Abstract
4002 Background: Cetuximab prolongs survival in pretreated advanced colorectal cancer (CRC) patients (pts). For these pts, the effect of palliative treatment on quality of life (QOL) is also an important outcome. Methods: CO.17 was a randomized controlled trial (n=572) of cetuximab combined with best supportive care (BSC) vs BSC alone in pts with pretreated epidermal growth factor receptor-positive advanced CRC. Primary endpoint was survival. QOL was a secondary endpoint using the EORTC QLQ-C30 at baseline, 4, 8, 16, and 24 weeks (wks). Primary endpoint for QOL compared physical function (PF) and global health status (Global) mean changes from baseline to 8 and 16 wks using Wilcoxon test. Negative change scores denote worsening QOL. The proportion of pts in either arm with at least a 10 unit deterioration at 8 and 16 wks from baseline was compared using Fischer’s exact test. Kaplan-Meier estimates and logrank tests on median time to definitive QOL deterioration, defined as at least a 10 unit deterioration in PF or Global, were evaluated. Exploratory analyses of all other scale and symptom change scores at 8 and 16 wks were also performed. Results: Compliance rates for QOL questionnaires was high at baseline, 94% each arm, but did drop off over time: 73% vs 60% at week 8 and 60% vs 39% at week 16 for cetuximab vs BSC, respectively. PF change scores at 8 wks were -3.9 for cetuximab vs -8.6 for BSC (p=.046); at 16 wks -5.9 vs -12.5 (p=.027). Global change scores were -0.5 vs -7.1 (p=.008) and -3.6 vs -15.2 (p=.008) at 8 and 16 wks respectively. The proportion of pts with deteriorating PF was 25% for cetuximab vs 35% for BSC at 8 wks (p=.051) and 30 vs 43% at 16 wks (p=.069). Deteriorating Global was seen in 23 vs 38% at 8 wks (p=.004) and 31 vs 49% at 16 wks (p=.0011). Time to PF deterioration was 5.4 months [95% CI 3.8–5.7] for cetuximab vs 3.7 months [2.0–3.9] for BSC (p=.022). Time to Global deterioration was 5.4 [3.9–5.7] vs 3.7 months [2.1–3.9] (p=.062). Exploratory analyses of all other scale and symptom change scores at 8 and 16 wks showed all differences of p<.05 also favored cetuximab. Conclusions: Cetuximab provides palliation in pretreated pts with advanced CRC, delaying deterioration in QOL as well as improving survival. [Table: see text]
Published Version
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