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Quality of Life Research
Gepubliceerd in: Quality of Life Research 5/2012

01-06-2012

Evaluating health-related quality-of-life therapeutic effectiveness in a clinical trial with extensive nonignorable missing data and heterogeneous response: results from a phase III randomized trial of gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer

Auteurs: Carol M. Moinpour, Gary W. Donaldson, Astra M. Liepa, Allen S. Melemed, Joyce O’Shaughnessy, Kathy S. Albain

Gepubliceerd in: Quality of Life Research | Uitgave 5/2012

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Abstract

Purpose

This manuscript presents health-related quality of life (HRQL) results from a phase III trial of gemcitabine-paclitaxel (GT) versus paclitaxel (T) in metastatic breast cancer patients.

Methods

Patients completed the Rotterdam Symptom Checklist (RSCL) and Brief Pain Inventory (BPI) at baseline and at the end of each cycle. Sensitivity analyses for six longitudinal pattern mixture models (PMMs) assessed potential bias due to informative dropout. Cumulative probability plots with 50% confidence intervals indicated the proportion of patients whose HRQL was likely to improve, decline, or stay the same.

Results

Sensitivity analyses addressing nonignorable missing RSCL data included 351 patients. The mean RSCL global HRQL score for GT was significantly and consistently better than that for T (all PMMs P < 0.040). The slope estimate of 1.5 points (100-point scale) per cycle from one PMM translated to a clinically significant 9-point improvement over six cycles with GT versus T. For GT, ~25% of patients were more likely than not to have improved HRQL, whereas that proportion for T was ~5%. PMMs showed no consistent treatment arm differences for BPI or other RSCL outcomes.

Conclusions

Adding gemcitabine to paclitaxel for the treatment of metastatic breast cancer is more likely to improve global HRQL over time compared to monotherapy treatment.
vorige artikel The effectiveness of psychosocial interventions designed to improve health-related quality of life (HRQOL) amongst asthmatic children and their families: a systematic review
volgende artikel Common tongue conditions affect quality of life: an issue to be recognized
Literatuur
1.
Bishop, J. F., Dewar, J., Toner, G. C., et al. (1999). Initial paclitaxel improves outcome compared with CMFP combination chemotherapy as front-line therapy in untreated metastatic breast cancer. Journal of Clinical Oncology, 17(8), 2355–2364.PubMed
2.
Jones, S. E., Erban, J., Overmoyer, B., et al. (2005). Randomized phase III study of docetaxel compared with paclitaxel in metastatic breast cancer. Journal of Clinical Oncology, 23(24), 5542–5551.PubMedCrossRef
3.
Hakamies-Blomqvist, L., Luoma, M., Sjöström, J., et al. (2000). Quality of life in patients with metastatic breast cancer receiving either docetaxel or sequential methotrexate and 5-fluorouracil. A multicentre randomised phase III trial by the Scandinavian breast group. European Journal of Cancer, 36(11), 1411–1417.PubMedCrossRef
4.
O’Shaughnessy, J., Miles, D., Vukelja, S., et al. (2002). Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results. Journal of Clinical Oncology, 20(12), 2812–2823.PubMedCrossRef
5.
Sledge, G. W., Neuberg, D., Bernardo, P., et al. (2003). Phase III trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: An intergroup trial (E1193). Journal of Clinical Oncology, 21(4), 588–592.PubMedCrossRef
6.
Winer, E. P., Berry, D. A., Woolf, S., et al. (2004). Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: Cancer and leukemia group B trial 9342. Journal of Clinical Oncology, 22(11), 2061–2068.PubMedCrossRef
7.
Bernhard, J., Gusset, H., & Hürny, C. (1998). Practical issues in quality of life assessment in multicentre trials conducted by the Swiss group for clinical cancer research. Statistics in Medicine, 17(5/6/7), 633–639.PubMedCrossRef
8.
Moinpour, C. M., Sawyers, T. J., McKnight, B., et al. (2000). Challenges posed by non-random missing quality of life data in an advanced-stage colorectal cancer clinical trial. Psycho-Oncology, 9(4), 340–354.PubMedCrossRef
9.
Fairclough, D. L. (2010). Design and analysis of quality of life studies in clinical trials, 2nd ed. Interdisciplinary statistics. Boca Raton, FL: Chapman & Hall/CRC.CrossRef
10.
Fayers, P. M., & Machin, D. (2000). Quality of life: Assessment, analysis, and interpretation. Chichester, United Kingdom: John Wiley & Sons Ltd.
11.
Pauler, D. K., McCoy, S., & Moinpour, C. (2003). Pattern mixture models for longitudinal quality of life studies in advanced stage disease. Statistics in Medicine, 22(5), 795–809.PubMedCrossRef
12.
Donaldson, G. W., & Moinpour, C. M. (2005). Learning to live with missing quality-of-life data in advanced-stage disease trials. Journal of Clinical Oncology, 23(30), 7380–7384.PubMedCrossRef
13.
Nabholtz, J. M., Senn, H. J., Bezwoda, W. R., et al. (1999). Prospective randomized trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group. Journal of Clinical Oncology, 17(5), 1413–1424.PubMed
14.
Kramer, J. A., Curran, D., Piccart, M., et al. (2000). Randomised trial of paclitaxel versus doxorubicin as first-line chemotherapy for advanced breast cancer: quality of life evaluation using the EORTC QLQ-C30 and the Rotterdam symptom checklist. European Journal of Cancer, 36(12), 1488–1497.PubMedCrossRef
15.
Nabholtz, J. M., Falkson, C., Campos, D., et al. (2003). Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: Results of a randomized, multicenter, phase III trial. Journal of Clinical Oncology, 21(6), 968–975.PubMedCrossRef
16.
O’Shaughnessy, J., Nag, S., & Calderillo-Ruiz, G., et al. (2003). Gemcitabine plus paclitaxel (GT) versus paclitaxel (T) as first-line treatment for anthracycline pre-treated metastatic breast cancer (MBC): Interim results of a global phase III study. Proceedings of the American Society of Clinical Oncology, 22(7s), 25.
17.
Albain, K., Nag, S., & Calderillo-Ruiz, G., et al. (2004). Global phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): First report of overall survival. Journal of Clinical Oncology, 22(14s), 510.
18.
Moinpour, C. M., Wu, J., & Donaldson, G. W., et al. (2004). Gemcitabine plus paclitaxel versus paclitaxel as first-line treatment for anthracycline pre-treated metastatic breast cancer: Quality-of-life and pain palliation results from the global phase III study. Journal of Clinical Oncology, 22(14s), 621.
19.
Albain, K. S., Nag, S. M., Calderillo-Ruiz, G., et al. (2008). Gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer and prior anthracycline treatment. Journal of Clinical Oncology, 26(24), 3950–3957.PubMedCrossRef
20.
Hogan, J. W., & Laird, N. M. (1997). Mixture models for the joint distribution of repeated measures and event times. Statistics in Medicine, 16(3), 239–257.PubMedCrossRef
21.
Hogan, J. W., & Laird, N. M. (1997). Model-based approaches to analysing incomplete longitudinal and failure time data. Statistics in Medicine, 16(3), 259–273.PubMedCrossRef
22.
Nabholtz, J. M., Gelmon, K., Bontenbal, M., et al. (1996). Multicenter, randomized comparative study of two doses of paclitaxel in patients with metastatic breast cancer. Journal of Clinical Oncology, 14(6), 1858–1867.PubMed
23.
de Haes, J. C., van Knippenberg, F. C., & Neijt, J. P. (1990). Measuring psychological and physical distress in cancer patients: Structure and application of the Rotterdam symptom checklist. British Journal of Cancer, 62(6), 1034–1038.PubMedCrossRef
24.
de Haes, J. C. J. M., Olschewski, M., Fayers, P., et al. (1996). Measuring the quality of life of cancer patients with the Rotterdam symptom checklist (RSCL). A Manual. Groningen, the Netherlands: Northern Centre for Healthcare Research, University of Groningen.
25.
Cleeland, C. S., & Ryan, K. M. (1994). Pain assessment: Global use of the brief pain inventory. Annals of the Academy of Medicine, Singapore, 23(2), 129–138.PubMed
26.
Hopwood, P., Howell, A., & Maguire, P. (1991). Screening for psychiatric morbidity in patients with advanced breast cancer: Validation of two self-report questionnaires. British Journal of Cancer, 64(2), 353–356.PubMedCrossRef
27.
Ramirez, A. J., Towlson, K. E., Leaning, M. S., et al. (1998). Do patients with advanced breast cancer benefit from chemotherapy? British Journal of Cancer, 78(11), 1488–1494.PubMedCrossRef
28.
Richards, M. A., Hopwood, P., Ramirez, A. J., et al. (1992). Doxorubicin in advanced breast cancer: Influence of schedule on response, survival and quality of life. European Journal of Cancer, 28(6–7), 1023–1028.CrossRef
29.
Cleeland, C. S., Gonin, R., Hatfield, A. K., et al. (1994). Pain and its treatment in outpatients with metastatic cancer. New England Journal of Medicine, 330(9), 592–596.PubMedCrossRef
30.
Twycross, R., Harcourt, J., & Bergl, S. (1996). A survey of pain in patients with advanced cancer. Journal of Pain and Symptom Management, 12(5), 273–282.PubMedCrossRef
31.
Collins, C., Eary, J. F., Donaldson, G., et al. (1993). Samarium-153-EDTMP in bone metastases of hormone refractory prostate carcinoma: A phase I/II trial. Journal of Nuclear Medicine, 34(11), 1839–1844.PubMed
32.
Donaldson, G. W. (1989). The determining role of theory in measurement practice. In C. R. Chapman & J. D. Loeser (Eds.), Advances in pain research and therapy: Issues in pain measurement (Vol. 12, pp. 17–35). New York, NY: Raven Press.
33.
Little, R. J. A. (1993). Pattern-mixture models for multivariate incomplete data. Journal of the American Statistical Association, 88(421), 125–134.CrossRef
34.
Little, R. J. A. (1994). A class of pattern-mixture models for multivariate incomplete data. Biometrika, 81(3), 471–483.CrossRef
35.
Hedeker, D., & Gibbons, R. D. (1997). Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychological Methods, 2(1), 64–78.CrossRef
36.
Lin, H., McCulloch, C. E., & Rosenheck, R. A. (2004). Latent pattern mixture models for informative intermittent missing data in longitudinal studies. Biometrics, 60(2), 295–305.PubMedCrossRef
37.
Cleveland, W. S. (1985). The elements of graphing data. Monterey, CA: Wadsworth.
38.
Donaldson, G. (2008). Patient-reported outcomes and the mandate of measurement. Quality of Life Research, 17(10), 1303–1313.PubMedCrossRef
39.
Donaldson, G. W., & Moinpour, C. M. (2002). Individual differences in quality of life treatment response. Medical Care, 40(6), III39–III53.
40.
Littell, R. C., Milliken, G. A., Stroup, W. W., et al. (1996). SAS system for mixed models. Cary, NC: SAS Institute.
41.
Moinpour, C. M., Donaldson, G. W., & Liepa, A. M., et al. (2007). Cumulative probability plots: A visual summary of patient benefit due to therapy. 2007 International Society for Quality of Life Research meeting abstracts [www.​isoqol.​org/​2007mtgabstracts​]. The QLR Journal, A-9, Abstract #1583.
42.
43.
Cohen, J. (1988). Statistical power analysis for behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum and Associates.
44.
Osoba, D., Rodrigues, G., Myles, J., et al. (1998). Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical Oncology, 16(1), 139–144.PubMed
45.
Geels, P., Eisenhauer, E., Bezjak, A., et al. (2000). Palliative effect of chemotherapy: Objective tumor response is associated with symptom improvement in patients with metastatic breast cancer. Journal of Clinical Oncology, 18(12), 2395–2405.PubMed
46.
Hopwood, P., Watkins, J., Ellis, P., et al. (2008). Clinical interpretation of quality-of-life outcomes: An investigation of data from the randomized trial of gemcitabine plus paclitaxel compared with paclitaxel alone for advanced breast cancer. The Breast Journal, 14(3), 228–235.PubMedCrossRef
47.
Goodwin, P. J., Black, J. T., Bordeleau, L. J., et al. (2003). Health-related quality-of-life measurement in randomized clinical trials in breast cancer–taking stock. The Journal of the National Cancer Institute, 95(4), 263–281.CrossRef
48.
Bottomley, A., & Therasse, P. (2002). Quality of life in patients undergoing systemic therapy for advanced breast cancer. The lancet Oncology, 3(10), 620–628.PubMedCrossRef
49.
Bernhard, J., Cella, D. F., Coates, A. S., Fallowfield, L., Ganz, P. A., Moinpour, C. M., et al. (1998). Missing quality of life data in cancer clinical trials: Serious problems and challenges. Statistics in Medicine, 17(5–7), 517–532.PubMedCrossRef
50.
Bernhard, J., & Gelber, R. D. [Guest Editors] (1998). Workshop on missing data in quality of life research in cancer clinical trials: Practical and methodological issues. Statistics in Medicine, 17(5–7), 511–796.
51.
Singer, J. D., & Willett, J. B. (2003). Applied longitudinal data analysis: Modeling change and event occurrence. New York: Oxford University Press.
52.
Little, R. J. A. (1995). Modeling the drop-out mechanism in repeated-measures studies. Journal of the American Statistical Association, 90(431), 1112–1121.
53.
Rubin, D. B. (1976). Inference and missing data. Biometrika, 63(3), 581–592.CrossRef
54.
Laird, N. M., & Ware, J. H. (1982). Random-effects models for longitudinal data. Biometrics, 38(4), 963–974.PubMedCrossRef
55.
Troxel, A. B., Fairclough, D. L., Curran, D., & Hahn, E. A. (1998). Statistical analysis of quality of life with missing data in cancer clinical trials. Statistics in Medicine, 17(5–7), 653–666.PubMedCrossRef
Metagegevens
Titel
Evaluating health-related quality-of-life therapeutic effectiveness in a clinical trial with extensive nonignorable missing data and heterogeneous response: results from a phase III randomized trial of gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer
Auteurs
Carol M. Moinpour
Gary W. Donaldson
Astra M. Liepa
Allen S. Melemed
Joyce O’Shaughnessy
Kathy S. Albain
Publicatiedatum
01-06-2012
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 5/2012
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-011-9999-z

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