Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone

Donna L. Berry, Carol M. Moinpour, Caroline S. Jiang, Donna Pauler Ankerst, Daniel P. Petrylak, Lynne V. Vinson, Primo N Lara, Sharon Jones, Mary E. Taplin, Patrick A. Burch, Maha H A Hussain, E. David Crawford

Research output: Contribution to journalArticle

73 Citations (Scopus)

Abstract

Purpose: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms. Methods: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions. Results: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms. Conclusion: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.

Original languageEnglish (US)
Pages (from-to)2828-2835
Number of pages8
JournalJournal of Clinical Oncology
Volume24
Issue number18
DOIs
StatePublished - Jun 20 2006
Externally publishedYes

Fingerprint

docetaxel
Estramustine
Mitoxantrone
Prednisone
Prostatic Neoplasms
Quality of Life
Pain
Survival
Intention to Treat Analysis
Pain Measurement
Prostate-Specific Antigen
Androgens
Analgesics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Quality of life and pain in advanced stage prostate cancer : Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. / Berry, Donna L.; Moinpour, Carol M.; Jiang, Caroline S.; Ankerst, Donna Pauler; Petrylak, Daniel P.; Vinson, Lynne V.; Lara, Primo N; Jones, Sharon; Taplin, Mary E.; Burch, Patrick A.; Hussain, Maha H A; Crawford, E. David.

In: Journal of Clinical Oncology, Vol. 24, No. 18, 20.06.2006, p. 2828-2835.

Research output: Contribution to journalArticle

Berry, DL, Moinpour, CM, Jiang, CS, Ankerst, DP, Petrylak, DP, Vinson, LV, Lara, PN, Jones, S, Taplin, ME, Burch, PA, Hussain, MHA & Crawford, ED 2006, 'Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone', Journal of Clinical Oncology, vol. 24, no. 18, pp. 2828-2835. https://doi.org/10.1200/JCO.2005.04.8207
Berry, Donna L. ; Moinpour, Carol M. ; Jiang, Caroline S. ; Ankerst, Donna Pauler ; Petrylak, Daniel P. ; Vinson, Lynne V. ; Lara, Primo N ; Jones, Sharon ; Taplin, Mary E. ; Burch, Patrick A. ; Hussain, Maha H A ; Crawford, E. David. / Quality of life and pain in advanced stage prostate cancer : Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 18. pp. 2828-2835.
@article{be36ec5f1b7b49d7b76b4174bc3b65dc,
title = "Quality of life and pain in advanced stage prostate cancer: Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone",
abstract = "Purpose: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms. Methods: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions. Results: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms. Conclusion: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.",
author = "Berry, {Donna L.} and Moinpour, {Carol M.} and Jiang, {Caroline S.} and Ankerst, {Donna Pauler} and Petrylak, {Daniel P.} and Vinson, {Lynne V.} and Lara, {Primo N} and Sharon Jones and Taplin, {Mary E.} and Burch, {Patrick A.} and Hussain, {Maha H A} and Crawford, {E. David}",
year = "2006",
month = "6",
day = "20",
doi = "10.1200/JCO.2005.04.8207",
language = "English (US)",
volume = "24",
pages = "2828--2835",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "18",

}

TY - JOUR

T1 - Quality of life and pain in advanced stage prostate cancer

T2 - Results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone

AU - Berry, Donna L.

AU - Moinpour, Carol M.

AU - Jiang, Caroline S.

AU - Ankerst, Donna Pauler

AU - Petrylak, Daniel P.

AU - Vinson, Lynne V.

AU - Lara, Primo N

AU - Jones, Sharon

AU - Taplin, Mary E.

AU - Burch, Patrick A.

AU - Hussain, Maha H A

AU - Crawford, E. David

PY - 2006/6/20

Y1 - 2006/6/20

N2 - Purpose: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms. Methods: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions. Results: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms. Conclusion: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.

AB - Purpose: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms. Methods: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions. Results: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms. Conclusion: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.

UR - http://www.scopus.com/inward/record.url?scp=33745570865&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33745570865&partnerID=8YFLogxK

U2 - 10.1200/JCO.2005.04.8207

DO - 10.1200/JCO.2005.04.8207

M3 - Article

C2 - 16782921

AN - SCOPUS:33745570865

VL - 24

SP - 2828

EP - 2835

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 18

ER -