Abstract 3600
Background
Ra223 is a life-prolonging alpha-emitter bone targeted therapy for mCRPC patients with bone metastases. However, evidence on biomarkers that may help us in patient selection are lacking. Total ALP (tALP) appeared to be a potential marker of Ra223 effect in early studies (Sartor, Ann Oncol, 2017). Other bone-related markers, as bone-specific ALP (BALP), have demonstrated its prognostic value in mCRPC patients with bone metastases (Fizazi K, Eur Urol, 2015; Lara PN, J Natl Cancer Inst, 2014).
Methods
PRORADIUM (NCT022925702) is a prospective multicentre cohort study in mCRPC patients treated with Ra223. The primary aim was to assess the impact of baseline serum biomarkers of bone formation (BALP and C-terminal of type 1 collagen propeptide [CICP]) on overall survival (OS). Secondary aims include the correlation of progression-free survival (PFS), time to PSA progression (TTPP) and skeletal-related events free-survival (SRE-FS) with serum bone markers.
Results
142 out of 168 pts enrolled in the study were included in this preliminary analysis. Median age was 74 yrs, 85.5% pts had ECOG 0-1, 52% pts completed 5-6 cycles of Ra223. Higher baseline levels of BALP and CICP were associated to number of metastases in bone-scan (p = 0.007 and p = 0.016, respectively) and baseline pain (p = 0.014 and p = 0.050, respectively). After a median follow-up of 18 months, 91 deaths were observed, with a median OS of 11.5 months (95%CI: 9.1-13.9). Patients with baseline BALP and CICP values above the median showed a trend to shorter TTPP (BALP: 2.8 vs 3.1 m, p = 0.016; CICP: 2.8 vs 3.0 m, p = 0.091) and PFS (BALP: 4.4 vs 5.1 m, p = 0.070; CICP: 4.2 vs 5.5 m, p = 0.281), respectively. The elevation of bone markers above the median was significantly associated with worse OS (BALP: 8.8 vs 17.9 m, p < 0.001; CICP: 9.4 vs 16.8 m, p = 0.001). There were not associations found with SRE-FS.
Conclusions
Our results suggest that baseline serum markers of bone formation may serve as biomarkers for prognosis in mCRPC patients treated with Ra233.
Clinical trial identification
NCT022925702.
Editorial acknowledgement
Legal entity responsible for the study
IBIMA and CNIO.
Funding
Bayer, CRIS Cancer Foundation, Grant from Instituto de Salud Carlos III (PI16/01565).
Disclosure
N. Romero Laorden: Honoraria (self), Travel / Accommodation / Expenses: Bayer, Astellas Pharma, Janssen-Cilag, Sanofi-Aventis, PharmaMar, MSD, Roche. R. Lozano Mejorada: Honoraria (self): Roche, Janssen-Cilag, Bayer; Research grant / Funding (institution): Bayer, Janssen-Cilag; Travel / Accommodation / Expenses: Roche, Janssen-Cilag, Astellas Pharma. E. Almagro Casado: Honoraria (self): MSD; Travel / Accommodation / Expenses: BMS. E. Gonzalez Billalabeitia: Travel / Accommodation / Expenses: BMS, Pfizer, Janssen-Cilag, Astellas Pharma, Sanofi. A. Montesa: Advisory / Consultancy: Janssen-Cilag, Pfizer, Sanofi, Astellas Pharma; Travel / Accommodation / Expenses: Pfizer. G.A. De Velasco Oria de Rueda: Honoraria (self), Advisory / Consultancy: Pfizer, Novartis, Ipsen, Astellas Pharma, BMS, Bayer, MSD, Roche. R. Morales Barrera: Honoraria (self): MSD, Sanofi, AstraZeneca, Janssen, Roche/Genentech; Advisory / Consultancy: MSD, Sanofi, AstraZeneca, Janssen, Roche/Genentech; Speaker Bureau / Expert testimony: MSD, Sanofi, AstraZeneca, Asofarma, Janssen; Research grant / Funding (institution): AB Science, Aragon Pharmaceuticals, INC, Astellas Pharma, AstraZeneca, Aveo Pharmaceuticals, Bayer, Blueprint Medicines Corporation, BN Immunotherapeutics, Boehringer Ingelheim España, BMS, Clovis Oncology, Cougar Technology, Deciphera Pharmaceuticals LL; Travel / Accommodation / Expenses: MSD, Roche, Lilly, Clovis Oncology, Bayer, Janssen-Cilag, Astellas Pharma, AstraZeneca. D. Lorente: Honoraria (self): Janssen-Cilag, Bayer, Astellas Pharma, Sanofi; Advisory / Consultancy: Janssen-Cilag, Bayer, Sanofi; Travel / Accommodation / Expenses: Sanofi, Astellas, Janssen-Cilag, Celgene. E. Castro: Honoraria (self): Astellas Pharma, Janssen-Cilag, AstraZeneca, Bayer, Pfizer; Advisory / Consultancy: Bayer, Janssen-Cilag; Research grant / Funding (institution): Janssen-Cilag, AstraZeneca, Bayer, Genentech, Roche, Pfizer, Astellas Medivation, Tokai Pharmaceuticals; Travel / Accommodation / Expenses: Bayer, Janssen-Cilag, Roche, Astellas Pharma. D. Olmos Hidalgo: Honoraria (self): Janssen-Cilag, Bayer, Sanofi; Advisory / Consultancy: Bayer, Janssen-Cilag, AstraZeneca, Clovis Oncology; Research grant / Funding (institution): Bayer, Janssen, AstraZeneca, Roche/Genentech, Medivation/Pfizer, Astellas, Tokai, MSD, GSK; Travel / Accommodation / Expenses: Bayer, Janssen-Cilag, Ipsen. All other authors have declared no conflicts of interest.
Resources from the same session
4096 - Patient experience and use of an intervention combining nurse-led telephone and technologies for the monitoring of oral cancer medication
Presenter: Marie Ferrua
Session: Poster Display session 3
Resources:
Abstract
6042 - Harnessing nurse leadership to implement a project for electronic scheduling of chemotherapy
Presenter: Emma Masters
Session: Poster Display session 3
Resources:
Abstract
3123 - Turkish Cancer Patients’ Preference for Information and Communication Technologies
Presenter: Esra ildes
Session: Poster Display session 3
Resources:
Abstract
6062 - Unmet Needs in Oncology Research related to radiological response evaluation: a multi-center survey in three European countries
Presenter: Sophie Nisse Durgeat
Session: Poster Display session 3
Resources:
Abstract
6109 - A program implementation to facilitate intraoperative brachytherapy between hospitals
Presenter: Marc Garcia Casellas
Session: Poster Display session 3
Resources:
Abstract
1772 - Using Mobile-Based Health Care Applications Outcomes: Mini Systematic Review
Presenter: Aydanur Aydin
Session: Poster Display session 3
Resources:
Abstract
2792 - Evaluation of an education program for cancer patients receiving chemotherapy
Presenter: Iraqi Amina
Session: Poster Display session 3
Resources:
Abstract
3715 - iGestSaúde: Application for self-management of symptoms during chemotherapy treatment
Presenter: Bruno Magalhaes
Session: Poster Display session 3
Resources:
Abstract
3854 - Palliative care requirements of cancer patients and investigation of knowledge and expectations related to palliative care of the patients and their families
Presenter: Ozlem Topkaya
Session: Poster Display session 3
Resources:
Abstract
4997 - Hospice care, what to expect? An exploration of the expectation of future hospice patients
Presenter: Merel van Klinken
Session: Poster Display session 3
Resources:
Abstract