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 (%)a | All patients N = 333 | Prior Abi n = 67 | EOD 0–2 (≤20 metastatic lesions) n = 149 | EOD 3–4 (>20 metastatic lesions) n = 165 |
|---|---|---|---|---|
| During Ra-223 treatment | 8/312 (2.6) | 3/57 (5.3) | 0/144 (0) | 8/151 (5.3) |
| Follow-up after end of Ra-223 treatment | 6/162 (3.7) | 2/28 (7.1) | 1/84 (1.2) | 5/74 (6.8) |
| During long-term follow-upb | 21/144 (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 intervention | 33/315 (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) |
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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