Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

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)

Date

09 Oct 2016

Session

Poster display

Presenters

Anna Ferrari

Citation

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

Authors

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
More

Resources

Background

Men with a PSA doubling time (PSADT)

Methods

108 PC pts with PSA >2 ng/mL, PSADT 

Results

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

Conclusions

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

N/A

Funding

National Cancer Institute, Cancer Treatment Evaluation Program

Disclosure

All authors have declared no conflicts of interest.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings