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Open Access Research article

Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study

Josef Thaler1*, Meinolf Karthaus2, Laurent Mineur3, Richard Greil4, Henry Letocha5, Ralf Hofheinz6, Eva Fernebro7, Erick Gamelin8, Ana Baños9 and Claus-Henning Köhne10

Author affiliations

1 Department of Internal Medicine IV - Haematology and Oncology, Hospital Wels-Grieskirchen, Wels, Austria

2 Department of Haematology and Oncology, Neuperlach Hospital, Munich, Germany

3 Department of Oncology and Radiotherapy, Institute Sainte-Catherine, Avignon, France

4 IIIrd Medical Department with Hematology and Medical Oncology, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, Austria

5 Oncology Clinic, Västerås Hospital, Västerås, Sweden

6 Day treatment centre at the Interdisciplinary Tumour Centre Mannheim, University Medical Centre, Mannheim, Germany

7 Department of Oncology, Lund University Hospital, Lund, Sweden

8 Department of Oncology, Paul Papin Cancer Institute, Angers, France

9 Department of Biostatistics, Amgen Limited, Uxbridge, UK

10 Department of Oncology and Haematology, Oldenburg Hospital, Oldenburg, Germany

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Citation and License

BMC Cancer 2012, 12:438  doi:10.1186/1471-2407-12-438

Published: 29 September 2012

Abstract

Background

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. 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.

Methods

Integument-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.

Results

154 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.

Conclusions

First-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 registration

ClinicalTrials.gov NCT00508404

Keywords:
Colorectal cancer; Panitumumab; Quality of life; Tolerability