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Annals of Oncology Advance Access published online on July 24, 2009
Annals of Oncology, doi:10.1093/annonc/mdp323
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Sunitinib malate for metastatic castration-resistant prostate cancer following docetaxel-based chemotherapy

G. Sonpavde1,2,*, P. O. Periman1,3, D. Bernold1,4, D. Weckstein1,5, M. T. Fleming1,6, M. D. Galsky1,7, W. R. Berry1,8, F. Zhan1, K. A. Boehm1, L. Asmar1 and T. E. Hutson1,9

1 US Oncology Research, Inc., Houston, TX
2 Texas Oncology PA, Webster, TX
3 Texas Oncology PA, Amarillo, TX
4 Interlakes Oncology Hematology, Rochester, NY
5 New Hampshire Hematology-Oncology, P.A., Hooksett, NH
6 Virginia Oncology Associates, Hampton, VA
7 Comprehensive Cancer Centers of Nevada, Las Vegas, NV
8 Cancer Centers of North Carolina, Raleigh, NC
9 Baylor Sammons Cancer Center, Dallas, TX, USA

* Correspondence to: Dr G. Sonpavde, Texas Oncology Cancer Center, 501 Medical Center Boulevard, Webster, TX 77598, USA. Tel: +1-281-332-7505; Fax: +1-281-332-8429; E-mail: Guru.Sonpavde{at}USOncology.com

Background: Systemic therapy options are limited for metastatic castration-resistant prostate cancer (CRPC) patients who progress following docetaxel (Taxotere). This phase II trial evaluated sunitinib malate in patients with progressing metastatic CRPC following prior docetaxel.

Patients and methods: Patients with metastatic CRPC progressing following one to two chemotherapy regimens including docetaxel were included. The primary end point was progression-free survival (PFS) per radiographic and clinical evaluations. Oral sunitinib was administered 50 mg/day 4-weeks on followed by 2-weeks off per cycle up to a maximum of eight cycles or until clinical progression or intolerable toxicity.

Results: Thirty-six patients with a median age of 69.5 years were accrued. The median PFS was 19.4 weeks with a 12-week PFS of 75.8%. Four patients (12.1%) had a ≥50% prostate-specific antigen (PSA) decline and seven (21.2%) had a ≥30% PSA decline. Two of 18 patients (11.1%) with measurable disease demonstrated 30% declines by RECIST and eight (44.4%) displayed some shrinkage. A decline in pain score ≥2 points occurred in 13.6% of 22 assessable patients. Drug discontinuation due to toxic effects occurred in 52.8% of patients.

Conclusion: Sunitinib malate demonstrated promising activity in metastatic CRPC progressing after prior docetaxel.

castration-resistant prostate cancer, sunitinib malate

Received for publication January 22, 2009. Revision received April 7, 2009. Accepted for publication May 12, 2009.


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