860P - Pain evaluation in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in the PARABO observation study

• Published in: Annals of oncology Vol. 30; p. v336
• Main Authors: Palmedo, H., Eschmann, S., Werner, A., Selinski, I., Möllers, M.-O., Kalinovsky, J., Benson, A., Poeppel, T.
• Format: Journal Article
• Language: English
• Published: Elsevier Ltd 01.10.2019
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdz248.017

Ra-223 demonstrated a significant overall survival benefit and favourable safety profile in mCRPC in the ALSYMPCA study (Parker C et al. N Engl J Med 2013; 369:213–223). PARABO (NCT02398526) is an ongoing, prospective, observational, non-interventional, single-arm study with a primary objective to evaluate pain response in mCRPC pts treated with Ra-223 in a real-world setting. The aim of this interim analysis was to assess the impact of Ra-223 on pain response, with and without the use of opioids. Pain response was determined by the worst pain item on the Brief Pain Inventory–Short Form (BPI-SF) questionnaire. A clinically meaningful pain response was defined as an improvement of≥2 points; a 95% exact (Clopper–Pearson) confidence interval was reported. Of the 346 pts enrolled, 311 were included in the interim safety analysis set, 49% of whom used opioids at any time in the study. At baseline (BL), 185/311 (59.5%) had an ECOG performance status of 1 and 222/304 (73.0%) had ≥6 metastatic lesions (but not a superscan). Lumbar vertebrae, pelvis and thigh were amongst the most frequently reported areas of most pain at BL. During the observation period after Ra-223 treatment, 126/211 (59.7%) pts had a clinically meaningful pain response. Of the pts who used opioids vs those who did not, 62/113 (54.9%) vs 64/98 (65.3%) had a clinically meaningful pain response, and 28/110 (25.5%) vs 19/127 (15.0%) achieved almost complete relief after the third dose of Ra-223, respectively.Table860PTableRa-223 without opioid use (n=160)Ra-233 with opioid use (n=151)All pts (N=311)BPI-SF change ≥2 at observation,* % (95% CI)(n=98) 65.3 (55.0–74.6)(n=113) 54.9 (45.2–64.3)(n=211) 59.7 (52.8–66.4)Pain relief due to pain medications** at third Ra-223 dose,‡ % 0%–20% (no relief) 30%–70% (some relief) 80%–100% (almost complete relief) Missing data(n=127) 31.5 25.2 15.0 28.417.3 47.3 25.5 10.024.9 35.4 19.8 19.8*QoL-Set-Pain-Response (n=211);**QoL-Set-BPI-SF (n=269); †This time point was chosen due to limited study numbers at later doses;‡According to patients’ answer to the question “In the last 24hours, how much relief have pain treatments or medications provided?” in the BPI-SF questionnaire. In this study, reflective of real clinical practice, the majority (73.0%) of pts had multiple lesions at BL and almost half (49%) used opioids. Over half (59.7%) of pts reported a decrease in worst pain after Ra-223 treatment, irrespective of opioid use. Of pts who used vs did not use opioids, 54.9% vs 65.3% achieved a clinically meaningful pain response. Overall, a fifth (19.8%) of pts achieved almost complete relief after the third dose of Ra-223. NCT02398526. Jenny Feehan of OPEN Health Medical Communications (London, UK), with financial support from Bayer. Bayer Pharma AG. Bayer Pharma AG. H. Palmedo: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. S. Eschmann: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. A. Werner: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer Pharmaceuticals; Advisory / Consultancy: Novartis. I. Selinski: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. M. Möllers: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. J. Kalinovsky: Full / Part-time employment: Bayer Pharmaceuticals. A. Benson: Full / Part-time employment: Bayer Pharmaceuticals. All other authors have declared no conflicts of interest.