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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

3983 - Clinical outcome with radium-223 (Ra-223) in patients (pts) previously treated with abiraterone (Abi) or enzalutamide (Enza): A retrospective study of real-world (RW) data from pts with metastatic castration-resistant prostate cancer (mCRPC)

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Radiation Oncology

Tumour Site

Prostate Cancer

Presenters

Celestia Higano

Citation

Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284

Authors

C.S. Higano1, B. Tombal2, K. Miller3, F. Saad4, O. Sartor5, K. Tangirala6, X. Jiao7, J. Kalinovsky8, C.N. Sternberg9

Author affiliations

  • 1 Division Of Oncology, University of Washington, 98195 - Seattle/US
  • 2 Urology, Cliniques Universitaires Saint-Luc, Brussels/BE
  • 3 Urology, Charité Berlin, Berlin/DE
  • 4 Urology, University of Montreal Hospital Center, Montreal/CA
  • 5 Tulane Cancer Center, Tulane Medical School, New Orleans/US
  • 6 Medical Affairs, Bayer US LLC, Pharmaceuticals, Whippany/US
  • 7 Rwe Strategy & Outcomes Data Generation, Bayer US LLC, Pharmaceuticals, Whippany/US
  • 8 Medical Oncology, Bayer Consumer Care AG, Basel/CH
  • 9 Medical Oncology, San Camillo-Forlanini Hospital, Rome/IT
More

Resources

Abstract 3983

Background

Ra-223 pivotal phase 3 trial was conducted prior to Abi and Enza becoming available. Here, we analysed registry data to determine clinical outcomes with Ra-223 therapy in pts previously treated with Abi or Enza in a RW setting.

Methods

This was a retrospective study of data from the Flatiron prostate cancer registry, providing electronic health records from >245 US cancer clinics. Data were collected from 01/01/2013–30/06/2017. Ra-223-treated mCRPC pts were included; prior to receiving Ra-223, pts completed Abi/Enza/both. Prior Abi and prior Enza groups excluded pts with concomitant/concurrent Abi or Enza. Baseline was defined as the index date at start of Ra-223 therapy. Pts were followed until death or study end. Descriptive analysis was performed for baseline characteristics, prior Abi or Enza therapy, skeletal-related events (SREs) and OS (Kaplan–Meier method).

Results

Among 625 Ra-223-treated pts, 29.9% (n = 187) and 26.2% (n = 164) completed prior Abi or Enza treatment, respectively (Table). At baseline, SREs were documented in 50% (314/625) of pts (48% [89/187] in prior Abi and 53% [87/164] in prior Enza pts). During/following Ra-223 therapy, SREs were reported at a similar rate in prior Abi (21% [39/185]) and prior Enza pts (20% [33/163]). Pathological fractures were reported in 10% (61/623) of pts (7% [13/185] and 6% [10/163] in prior Abi and prior Enza pts, respectively). Median (95% CI) OS was 15.2 (13.2–16.3) months in all pts (10.5 [8.6–12.3] for prior Abi and 9.8 [7.8–13.2] for prior Enza pts).Table: 827P

Ra-223 pts with prior Abi (n = 187)Ra-223 pts with prior Enza (n = 164)All Ra-223 pts (n = 625)
Baseline characteristics
Age, median (years)757573
ECOG 0–1, n (%)84 (45.0)73 (44.5)260 (41.6)
ALP (U/L), median111113108
PSA (μg/L), median675338
LDH (U/L), median204207196
Time from castration resistance to baseline, median (months)181611
Pts with prior SREs, n (%)89 (47.6)87 (53.0)314 (50.2)
Duration of prior therapy (months)
Abi, median (range)5.8 (0.0–46.9)Not applicableNot calculated
Enza, median (range)Not applicable4.8 (0.0–49.0)Not calculated
Clinical outcomes with Ra-223 therapy
Follow-up time, median (months)779
Ra-223 doses, median (range)4 (1–6)4 (1–6)4 (1–6)
Pts with SREs, n (%)39 (21)33 (20)168 (27)
Pts with pathological fractures, n (%)13 (7)10 (6)61 (10)
Median time from castration resistance to death (months)292626
OS, median (95% CI) (months)10.5 (8.6, 12.3)9.8 (7.8, 13.2)15.2 (13.2, 16.3)

Conclusions

In this retrospective RW study of 4 yr clinical practice, a high proportion of pts had SREs prior to start of Ra-223. Sequential use of Ra-223 after Abi or Enza does not negatively affect bone-related safety outcomes when compared with the overall cohort. Ra-223 is a feasible treatment option after Abi or Enza.

Clinical trial identification

Legal entity responsible for the study

Bayer.

Funding

Bayer.

Editorial Acknowledgement

Medical writing support was provided by Samantha Kew, BSc, of Scion, London UK, funded by Bayer.

Disclosure

C.S. Higano: Advisory boards: Astellas, Bayer, Blue Earth Diagnostics, Ferring, Janssen, Myriad, Tolmar; Sponsored research: Aragon, Astellas, AstraZeneca, Dendreon, Genentech, Medivation, Emergent, Bayer, Pfizer, Hofman Laroche; Employment: Spouse employed in leadership position: CTI Biopharma. B. Tombal: Investigator, paid advisor: Bayer, Astellas, Janssen, Sanofi. K. Miller: Honoraria, consultation fees: Amgen, Bayer, BMS, Ferring, Janssen, MSD, Novartis, Pfizer, Roche, Sotio, Takeda, Tolmar. F. Saad: Consultant, research grants: Bayer, Amgen, Astellas, Jansssen, Sanofi and AstraZeneca. O. Sartor: Consultant, investigator: Bayer. K. TangiralaX. Jiao, J. Kalinovsky: Employee: Bayer Healthcare. C.N. Sternberg: Bayer, Sanofi, Pfizer, Janssen, Astellas, Clovis, AstraZeneca.

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