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Health-related quality of life (HRQL) associated with bortezomib compared with high-dose dexamethasone in relapsed multiple myeloma (MM): Results from APEX study
- Source :
- Journal of Clinical Oncology. 23:6535-6535
- Publication Year :
- 2005
- Publisher :
- American Society of Clinical Oncology (ASCO), 2005.
-
Abstract
- 6535 Background: A large randomized phase 3 study (APEX) (Blood 2004;104: Abstract 336.5) in relapsed MM demonstrated significant clinical benefits (time to progression, response, and survival) associated with bortezomib therapy over high-dose dexamethasone, with comparable grade 3 and 4 toxicities. HRQL data were prospectively collected during the study. Methods: Two HRQL instruments (EORTC QLQ-C30 and FACT/GOG-NTX) were administered at baseline, weeks 6, 12, 18, 24, 30, 36, and 42, or until discontinuation of protocol treatment. Data were analyzed based on modified intention-to-treat analysis; 44 of 642 patients were excluded due to no baseline or no follow-up HRQL data. At baseline, the 2 treatment groups were comparable on demographic and clinical characteristics, NTX score, and on most EORTC scores. There were substantial missing HRQL data (from 12.5% at week 6 to 75.6% at week 42), primarily due to premature closure of the study and disease progression. Extensive statistical analyses were undertaken...
- Subjects :
- Health related quality of life
Cancer Research
medicine.medical_specialty
High dose dexamethasone
business.industry
Bortezomib
Phases of clinical research
social sciences
medicine.disease
humanities
Surgery
Apex (geometry)
Discontinuation
Oncology
Internal medicine
medicine
business
Multiple myeloma
Dexamethasone
medicine.drug
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 23
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi...........ec89a5c9753a8064eb97d7555fadf1d1