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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
- Article/chapterEnglish2017
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OXFORD UNIV PRESS,2017
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electronicrdacarrier
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LIBRIS-ID:oai:DiVA.org:umu-140899
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https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-140899URI
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https://doi.org/10.1093/annonc/mdx331DOI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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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.
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Heinrich, D.
(author)
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Mariados, N.
(author)
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Mendez Vidal, M. J.
(author)
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Keizman, D.
(author)
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Thellenberg Karlsson, CamillaUmeå universitet,Institutionen för strålningsvetenskaper(Swepub:umu)cath0005
(author)
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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.
(author)
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Rosenbaum, E.
(author)
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Severi, S.
(author)
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Trigo Perez, J. M.
(author)
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Wagner, V.
(author)
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Li, R.
(author)
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Nordquist, L. T.
(author)
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Umeå universitetInstitutionen för strålningsvetenskaper
(creator_code:org_t)
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In:Annals of Oncology: OXFORD UNIV PRESS28:10, s. 2464-24710923-75341569-8041
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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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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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Umeå University