11/14/2016
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`157911-172
`
`Published on Meeting Library (http://meetinglibrary.asco.org)
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`Prospective evaluation of the response to prednisone-dexamethasone switch in castration-resistant prostate
`cancer patients treated with abiraterone pre- and post-docetaxel.
`
`Meeting:
`2016 Genitourinary Cancers Symposium
`
`Category:
`Genitourinary Cancer
`
`Subcategory:
`Prostate Cancer - Advanced Disease
`
`Session Type and Session Title:
`Poster Session B: Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, and Testicular Cancers
`
`Abstract Number:
`327
`
`Citation:
`J Clin Oncol 34, 2016 (suppl 2S; abstr 327)
`
`Author(s):
`Nuria Romero-Laorden, Elena Castro, Rebeca Lozano, M Isabel Sáez, Jeannette Valero, Floortje Van de Poll, M
`Paz Nombela, Juan Francisco Rodriguez-Moreno, A. Montesa, Gala Grau, Leticia Rivera, David Olmos;
`Spanish National Cancer Research Center, Madrid, Spain; Spanish National Cancer Research Centre, Madrid,
`Spain; IBSAL, Servicio Oncología Hospital Universitario de Salamanca, Salamanca, Spain; CNIO-IBIMA
`Genitorurinary Cancer Clinical Research Unit, Hospitales Universitarios Virgen de la Victoria & Regional de
`Málaga, Malaga, Spain; Clara Campal Comprehensive Cancer Center, HM Sanchinarro, Madrid, Spain; Prostate
`Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain
`
`Background: Abiraterone acetate (AA) administered with prednisone (P) to reduce mineralocorticoid-related
`adverse events improves survival in CRPC with a favourable tolerance profile. However, in the phase I/II of AA
`without steroids, dexamethasone 0,5mg/day was added after biochemical progression reaching a 25% of PSA
`decline. Lorente et al (BJC, 2014) showed durable biochemical responses in 40% of cases treated with AA and
`steroid switch in the post-docetaxel setting. We hypothesize that P to D switch in patients with biochemical
`progression to AA+P would lead to secondary responses also in the pre-docetaxel setting. Methods: Change of
`P 5mg/12h to D 0.5mg/24h was prospectively tested in clinically stable CRPC with biochemical progression ( >
`25% PSA rise over nadir, confirmed in a second determination) and/or limited radiological progression ( < 3
`new bone/lymphatic metastasis, non-bulky), after ³12 weeks of AA+P. PSA was monitored q4wks. CT- & bone-
`scans were performed every 12-16 weeks. Biochemical and radiological responses were evaluated by PSAWG2
`and RECIST criteria. Survival outcomes were calculated using Kaplan-Meier method. Results: 18 patients were
`included (11 pre- & 7 post-docetaxel). Median age 72 (60-85); visceral, bone and/or lymph metastasis were
`present in 17%, 83% and 50% of patients. Median PSA at AA+P and AA+D commencement was 81 ng/ml and
`100ng/ml, respectively. Biochemical response was observed in 83% of patients: 56% with a PSA decrease ≥
`30%, and 28% with PSA decrease ≥ 50%. Median biochemical progression-free survival (bPFS) with AA+P
`was 5.7 months (CI95% 2.9-9.1) and 3.8m (CI95% 1.4-6.5) in the pre- and post-docetaxel setting, respectively.
`Median bPFS with AA+D was 5.4m (1.2-8.8) and 2.5 (CI95% 1.1-2.9) in the pre- and post-docetaxel settings.
`Two radiological partial responses were observed with AA+D. Conclusions: Clinically stable patients with
`Amerigen Exhibit 1130
`Amerigen v. Janssen IPR2016-00286
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`http://meetinglibrary.asco.org/print/2132571
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`11/14/2016
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`157911-172
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`limited disease progression after AA+P may benefit from steroid switch in both the pre- and post-docetaxel
`settings.
`
`Source URL: http://meetinglibrary.asco.org/content/157911-172
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`http://meetinglibrary.asco.org/print/2132571
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