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

Research Article

Ralf Hofheinz¹  Ana Baños²  Meinolf Karthaus³  Josef Thaler⁴  Claus-Henning Köhne⁵  Laurent Mineur⁶  Eva Fernebro⁷  Erick Gamelin⁸  Richard Greil⁹  Henry Letocha^1,10 

[1] Day treatment centre at the Interdisciplinary Tumour Centre Mannheim, University Medical Centre, Mannheim, Germany;Department of Biostatistics, Amgen Limited, Uxbridge, UK;Department of Haematology and Oncology, Neuperlach Hospital, Munich, Germany;Department of Internal Medicine IV - Haematology and Oncology, Hospital Wels-Grieskirchen, Wels, Austria;Department of Oncology and Haematology, Oldenburg Hospital, Oldenburg, Germany;Department of Oncology and Radiotherapy, Institute Sainte-Catherine, Avignon, France;Department of Oncology, Lund University Hospital, Lund, Sweden;Department of Oncology, Paul Papin Cancer Institute, Angers, France;IIIrd Medical Department with Hematology and Medical Oncology, Oncologic Center, Paracelsus Medical University Salzburg, Salzburg, Austria;Oncology Clinic, Västerås Hospital, Västerås, Sweden;

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

DOI  :  10.1186/1471-2407-12-438

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

来源: Springer

【 摘 要 】

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

【 授权许可】

CC BY   
© Thaler et al.; licensee BioMed Central Ltd. 2012