Abstract 5331
Background
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.
Methods
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.
Results
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.Table:
860P
Ra-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 28.4 | 17.3 47.3 25.5 10.0 | 24.9 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 24 hours, how much relief have pain treatments or medications provided?” in the BPI-SF questionnaire.
Conclusions
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.
Clinical trial identification
NCT02398526.
Editorial acknowledgement
Jenny Feehan of OPEN Health Medical Communications (London, UK), with financial support from Bayer.
Legal entity responsible for the study
Bayer Pharma AG.
Funding
Bayer Pharma AG.
Disclosure
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.
Resources from the same session
2600 - Atezolizumab (atezo) vs chemotherapy (chemo) in patients (pts) with platinum-treated locally advanced or metastatic urothelial carcinoma (mUC): a long-term overall survival (OS) and safety update from the Phase III IMvigor211 study
Presenter: Michiel Van der Heijden
Session: Poster Display session 3
Resources:
Abstract
3598 - Three-Year Follow-Up From the Phase 3 KEYNOTE-045 Trial: Pembrolizumab (Pembro) Versus Investigator’s Choice (Paclitaxel, Docetaxel, or Vinflunine) in Recurrent, Advanced Urothelial Cancer (UC)
Presenter: Andrea Necchi
Session: Poster Display session 3
Resources:
Abstract
2382 - First Report of Efficacy and Safety From a Phase 2 Trial of Tislelizumab, an Anti-PD-1 Antibody, for the Treatment of PD-L1+ Locally Advanced or Metastatic Urothelial Carcinoma (UC) in Asian Patients
Presenter: Dingwei Ye
Session: Poster Display session 3
Resources:
Abstract
2388 - Quality of Life of Metastatic Urothelial Cancer (mUC) Patients Treated with Enfortumab Vedotin (EV) Following Platinum-Containing Chemotherapy and a Checkpoint Inhibitor (CPI): Data from EV-201 Cohort 1
Presenter: Bradley McGregor
Session: Poster Display session 3
Resources:
Abstract
3748 - Safety and efficacy of atezolizumab (atezo) in patients (pts) with autoimmune disease (AID): subgroup analysis of the SAUL study in locally advanced/metastatic urinary tract carcinoma
Presenter: Yohann Loriot
Session: Poster Display session 3
Resources:
Abstract
1126 - Validation of the VIO prognostic index in patients with metastatic urothelial carcinoma treated with immune-checkpoint inhibitors
Presenter: Rafael Morales Barrera
Session: Poster Display session 3
Resources:
Abstract
3693 - Pathologic outcomes after neoadjuvant chemotherapy for high-risk muscle invasive bladder cancer
Presenter: Justin Matulay
Session: Poster Display session 3
Resources:
Abstract
4840 - Analysis of response to prior therapies and therapies after treatment with erdafitinib in fibroblast growth factor receptor (FGFR)-positive patients (pts) with metastatic urothelial carcinoma (mUC)
Presenter: Arlene Siefker-Radtke
Session: Poster Display session 3
Resources:
Abstract
1221 - Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)
Presenter: Jean Hoffman-censits
Session: Poster Display session 3
Resources:
Abstract
1715 - National Small Cell Bladder Cancer Audit: Results from 26 UK institutions
Presenter: Caroline Chau
Session: Poster Display session 3
Resources:
Abstract