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Poster display

2021 - E2809. Androgen receptor (AR) modulation by bicalutamide (Bic) and MK-2206 (MK) in prostate cancer (PC) patients (pts) with rising PSA at high risk of progression after local treatment (tx)


09 Oct 2016


Poster display


Anna Ferrari


Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372


A. Ferrari1, Y. Chen2, G. Hudes3, M. Carducci4, E.S. Antonarakis5, N.M. Hahn6, H. Ma7, Y. Wong3, T. Mayer1, R.A. Somer8, B. Carthon9, R. Dipaola1

Author affiliations

  • 1 Medical Oncology, The Cancer Institute of New Jersey, 08903 - New Brunswick/US
  • 2 Biostastictics, Dana-Farber Cancer Institute, 02446 - Boston/US
  • 3 Medical Oncology, Fox Chase Cancer Center, 19111 - Philadelphia/US
  • 4 Oncology, Johns Hopkins University, 21231 - Baltimore/US
  • 5 Medical Oncology, Johns Hopkins University, 21231 - Baltimore/US
  • 6 Cancer Pavilion, Johns Hopkins Medical Institution, 46202 - Indianapolis/US
  • 7 Cancer Center, New York University, 10016 - New York/US
  • 8 Medical Oncology, Cooper University Hospital, 08043 - Camden/US
  • 9 Hematology Oncology, Emory University Winship Cancer Institute, 30322 - Atlanta/US


Abstract 2021


Men with a PSA doubling time (PSADT)


108 PC pts with PSA >2 ng/mL, PSADT 


A/B, accrued 54/54, started tx 50/53, Tx arm characteristics were balanced according to age, PS, Gleason score, local tx type, testosterone, mPSA and PSADT. Tox Grade (G: Arm, pts): G4: B, 2 (embolism, hyperglycemia). G3: A, 1 (LFTs); B, 32 (rash 20, hyperglycemia 5, low lymphs 5, hypertension, 4). At 30 mo follow-up 3 died, Arm A vs B pts: 14 (26%) vs 7 (13%) started Bic early; 8 (15%, none for AE's) vs 21 (39%; 14 for AE's) stopped tx before 11 cy; at 11 and 18 cy, 42 (78%) and 31 (57%) vs 32 (59%) and 24 (44%) initiated planned tx and 4 and 6 vs 5 and 6 ( %) discontinued tx due to progression. Intent to treat analysis showed no effect of MK on PSA decline after 11cy (p = 0.39). An exploratory analysis of pts who completed or progressed on the planned tx at 11 and 18 cy: A, 48 (89%) and 41 (71%) vs B, 36 (67%) and 31 (57%). Excluding the disproportionate number of B dropouts due to MK Tox while continuing Bic, B showed a trend towards a higher fraction of pts achieving PSA


In overall PC pts with a rapidly rising PSA at recurrence, adding MK for variable number of cy to ongoing Bic had no beneficial effect at 11mo. Considering only pts who received MK+ Bic as planned, however, some positively interactive effect was suggested, raising the possibility that a subset of genetically heterogeneous PC might be benefited by this combination.

Clinical trial identification

National Cancer Institute NCT01251861 Study first Received: 12/01/2010

Legal entity responsible for the study



National Cancer Institute, Cancer Treatment Evaluation Program


All authors have declared no conflicts of interest.

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