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Patient-reported Outcomes from a Phase III Randomized Controlled Trial Exploring Optimal Sequencing of Short-term Androgen Deprivation Therapy with Prostate Radiotherapy in Localized Prostate Cancer - ScienceDirect

Patient-reported Outcomes from a Phase III Randomized Controlled Trial Exploring Optimal Sequencing of Short-term Androgen Deprivation Therapy with Prostate Radiotherapy in Localized Prostate Cancer - ScienceDirect

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Patient-reported Outcomes from a Phase III Randomized Controlled Trial Exploring Optimal Sequencing of Short-term Androgen Deprivation Therapy with Prostate Radiotherapy in Localized Prostate Cancer

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*Presented in part at the Genitourinary Cancers Symposium 2020, San Francisco, California (Journal of Clinical Oncology 38, no. 6_suppl (February 20, 2020) 315-315)

ABSTRACT

Background

Two phase III randomized controlled trials (xxxx, RTOG-9413) and a meta-analysis have shown an impact of sequencing of androgen deprivation therapy (ADT) and radiotherapy on oncologic outcomes in prostate cancer (PCa). However, the impact of sequencing strategy on health-related quality of life (HR-QoL) is unclear. Here, we present the patient-reported HR-QoL outcomes from the xxxx study.

Methods

In this trial, PCa patients with Gleason score ≤7, clinical stage T1b-T3a, and prostate-specific antigen <30 ng/mL were randomly assigned to neoadjuvant and concurrent ADT for 6 months starting 4 months before or concurrent and adjuvant ADT for 6 months starting simultaneously with prostate radiotherapy. HR-QoL was assessed using European Organisation for Research and Treatment of Cancer QoL questionnaires. Time until definitive deterioration was defined as time from random allocation to the first deterioration of at least 10 points with no further improvement of ≥10 points or if the patient had progression, death or dropped out after deterioration, resulting in missing data. Stratified log-rank test was applied for between-group comparisons of time-to-event estimates.

Results

Overall, 393 patients (194 and 199 in two arms, respectively) were evaluable except 214 (101 and 113 in the two arms, respectively) for sexual function. Five-year rates of freedom from definitive deterioration of bowel symptoms, urinary symptoms, and sexual activity were 33·4%, 33·1%, and 38·5% in neoadjuvant and 34·1%, 35·4%, and 36·7% in adjuvant group, respectively with no significant between-group differences. Adjuvant approach was associated with reduced risk of definitive deterioration of sexual function (hazard ratio: 0·68, 95% confidence intervals: 0·49–0·94, p=0·02). With respect to clinical relevance, mean score change for sexual function showed only a “small to moderate” difference favoring adjuvant group at and beyond 3 years.

Conclusions

In this study, there was no difference in the bowel or urinary symptoms between adjuvant and neoadjuvant approach. Considering a significant likelihood of type I and type II errors and due to lack of a persistent and clinically meaningful between-group difference in mean score change over time, our findings do not confer a clear and conclusive picture on impact of sequencing strategy on sexual function.

Keywords

localized prostate cancer

radiotherapy

health-related quality of life

sequencing of treatment

androgen deprivation therapy

List of Abbreviations

ADT

Androgen deprivation therapy

bRFS

Biochemical relapse-free survival

EORTC

European Organisation for Research and Treatment of Cancer

HR-QoL

Health-related quality of life

QLQ

quality of life questionnaire

TUDD

Time until definitive deterioration

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© 2021 Elsevier Inc. All rights reserved.

 

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