Randomized Phase III Study of I.V. Vinorelbine plus hormonotherapy versus hormonotherapy alone in hormone refractory prostate cancer (HRPC)

Reviewer: Walter Sall, MD
Last Modified: May 31, 2003

Presenter: R.P Abrett
Presenter's Affiliation: Groote Schuur Hospital, Cape Town, South Africa
Type of Session: Scientific


  • Vinorelbine has been shown to be active in hormone refractory prostate cancer.
  • Controversy exists regarding the proper palliative management of hormone refractory patients who have failed first line hormonal therapy
  • This trial intended to determine whether the addition of vinorelbine, a cytotoxic agent, provided benefit when added to second line hormone therapy.

Materials and Methods

  • This is a prospective randomized trial of 414 patients randomized to vinorelbine (VRL)30mg/m2, days 1 and 8 every three weeks with hydrocortisone 40mg/day +/- aminogluthimide or hydrocortisone 40mg/day +/- aminoglutethimide alone.
  • Patients randomized from 1997-2001.
  • Further chemotherapy was allowed after progression.
  • Eligible patients had progressive metastatic disease after 1st line hormone therapy.
  • Primary Endpoint: progression free survival.
  • Seconday endpoints: PSA response, pain response, change in KPS and overall survival


  • Patient characteristics and prognostic factors were similar between the two groups
  • 6 month progression free survival was 34.4% with VRL vs. 23.7% without. (P=0.055)
  • No Overall Survival difference.
  • PFS survival was better without aminoglutethimide.
  • Decreased pain was seen in 30.6% of patients treated with VRL vs. 19.2% treated without. (p=0.008)
  • The only significant toxicity difference was the grade IV neutropenia seen in 6.5% of VRL treated patients.

Author's Conclusions

  • Progression free survival is significantly improved witht the addition of VRL.
  • PSA response is significantly better with VRL.
  • VRL was well tolerated with minimal toxicity.
  • VRL is active and well tolerated in hormone refractory prostae cancer.

Clinical/Scientific Implications

    Controversy exists regarding the utility of cytotoxic chemotherapy agents in the treatment of metastatic hormone refractory prostate cancer. The absence of data showing a survival benefit has called into question the use of a therapy with the potential for significant toxicity in this elderly population. These data support the use of vinorelbine in hormone refractory prostate cancer. Once again, no OS difference is seen. However, the patients did appear to achieve a significant palliative benefit as seen in improved pain and RFS with the addition of VRL. Little toxicity was seen. VRL may be considered another option in the management of this difficult to treat patient population.

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