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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

5139 - Symptomatic skeletal event (SSE) dynamics in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223): An interim review of a prospective, non-interventional study (PARABO)

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Radiation Oncology

Tumour Site

Prostate Cancer

Presenters

Thorsten Poeppel

Citation

Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284

Authors

T. Poeppel1, S. Eschmann2, A. Werner3, I. Selkinski4, M. Möllers5, T. Neußer6, A. Benson7, J. Kalinovsky8, H. Palmedo9

Author affiliations

  • 1 Nuclear Medicine, University Hospital Essen, D-45147 - Essen/DE
  • 2 Nuclear Medicine, Marienhospital, Stuttgart/DE
  • 3 Nuclear Medicine, Radiology Schwetzingen, Schwetzingen/DE
  • 4 Nuclear Medicine, Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden/DE
  • 5 Nuclear Medicine, Prof. Dr. Uhlenbrock & Partner, Dortmund/DE
  • 6 Non-interventional Studies, Bayer Vital GmbH, Leverkusen/DE
  • 7 Medical Affairs Statistics And Integrated Analysis, Bayer HealthCare, Whippany/US
  • 8 Medical Oncology, Bayer Consumer Care AG, Basel/CH
  • 9 Nuclear Medicine, Nuclear Medicine Center for Radiology, Bonn/DE
More

Resources

Abstract 5139

Background

Phase III Ra-223 study (ALSYMPCA) was conducted before the availability of abiraterone (Abi). The ongoing PARABO study will investigate the outcome of Ra-223-treated mCRPC pts in real-life clinical practice in Germany (NCT02398526). This analysis aimed to describe the SSE profile in Ra-223-treated pts based on extent of disease (EOD) or prior Abi use.

Methods

PARABO is a prospective, single-arm observational study of 348 pts with mCRPC and bone metastases who initiated Ra-223 treatment. A descriptive analysis was carried out for overall survival (OS) and SSEs (EBRT, symptomatic pathologic fractures, spinal cord compression or surgical intervention) in Ra-223-treated pts who received Abi as part of previous treatment. SSEs were summarised by EOD (0–2: ≤20 metastases; 3–4: >20 metastases/Superscan).

Results

Of 333 Ra-223-treated pts, 165 (50%) had EOD 3–4; 67 (20%) had completed prior Abi (median duration of Abi: 10.8 mo). Median time from castration resistance to Ra-223 treatment: 9.5 mo for all pts, 18.9 mo for prior Abi pts. At baseline, 45/66 (68%) prior Abi pts had EOD 3–4 and 45/67 (67%) had received prior chemotherapy. Bone health agent use at baseline was reported in 22 (33%) prior Abi pts. Median follow-up was 6.4 mo for the overall cohort. Median OS (95% CI): 16.9 (12.6–18.9) mo for all pts, 11.2 (8.1–15.2) mo for prior Abi pts. SSEs occurred in 10% of the overall cohort and 20% of prior Abi pts. Pts with more advanced disease (EOD 3–4) received more EBRT, while pathological fracture rate was ∼3% in all groups.Table: 828P

SSE, n (%)aAll patients N = 333Prior Abi n = 67EOD 0–2 (≤20 metastatic lesions) n = 149EOD 3–4 (>20 metastatic lesions) n = 165
During Ra-223 treatment8/312 (2.6)3/57 (5.3)0/144 (0)8/151 (5.3)
Follow-up after end of Ra-223 treatment6/162 (3.7)2/28 (7.1)1/84 (1.2)5/74 (6.8)
During long-term follow-upb21/144 (14.6)7/30 (23.3)9/71 (12.7)12/70 (17.1)
Over the course of the study EBRT Pathological fractures Spinal cord compression Surgical intervention33/315 (10.5) 24/315 (7.6) 10/315 (3.2) 8/315 (2.5) 6/315 (1.9)12/59 (20.3) 9/59 (15.3) 2/59 (3.4) 2/59 (3.4) 1/59 (1.7)10/145 (6.9) 5/145 (3.4) 5/145 (3.4) 3/145 (2.1) 4/145 (2.8)23/153 (15.0) 19/153 (12.4) 5/153 (3.3) 5/153 (3.3) 2/153 (1.3)
a

Percentages calculated based on number of pts for whom documentation was available within the specified time period.

b

>30 days after treatment completion.

Conclusions

Pts previously treated with Abi received Ra-223 18.9 mo after CRPC diagnosis, had generally received prior chemotherapy and had higher tumour burden, resulting in 11.2 mo median OS. Pts with higher tumour burden or prior Abi had more SSEs, mainly related to EBRT use; frequency of fractures was low and similar across groups.

Clinical trial identification

NCT02398526.

Legal entity responsible for the study

Bayer.

Funding

Bayer.

Editorial Acknowledgement

Medical writing support was provided by Risha Bulusu, MSc, of Scion, London UK.

Disclosure

T. Neußer: Employee: Bayer Healthcare; Holds stocks: Bayer. J. Kalinovsky: Employee: BayerHealthcare. All other authors have declared no conflicts of interest.

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