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

BMC Cancer

Claus-Henning Köhne⁸  Ana Baños¹  Erick Gamelin⁴  Eva Fernebro⁹  Ralf Hofheinz²  Henry Letocha³  Richard Greil⁷  Laurent Mineur⁶  Meinolf Karthaus⁵  Josef Thaler^1,10 

[1]Department of Biostatistics, Amgen Limited, Uxbridge, UK

[2]Day treatment centre at the Interdisciplinary Tumour Centre Mannheim, University Medical Centre, Mannheim, Germany

[3]Oncology Clinic, Västerås Hospital, Västerås, Sweden

[4]Department of Oncology, Paul Papin Cancer Institute, Angers, France

[5]Department of Haematology and Oncology, Neuperlach Hospital, Munich, Germany

[6]Department of Oncology and Radiotherapy, Institute Sainte-Catherine, Avignon, France

[7]IIIrd Medical Department with Hematology and Medical Oncology, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, Austria

[8]Department of Oncology and Haematology, Oldenburg Hospital, Oldenburg, Germany

[9]Department of Oncology, Lund University Hospital, Lund, Sweden

[10]Department of Internal Medicine IV - Haematology and Oncology, Hospital Wels-Grieskirchen, Wels, Austria

关键词: Tolerability;    Quality of life;    Panitumumab;    Colorectal cancer;   

Others  :  1080171
DOI  :  10.1186/1471-2407-12-438

 received in 2012-03-16, accepted in 2012-09-12,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Thaler et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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