Background: CA15.3 is often the sole TM followed in MBC, although guidelines suggest that adding CEA can be considered. However, there are no guidelines on how to proceed in the event of negative CA15.3 at diagnosis. Aims: To analyse the benefit, if any, of a multi TM panel at diagnosis and follow up, focusing on those with a normal CA15.3 at diagnosis. To determine whether TM elevation correlates with site of metastases and histopathology. Methods: From 2001 to 2018, we analysed CA15.3, CEA, CA-125 and CA19.9 levels in 193 evaluable MBC patients from diagnosis and followed until patient last attendance. Tests of association were conducted to explore the correlation between TMs and sites of metastases and histology. Median follow up was 2.7 years.Results: CA15.3 was the most commonly raised TM (122/193, 63%), followed by 45%), CEA (73/193, 37%) and CA19.9 (29/168, 17%). Seventy-one of 193 (36%) had a normal CA15.3 at diagnosis. Of these, 33/66 (50%) were pan TM negative, 16/66 (24%) had an isolated raised CA-125, followed by 7/66 (11%) with an isolated raised CEA. On follow up, 18/71 (25%) remained TM negative, 28/71 (39%) developed a raised CA15.3 after a median follow up of 10 months. Seventeen of 28 (61%) with a normal CA 15.3 at diagnosis had other markers raised. Tests of association exploring TM patterns and tumour histology and sites of metastases will be presented.
Conclusions:Adding CEA and CA-125, but not CA19.9 to CA15.3, added diagnostic value and in those with a normal CA15.3 at diagnosis, it was beneficial to continue following all three markers with the majority of patients having at least one marker their clinician could follow. A normal CA15.3 at diagnosis was found in 36% of our patients and in the absence of guidelines, remains an unmet diagnostic need that requires further investigation Editorial material and organization c Background: Enzalutamide (ENZA) has demonstrated benefit in men with metastatic and nonmetastatic castration-resistant prostate cancer (CRPC). Efficacy in men with mHSPC is unknown. Methods: ARCHES is a global, double-blind, phase 3 study (NCT02677896). Patients with mHSPC were randomized 1:1 to ENZA (160 mg/day) + androgen deprivation therapy (ADT) or placebo (PBO)+ADT, stratified by disease volume (CHAARTED criteria) and prior docetaxel. Primary endpoint: radiographic progression-free survival (rPFS) assessed centrally or death within 24 weeks of treatment discontinuation. Secondary endpoints included time to PSA progression, PSA and radiographic responses and overall survival (OS). Treatment continued until disease progression or unacceptable toxicity. Results: One thousand one hundred fifty men were randomized to ENZA (n = 574) or PBO (n = 576); baseline characteristics were 72 wileyonlinelibrary.com/journal/ajco Asia-Pac J Clin Oncol. 2019;15(Suppl. 5):72-100. POSTER ABSTRACTS 73 TA B L E 1 Endpoint ENZA+ADT (n = 574) PBO+ADT (n = 576)Primary: rPFS, HR (95% CI) 0.39* (0.30, 0.50) Median (mo) NR 19.4 Key secondary Time to PSA progression, HR (95% CI) 0.19* (0.13, 0.26)...