561P - Quality of life analysis in patients with KRAS wild-type metastatic colorectal cancer treated with first-line FOLFIRI plus cetuximab

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Supportive Measures
Colon and Rectal Cancer
Presenter István Láng
Authors I. Láng1, C.H. Köhne2, G. Folprecht3, P. Rougier4, D. Curran5, E. Hitre6, U. Sartorius7, I. Griebsch7, E. Van Cutsem8
  • 1Dept. Med. Oncology And Clin. Pharmacology B, National Institute of Oncology, H-1122 - Budapest/HU
  • 2Department Of Oncology And Hematology, Klinikum Oldenburg, Oldenburg/DE
  • 3Department Of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden/DE
  • 4Digestive Oncology Department, European Hospital George Pompidou, Paris/FR
  • 5Managing Director, Omega Research, Dublin/IE
  • 6Department Of Medical Oncology And Clinical Pharmacology “b”, National Institute of Oncology, H-1122 - Budapest/HU
  • 7Global Clinical Development Unit Oncology, Merck KGaA, Darmstadt/DE
  • 8Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven/BE



In the CRYSTAL study adding cetuximab to first-line FOLFIRI significantly improved clinical outcome in patients (pts) with KRAS wild-type metastatic colorectal cancer (mCRC). Quality of life (QoL) was assessed and associations with tumor response and survival were studied.

Material and methods

The European Organization for Research and Treatment of Cancer QoL questionnaire core-30 was used. The primary analysis was a pattern-mixture analysis for the global health score (GHS)/QoL and social functioning scales. Exploratory analyses included the change from baseline QoL scores by severity of skin reactions, the change in reported symptoms from baseline according to tumor response and treatment, and the effect of symptomatic status at baseline on response and survival.


QoL was evaluable in 627/666 pts (94%) with KRAS wild-type tumors, 52% received FOLFIRI, and 48% FOLFIRI plus cetuximab. No significant differences for GHS/QoL (p = 0.12) and social functioning scores (p = 0.43) were found between the treatment arms. In pts receiving cetuximab, the mean change from baseline in GHS/QoL was 3.00 in pts without skin reactions compared with -1.09 and -0.51 in those with grade I and grade II-IV early skin reactions, respectively. Social functioning score worsened in pts with no skin reactions (mean -6.41) compared with a slight improvement in those with grade I (mean 1.64) and grade II-IV (mean 1.48) early skin reactions, respectively. Tumor response was higher (58% vs 40%, p = 0.0002) and survival longer (hazard ratio 1.68, p < 0.0001) in asymptomatic versus symptomatic pts at baseline. FOLFIRI plus cetuximab increased tumor response in symptomatic (65% vs 52%, p = 0.0388) and asymptomatic pts at baseline (52% vs 31%, p = 0.0034), and in pts whose tumors had responded, maximum symptom relief from baseline occurred earlier (8 vs 16 weeks) compared with FOLFIRI alone.


Adding cetuximab to FOLFIRI improved clinical outcome without negatively impacting on QoL, improving response despite baseline symptoms and leading to earlier symptom relief in pts whose tumors had responded. Symptom status at baseline was demonstrated to be a useful prognostic factor in mCRC.


C. Köhne: The author reports honoraria from Pfizer and Merck KGaA.

G. Folprecht: The author reports consultant/advisory roles for Merck KGaA, Roche and BMS, honoraria from Merck KGaA, Pfizer, Roche and Novartis and research funding from Merck KGaA.

P. Rougier: The author reports, in relation to the topic concerned, honoraria for three years from Merck KGaA for participation at scientific boards and symposia.

D. Curran: The author acted as a consultant (on statistical and QoL analysis) for Merck KGaA.

U. Sartorius: The author is an employee of Merck KGaA.

I. Griebsch: At the time of this research, the author was an employee of Merck KGaA.

E. Van Cutsem: The author has received research funding from Merck KGaA.

All other authors have declared no conflicts of interest.