Universität zu Köln

Saad, Fred, Gillessen, Silke ORCID: 0000-0001-5746-6555, Heinrich, Daniel, Keizman, Daniel, O'Sullivan, Joe M., Nilsson, Sten, Miller, Kurt, Wirth, Manfred, Reeves, John, Seger, Monica, Carles, Joan and Heidenreich, Axel (2019). Disease Characteristics and Completion of Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Radium-223 in an International Early Access Program. Clin. Genitourin. Cancer, 17 (5). S. 348 - 361. DALLAS: CIG MEDIA GROUP, LP. ISSN 1938-0682

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Abstract

In this post hoc analysis we investigated associations between baseline characteristics and number of radium-223 injections in a phase IIIb, single-arm study in the setting of an international early access program. Patients with less advanced metastatic castration-resistant prostate cancer described by more favorable baseline characteristics were more likely to complete 5 to 6 than 1 to 4 injections and had longer overall survival. Background: Radium-223 is approved by the US Food and Drug Administration and European Medicines Agency for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are currently no markers for selecting patients most likely to complete radium-223 treatment. Patients and Methods: In this phase IIIb, international, single-arm study, patients received radium-223, 55 kBq/kg, every 4 weeks for <= 6 cycles. Primary end points were safety and overall survival. In post hoc analyses patients were grouped according to number of radium-223 injections received (1-4 or 5-6). Associations between baseline covariates and number of injections were investigated. Results: Of 696 eligible patients, 473 (68%) had received 5 to 6 radium-223 injections and 223 (32%) 1 to 4 injections. Patients with less pain (moderate-severe vs. none-mild, odds ratio [OR], 0.41; P < .0001), lower Eastern Cooperative Oncology Group performance status (>= 2 vs. 0-1, OR, 0.51; P = .0074), lower prostate-specific antigen level (>141 mu g/L vs. <= 141 mu g/L, OR, 0.40; P < .0001), and higher hemoglobin level (<10 g/dL vs. >= 10 g/dL, OR, 0.50; P = .0206) were more likely to receive 5 to 6 than 1 to 4 injections. Median overall survival was not reached and was 6.3 months (95% confidence interval, 5.4-7.4) in patients who had received 5 to 6 and 1 to 4 radium-223 injections, respectively. Adverse events were less common in patients who received 5 to 6 than 1 to 4 injections; anemia was reported in 87 (18%) and 64 (29%) patients, respectively. Conclusion: Patients with less advanced mCRPC are more likely to receive 5 to 6 radium-223 injections and to achieve better overall survival. Consideration of baseline and disease characteristics is recommended before initiation of radium-223 treatment.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Saad, Fred UNSPECIFIED UNSPECIFIED UNSPECIFIED Gillessen, Silke UNSPECIFIED orcid.org/0000-0001-5746-6555 UNSPECIFIED Heinrich, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Keizman, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED O'Sullivan, Joe M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Nilsson, Sten UNSPECIFIED UNSPECIFIED UNSPECIFIED Miller, Kurt UNSPECIFIED UNSPECIFIED UNSPECIFIED Wirth, Manfred UNSPECIFIED UNSPECIFIED UNSPECIFIED Reeves, John UNSPECIFIED UNSPECIFIED UNSPECIFIED Seger, Monica UNSPECIFIED UNSPECIFIED UNSPECIFIED Carles, Joan UNSPECIFIED UNSPECIFIED UNSPECIFIED Heidenreich, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-132609
DOI:	10.1016/j.clgc.2019.05.012
Journal or Publication Title:	Clin. Genitourin. Cancer
Volume:	17
Number:	5
Page Range:	S. 348 - 361
Date:	2019
Publisher:	CIG MEDIA GROUP, LP
Place of Publication:	DALLAS
ISSN:	1938-0682
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language 1ST-LINE CHEMOTHERAPY; SKELETAL METASTASES; ABIRATERONE ACETATE; SURVIVAL; RA-223; PREDICTION; DICHLORIDE; ADJUVANT; MODEL; MEN Multiple languages Oncology; Urology & Nephrology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/13260