Pain response and clinical outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223): Final results from a prospective, noninterventional study (PARABO)
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Le résumé fourni par la source
Ziel/Aim PARABO (NCT02398526), a prospective, single-arm, observational study, assessed pain outcomes in German patients with mCRPC who received Ra-223 in real-life clinical practice setting. Methodik/Methods Outcomes include clinically meaningful pain response, ie, a≥2-point improvement in Brief Pain Inventory short form (BPI-SF) worst pain score, OS, SSEs and safety. Ergebnisse/Results 354 patients were evaluable for effectiveness and 356 for safety; 214 patients (60.1%) completed 6 Ra-223 cycles –reasons for early termination were adverse events (AEs; n=43, 12.1%) and disease progression (n=36, 10.1%). At baseline (BL), most patients had Eastern Cooperative Oncology Group performance status 0/1 (73.4%),>6 metastatic lesions (86.5%),≥1 prior systemic anticancer therapy (68.4%, median 1 prior therapy overall, median 2 prior therapies in the 242 patients with prior therapy), and no or mild pain (68.6%). 52.5% received concomitant bone-health agents. During Ra-223 therapy, 59.3% of 216 patients with BL worst pain score>1 had a pain response; response was greater in patients with 5–6 vs 1–4 cycles of Ra-223 (67.1% [98/146] vs 42.9% [30/70]). Mean BPI-SF component scores improved or were maintained from BL during Ra-223 treatment. By cycle 6, 24.0% of patients reported 80–100% pain relief. Median OS was 17.2 months (95% CI 15.3–19.0) and was longer in patients with 5–6 vs 1–4 cycles (20.7 vs 5.7 months). 25.8% experienced drug-related treatment-emergent AEs (TEAEs), most often anaemia (9.3%), diarrhoea (4.8%), and fatigue (2.8%); 11.2% experienced grade≥3 drug-related TEAEs. 14.7% of patients experienced SSEs during the study, including new pathologic fractures in 7.3%. Schlussfolgerungen/Conclusions 60% of patients had a clinically meaningful pain response. A pain response was achieved in 2/3 of patients who received 5–6 cycles and 42.9% who received 1–4 injections. The overall clinical outcomes with radium-223, including pain response, OS, and safety were consistent with previous observations. Publication History Article published online: 14 April 2022 © 2022. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Pain response and clinical outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223): Final results from a prospective, noninterventional study (PARABO)
- Date Crossref
- 01/04/2022
- Éditeur
- Georg Thieme Verlag KG
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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Klinik und Poliklinik für Nuklearmedizin pays non établi dans la noticeÉtablissement de santé
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Marienhospital Stuttgart pays non établi dans la noticeÉtablissement de santé
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Klinikum Weiden pays non établi dans la noticeÉtablissement de santé
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Klinik und Poliklinik für Nuklearmedizin, Marienhospital Stuttgart et Diakovere, avec 9 autres affiliations.
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