Association of progression-free survival with patient-reported outcomes and survival: results from a randomised phase 3 trial of panitumumab

S Siena, M Peeters, E Van Cutsem, Y Humblet, P Conte, E Bajetta, D Comandini, G Bodoky, G Van Hazel, T Salek, M Wolf, G Devercelli, M Woolley, R G Amado, S Siena, M Peeters, E Van Cutsem, Y Humblet, P Conte, E Bajetta, D Comandini, G Bodoky, G Van Hazel, T Salek, M Wolf, G Devercelli, M Woolley, R G Amado

Abstract

In a randomised phase 3 trial, panitumumab significantly improved progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC). This analysis characterises the association of PFS with CRC symptoms, health-related quality of life (HRQoL), and overall survival (OS). CRC symptoms (NCCN/FACT CRC symptom index, FCSI) and HRQoL (EQ-5D) were assessed for 207 panitumumab patients and 184 best supportive care (BSC) patients who had at least one post-baseline patient-reported outcome (PRO) assessment. Patients alive at week 8 were included in the PRO and OS analyses and categorised by their week 8 progression status as follows: no progressive disease (no PD; best response of at least stable disease) vs progressive disease (PD). Standard imputation methods were used to assign missing values. Significantly more patients were progression free at weeks 8-24 with panitumumab vs BSC. After excluding responders, a significant difference in PFS remained favouring panitumumab (HR=0.63, 95% CI=0.52-0.77; P<0.0001). At week 8, lack of disease progression was associated with significantly and clinically meaningful lower CRC symptomatology for both treatment groups and higher HRQoL for panitumumab patients only. Overall survival favoured no PD patients vs PD patients alive at week 8. Lack of disease progression was associated with better symptom control, HRQoL, and OS.

Figures

Figure 1
Figure 1
Phase 3 study schema.
Figure 2
Figure 2
Sensitivity analysis of progression-free survival (PFS) with and without responders in the panitumumab group.
Figure 3
Figure 3
Mean FACT-FCSI difference (95% CI) in scores by progression status at week 8 (central review, patient-reported outcome (PRO) all enrolled, landmark analysis).
Figure 4
Figure 4
Mean EQ-5D Health Index Difference (95% CI) in scores by progression status at week 8 (central review, patient-reported outcome (PRO) all enrolled, landmark analysis).
Figure 5
Figure 5
Overall survival (OS) in subset of panitumumab patients alive at week 8 and categorised by tumour progression status at week 8.

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Source: PubMed

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