Abstract LBA64
Background
The DADSPORT Meta-analysis Collaboration conducted a systematic review and meta-analysis of results from NRG/RTOG 9601, GETUG-AFU 16, NRG/RTOG 0534 and newly-available, RADICALS-HD trials to assess the effect of hormone therapy (HT) in men receiving radiotherapy (RT) following radical prostatectomy for localised prostate cancer.
Methods
We assessed the effects of adding HT to post-operative RT on overall survival (OS) and metastases-free survival (MFS), using published results and working with trialists to obtain additional data, including pre-publication results of RADICALS-HD. Primary analysis was a fixed-effect, inverse-variance meta-analysis, stratified by hormone duration (no HT, 6m and 24m of HT) following RT. A pre-specified sensitivity analysis excluded men from NRG/RTOG 9601 who had PSA >1.5ng/ml at randomisation.
Results
Based on all 4 eligible trials (701 deaths, 4452 men; 100% of all randomised), and median follow up ≥8 yrs, there was no clear improvement in OS with HT compared to no HT (HR 0.89, 95% CI 0.77-1.03). The effects on OS for 6m and 24m duration of HT versus no HT were similar, as were results of a sensitivity analysis to exclude men with PSA >1.5ng/mL (Table 1). Data on MFS from 2 trials of 24m HT vs no HT are not yet available. Based on data from 3 trials (653 events, 3364 men; 100%), there was evidence that 6m HT improved MFS compared to no HT (HR 0.82, 95% CI 0.70-0.96, p=0.013). Table: LBA64
Results for overall survival
Treatment comparison | No. of trials included | No. of events/men | Hazard ratio (HR) (95% CI), p-value | Heterogeneity I 2 , p-value |
HT (any duration) vs no HT | 4 | 701/4452 | 0.89 (0.77-1.03), p=0.13 | I2=0, p=0.42 |
HT (any duration) vs no HT:Sensitivity analysis | 4 | 650/4334 | 0.93 (0.80-1.08), p=0.35 | I2=0, p=0.67 |
6m HT vs no HT | 3 | 419/3364 | 0.90 (0.74-1.09), p=0.28 | I2=0, p=0.98 |
24m HT vs no HT | 2 | 282/1088 | 0.89 (0.72-1.10), p=0.29 | I2=74%, p=0.05 |
24m HT vs no HT:Sensitivity analysis | 2 | 231/970 | 0.98 (0.78-1.23), p=0.87 | I2=49%, p=0.16 |
Conclusions
We provide the most reliable evidence to date regarding the effects of HT with post-operative radiotherapy. Thus far, there is no clear evidence that the addition of HT improves OS, but 6m HT improves MFS. We aim to present updated results of the effects of HT on OS, MFS and prostate cancer-specific survival, including network meta-analysis incorporating all direct and indirect evidence, as well as effects by pre-defined patient subgroups.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
UK Medical Research Council.
Disclosure
C.C. Parker: Financial Interests, Institutional, Other, Lecture: Bayer; Financial Interests, Personal, Invited Speaker: Janssen; Non-Financial Interests, Personal, Advisory Board: Myovant, ITM Radiopharma; Financial Interests, Institutional, Advisory Board: AAA. M.R. Sydes: Financial Interests, Institutional, Funding: Astellas, Clovis Oncology, Janssen, Pfizer, Novartis, Sanofi-Aventis; Financial Interests, Personal, Training: Lilly Oncology, Janssen. A.U. Kishan: Financial Interests, Personal and Institutional, Funding: Prostate Cancer National Institutes of Health Specialized Programs of Research Excellence ; Financial Interests, Personal and Institutional, Research Grant: Department of Defense, Radiological Society of North America, the STOP Cancer organization, the Jonsson Comprehensive Cancer Center, and the Prostate Cancer Foundation. C. Catton: Non-Financial Interests, Personal, Advisory Board: Bayer, AbbVie Corp; Financial Interests, Personal and Institutional, Funding: Tersera Corp. All other authors have declared no conflicts of interest.
Resources from the same session
1360MO - Quality of life and patient-relevant endpoints with darolutamide in the phase III ARASENS study
Presenter: Karim Fizazi
Session: Mini Oral session: GU tumours, prostate
Resources:
Abstract
Slides
Webcast
Invited Discussant 1360MO and LBA64
Presenter: Nicolas Mottet
Session: Mini Oral session: GU tumours, prostate
Resources:
Slides
Webcast
1359MO - Differential treatment response with nodal metastases in metastatic hormone-sensitive prostate cancer (mHSPC) and evaluation of nodal (N) burden as a prognostic biomarker: Ancillary studies of the docetaxel and abiraterone acetate and prednisolone (AAP) phase III trials from STAMPEDE
Presenter: Áine Haran
Session: Mini Oral session: GU tumours, prostate
Resources:
Abstract
Slides
Webcast
1361MO - 8-month PSA strongly predicts outcomes of men with metastatic castration-sensitive prostate cancer in the PEACE-1 phase III trial
Presenter: Gwenaëlle Gravis Mescam
Session: Mini Oral session: GU tumours, prostate
Resources:
Abstract
Slides
Webcast
Invited Discussant 1359MO and 1361MO
Presenter: Boris Hadaschik
Session: Mini Oral session: GU tumours, prostate
Resources:
Slides
Webcast
LBA65 - SAKK 08/14 - IMPROVE Investigation of metformin in patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with enzalutamide vs. enzalutamide alone. A randomized, open label, phase II trial
Presenter: Christian Rothermundt
Session: Mini Oral session: GU tumours, prostate
Resources:
Abstract
Slides
Webcast
1362MO - Pembrolizumab + olaparib vs abiraterone (abi) or enzalutamide (enza) for patients (pts) with previously treated metastatic castration-resistant prostate cancer (mCRPC): Randomized open-label phase III KEYLYNK-010 study
Presenter: Evan Yu
Session: Mini Oral session: GU tumours, prostate
Resources:
Abstract
Slides
Webcast
1363MO - Cabazitaxel every 2 weeks versus every 3 weeks in older patients with metastatic castration-resistant prostate cancer (mCRPC): The CABASTY randomized phase III trial
Presenter: Stephane Oudard
Session: Mini Oral session: GU tumours, prostate
Resources:
Abstract
Slides
Webcast
1364MO - Preliminary phase II results of the CYPIDES study of ODM-208 in metastatic castration-resistant prostate (mCRPC) cancer patients
Presenter: Karim Fizazi
Session: Mini Oral session: GU tumours, prostate
Resources:
Abstract
Slides
Webcast
Invited Discussant LBA65, 1362MO, 1363MO and 1364MO
Presenter: Martijn Lolkema
Session: Mini Oral session: GU tumours, prostate
Resources:
Slides
Webcast