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  • / The relationship between a priori defined prognostic risk groups and and overall survival (OS) in men with metastatic hormone sensitive prostate cancer (mHSPC).

The relationship between a priori defined prognostic risk groups and and overall survival (OS) in men with metastatic hormone sensitive prostate cancer (mHSPC).

Abstract Poster

Authors

Susan Halabi

Susan Halabi

Duke University Medical Center, Durham, NC

Susan Halabi , Siyuan S Guo , Akash Roy , Larysa Rydzewska , Peter Godolphin , Maha H. A. Hussain , Catherine Tangen , Ian Thompson Jr., Wanling Xie , Michael Anthony Carducci , Matthew Raymond Smith , Michael J. Morris , Gwenaelle Gravis , David P. Dearnaley , Paul Verhagen , Takayuki Goto , Nicholas D. James , Mahesh Parmar , Marc E. Buyse , Christopher Sweeney

Organizations

Duke University Medical Center, Durham, NC, Duke University, Durham, NC, MRC Clinical Trials Unit at UCL, London, United Kingdom, Northwestern University, Chicago, IL, SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA, Christus Health, San Antonio, TX, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, Institut Paoli-Calmettes, Marseille, France, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom, Erasmus Medical Center, Rotterdam, Netherlands, Deparment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan, The Institute of Cancer Research, London, United Kingdom, Medical Research Council at UCL, London, United Kingdom, International Drug Development Institute, Louvain-La-Neuve, Belgium, South Australian Immunogenomics Cancer Institute, University of Adelaide, Adelaide, Australia

Research Funding

Other Foundation
Prostate Cancer Foundation

Background: Prior analyses have shown that men who present with high volume (HV) disease and de novo metastases have shorter OS compared with other mHSPC subgroups. The objective of this analysis was to determine the prognostic relationship between a-priori defined 4-prognostic groups and OS in men with mHSPC and in a subset of trials in patients treated with androgen deprivation therapy (ADT) +docetaxel. This hypothesis was investigated by the STOPCAP M1 collaborators. Methods: We obtained individual patient data (IPD) from 13 randomized trials comparing treatment regimens (ADT or ADT + docetaxel in the control or research arms) in mHSPC. OS was defined as the time between date of randomization and date of death/or last follow-up. Patients (pts) were classified into 4 mutually exclusive groups. Poor prognostic risk-group was defined as HV (presence of visceral metastases, and/or > 4 bone metastases or presence of bone metastases beyond pelvic or vertebral bones) plus synchronous diagnosis (SYN); whereas intermediate risk groups were patients with HV and metachronous (MET; intermediate A) or low volume plus SYN (intermediate B); and lastly good risk group had LV plus MET. The proportional hazards model was used to estimate the hazard ratio (HR) and assess the prognostic significance of risk groups in predicting OS adjusting for treatment. Results: Of 6041 pts included in this analysis, 60% (3622 pts) had died. Median follow-up time=5-years. Overall 11%, 8%, 47% and 34% were in the good, intermediate A, intermediate B and poor risk groups, respectively and for trials including docetaxel (n=2627 pts) 9%, 5%, 39% and 47% respectively. HRs for risk groups are shown in the table. Conclusions: Differences in OS across the risk groups were observed. Further work is needed to investigate if more precise prognostic groups can be defined such as better characterization of patients' groupings of extent of bone metastases and visceral metastases. Clinical trial information: NCT00309985; NCT00268476; NCT00104715; NCT00079001; NCT00002651; NCT00685646.

Good
(LV+MET) (n=686)		Intermediate A (HV+MET)
(n=465)		Intermediate B
(LV+SYN)
(n=2852)		Poor
(HV+SYN)
(n=2038)
Median OS in 6,041 pts, units*=12
(years; 95% CI)		6.4 (5.8-7.4)5.1 (4.8-5.8)4.8 (4.5-5.0)3.6 (3.5-3.8)
HR for risk group vs ref (95% CI)0.53 (0.47-0.60)0.76 (0.71-0.82)0.73 (0.64-0.82)Ref
Median OS in 2,627 pts, units*=4
(years; 95% CI)
ADT
ADT + Docetaxel
NE (8.2-NE)
6.9 (5.8-NE)
4.3 (2.9-5.2)
5.5 (3.1-6.2)
4.7 (4.2-5.4)
6.0 (5.4-6.5)
2.9 (2.7-3.1)
3.8 (3.5-4.0)
HR for risk group vs ref ADT (95% CI)
HR for risk group vs ref
ADT+Docetaxel (95% CI)		0.21 (0.15-0.30)
0.41 (0.30-0.55)		0.78 (0.57-1.06)
0.73 (0.54-0.99)		0.51 (0.44-0.59)
0.57 (0.48-0.66)		Ref
Ref

*Units= number of trial comparisons; Ref=referent; HR=hazard ratio, CI=confidence interval, NE=not estimated.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Prostate, Testicular, and Penile

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Prostate Cancer– Advanced/Hormone-Sensitive

Clinical Trial Registration Number

NCT00309985; NCT00268476; NCT00104715; NCT00079001; NCT00002651; NCT00685646

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr 5073)

DOI

10.1200/JCO.2023.41.16_suppl.5073

Abstract #

5073

Poster Bd #

167

Abstract Disclosures

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