Quality of life in clinical trials of adjuvant therapies. International Breast Cancer Study Group (formerly Ludwig Group).
Clinical trials of adjuvant therapies usually measure the effectiveness of treatments by comparing disease-free survival or overall survival. These take into consideration only indirectly the quality of life experienced by the patients. We present some approaches that were developed to assess the impact of adjuvant therapy on the quality of life of breast cancer patients, as well as new methods created to compare treatments based on time spent without symptoms and toxicity (TWiST). The integration of these two methods (measuring quality and comparing duration of time) will provide a new tool for evaluating benefits from treatments given in the adjuvant setting.
Gelber
R D
RD
Division of Biostatistics and Epidemiology, Dana-Farber Cancer Institute, Boston, MA 02115.
Goldhirsch
A
A
Hürny
C
C
Bernhard
J
J
Simes
R J
RJ
D000970:Antineoplastic Agents / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D015201:Meta-Analysis as Topic; D011788:Quality of Life; D011795:Surveys and Questionnaires; D015996:Survival Rate; D013997:Time Factors
D000970:Antineoplastic Agents