.033) and pain (p = 0.034). Over time, no significant change in QoL was reported, although all four therapies resulted in generally low levels of decisional regret and similar trends of improved pain but worsened mood (p = 0.006 and 0.02, respectively). At baseline, frailty status correlated with worse FACT-G total (p < 0.001) and functional well-being (p < 0.001), as well as worse depression scores (p < 0.001). According to FI-stratified analysis, frail patients experienced similar QoL-related outcomes to fit patients for all measures aside from mood (p < 0.001). Contrary to our hypotheses, frailty was not associated with significant worsening in emotional well-being or functional well-being in response to mCRPC treatment. Conclusions: Of the older men receiving care for mCRPC, frail patients may experience generally similar trends in QoL as fit patients. Interestingly, frailty status, rather than treatment modality, may play more of a contributory role to changes in QoL-related outcomes over time.


2016 ◽  
Vol 27 (5) ◽  
pp. 868-874 ◽  
Author(s):  
S. Nilsson ◽  
P. Cislo ◽  
O. Sartor ◽  
N.J. Vogelzang ◽  
R.E. Coleman ◽  
...  

BMC Urology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Andrea Necchi ◽  
Hiroyuki Nishiyama ◽  
Nobuaki Matsubara ◽  
Jae-Lyun Lee ◽  
Daniel P. Petrylak ◽  
...  

Abstract Background To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC). Methods RANGE—a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m2) or placebo plus docetaxel were administered every 21 days until disease progression or unacceptable toxicity. Patients received maximum 10 cycles of docetaxel. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EuroQoL five-dimensions (EQ-5D-5L) were administered at baseline, start of each cycle, and 30-day follow-up visit. A ≥ 10-point change in QLQ-C30 scores was considered meaningful. Rates of improved/stable scores were compared between treatment arms using Fisher’s exact test. Time to deterioration (TtD) was estimated and compared using Kaplan–Meier estimation and log-rank test. Results Of the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compliance was ≥ 88% for first 8 cycles. Mean baseline QLQ-C30 scores were similar between arms, with global quality of life (QoL), fatigue, pain, and insomnia having greatest impairment. Postbaseline rates of improved/stable QLQ-C30 scores were similar between treatment arms except for greater improvement in pain score with ramucirumab. TtD of QLQ-C30 scales favored ramucirumab arm. Baseline EQ-5D-5L index and visual analogue scale scores were similar between arms, followed by relatively stable on-treatment scores. EQ-5D-5L scores worsened at post-discontinuation follow-up visit. Conclusions Ramucirumab plus docetaxel did not negatively impact QoL compared with docetaxel alone in platinum-refractory aUC. Improved TtD and tumor associated rates of pain favored ramucirumab treatment. Clinical trail registration NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125. Date of registration: April 24th 2015


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