Clinical outcomes of a Dutch prospective observational registry of metastatic castration resistant prostate cancer (mCRPC) patients treated with radium-223 (Ra-223).

Authors

null

Rebecca Louhanepessy

Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands

Rebecca Louhanepessy , Sushil Badrising , Vincent van der Noort , Jules L. L. M. Coenen , Paul Hamberg , Aart Beeker , Nils Wagenaar , Marnix G.E.H. Lam , Filiz Celik , Olaf Loosveld , Ad Oostdijk , Johanna Maria Zuetenhorst , Erik Vegt , Wilbert Zwart , Andre M. Bergman

Organizations

Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, Radboud UMC, Nijmegen, Netherlands, Netherlands Cancer Institute, Amsterdam, Netherlands, Isala Clinics, Zwolle, Netherlands, Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands, Spaarne Gasthuis Hoofddorp, Hoofddorp, Netherlands, Ziekenhuisgroep Twente, Hengelo, Netherlands, University Medical Center Utrecht, Utrecht, Netherlands, Deventer Ziekenhuis, Deventer, Netherlands, Amphia Hospital, Breda, Netherlands, Isala, Zwolle, Netherlands, Sint Franciscus Gasthuis, Rotterdam, Netherlands, Netherlands Cancer Center - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, Department of Medical Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands

Research Funding

Other

Background: In 2012 the ALSYMPCA study established a 3.6 month Overall Survival (OS) benefit of mCRPC patients treated with Ra-223 over placebo. To date clinical outcomes of Ra-223 treatment in a non-study population have not been prospectively evaluated. Methods: The ROTOR registry aimed to include 300 patients in 20 Dutch hospitals prior to Ra-223 treatment at the physician’s discretion. Clinical parameters collected included: positioning of Ra-223, Adverse Events (AE’s; CTCAE v4.03), Skeletal Related Events (SRE) and survival data. SRE was defined as radiotherapy to a bone metastasis, a new pathological fracture, spinal cord compression and/or bone surgery. Progression-Free Survival (PFS) was defined as survival until radiological or clinical progression, subsequent treatment or death. Results: Between April 2014 and September 2017, 305 patients were included of whom 300 were evaluable. The mean age of patients was 72.6 (range 46.3-91.5) years, 255 (85%) had ≥ 6 bone metastases and 197 (65.5%) were pretreated with taxanes and/or abiraterone or enzalutamide (214 (71.3%)). Two-hundred and ninety (96.7%) patients were treated with Ra-223. Twenty-nine (9.7%), 104 (34.7%), 96 (32%) and 66 (22%) patients received Ra-223 as a first, second, third, ≥ fourth mCRPC treatment line, respectively. Patients received an average of 4.6 (SD 1.8) cycles of Ra-223, while 140 (46.7%) completed all six cycles. After a median follow-up of 13.2 months, PFS was 5.1 (CI 4.5-5.8) months and OS 15.2 (CI 12.8-17.6) months. Eighty-two (27.3%) patients were hospitalized during Ra-223 treatment (Serious AE). Grade ≥ 3 anemia, neutropenia and thrombocytopenia was found in 54 (18.0%), 8 (2.7%) and 11 (3.7%) patients, respectively. Other frequent AE’s (all grades) were nausea (90 (30%)), diarrhea (83 (27.7%)) and fatigue (178 (59.3%)). SREs were observed in 46 (15.3%) patients; 22 (7.3%) received radiotherapy, 6 (2%) developed pathologic fractures, 17 (5.6%) spinal cord compression and 1 (0.3%) received bone surgery during Ra-223 therapy. Conclusions: The non-study ROTOR population had characteristics, all grade AEs and OS comparable with the treatment arm of ALSYMPCA. Clinical trial information: NCT03223597

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Abstract Details

Meeting

2019 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers

Track

Urothelial Carcinoma,Prostate Cancer,Penile, Urethral, Testicular, and Adrenal Cancers

Sub Track

Prostate Cancer - Advanced Disease

Clinical Trial Registration Number

NCT03223597

Citation

J Clin Oncol 37, 2019 (suppl 7S; abstr 323)

DOI

10.1200/JCO.2019.37.7_suppl.323

Abstract #

323

Poster Bd #

E9

Abstract Disclosures