Abstract
BackgroundIntegument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy. Panitumumab is a fully human monoclonal antibody targeting the EGFR that significantly improves progression-free survival when added to chemotherapy in patients with metastatic colorectal cancer who have wild-type (WT) KRAS tumours. Primary efficacy and tolerability results from a phase II single-arm study of first-line panitumumab plus FOLFIRI in patients with metastatic colorectal cancer have been reported. Here we report additional descriptive tolerability and quality of life data from this trial.MethodsIntegument-related toxicities and quality of life were analysed; toxicities were graded using modified National Cancer Institute Common Toxicity Criteria. Kaplan-Meier estimates of time to and duration of first integument-related toxicity were prepared. Quality of life was measured using EuroQoL EQ-5D and EORTC QLQ-C30. Best overall response was analysed by skin toxicity grade and baseline quality of life. Change in quality of life was analysed by skin toxicity severity.Results154 patients were enrolled (WT KRAS n = 86; mutant KRAS n = 59); most (98%) experienced integument-related toxicities (most commonly rash [42%], dry skin [40%] and acne [36%]). Median time to first integument-related toxicity was 8 days; median duration was 334 days. Overall, proportionally more patients with grade 2+ skin toxicity responded (56%) compared with those with grade 0/1 (29%). Mean overall EQ-5D health state index scores (0.81 vs. 0.78), health rating scores (72.5 vs. 71.0) and QLQ-C30 global health status scores (65.8 vs. 66.7) were comparable at baseline vs. safety follow-up (8 weeks after completion), respectively and appeared unaffected by skin toxicity severity.ConclusionsFirst-line panitumumab plus FOLFIRI has acceptable tolerability and appears to have little impact on quality of life, despite the high incidence of integument-related toxicity.Trial registrationClinicalTrials.gov NCT00508404
Highlights
Integument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy
While FOLFIRI is associated with severe diarrhoea and neutropenia [7], EGFR inhibitors are associated with unique side effects, mostly different to those seen during chemotherapy
Most characteristics were similar between KRAS groups, the MT KRAS patientreported outcomes (PROs) population included proportionally more women (20% vs. 46%), elderly patients (≥75 years of age; 7% vs. 19%) and patients with colon cancer (57% vs. 67%) compared with the WT population (Table 1)
Summary
Integument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy. Panitumumab is a fully human monoclonal antibody targeting the EGFR that significantly improves progression-free survival when added to chemotherapy in patients with metastatic colorectal cancer who have wild-type (WT) KRAS tumours. Addition of epidermal growth factor receptor (EGFR)-targeted agents (e.g. the chimeric antibody cetuximab or the fully human antibody panitumumab) to FOLFIRI significantly improves outcomes in patients with wild-type (WT) KRAS tumours [3,4]. Dermatological toxicities often resolve upon therapy discontinuation [11], these side effects can negatively affect treatment compliance and quality of life [12] They can lead to dose modification or discontinuation [13], potentially affecting the overall effectiveness of anti-EGFR treatment. Maintenance of quality of life is an important treatment goal and patientreported outcomes (PROs) are a useful way of measuring the impact of treatment on quality of life
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