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Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer.

Publication ,  Journal Article
Sonpavde, G; Matveev, V; Burke, JM; Caton, JR; Fleming, MT; Hutson, TE; Galsky, MD; Berry, WR; Karlov, P; Holmlund, JT; Wood, BA; Brookes, M ...
Published in: Annals of oncology : official journal of the European Society for Medical Oncology
July 2012

AT-101 (A), a small molecule oral inhibitor of the Bcl-2 family, has activity alone and in combination with docetaxel (Taxotere) and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC). A randomized, double-blind, placebo-controlled phase II trial compared DP combined with either AT-101 (A) or placebo in chemonaive mCRPC.Men with progressive mCRPC despite androgen deprivation were eligible and randomized 1:1. Patients received docetaxel (75 mg/m2 day 1) and prednisone 5 mg orally twice daily every 21 days with either AT-101 (40 mg) or placebo twice daily orally on days 1-3. The primary end point was overall survival (OS).Two hundred and twenty-one patients were randomly assigned. Median OS for AT-101 plus docetaxel-prednisone (ADP) and placebo-DP was 18.1 versus 17.8 months [hazard ratio (HR) 1.07, 95% confidence interval 0.72-1.55, P=0.63]. Secondary end points were also not statistically different. Grade 3/4 toxic effects for ADP versus placebo-DP were cardiac events (5% versus 2%), lymphopenia (23% versus 16%), neutropenia (47% versus 40%), ileus (2% versus 0%) and pulmonary embolism (6% versus 2%). In a subgroup of high-risk mCRPC (n=34), outcomes appeared to favor ADP (median OS 19 versus 14 months).AT-101 was tolerable but did not extend OS when combined with DP in mCRPC; a potential benefit was observed in high-risk patients.

Published In

Annals of oncology : official journal of the European Society for Medical Oncology

DOI

EISSN

1569-8041

ISSN

0923-7534

Publication Date

July 2012

Volume

23

Issue

7

Start / End Page

1803 / 1808

Related Subject Headings

  • Treatment Outcome
  • Taxoids
  • Proto-Oncogene Proteins c-bcl-2
  • Prostatic Neoplasms
  • Prednisone
  • Placebos
  • Orchiectomy
  • Oncology & Carcinogenesis
  • Neoplastic Cells, Circulating
  • Middle Aged
 

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Sonpavde, G., Matveev, V., Burke, J. M., Caton, J. R., Fleming, M. T., Hutson, T. E., … Leopold, L. (2012). Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer. Annals of Oncology : Official Journal of the European Society for Medical Oncology, 23(7), 1803–1808. https://doi.org/10.1093/annonc/mdr555
Sonpavde, G., V. Matveev, J. M. Burke, J. R. Caton, M. T. Fleming, T. E. Hutson, M. D. Galsky, et al. “Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer.Annals of Oncology : Official Journal of the European Society for Medical Oncology 23, no. 7 (July 2012): 1803–8. https://doi.org/10.1093/annonc/mdr555.
Sonpavde G, Matveev V, Burke JM, Caton JR, Fleming MT, Hutson TE, et al. Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer. Annals of oncology : official journal of the European Society for Medical Oncology. 2012 Jul;23(7):1803–8.
Sonpavde, G., et al. “Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer.Annals of Oncology : Official Journal of the European Society for Medical Oncology, vol. 23, no. 7, July 2012, pp. 1803–08. Epmc, doi:10.1093/annonc/mdr555.
Sonpavde G, Matveev V, Burke JM, Caton JR, Fleming MT, Hutson TE, Galsky MD, Berry WR, Karlov P, Holmlund JT, Wood BA, Brookes M, Leopold L. Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer. Annals of oncology : official journal of the European Society for Medical Oncology. 2012 Jul;23(7):1803–1808.
Journal cover image

Published In

Annals of oncology : official journal of the European Society for Medical Oncology

DOI

EISSN

1569-8041

ISSN

0923-7534

Publication Date

July 2012

Volume

23

Issue

7

Start / End Page

1803 / 1808

Related Subject Headings

  • Treatment Outcome
  • Taxoids
  • Proto-Oncogene Proteins c-bcl-2
  • Prostatic Neoplasms
  • Prednisone
  • Placebos
  • Orchiectomy
  • Oncology & Carcinogenesis
  • Neoplastic Cells, Circulating
  • Middle Aged