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Gepubliceerd in: Quality of Life Research 2/2009

01-03-2009

Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial

Auteurs: Carol M. Moinpour, Gary W. Donaldson, Yoshio Nakamura

Gepubliceerd in: Quality of Life Research | Uitgave 2/2009

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Abstract

Purpose

This paper applies the Dynamically Modified Outcomes (DYNAMO) model to a clinical trial of two chemotherapeutic regimens on global health-related quality of life (GHRQL) in hormone-refractory prostate cancer.

Methods

DYNAMO identifies the causal influences operating in a clinical trial and their mediation, moderation, and modulation by uncontrolled variables. The Southwest Oncology Group trial S9916 randomized assignment to mitoxantrone plus prednisone (M + P) versus docetaxel plus estramustine (D + E) treatments. In this application, we examine baseline-adjusted impacts of worst pain (McGill Pain Questionnaire) on GHRQL (EORTC Quality of Life Questionnaire-C30) at 10 weeks.

Results

The average treatment levels of pain did not differ, hence, the average mediated effect of treatment on GHRQL was zero. Nonetheless, M + P reduced the impact (the relational outcome) of pain on GHRQL by 54% relative to D + E. Individual variation in the relational outcome (modulation) was of the same magnitude as the average difference between the groups. Performance status moderated the direct effects of treatment, with D + E being more effective in good, but not poor, performance strata.

Conclusions

The DYNAMO approach comprehensively accounted for treatment effects. Rather than a single average effect, there were three distinct treatment effects: one direct effect for each performance status level and a direct effect on the relationship between pain and GHRQL.
Voetnoten
1
These standard adjustments have no effect on the interpretation of the key features of the model, but merely condition responses on baseline values.
 
2
In this and all statements drawn from Figs. 3 and 4, the conclusions about therapeutic impact pertain to receiving one therapy instead of the other. The attributed causal impacts are relative, not absolute.
 
Literatuur
1.
4.
go back to reference Petrylak, D. P., Tangen, C. M., Hussein, M. H. A., Lara, P. N., Jr., Jones, J. A., Taplin, M. E., et al. (2004). Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. The New England Journal of Medicine, 351(15), 1513–1520. doi: 10.​1056/​NEJMoa041318. PubMedCrossRef Petrylak, D. P., Tangen, C. M., Hussein, M. H. A., Lara, P. N., Jr., Jones, J. A., Taplin, M. E., et al. (2004). Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. The New England Journal of Medicine, 351(15), 1513–1520. doi: 10.​1056/​NEJMoa041318. PubMedCrossRef
5.
go back to reference Berry, D. L., Moinpour, C. M., Jiang, C. S., Ankerst, D. P., Petrylak, D. P., Vinson, L. V., et al. (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, 24(18), 2828–2835. doi: 10.​1200/​JCO.​2005.​04.​8207. PubMedCrossRef Berry, D. L., Moinpour, C. M., Jiang, C. S., Ankerst, D. P., Petrylak, D. P., Vinson, L. V., et al. (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, 24(18), 2828–2835. doi: 10.​1200/​JCO.​2005.​04.​8207. PubMedCrossRef
6.
go back to reference Laird, N. M., & Ware, J. H. (1982). Random-effects models for longitudinal data. Biometrics, 38, 963–974. PubMedCrossRef Laird, N. M., & Ware, J. H. (1982). Random-effects models for longitudinal data. Biometrics, 38, 963–974. PubMedCrossRef
8.
go back to reference Singer, J. D., & Willett, J. B. (2003). Applied longitudinal data analysis: Modeling changes and event occurrence. New York: Oxford University Press. Singer, J. D., & Willett, J. B. (2003). Applied longitudinal data analysis: Modeling changes and event occurrence. New York: Oxford University Press.
9.
go back to reference Kline, R. B. (2005). Principles and practice of structural equation modeling. New York: Guilford Press. Kline, R. B. (2005). Principles and practice of structural equation modeling. New York: Guilford Press.
10.
go back to reference Sinibaldi, V. J., Carducci, M. A., Moore-Cooper, S., Laufer, M., Zahurak, M., & Eisenberger, M. A. (2002). Phase II evaluation of docetaxel plus one-day oral estramustine phosphate in the treatment of patients with androgen independent prostate carcinoma. Cancer, 94(5), 1457–1465. doi: 10.​1002/​cncr.​10350. PubMedCrossRef Sinibaldi, V. J., Carducci, M. A., Moore-Cooper, S., Laufer, M., Zahurak, M., & Eisenberger, M. A. (2002). Phase II evaluation of docetaxel plus one-day oral estramustine phosphate in the treatment of patients with androgen independent prostate carcinoma. Cancer, 94(5), 1457–1465. doi: 10.​1002/​cncr.​10350. PubMedCrossRef
11.
go back to reference Tannock, I. F., Osoba, D., Stockler, M. R., Ernst, D. S., Neville, A. J., Moore, M. J., et al. (1996). Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: A Canadian randomized trial with palliative end points. Journal of Clinical Oncology, 14(6), 1756–1764. PubMed Tannock, I. F., Osoba, D., Stockler, M. R., Ernst, D. S., Neville, A. J., Moore, M. J., et al. (1996). Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: A Canadian randomized trial with palliative end points. Journal of Clinical Oncology, 14(6), 1756–1764. PubMed
13.
go back to reference Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. doi: 10.​1093/​jnci/​85.​5.​365. PubMedCrossRef Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85(5), 365–376. doi: 10.​1093/​jnci/​85.​5.​365. PubMedCrossRef
14.
go back to reference Fayers, P. M., Aaronson, N. K., Bjordal, K., Groenvold, M., Curran, D., Bottomley, A., et al. (2001). EORTC QLQ-C30 scoring manual. Brussels: EORTC. Fayers, P. M., Aaronson, N. K., Bjordal, K., Groenvold, M., Curran, D., Bottomley, A., et al. (2001). EORTC QLQ-C30 scoring manual. Brussels: EORTC.
15.
go back to reference Borghede, G., & Sullivan, M. (1996). Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30. Quality of Life Research, 5, 212–222. doi: 10.​1007/​BF00434743. PubMedCrossRef Borghede, G., & Sullivan, M. (1996). Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30. Quality of Life Research, 5, 212–222. doi: 10.​1007/​BF00434743. PubMedCrossRef
16.
go back to reference Muthén, L. K., & Muthén, B. (1998–2005). Mplus user’s guide. Los Angeles: Muthén & Muthén. Muthén, L. K., & Muthén, B. (1998–2005). Mplus user’s guide. Los Angeles: Muthén & Muthén.
17.
go back to reference Pearl, J. (2000). Causality: Models, reasoning, and inference. Cambridge: Cambridge University Press. Pearl, J. (2000). Causality: Models, reasoning, and inference. Cambridge: Cambridge University Press.
23.
go back to reference Kraemer, H. C., Lowe, K. K., & Kupfer, D. J. (2005). To your health: How to understand what research tells us about risk. New York: Oxford University Press. Kraemer, H. C., Lowe, K. K., & Kupfer, D. J. (2005). To your health: How to understand what research tells us about risk. New York: Oxford University Press.
25.
go back to reference Edwards, D. (1995). Introduction to graphical modeling. New York: Springer-Verlag. Edwards, D. (1995). Introduction to graphical modeling. New York: Springer-Verlag.
26.
go back to reference Edwards, D. (1995). MIM release 3.2. Boston: Free Software Foundation. Edwards, D. (1995). MIM release 3.2. Boston: Free Software Foundation.
Metagegevens
Titel
Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial
Auteurs
Carol M. Moinpour
Gary W. Donaldson
Yoshio Nakamura
Publicatiedatum
01-03-2009
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 2/2009
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-008-9433-3

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