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Comparison of Adjuvant Therapies Using Quality-Of-Life Considerations

Published online by Cambridge University Press:  10 March 2009

Richard D. Gelber
Affiliation:
Harvard medical School and School of Public HealthDana-Farber Cancer Institute, Boston
A. Goldhirsch
Affiliation:
Ospedale San Giovanni, Bellinzona Ospedale Civico, Lugano Ospedale Beata Vergine, Mendrisio

Extract

The benefit for patients with operable breast cancer treated with adjuvant systemic therapy is small, if reduction of early mortality within the context of randomized control trials is used for treatment comparison. One might consider that the 75%–85% of patients who die despite treatment are overtreated, as are patients who remain alive even without therapy within a given time frame. Larger treatment benefits in terms of avoided or delayed breast cancer relapse have been demonstrated even at early phases of follow-up in the vast majority of adjuvant trials. Exposure of all patients to adjuvant therapy at a time at which no symptoms of disease are present is detrimental in terms of quality of life.

Based on our assumption that the quality of life of the patient is typically altered both by subjective toxic effects of adjuvant treatment and by the appearance of relapse, we developed a method of comparing treatment effects in terms of time without symptoms of disease and toxicity of treatment (TWiST). Because the impact of treatment on relapse rates appears earlier than survival effects in all adjuvant therapy trials, and because the value of time without relapse in terms of the quality of life of the patients is as yet poorly defined, we have generalized our method of comparing treatment attitudes to include individual qualitative judgment values. The experience gained from integrating quality-of-life issues into clinical trials for breast cancer might also be applied to other diseases characterized by a chronic course, toxic treatments, and gains in periods of relative or absolute freedom from toxic effects and progressive disease.

Type
Special Section: Technology Assessment and Surgical Policy
Copyright
Copyright © Cambridge University Press 1989

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References

REFERENCE

Anonymous. Clinical alert stimulates changes in practice. Journal of the National Cancer Institute, 1988, 80, 1185–87.Google Scholar
Baum, M., Priestman, T., West, R. R. et al. A comparison of subjective responses in a trial comparing endocrine with cytotoxic treatment in advanced carcinoma of the breast. In Mouridsen, H. T. & Palshof, T. (Eds.), Breast cancer–Experimental and clinical aspects. Elmsford, NY: Pergamon Press, 1980, 223–26.Google Scholar
Coates, A., Gebski, V., Bishop, J. F. et al. , for the Australian-New Zealand Breast Cancer Trials Group, Clinical Oncological Society of Australia. Improving the quality of life during chemotherapy for advanced breast cancer: A comparison of intermittent and continuous treatment strategies. New England Journal of Medicine, 1987, 317, 1490–95.Google Scholar
Coates, A., Fischer, Dillenbeck C., McNeal, D. R. et al. On the receiving end–II. Linear analogue self-assessment (LASA) in evaluation of the quality of life of cancer patients receiving therapy. European Journal of Cancer and Clinical Oncology, 1983, 19, 1633–37.Google Scholar
Gelber, R. D., Goldhirsch, A., Castiglione, M., Price, K., Isley, M., & Coates, A., for the Ludwig Breast Cancer Study Group. Time without symptoms and toxicity (TWiST): A quality-of-life-oriented endpoint to evaluate adjuvant therapy. In Salmon, S. E. (Ed.), Adjuvant therapy of cancer, vol. 5. Philadelphia: Grune & Stratton, 1987, 455–65.Google Scholar
Gelber, R. D., & Goldhirsch, A., for the Ludwig Breast Cancer Study Group. A new endpoint for the assessment of adjuvant therapy in postmenopausal women with operable breast cancer. Journal of Clinical Oncology, 1986, 4, 1772–79.Google Scholar
Goldhirsch, A., & Gelber, R. D. Adjuvent systemic therapy for breast cancer patients without lymph node metastases (N-). In Cavalli, F. (Ed.), Endocrine therapy of breast cancer, vol. 3. U. Veronesi (Series ed.). Berlin: Springer-Verlag and ESO [European School of Oncology Monographs], 1989, 1, 3743.Google Scholar
Goldhirsch, A., Gelber, R. D., Simes, R. J., Glasziou, P., & Coates, A.Costs and benefits of adjuvant therapy in breast cancer: A quality-adjusted survival analysis. Journal of Clinical Oncology, 1989, 7, 3644.Google Scholar
Goldhirsch, A., Gelber, R. D., & Castiglione, M.Relapse of breast cancer after adjuvant treatment in premenopausal and perimenopausal women: Patterns and prognoses. Journal of Clinical Oncology, 1988, 6, 8997.Google Scholar
Goldhirsch, A., & Gelber, R. D., for the Ludwig Breast Cancer Study Group. Adjuvant therapy for breast cancer: The Ludwig Breast Cancer Trials, 1987. In Salmon, S. E. (Ed.), Adjuvant therapy of cancer, vol. 5. Philadelphia: Grune & Stratton, 1987, 297309.Google Scholar
Henderson, I. C.Adjuvant systemic therapy for early breast cancer. Current Problems in Cancer, 1987, 2, 125207.Google Scholar
Nemoto, T., Vana, J., Bedwani, R. N. et al. Management and survival of female breast cancer. Results of a national survey by the American College of Surgeons. Cancer, 1980, 45, 2917–24.Google Scholar
Early Breast Cancer Trialists' Collaborative Group. Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer: An overview of 61 randomized trials among 28,896 women. New England Journal of Medicine, 1988, 319, 1681–92.Google Scholar