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.

Phase III intermittent MAB vs continuous MAB

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4513-4513 ◽  
Author(s):  
F. M. Calais Da Silva ◽  
F. Calais Da Silva ◽  
A. Bono ◽  
M. Brausi ◽  
P. Whelan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Induction Treatment ◽  
Intermittent Therapy ◽  
Continuous Therapy ◽  
Therapeutic Tools ◽  
Depot Injections

4513 Background: Patients with locally advanced or metastatic prostate cancer cannot be cured with any of the therapeutic tools available today. Methods: After an initial induction treatment of three months, with CPA 200 mg for two week’s and then monthly depot injections of LHRH analogue (decaptyl) plus 200 mg of CPA daily in 766 patients with locally advanced or metastatic prostate cancer, 626 patients whose PSA decreased below 4 or to 80% below their initial value, were randomised to intermittent or continuous therapy. Results: Among the 314 patients on Intermittent therapy, 50% have been off therapy for at least 52 weeks following the initial LHRH therapy, 29% have been off therapy for over 36 months. For the 197 patients whose PSA went down to ≤ 2 ng/ml, the median time off therapy was 74 weeks. When these patients returned to therapy they had a median of 14 weeks of treatment, followed by a second period off therapy, median 70 weeks. Patients with PSA < 2 ng/ml have spent a median of 82% of their time receiving no therapy.After a median follow up of 51 months, 321 patients have died: 162 in the Intermittent arm compared to 159 in the Continuous arm (HR = 1.03 [95% confidence interval 0.83, 1.28; p = 0.79]). Estimated survival at 5 years was 53.8% in the Intermittent Group and 51.0% in the Continuous Group.Subjective or Objective progression was noted in 224 patients, 113 on the intermittent arm and 111 on the continuous arm with a hazard ratio of 1.09 (95% CI 0.84, 1.42), p=0.52. The main differences in quality of life between the two arms of the study were confined to sexual function.Sexual activity was significantly greater (p<0.01) in the intermittent arm with 41% of men reporting sexual activity at 9 months, 40% at 15 months and 35% at 21 months.The most commonly reported side effects were hot flushes, were more frequently among those on Continuous Therapy, 30% of continuous patients compared to 20% of intermittent patients, p < 0.01. Conclusions: There is no evidence that Intermittent therapy leads to a significantly elevated hazard of dying (p = 0.79) or to a greater subjective or objective progression (p = 0.52) and with less impact on quality of live and less medication, patients with PSA < 2 ng/ml on randomisation have spent a median of 82% of their time receiving no therapy. We think that intermittent therapy is an option to use in regular clinic. No significant financial relationships to disclose.

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

Preliminary quality-of-life outcomes for SWOG-9346: Intermittent androgen deprivation in patients with hormone-sensitive metastatic prostate cancer (HSM1PC)—Phase III.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4571-4571 ◽  
Author(s):  
Carol Moinpour ◽  
Donna Lynn Berry ◽  
Benjamin Ely ◽  
Catherine M. Tangen ◽  
Celestia S. Higano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Androgen Deprivation ◽  
Phase Iii ◽  
Life Outcomes ◽  
Significance Level ◽  
Symptom Distress Scale ◽  
Distress Scale

4571 Background: The relative quality of life (QOL) for patients with newly diagnosed, metastatic prostate cancer, treated with intermittent androgen deprivation (IAD) has been assumed and hypothesized, yet never compared in a well-powered randomized trial (RT) to continuous androgen deprivation (CAD). SWOG-9346 provided such a RT in which to test QOL differences between CAD and IAD in men with metastatic prostate cancer. Methods: Patients were randomized to CAD or IAD. Patients completed the SWOG QOL Questionnaire (SF-20/SF-36, Symptom Distress Scale, treatment-specific symptoms, global QOL) at randomization and months (mo) 3, 9, and 15 post-randomization. Five QOL change scores at one time point (mo 3) were designated as primary for the QOL endpoint and are reported in this abstract: impotence, libido, energy/vitality (E/V), physical function (PF), and emotional function (EF). Significance level was adjusted for 5 comparisons (used p=0.01). Results: 615 patients in the CAD arm and 633 in the IAD arm completed the QOL questionnaire at baseline. Change between baseline and 3 months differed for the two arms with CAD reporting statistically significantly more impotence and less libido than IAD. EF was also slightly better for the IAD arm. Conclusions: These results indicate better sexual function in men receiving IAD versus CAD through post-randomization month 3. Additional benefits for IAD may include better PF, E/V and EF. Ongoing analyses will address the role of missing data, additional follow-up assessments, and resumption of therapy in the IAD arm. [Table: see text]

Coronary endarterectomy in coronary artery disease: Factors affecting graft patency and survival

2021 ◽  
pp. 021849232110068
Author(s):  
Simon CY Chow ◽  
Jacky YK Ho ◽  
Micky WT Kwok ◽  
Takuya Fujikawa ◽  
Kevin Lim ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Graft Patency ◽  
Complete Revascularization ◽  
Coronary Endarterectomy ◽  
Factors Affecting ◽  
Early Results ◽  
Cerebrovascular Events ◽  
Obtuse Marginal ◽  
One Year

Background Coronary endarterectomy aims to improve completeness of revascularization in patients with occluded coronary vessels. The benefits of coronary endarterectomy remain uncertain. The aim of this study was to evaluate short-term surgical outcomes and factors affecting graft patency post-coronary endarterectomy. Methods Between 2009 and 2019, 81 consecutive patients who had coronary endarterectomy done were evaluated for their perioperative and early results. A total of 36 patients with follow-up coronary studies were included in patency analysis. Mortality rates, major adverse cardiac and cerebrovascular events, and graft patency were outcomes of interest. Survival and risk factor analysis were performed with Kaplan–Meier and logistic regression analysis. Results The average age of the cohort was 61.9 ± 9.29 years. Complete revascularization rate was 95.4% post-coronary endarterectomy. The 30-day and 1-year mortality was 2.5 and 6.2%, respectively. One-year major adverse cardiac and cerebrovascular events rate was 11.1%. Periprocedural myocardial infarction rate was 7.4%. Three patients required repeat revascularization within a mean follow-up duration of 49.6 ± 36.5 months. Overall graft patency was 89.2% at 20.2 months and graft patency post-coronary endarterectomy was 85.4%. Arterial grafts showed 100% patency. Vein grafts to endarterectomized obtuse marginal branch had patency rates of 33.3%. Multiple endarterectomies were associated with worse one-year major adverse cardiac and cerebrovascular events (OR: 28.6 ± 1.16; P = 0.003). Conclusions Coronary endarterectomy facilitates completeness of revascularization and does not increase early mortality. Graft patency post-coronary endarterectomy on obtuse marginal artery was suboptimal. Judicious use of coronary endarterectomy should be practiced to balance the need of completeness of revascularization against the risk of myocardial infarction.

scholarly journals Fear of Falling, Recurrence of Falls, and Quality of Life in Patients with a Low Energy Fracture—Part II of an Observational Study

Medicina ◽  
2021 ◽  
Vol 57 (6) ◽  
pp. 584
Author(s):  
Puck C. R. van der Vet ◽  
Jip Q. Kusen ◽  
Manuela Rohner-Spengler ◽  
Björn-Christian Link ◽  
Roderick M. Houwert ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Fall Risk ◽  
Fear Of Falling ◽  
Low Energy ◽  
Activity Levels ◽  
Activity Restriction ◽  
One Year ◽  
Falls In Elderly

Background and objective: Falls in elderly cause injury, mortality, and loss of independence, making Fear of Falling (FoF) a common health problem. FoF relates to activity restriction and increased fall risk. A voluntary intervention including fall risk assessment and prevention strategies was implemented to reduce falls in elderly patients with low energy fractures (LEF). The primary purpose of this study was to evaluate FoF and the number of subsequent falls in trauma patients one year after a LEF. The secondary aim was to examine how FoF affects patients’ lives in terms of Quality of Life (QoL), mobility, and activity levels. Finally, participation in the voluntary fall prevention program (FPP) was evaluated. Materials and Methods: Observational cohort study in one Swiss trauma center. LEF patients, treated between 2012 and 2015, were analyzed one year after injury. Primary outcomes were Falls-Efficacy Score-International (FES-I) and number of subsequent falls. Secondary outcomes were EuroQoL-5-Dimensions-3-Levels (EQ5D-3L), mobility, activity levels, and participation in the FPP. Subgroup analysis was performed for different age categories. Results: 411 patients were included for analysis. Mean age was 72 ± 9.3, mean FES-I was 21.1 ± 7.7. Forty percent experienced FoF. A significant negative correlation between FoF and QoL (R = 0.64; p < 0.001) was found. High FoF correlated with lower activity levels (R= −0.288; p < 0.001). Six percent visited the FPP. Conclusions: At follow-up, 40% suffered from FoF which seems to negatively affect patients’ QoL. Nevertheless, participation in the FPP was low. Simply informing patients about their susceptibility to falls and recommending participation in FPPs seems insufficient to motivate and recruit patients into FPPs. We suggest implementing repeated fall risk- and FoF screenings as standard procedures in the follow-up of LEF, especially in patients aged over 75 years.

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

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.

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