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
3117 - A modified Edmonton Symptom Assessment Scale for assessing symptoms in one day chemotherapy clinic
Presenter: Anjuleta Kampitsi
Session: Poster Display session 3
Resources:
Abstract
6058 - Level of physical activity and nutritional status in cancer patients with fatigue: an exploratory cross-sectional study
Presenter: Patrick Jahn
Session: Poster Display session 3
Resources:
Abstract
1980 - Catheter related necrotizing fascitiis in haematological patients. Case report and implications for nursing
Presenter: Arianna Rosich Soteras
Session: Poster Display session 3
Resources:
Abstract
3984 - Everyday life with Long-term Chemotherapy Induced Peripheral Neuropathy among Patient in Adjuvant Treatment for Colorectal Cancer – a Multi Methods Study
Presenter: Marlene Jensen
Session: Poster Display session 3
Resources:
Abstract
2202 - Scalp cooler is effective in reducing chemotherapy-induced alopecia among breast cancer patients : a single institution experience
Presenter: Emilia Gianotti
Session: Poster Display session 3
Resources:
Abstract
5942 - Nursing management of fatigue in cancer patients: mixed methods study
Presenter: Angela Tolotti
Session: Poster Display session 3
Resources:
Abstract
2930 - Awareness of Nursing Students about the Warning Signs of Cancer
Presenter: Hatice Yakar
Session: Poster Display session 3
Resources:
Abstract
2978 - Assessment of quality of life in patients with cancer and diabetes 2 in Northern Greece.
Presenter: STYLIANI MICHALOPOULOU
Session: Poster Display session 3
Resources:
Abstract
3400 - Radiation dose variables related to the causes of skin toxicities in women with breast cancer: a study proposal
Presenter: EULALIA PUJOL
Session: Poster Display session 3
Resources:
Abstract
2156 - How should the symptoms be managed after breast cancer surgery? An example of mobile app
Presenter: AYDANUR AYDIN
Session: Poster Display session 3
Resources:
Abstract