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Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial.

Publication ,  Journal Article
Zurita, AJ; George, DJ; Shore, ND; Liu, G; Wilding, G; Hutson, TE; Kozloff, M; Mathew, P; Harmon, CS; Wang, SL; Chen, I; Chow Maneval, E ...
Published in: Ann Oncol
March 2012

BACKGROUND: This phase 1/2 study assessed sunitinib combined with docetaxel (Taxotere) and prednisone in chemotherapy-naive metastatic, castration-resistant prostate cancer (mCRPC) patients. PATIENTS AND METHODS: To determine the recommended phase 2 dose (RP2D), 25 patients in four dose escalation cohorts received 3-week cycles of sunitinib (2 weeks on, 1 week off), docetaxel and prednisone, preceded by a 4-week sunitinib 50 mg/day lead in. RP2D was evaluated in 55 additional patients. The primary end point was prostate-specific antigen (PSA) response rate. RESULTS: One phase 1 dose-limiting toxicity occurred (grade 3 hyponatremia). The RP2D was sunitinib 37.5 mg/day, docetaxel 75 mg/m2 and prednisone 5 mg b.i.d. During phase 2, confirmed PSA responses occurred in 31 patients [56.4% (95% confidence interval 42.3-69.7)]. Median time to PSA progression was 9.8 months. Forty-one patients (75%) were treated >3 months, 12 (22%) completed the study (16 cycles) and 43 (78%) discontinued (36% for disease progression and 27% adverse events). The most frequent treatment-related grade 3/4 adverse events were neutropenia (53%; 15% febrile) and fatigue/asthenia (16%). Among 33 assessable patients, 14 (42.4%) had confirmed partial response. Median progression-free and overall survivals were 12.6 and 21.7 months, respectively. CONCLUSION: This combination was moderately well tolerated, with promising response rate and survival benefit, justifying further investigation in mCRPC.

Duke Scholars

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

March 2012

Volume

23

Issue

3

Start / End Page

688 / 694

Location

England

Related Subject Headings

  • Taxoids
  • Sunitinib
  • Pyrroles
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Prednisone
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Middle Aged
 

Citation

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Zurita, A. J., George, D. J., Shore, N. D., Liu, G., Wilding, G., Hutson, T. E., … Logothetis, C. J. (2012). Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial. Annals of Oncology : Official Journal of the European Society for Medical Oncology, 23(3), 688–694. https://doi.org/10.1093/annonc/mdr349
Zurita, A. J., D. J. George, N. D. Shore, G. Liu, G. Wilding, T. E. Hutson, M. Kozloff, et al. “Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial.Annals of Oncology : Official Journal of the European Society for Medical Oncology 23, no. 3 (March 2012): 688–94. https://doi.org/10.1093/annonc/mdr349.
Zurita AJ, George DJ, Shore ND, Liu G, Wilding G, Hutson TE, et al. Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial. Annals of oncology : official journal of the European Society for Medical Oncology. 2012 Mar;23(3):688–94.
Zurita, A. J., et al. “Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial.Annals of Oncology : Official Journal of the European Society for Medical Oncology, vol. 23, no. 3, Mar. 2012, pp. 688–94. Epmc, doi:10.1093/annonc/mdr349.
Zurita AJ, George DJ, Shore ND, Liu G, Wilding G, Hutson TE, Kozloff M, Mathew P, Harmon CS, Wang SL, Chen I, Chow Maneval E, Logothetis CJ. Sunitinib in combination with docetaxel and prednisone in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer: a phase 1/2 clinical trial. Annals of oncology : official journal of the European Society for Medical Oncology. 2012 Mar;23(3):688–694.
Journal cover image

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

March 2012

Volume

23

Issue

3

Start / End Page

688 / 694

Location

England

Related Subject Headings

  • Taxoids
  • Sunitinib
  • Pyrroles
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Prednisone
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Middle Aged