Health related quality of life of XXXX in TEACH, a randomised placebo controlled adjuvant trial of @entity9433 in early stage @entity1 Epidermal Growth Factor Receptor ( @entity1722 ) overexpressing @entity0 .

@entity1 @entity1032 @entity137 @entity0 @entity1910 @entity9433 @entity294 @entity158 @entity922 @entity970 @entity1722
BACKGROUND: To evaluate health related quality of life (HRQOL) in TEACH, a phase III randomized placebo controlled trial of 12months of adjuvant @entity9433 in @entity1722 positive ( @entity1722 +) early @entity0 which demonstrated marginal benefit in disease-free survival. METHODS: @entity1 on TEACH completed the Short Form 36-item health survey (version2; SF-36v2) at the baseline, six and 12months after therapy initiation and six monthly thereafter. Mean changes were compared between treatment groups for two summary measures (Physical and Mental Component Summary scores; PCS and @entity1032 ) and eight domain measures (physical functioning, role physical, bodily @entity158 , general health, vitality, social functioning, role emotional and mental health), and in @entity1 discontinuing therapy. A five-point change was deemed a @entity922 ( @entity922 ). Response analysis compared the proportion of @entity1 demonstrating a @entity922 in HRQOL, and a regression analysis identified predictors of worsening HRQOL. FINDINGS: 3074 (97%) subjects completed baseline SF-36v2. During the initial 12months, summary SF-36v2 scores decreased in both arms but did not reach @entity922 ( @entity922 ) despite significant incidences of @entity294 and @entity1910 in @entity9433 treated @entity1 . At six months, @entity1 receiving @entity9433 had more significant reductions (p<0.01 versus placebo) in social functioning. Early treatment discontinuations were more frequent on @entity9433 (32% versus 18%), and were associated with more substantial decrements of HRQOL in both arms. For those discontinuing primarily due to adverse events, decrements in HRQOL reached @entity922 in @entity1032 ( @entity1032 ) only. Lower baseline HRQOL was a significant predictor of worsening HRQOL (p<0.05). INTERPRETATION: Despite frequent but usually mild @entity137 , adjuvant @entity9433 is not associated with clinically significant decreases in overall HRQOL. These placebo-controlled results may also help to inform physicians and @entity1 using @entity9433 in metastatic @entity1722 positive @entity0 . FUNDING: GlaxoSmithKline. The AVON Foundation NY supported @entity970 , DF and BM and The Friends of the Mater Foundation supported FB.
