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ePoster Display

594P - Pain efficacy with radium-223 (Ra-223) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in the PARABO observational study

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Site

Prostate Cancer

Presenters

Holger Palmedo

Citation

Annals of Oncology (2021) 32 (suppl_5): S626-S677. 10.1016/annonc/annonc702

Authors

H. Palmedo1, H. Ahmadzadehfar2, S. Eschmann3, I. Selkinski4, F. Straube5, A. Niesen6, J. Schönberger7, V. Barsegian8, K. Liepe9, F.M. Mottaghy10, R. Guan11, J. Pinkert12, S. Buetikofer13, K. Herrmann14

Author affiliations

  • 1 Department Of Nuclear Medicine, Institute of Radiology and Nuclear Medicine Kaiser-Passage and PET/CT Center, Johanniter Hospital, 53127 - Bonn/DE
  • 2 Nuclear Medicine, Klinikum Westfalen, 44309 - Dortmund/DE
  • 3 Nuclear Medicine, Marienhospital Stuttgart, Stuttgart/DE
  • 4 Nuclear Medicine, Radiomedicum, Frankfurt/DE
  • 5 Nuclear Medicine, Harzer PET-Zentrum & Nuklearmedizin, Goslar/DE
  • 6 Nuclear Medicine, Diakovere Henriettenstift, Hanover/DE
  • 7 Nuclear Medicine, Klinikum Weiden, Weiden/DE
  • 8 Nuclear Medicine, Helios Kliniken Schwerin, Schwerin/DE
  • 9 Nuclear Medicine, Klinikum Frankfurt (Oder) GmbH Nuklearmedizin, Frankfurt/DE
  • 10 Department Of Nuclear Medicine, University Hospital RWTH Aachen University, Aachen/DE
  • 11 Biostatistics, Bayer HealthCare Pharmaceuticals, Whippany/US
  • 12 Pharmacovigilence, Bayer AG, Berlin/DE
  • 13 -, Bayer AG, Berlin/DE
  • 14 Nuclear Medicine, Universitätsklinikum Essen, Essen/DE

Resources

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Abstract 594P

Background

Ra-223 is a bone targeted alpha emitter approved for treatment of mCRPC on the basis of a significant survival advantage and favorable safety profile vs placebo in a phase III trial. Ra-223 also delayed opioid use and external beam radiotherapy vs placebo in post hoc analyses of that trial. PARABO (NCT02398526) is a prospective, observational, noninterventional, single-arm study evaluating pain efficacy in pts with mCRPC treated with Ra-223 in German real-life nuclear medicine settings.

Methods

The primary outcome was pain response, defined as a ≥2 point improvement in Brief Pain Inventory short form (BPI-SF) worst pain score in pts with baseline worst pain >1. Here we assessed pain response in the overall population and by extent of disease (EOD; ≤20 vs >20 lesions), opioid use, and Ra-223 cycles received (5–6 vs ≤4). BPI-SF component scores were assessed at each visit.

Results

This analysis (data cutoff July 16, 2020) includes 354 pts who started Ra-223 between Mar 2015 and Dec 2017. At baseline, 260 pts (73%) had Eastern Cooperative Oncology Group performance status 0/1; 37 (10%) had <6 metastatic lesions, 124 (35%) had 6–20 lesions, 127 (36%) had >20 lesions, and 55 (15%) had a superscan; 242 pts (68%) had received prior systemic life-prolonging therapy (median 2). In total, 169 pts (48%) used opioids at any time (116 used opioids before/at baseline, 53 started opioids during Ra-223 therapy). Overall, pts received a median of 6 Ra-223 injections (range 1–6); 236 (67%) had 5–6 injections, and 118 (33%) had ≤4 injections. Of 216 pts with baseline worst pain >1, 128 (59%) had a clinically meaningful pain response; the rate was 60% in pts with ≤20 lesions vs 59% in pts with >20 lesions; 65% in pts with opioid use vs 54% in pts without opioid use; and 67% in pts with 5–6 Ra-223 injections vs 43% in pts with ≤4 injections. Mean BPI-SF component scores during Ra-223 treatment improved or were maintained from baseline, regardless of EOD or opioid use.

Conclusions

In this real-life study, pts with mCRPC experienced reduction of bone-associated pain during Ra-223 therapy, regardless of EOD or opioid use. The benefit appeared most pronounced in pts who received 5–6 cycles of Ra-223.

Clinical trial identification

NCT02398526.

Editorial acknowledgement

Sara Black, ISMPP CMPP™, from OPEN Health, London, UK, provided medical writing support.

Legal entity responsible for the study

Bayer AG, Berlin, Germany.

Funding

Bayer AG, Berlin, Germany.

Disclosure

K. Liepe: Financial Interests, Personal, Other, Consultant: Serene; Financial Interests, Personal, Other, Consultant: Rotop. F.M. Mottaghy: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: NanoMab; Financial Interests, Institutional, Research Grant: GE; Financial Interests, Institutional, Research Grant: Siemens; Financial Interests, Institutional, Research Grant: NonoMab. R. Guan: Financial Interests, Personal, Full or part-time Employment: Bayer. J. Pinkert: Financial Interests, Personal, Full or part-time Employment: Bayer. S. Buetikofer: Financial Interests, Personal, Full or part-time Employment: Bayer. K. Herrmann: Financial Interests, Personal, Other, Personal fees: Bayer; Financial Interests, Personal, Other, personal fees: Sofie Biosciences; Financial Interests, Personal, Other, personal fees: Sirtex; Financial Interests, Personal, Other, personal fees: Adacap; Financial Interests, Personal, Other, Personal fees: Curium; Financial Interests, Personal, Other, personal fees: Endocyte; Financial Interests, Personal, Other, personal fees: BTG; Financial Interests, Personal, Other, personal fees: Ipsen; Financial Interests, Personal, Other, personal fees: Siemens Healthineers; Financial Interests, Personal, Other, personal fees: GE Healthcare; Financial Interests, Personal, Other, personal fees: Amgen; Financial Interests, Personal, Other, personal fees: Novartis; Financial Interests, Personal, Other, personal fees: Y-mAbs; Financial Interests, Personal, Other, personal fees: Aktis Oncology; Financial Interests, Personal, Other, personal fees: Theragnostics; Financial Interests, Personal, Other, personal fees: Pharma 15; Non-Financial Interests, Personal, Other, non financial support: ABX. All other authors have declared no conflicts of interest.

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