Evaluation of quality-of-life side effects and duration of therapy in a phase III study of intermittent monotherapy versus continuous combined androgen deprivation

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 5064-5064
Author(s):  
F. E. Calais da Silva ◽  
F. M. Calais da Silva ◽  
F. Gonçalves ◽  
A. Santos ◽  
J. Kliment ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
Duration Of Therapy ◽  
Phase Iii Study

EVALUATION OF QUALITY OF LIFE, SIDE EFFECTS AND DURATION OF THERAPY IN A PHASE 3 STUDY OF INTERMITTENT MONOTHERAPY VERSUS CONTINUOUS COMBINED ANDROGEN DEPRIVATION

2008 ◽  
Vol 7 (3) ◽  
pp. 205 ◽  
Author(s):  
F.E. Calais Da Silva ◽  
F. Goncalves ◽  
A. Santos ◽  
J. Kliment ◽  
F.M. Calais Da Silva ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Androgen Deprivation ◽  
Phase 3 ◽  
Duration Of Therapy

EVALUATION OF QUALITY OF LIFE, SIDE EFFECTS AND DURATION OF THERAPY IN A PHASE 3 STUDY OF INTERMMITTENT MONOTHERAPY VERSUS CONTINOUS COMBINED ANDROGEN DEPRIVATION

2008 ◽  
Vol 179 (4S) ◽  
pp. 251-252
Author(s):  
Fernando Calais Da Silva ◽  
Frederico Goncalves ◽  
Americo Santos ◽  
Jan Kliment ◽  
Peter Whelan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Androgen Deprivation ◽  
Phase 3 ◽  
Duration Of Therapy

scholarly journals A Dutch phase III randomized multicenter trial: whole brain radiotherapy vs. stereotactic radiotherapy for 4-10 brain metastases

2021 ◽  
Author(s):  
Dianne Hartgerink ◽  
Anna Bruynzeel ◽  
Danielle Eekers ◽  
Ans Swinnen ◽  
Coen Hurkmans ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Brain Metastases ◽  
Survival Rates ◽  
Whole Brain Radiotherapy ◽  
Phase Iii ◽  
Whole Brain ◽  
Brain Radiotherapy ◽  
One Year

Abstract Background The clinical value of whole brain radiotherapy (WBRT) for brain metastases (BM) is a matter of debate due to the significant side effects involved. Stereotactic radiosurgery (SRS) is an attractive alternative treatment option that may avoid these side effects and improve local tumor control. We initiated a randomized trial (NCT02353000) to investigate whether quality of life is better preserved after SRS compared with WBRT in patients with multiple brain metastases. Methods Patients with 4 to 10 BM were randomized between the standard arm WBRT (total dose 20 Gy in 5 fractions) or SRS (single fraction or 3 fractions). The primary endpoint was the difference in quality of life (QOL) at three months post-treatment. Results The study was prematurely closed due to poor accrual. A total of 29 patients (13%) were randomized, of which 15 patients have been treated with SRS and 14 patients with WBRT. The median number of lesions were 6 (range, 4-9) and the median total treatment volume was 13.0 cc 3 (range, 1.8-25.9 cc 3). QOL at three months decreased in the SRS group by 0.1 (SD=0.2), compared to 0.2 (SD=0.2) in the WBRT group (p=0.23). The actuarial one-year survival rates were 57% (SRS) and 31% (WBRT) (p=0.52). The actuarial one-year brain salvage-free survival rates were 50% (SRS) and 78% (WBRT) (p=0.22). Conclusion In patients with 4 to 10 BM, SRS alone resulted in one-year survival for 57% of patients while maintaining quality of life. Due to the premature closure of the trial, no statistically significant differences could be determined.

scholarly journals Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer

2009 ◽  
Vol 102 (1) ◽  
pp. 59-67 ◽  
Author(s):  
T Conroy ◽  
M Hebbar ◽  
J Bennouna ◽  
M Ducreux ◽  
M Ychou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Phase Iii Study

scholarly journals Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial

2018 ◽  
Vol 36 (25) ◽  
pp. 2578-2584 ◽  
Author(s):  
Jonathan Strosberg ◽  
Edward Wolin ◽  
Beth Chasen ◽  
Matthew Kulke ◽  
David Bushnell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Status ◽  
Global Health ◽  
Phase Iii ◽  
High Dose ◽  
Health Related Qol ◽  
Health Related ◽  
Phase Iii Study ◽  
The Impact

Purpose Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life (QoL). We assessed the impact of 177Lu-Dotatate treatment on time to deterioration in health-related QoL. Methods The NETTER-1 trial is an international phase III study in patients with midgut NETs. Patients were randomly assigned to treatment with 177Lu-Dotatate versus high-dose octreotide. European Organisation for Research and Treatment of Cancer quality-of-life questionnaires QLQ C-30 and G.I.NET-21 were assessed during the trial to determine the impact of treatment on health-related QoL. Patients completed the questionnaires at baseline and every 12 weeks until tumor progression. QoL scores were converted to a 100-point scale according to European Organisation for Research and Treatment of Cancer instructions, and individual changes from baseline scores were assessed. Time to QoL deterioration (TTD) was defined as the time from random assignment to the first QoL deterioration ≥ 10 points for each patient in the corresponding domain scale. All analyses were conducted on the intention-to-treat population. Patients with no deterioration were censored at the last QoL assessment date. Results TTD was significantly longer in the 177Lu-Dotatate arm (n = 117) versus the control arm (n = 114) for the following domains: global health status (hazard ratio [HR], 0.406), physical functioning (HR, 0.518), role functioning (HR, 0.580), fatigue (HR, 0.621), pain (HR, 0.566), diarrhea (HR, 0.473), disease-related worries (HR, 0.572), and body image (HR, 0.425). Differences in median TTD were clinically significant in several domains: 28.8 months versus 6.1 months for global health status, and 25.2 months versus 11.5 months for physical functioning. Conclusion This analysis from the NETTER-1 phase III study demonstrates that, in addition to improving progression-free survival, 177Lu-Dotatate provides a significant QoL benefit for patients with progressive midgut NETs compared with high-dose octreotide.

Phase III study of intermitent monotherapy versus continuous combined androgen deprivation

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5125-5125 ◽  
Author(s):  
F. E. Calais da silva ◽  
F. M. Calais da Silva ◽  
F. Gonçalves ◽  
A. Santos ◽  
J. Kliment ◽  
...  
Keyword(s):  
Metastatic Prostate Cancer ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
Intermittent Therapy ◽  
Target Sample Size ◽  
Early Results ◽  
Phase Iii Study ◽  
One Year

5125 Background: The intermittent monotherapy vs continuous combined androgen deprivation using an LHRH analogue and ciproterone acetate and associated components of quality of life. Methods: 854 patients (aged 44–81, mean 72) have been randomised (419 to Continuous and 435 to Intermittent). 350 patients have been randomised in the last years and the study is close to the target sample size 900 patients. The median PSA at randomisation is 1.0 ng/ml ranging from 0.1 to 4. 48 % of patients have a PSA less than 1 ng/ml at randomisation. Results: 1,000 men with a median PSA of 15.9ng/ml were registered between October 1999 and October 2006. 24% of registered patients have a PSA less than 10ng/ml; 39.3% of registered patients have a PSA greater than 20 ng/ml. 90.1% have a T3 tumour and only 13.5% have metastatic prostate cancer. After randomisation, sexual activity increases in the intermittent group to 32% (6 months), 32% (12 months), 24% (24 months) while in the Continuous arm the corresponding percentages are 19%, 20%, 6%, respectively. Among the 435 Intermittent patients only 18% returned to therapy within one year of randomisation because of symptoms or an increase in PSA and 40% have yet to return to therapy within 4 years of randomisation. An estimated 82% (95% Confidence Interval 79%, 87%) of patients have remained free of therapy for at least one year and 60% (95% CI 53%, 68%) for at least 2 years. Patients whose PSA reduces to less than 1 ng/ml at randomisation are off therapy longer than those whose PSA is between 1 and 4 ng/ml (p<0.05). 80% of patients with PSA < 1 ng are off therapy for at least 1.5 years whereas 80% with PSA between 1 and 4 ng/ml are off therapy for at least 9 months. 60% of patients with PSA < 1 ng/ml are off therapy for 2.5 years while 60 % of patients with PSA 1–4 ng/ml are off therapy for 1.5 years. Among the 142 Intermittent patients who returned to therapy because of an increase in PSA or symptoms the median time on therapy was 16.7 weeks (95% CI 15.0, 22.1). The time on therapy did not depend upon PSA at randomisation, p=0.17. The median follow up period is 2.8 years. Conclusions: The early results from this trial are promising and are in line with previous studies of intermittent therapy. It is too early for any progression data. No significant financial relationships to disclose.

Sign in / Sign up

Export Citation Format

Share Document