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Re-treatment with r...
Re-treatment with radium-223 : first experience from an international, open-label, phase I/II study in patients with castration-resistant prostate cancer and bone metastases
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Sartor, O. (författare)
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Heinrich, D. (författare)
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Mariados, N. (författare)
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Mendez Vidal, M. J. (författare)
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Keizman, D. (författare)
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- Thellenberg Karlsson, Camilla (författare)
- Umeå universitet,Institutionen för strålningsvetenskaper
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Peer, A. (författare)
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Procopio, G. (författare)
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Frank, S. J. (författare)
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Pulkkanen, K. (författare)
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Rosenbaum, E. (författare)
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Severi, S. (författare)
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Trigo Perez, J. M. (författare)
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Wagner, V. (författare)
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Li, R. (författare)
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Nordquist, L. T. (författare)
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(creator_code:org_t)
- OXFORD UNIV PRESS, 2017
- 2017
- Engelska.
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Ingår i: Annals of Oncology. - : OXFORD UNIV PRESS. - 0923-7534 .- 1569-8041. ; 28:10, s. 2464-2471
- Relaterad länk:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Background: Six radium-223 injections at 4-week intervals is indicated for patients with castration-resistant prostate cancer and symptomatic bone metastases. However, patients usually develop disease progression after initial treatment. This prospective phase I/II study assessed re-treatment safety and efficacy of up to six additional radium-223 injections. Patients and methods: Patients had castration-resistant prostate cancer and bone metastases and six initial radium-223 injections with no on-treatment bone progression; all had subsequent radiologic or clinical progression. Concomitant agents were allowed at investigator discretion, excluding chemotherapy and initiation of new abiraterone or enzalutamide. The primary endpoint was safety; additional exploratory endpoints included time to radiographic bone progression, time to total alkaline phosphatase and prostate-specific antigen progression, radiographic progression-free survival, overall survival, time to first symptomatic skeletal event (SSE), SSE-free survival, and time to pain progression. Results: Among 44 patients, 29 (66%) received all six re-treatment injections. Median time from end of initial radium-223 treatment was 6 months. Forty-one (93%) reported >= 1 treatment-emergent adverse event. No grade 4-5 hematologic treatment-emergent adverse events occurred. Only one (2%) patient had radiographic bone progression; eight (18%) had radiographic soft tissue tumor progression (three lymph node and five visceral metastases). Median times to total alkaline phosphatase and prostate-specific antigen progression were not reached and 2.2 months, respectively. Median radiographic progression-free survival was 9.9 months (12.8-month maximum follow-up). Five (11%) patients died and eight (18%) experienced first SSEs. Median overall survival, time to first SSE, and SSE-free survival were not reached. Five (14%) of 36 evaluable patients (baseline worst pain score <= 7) had pain progression. After 2 years of follow-up, 28 (64%) patients died, and the median overall survival was 24.4 months. Conclusions: Re-treatment with a second course of six radium-223 injections after disease progression is well tolerated, with minimal hematologic toxicity and low radiographic bone progression rates in this small study with limited follow-up. Favorable safety and early effects on disease progression indicate that radium-223 re-treatment is feasible and warrants further evaluation in larger prospective trials.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- bone metastases
- injections
- prostate
- radium-223
- re-treatment
- safety
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Sartor, O.
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Heinrich, D.
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Mariados, N.
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Mendez Vidal, M. ...
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Keizman, D.
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Thellenberg Karl ...
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visa fler...
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Peer, A.
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Procopio, G.
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Frank, S. J.
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Pulkkanen, K.
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Rosenbaum, E.
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Severi, S.
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Trigo Perez, J. ...
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Wagner, V.
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Li, R.
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Nordquist, L. T.
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visa färre...
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