Bicalutamide and flutamide, each in combination with luteinizing hormone-releasing hormone analogs, in advanced prostate cancer: Exploratory analysis of impact of extent of disease by bone scan on outcome

Mark S. Soloway, Paul F. Schellhammer, Rooholloh Sharifi, Norman L. Block, Peter M. Venner, Anthony Patterson, Michael F. Sarosdy, Nicholas J. Vogelzang, Julie Schellenger, Geert J.C.M. Kolvenbag

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objectives: We performed an exploratory analysis to determine whether there was a difference between two antiandrogen-plus-luteinizing hormone-releasing hormone analogs (LHRHas) combinations in patients with minimal or extensive disease. Materials and Methods: Data from a prospective, randomized, double-blind study with a median follow-up of 160 weeks were used to perform an exploratory analysis of outcome with 2 combined androgen blockade regimens in 813 advanced prostate cancer patients based on disease status at entry (minimal or extensive disease). A total of 404 patients received bicalutamide plus LHRHa, and 409 patients received flutamide plus LHRHa. Patients were grouped prospectively by 'extent of disease' as determined by bone scan: minimal disease was defined as zero to five lesions, while extensive disease was defined as greater than or equal to six lesions. Patients with no lesions on bone scan (0 lesions) had to have at least one measurable nonskeletal metastasis. Results: Patients with minimal disease receiving bicalutamide plus LHRHa demonstrated a trend to longer survival as reflected by a hazard ratio (HR) of 0.79 (95% confidence interval 0.59-1.07), but this was not statistically significant. In the extensive disease group, the effects of bicalutamide plus LHRHa and flutamide plus LHRHa on disease progression and survival were similar (HR 0.96 and 0.90, respectively). Conclusions: Our results are consistent with previously published data demonstrating that patients with stage D2 prostate cancer and minimal disease have a better outcome than patients with extensive disease. In the patients with minimal disease per bone scan, there was a trend toward a benefit for bicalutamide plus LHRHa compared with flutamide plus LHRHa in terms of survival, but not in terms of disease progression.

Original languageEnglish (US)
Pages (from-to)137-145
Number of pages9
JournalProstate Journal
Volume2
Issue number3
DOIs
StatePublished - Aug 26 2000

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Flutamide
Bone Diseases
Gonadotropin-Releasing Hormone
Prostatic Neoplasms
Survival
Disease Progression
bicalutamide
Bone and Bones
Androgen Antagonists
Double-Blind Method
Androgens
Confidence Intervals
Neoplasm Metastasis

All Science Journal Classification (ASJC) codes

  • Oncology
  • Urology
  • Cancer Research

Cite this

Bicalutamide and flutamide, each in combination with luteinizing hormone-releasing hormone analogs, in advanced prostate cancer : Exploratory analysis of impact of extent of disease by bone scan on outcome. / Soloway, Mark S.; Schellhammer, Paul F.; Sharifi, Rooholloh; Block, Norman L.; Venner, Peter M.; Patterson, Anthony; Sarosdy, Michael F.; Vogelzang, Nicholas J.; Schellenger, Julie; Kolvenbag, Geert J.C.M.

In: Prostate Journal, Vol. 2, No. 3, 26.08.2000, p. 137-145.

Research output: Contribution to journalArticle

Soloway, Mark S. ; Schellhammer, Paul F. ; Sharifi, Rooholloh ; Block, Norman L. ; Venner, Peter M. ; Patterson, Anthony ; Sarosdy, Michael F. ; Vogelzang, Nicholas J. ; Schellenger, Julie ; Kolvenbag, Geert J.C.M. / Bicalutamide and flutamide, each in combination with luteinizing hormone-releasing hormone analogs, in advanced prostate cancer : Exploratory analysis of impact of extent of disease by bone scan on outcome. In: Prostate Journal. 2000 ; Vol. 2, No. 3. pp. 137-145.
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abstract = "Objectives: We performed an exploratory analysis to determine whether there was a difference between two antiandrogen-plus-luteinizing hormone-releasing hormone analogs (LHRHas) combinations in patients with minimal or extensive disease. Materials and Methods: Data from a prospective, randomized, double-blind study with a median follow-up of 160 weeks were used to perform an exploratory analysis of outcome with 2 combined androgen blockade regimens in 813 advanced prostate cancer patients based on disease status at entry (minimal or extensive disease). A total of 404 patients received bicalutamide plus LHRHa, and 409 patients received flutamide plus LHRHa. Patients were grouped prospectively by 'extent of disease' as determined by bone scan: minimal disease was defined as zero to five lesions, while extensive disease was defined as greater than or equal to six lesions. Patients with no lesions on bone scan (0 lesions) had to have at least one measurable nonskeletal metastasis. Results: Patients with minimal disease receiving bicalutamide plus LHRHa demonstrated a trend to longer survival as reflected by a hazard ratio (HR) of 0.79 (95{\%} confidence interval 0.59-1.07), but this was not statistically significant. In the extensive disease group, the effects of bicalutamide plus LHRHa and flutamide plus LHRHa on disease progression and survival were similar (HR 0.96 and 0.90, respectively). Conclusions: Our results are consistent with previously published data demonstrating that patients with stage D2 prostate cancer and minimal disease have a better outcome than patients with extensive disease. In the patients with minimal disease per bone scan, there was a trend toward a benefit for bicalutamide plus LHRHa compared with flutamide plus LHRHa in terms of survival, but not in terms of disease progression.",
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T1 - Bicalutamide and flutamide, each in combination with luteinizing hormone-releasing hormone analogs, in advanced prostate cancer

T2 - Exploratory analysis of impact of extent of disease by bone scan on outcome

AU - Soloway, Mark S.

AU - Schellhammer, Paul F.

AU - Sharifi, Rooholloh

AU - Block, Norman L.

AU - Venner, Peter M.

AU - Patterson, Anthony

AU - Sarosdy, Michael F.

AU - Vogelzang, Nicholas J.

AU - Schellenger, Julie

AU - Kolvenbag, Geert J.C.M.

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N2 - Objectives: We performed an exploratory analysis to determine whether there was a difference between two antiandrogen-plus-luteinizing hormone-releasing hormone analogs (LHRHas) combinations in patients with minimal or extensive disease. Materials and Methods: Data from a prospective, randomized, double-blind study with a median follow-up of 160 weeks were used to perform an exploratory analysis of outcome with 2 combined androgen blockade regimens in 813 advanced prostate cancer patients based on disease status at entry (minimal or extensive disease). A total of 404 patients received bicalutamide plus LHRHa, and 409 patients received flutamide plus LHRHa. Patients were grouped prospectively by 'extent of disease' as determined by bone scan: minimal disease was defined as zero to five lesions, while extensive disease was defined as greater than or equal to six lesions. Patients with no lesions on bone scan (0 lesions) had to have at least one measurable nonskeletal metastasis. Results: Patients with minimal disease receiving bicalutamide plus LHRHa demonstrated a trend to longer survival as reflected by a hazard ratio (HR) of 0.79 (95% confidence interval 0.59-1.07), but this was not statistically significant. In the extensive disease group, the effects of bicalutamide plus LHRHa and flutamide plus LHRHa on disease progression and survival were similar (HR 0.96 and 0.90, respectively). Conclusions: Our results are consistent with previously published data demonstrating that patients with stage D2 prostate cancer and minimal disease have a better outcome than patients with extensive disease. In the patients with minimal disease per bone scan, there was a trend toward a benefit for bicalutamide plus LHRHa compared with flutamide plus LHRHa in terms of survival, but not in terms of disease progression.

AB - Objectives: We performed an exploratory analysis to determine whether there was a difference between two antiandrogen-plus-luteinizing hormone-releasing hormone analogs (LHRHas) combinations in patients with minimal or extensive disease. Materials and Methods: Data from a prospective, randomized, double-blind study with a median follow-up of 160 weeks were used to perform an exploratory analysis of outcome with 2 combined androgen blockade regimens in 813 advanced prostate cancer patients based on disease status at entry (minimal or extensive disease). A total of 404 patients received bicalutamide plus LHRHa, and 409 patients received flutamide plus LHRHa. Patients were grouped prospectively by 'extent of disease' as determined by bone scan: minimal disease was defined as zero to five lesions, while extensive disease was defined as greater than or equal to six lesions. Patients with no lesions on bone scan (0 lesions) had to have at least one measurable nonskeletal metastasis. Results: Patients with minimal disease receiving bicalutamide plus LHRHa demonstrated a trend to longer survival as reflected by a hazard ratio (HR) of 0.79 (95% confidence interval 0.59-1.07), but this was not statistically significant. In the extensive disease group, the effects of bicalutamide plus LHRHa and flutamide plus LHRHa on disease progression and survival were similar (HR 0.96 and 0.90, respectively). Conclusions: Our results are consistent with previously published data demonstrating that patients with stage D2 prostate cancer and minimal disease have a better outcome than patients with extensive disease. In the patients with minimal disease per bone scan, there was a trend toward a benefit for bicalutamide plus LHRHa compared with flutamide plus LHRHa in terms of survival, but not in terms of disease progression.

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