A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer

C. J. Sweeney, F. J. Monaco, S. H. Jung, M. J. Wasielewski, J. Picus, R. H. Ansari, W. M. Dugan, Lawrence Einhorn

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background: The purpose was to evaluate the combined anti-microtubular regimen of vinorelbine and estramustine phosphate (EMP) in hormone refractory prostate cancer. Patients and methods: Weekly vinorelbine 20 mg/m2 (or 15 mg/m2 if a history of prior pelvic radiotherapy) was combined with EMP at 280 mg orally tds for 3 days (the day before, the day of and the day after vinorelbine infusion). After 8 weeks of therapy the combination was given every other week. Results: From February 1998 to February 1999, 23 men were enrolled with a median age of 69 years (range 50-83 years). The median prostate-specific antigen (PSA) at entry was 160 ng/ml (range 0-802 ng/ml). A median of 13 weeks of therapy was administered and the median follow-up was 14.8 months. Eleven patients (48%) had lower extremity edema requiring diuretic therapy, two (9%) had grade 2 granulocytopenia and four patients [17%; 95% confidence interval (CI) 5% to 39%] had a thrombo-embolic episode. There was no treatment-related mortality. Fifteen of 21 patients (71%; 95% CI 49% to 89%) had at least a 50% decrease in the PSA for at least 2 months with a median time to serologic progression of 3.5 months (range 0.75-10.5 months). One of eight patients (12.5%; 95% CI 0% to 53%) with measurable disease had a confirmed partial response. The estimated median survival was 15.1 months and the actual one year overall survival was 71% (95% CI 51% to 88%). Conclusions: Weekly vinorelbine with short course oral EMP is an active regimen as evaluated by rate of PSA response, time to progression and median survival. However, the toxicities of EMP, even when given as a short course, are still problematic.

Original languageEnglish
Pages (from-to)435-440
Number of pages6
JournalAnnals of Oncology
Volume13
Issue number3
DOIs
StatePublished - 2002

Fingerprint

Estramustine
Prostatic Neoplasms
Phosphates
Hormones
Prostate-Specific Antigen
Confidence Intervals
Survival
Agranulocytosis
Therapeutics
Diuretics
Reaction Time
Lower Extremity
Edema
Radiotherapy
vinorelbine
Mortality

Keywords

  • Estramustine
  • Hormone refractory prostate cancer
  • Vinorelbine

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer. / Sweeney, C. J.; Monaco, F. J.; Jung, S. H.; Wasielewski, M. J.; Picus, J.; Ansari, R. H.; Dugan, W. M.; Einhorn, Lawrence.

In: Annals of Oncology, Vol. 13, No. 3, 2002, p. 435-440.

Research output: Contribution to journalArticle

Sweeney, CJ, Monaco, FJ, Jung, SH, Wasielewski, MJ, Picus, J, Ansari, RH, Dugan, WM & Einhorn, L 2002, 'A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer', Annals of Oncology, vol. 13, no. 3, pp. 435-440. https://doi.org/10.1093/annonc/mdf029
Sweeney, C. J. ; Monaco, F. J. ; Jung, S. H. ; Wasielewski, M. J. ; Picus, J. ; Ansari, R. H. ; Dugan, W. M. ; Einhorn, Lawrence. / A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer. In: Annals of Oncology. 2002 ; Vol. 13, No. 3. pp. 435-440.
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abstract = "Background: The purpose was to evaluate the combined anti-microtubular regimen of vinorelbine and estramustine phosphate (EMP) in hormone refractory prostate cancer. Patients and methods: Weekly vinorelbine 20 mg/m2 (or 15 mg/m2 if a history of prior pelvic radiotherapy) was combined with EMP at 280 mg orally tds for 3 days (the day before, the day of and the day after vinorelbine infusion). After 8 weeks of therapy the combination was given every other week. Results: From February 1998 to February 1999, 23 men were enrolled with a median age of 69 years (range 50-83 years). The median prostate-specific antigen (PSA) at entry was 160 ng/ml (range 0-802 ng/ml). A median of 13 weeks of therapy was administered and the median follow-up was 14.8 months. Eleven patients (48{\%}) had lower extremity edema requiring diuretic therapy, two (9{\%}) had grade 2 granulocytopenia and four patients [17{\%}; 95{\%} confidence interval (CI) 5{\%} to 39{\%}] had a thrombo-embolic episode. There was no treatment-related mortality. Fifteen of 21 patients (71{\%}; 95{\%} CI 49{\%} to 89{\%}) had at least a 50{\%} decrease in the PSA for at least 2 months with a median time to serologic progression of 3.5 months (range 0.75-10.5 months). One of eight patients (12.5{\%}; 95{\%} CI 0{\%} to 53{\%}) with measurable disease had a confirmed partial response. The estimated median survival was 15.1 months and the actual one year overall survival was 71{\%} (95{\%} CI 51{\%} to 88{\%}). Conclusions: Weekly vinorelbine with short course oral EMP is an active regimen as evaluated by rate of PSA response, time to progression and median survival. However, the toxicities of EMP, even when given as a short course, are still problematic.",
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T1 - A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer

AU - Sweeney, C. J.

AU - Monaco, F. J.

AU - Jung, S. H.

AU - Wasielewski, M. J.

AU - Picus, J.

AU - Ansari, R. H.

AU - Dugan, W. M.

AU - Einhorn, Lawrence

PY - 2002

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N2 - Background: The purpose was to evaluate the combined anti-microtubular regimen of vinorelbine and estramustine phosphate (EMP) in hormone refractory prostate cancer. Patients and methods: Weekly vinorelbine 20 mg/m2 (or 15 mg/m2 if a history of prior pelvic radiotherapy) was combined with EMP at 280 mg orally tds for 3 days (the day before, the day of and the day after vinorelbine infusion). After 8 weeks of therapy the combination was given every other week. Results: From February 1998 to February 1999, 23 men were enrolled with a median age of 69 years (range 50-83 years). The median prostate-specific antigen (PSA) at entry was 160 ng/ml (range 0-802 ng/ml). A median of 13 weeks of therapy was administered and the median follow-up was 14.8 months. Eleven patients (48%) had lower extremity edema requiring diuretic therapy, two (9%) had grade 2 granulocytopenia and four patients [17%; 95% confidence interval (CI) 5% to 39%] had a thrombo-embolic episode. There was no treatment-related mortality. Fifteen of 21 patients (71%; 95% CI 49% to 89%) had at least a 50% decrease in the PSA for at least 2 months with a median time to serologic progression of 3.5 months (range 0.75-10.5 months). One of eight patients (12.5%; 95% CI 0% to 53%) with measurable disease had a confirmed partial response. The estimated median survival was 15.1 months and the actual one year overall survival was 71% (95% CI 51% to 88%). Conclusions: Weekly vinorelbine with short course oral EMP is an active regimen as evaluated by rate of PSA response, time to progression and median survival. However, the toxicities of EMP, even when given as a short course, are still problematic.

AB - Background: The purpose was to evaluate the combined anti-microtubular regimen of vinorelbine and estramustine phosphate (EMP) in hormone refractory prostate cancer. Patients and methods: Weekly vinorelbine 20 mg/m2 (or 15 mg/m2 if a history of prior pelvic radiotherapy) was combined with EMP at 280 mg orally tds for 3 days (the day before, the day of and the day after vinorelbine infusion). After 8 weeks of therapy the combination was given every other week. Results: From February 1998 to February 1999, 23 men were enrolled with a median age of 69 years (range 50-83 years). The median prostate-specific antigen (PSA) at entry was 160 ng/ml (range 0-802 ng/ml). A median of 13 weeks of therapy was administered and the median follow-up was 14.8 months. Eleven patients (48%) had lower extremity edema requiring diuretic therapy, two (9%) had grade 2 granulocytopenia and four patients [17%; 95% confidence interval (CI) 5% to 39%] had a thrombo-embolic episode. There was no treatment-related mortality. Fifteen of 21 patients (71%; 95% CI 49% to 89%) had at least a 50% decrease in the PSA for at least 2 months with a median time to serologic progression of 3.5 months (range 0.75-10.5 months). One of eight patients (12.5%; 95% CI 0% to 53%) with measurable disease had a confirmed partial response. The estimated median survival was 15.1 months and the actual one year overall survival was 71% (95% CI 51% to 88%). Conclusions: Weekly vinorelbine with short course oral EMP is an active regimen as evaluated by rate of PSA response, time to progression and median survival. However, the toxicities of EMP, even when given as a short course, are still problematic.

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