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Background Due to improved outcome in mCRPC, most prognostic models may not reflect the current treatment landscape. Recently, Armstrong et al (Ann Oncol 2018) published a prognostic model based on the phase III PREVAIL trial. Methods We applied the Armstrong prognostic model to patients (pts) treated in the COU-AA-302 trial. Variables included in the model: albumin, ALP, Hb, LDH, NLR, number of bone metastases, pain, pattern of spread, PSA, time from diagnosis. Pts were categorized into low ( Results 918 pts (84,4%) had data on all variables. Risk score (continuous) was associated with OS (HR 2.19; p Table . 864P OS rPFS TTPSAP Low 41.7m (38.7-46.8) 16.4m (13.8-19.1) 11.1m (8.3-11.2) Intermediate 24.6m (23.1-26.8) 8.3m (8-11) 5.6m (5.5-8.2) High 16.7m (11.7-30.2) 3.9m (3.6-4.1) 5.3m (3.7-8.3) Conclusions The Armstrong model is valid for mCRPC pts treated with first-line abiraterone. Less pts with high-risk features were included in COU-AA-302 than PREVAIL. These results may improve individual prognostic estimation and patient stratification in clinical trials. Study carried out under YODA Project #2018-3813. Clinical trial identification NCT00887198. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure D. Lorente: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Janssen; Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astellas; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bayer. All other authors have declared no conflicts of interest.

Background Clinically meaningful measures of response are needed in mCRPC. Post-treatment CTC decline have shown to be superior to PSA response in determining outcome in pts treated with AR signalling inhibitors. We compared the performance of CTC and PSA measures of response in mCRPC Doc-treated pts. Methods Baseline and post-treatment (6 to 9 weeks) CTC of mCRPC pts treated with Doc at first or second-line in a prospective study were determined with CellSearchTM platform. CTC response was defined: 30% decline from baseline (CTC30%), conversion (≥5 to 0 baseline CTC (CTC0). PSA response was determined at 12w as 30% (PSA30) or 50% decline (PSA50) from baseline. Cox-regression model were used to evaluate the association of baseline CTC (BLCTC), CTC response and PSA response measures with overall survival (OS), progression-free survival (PFS) or time to PSA progression (TTPP). C-index were used to evaluate the performance of each of the Cox regression model. Results 80 pts had evaluable BLCTC, 52 had evaluable post-treatment CTC count. Of 80 eligible pts, 53 (66.3%) received Doc at first-line. Median OS was 19 m (95%CI:16.4-21.8); median BLCTC was 7. BLCTC were associated with bone mts, higher PSA, ALP and LDH, and lower albumin levels. BLCTC was associated with OS (HR: 3.5; p Table . 889P N (%) HR (95%CI); p-value C-index CTC Conv 27 (51.9) 0.33 (0.18-0.60); p 0.665 CTC0 8 (15.4) 0.26 (0.10-0.67); p = 0.005 0.602 CTC30% 34 (65.4) 0.33 (0.18-0.61); p 0.644 PSA30 32 (61.5) 0.72 (0.40-1.30); p = 0.271 0.563 PSA50 22 (42.3) 0.68 (0.38-1.20); p = 0.183 0.595 Conclusions Baseline CTC were associated with OS, PFS and TTPP. CTC response measures were significantly associated with outcome, and showed a greater performance than PSA response measures in mCRPC Doc-treated pts. Legal entity responsible for the study Spanish National Cancer Research Center (CNIO) and The Institute of Cancer Research (ICR). Funding Has not received any funding. Disclosure R. Lozano Mejorada: Honoraria (self): Roche, Janssen-Cilag, Bayer; Research grant / Funding (institution): Bayer, Janssen-Cilag; Travel / Accommodation / Expenses: Roche, Janssen-Cilag, Astellas Pharma. 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, AstraZeneca, Clovis Oncology; Research grant / Funding (institution): Janssen-Cilag, AstraZeneca, Bayer; Travel / Accommodation / Expenses: Bayer, Janssen-Cilag, Roche, Astellas Pharma. N. Romero Laorden: Honoraria (self): MSD, Sanofi-Aventis, Astellas, Janssen-Cilag; Travel / Accommodation / Expenses: Bayer, Janssen-Cilag, Roche, PharmaMar; Research grant / Funding (institution): Bayer, Astellas, Janssen-Cilag, Sanofi-Aventis. E. Almagro Casado: Honoraria (self): MSD; Travel / Accommodation / Expenses: BMS. M. Saez: Honoraria (self): Bristol-Myers Squibb, Pfizer, Novartis, Bayer, Janssen-Cilag, Sanofi-Aventis, Astellas Pharma, Ipsen, EUSA Pharma; Advisory / Consultancy: Bristol-Myers Squibb, Pfizer, Novartis, Bayer, Janssen-Cilag, Sanofi-Aventis, Astellas Pharma, Ipsen, EUSA Pharma; Travel / Accommodation / Expenses: Bristol-Myers Squibb, Pfizer, Novartis, Bayer, Janssen-Cilag, Sanofi-Aventis, Astellas Pharma, Ipsen, EUSA Pharma. D. Olmos Hidalgo: Honoraria (self): Janssen-Cilag, Bayer, Sanofi; Advisory / Consultancy: Bayer, Janssen-Cilag, AstraZeneca, Clovis Oncology; Research grant / Funding (institution): Bayer, Janssen-Cilag, AstraZeneca, Roche/Genentech, Medications/Pfizer, Astellas, Tokai, MSD, GSK; Travel / Accommodation / Expenses: Bayer, Janssen-Cilag, Ipsen. All other authors have declared no conflicts of interest.

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 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. 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 Espana, 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.

Aim: The classification systems for febrile neutropenia F.N define groups of patients with high or low risk of developing complications during the episode, but they do not evaluate correctly which patients can be treated as outpatients, because up to 5-15 % of low risk patients suffer some kind of complication or even death. Methods: A retrospective study in only one institution of episodes of febrile neutropenia in outpatients with solid tumors between January 2004 and December 2011.The clinical differences between patients treated in hospital and those treated as outpatients were analyzed by means of a multivariate analysis to design a protocol algorithm. Results: A total of 250 patients were included. 173 (69.2%) patients underwent hospital treatment (PHT) and 77 (30.8%) were treated orally as outpatients (OP). Of the latter, none developed serious complications nor required admission. 12 clinical variables between PHT and OP were analyzed using logistic binary regression. Statistically significant differences were found, clinical factors favourable to outpatient treatment being: age 100/mm3 (OR, 14; 95% IC, 4,67 to 41,09); ECOG 10 days between cycle of chemotherapy (CC) and F.N episode (OR, 2,49; 95% IC, 1,01 to 6,19). The area under the curve for this model was 0.932 (p Conclusions: Ambulatory management is possible for patients with febrile neutropenia who are clinically stable and who present the above favourable clinical factors. Disclosure: All authors have declared no conflicts of interest.