80
18. 20. ZÁŘÍ 2014 / 18
TH
20
TH
SEPTEMBER 2014 / OLOMOUC
SYMPOZIUM SPOLEČNOSTI BOEHRINGER INGELHEIM
Sobota 20. 9. 2014 / 11.00–11.30 / Sál Pegasus
(54,7% druhá linie léčby, 37,2% třetí linie léčby). Střední doba
OS je 7,4 měsíce (95% IS 6,3–8,6). Výskyt nežádoucích příhod
stupně III a vyšších byl zaznamenán u 14% pacientů, nejčastěji
byly hlášeny kožní toxicity (8,7%) a průjem (2,8%).
Výsledky, kterých je v běžné klinické praxi v ČR dosahová-
no, odpovídají výsledkům pozorovaným v klinických studiích.
Cílem léčby ve druhém a třetím stadiu NSCLC je zejména kont-
rola symptomů nemoci a prodloužení života pacientů spolu se
zachováním jeho kvality. Důležitým aspektem je bezpečnost
používané léčby a schopnost řešit výskyt nežádoucích účinků,
které podle svého typu a stupně významně ovlivňují kvalitu
života nemocných s NSCLC. Léčba erlotinibem těmto kritériím
vyhovuje a výše uvedená data dokumentují, že erlotinib hraje
důležitou roli v léčbě pacientů s EGFR WT v pozdějších liniích
léčby.
Literatura
1.
Shepherd, FA, et al. N Engl J med 2005; 353: 123–132.
SYMPOZIUM SPOLEČNOSTI
BOEHRINGER INGELHEIM
Sobota 20. 9. 2014 / 11.00–11.30 / Sál Pegasus
Diagnosis and treatment of EGFR mutation-
positive advanced NSCLC in Austria – What could
be used under Czech conditions
Pirker R.
Department of Medicine I, Medical University of Vienna,
Austria
diagnosis:
Diagnosis of advanced NSCLC is based on his-
tology and molecular analysis. Molecular analysis of EGFR
mutations and ALK has become standard for patients with
advanced NSCLC.
egfrmutation testing:
The selection of patients for testing
and the schedule of testing vary between countries. In Austria,
all patients with newly diagnosed adenocarcinomas of the lung
are currently tested for the presence of EGFRmutations and ALK
translocations at the time of diagnosis. Simultaneous testing of
both parameters is supposed to be automatically performed
by the pathologists without requirements for specific ordering
by the treating physicians. Other countries have implemented
a sequential approach of testing. To ensure timely testing, the
close co-operation between pathologists and clinicians is impor-
tant and the detailed procedures of testing have to be arranged
locally. In order to successfully implement EGFRmutation testing
in Austria, educational meetings and establishment of national
diagnostic guidelines were very helpful.
insigHt study:
The INSIGHT observational study was
performed in order to gain insight into EGFR mutation testing
and treatment of patients with EGFR mutation-positive NSCLC
in clinical practice in Central Europe. A total of 1785 patients
from 14 centers of 6 Central European countries (Austria, Czech
Republic, Hungary, Poland, Slovenia, Slovakia) were enrolled.
The patients had the following baseline characteristics: me-
dian age 64 (range 29-93); 61% male; 99.9% Caucasians; 79%
performance status ECOG 0/1; 17% never-smokers, 44% for-
mer smokers, 39% current smokers; tumor stages I, II, II and
IV in 9%, 7%, 24% and 61%; 79% adenocarcinomas, 10%
squamous cell carcinomas. EGFR mutation testing was done
by PCR-RFLP, Roche Cobas EGFR mutation test, sequencing,
high resolution melting or another method. EGFR mutations
were detected in tumors of 247 (13.8%) patients. Patients with
mutation-positive tumors were more frequently females than
males, never-smokers than former or current smokers, and
had adenocarcinomas in 87%. Mutation rates showed some
variation between centers, probably due to different patient
selection criteria for EGFR mutation testing. The mutation rate
increased from 5.7% in current smokers, to 12.1% in former
smokers and to 40.4% in never-smokers. Exon 19 deletions
were seen in 107 (43%) patients and L858R point mutations
in 70 (28%) patients. Thus the INSIGHT project demonstrated
that EGFR mutation testing has been established in routine
practice in major cancer centers of Central Europe.
treatment:
Patients with EGFR mutations receive first-
line therapy with one of the approved EGFR tyrosine kinase
inhibitors (afatinib, erlotinib, gefitinib). In these patients, each
of these drugs increased progression-free survival and im-
proved quality of life compared to first-line chemotherapy in
phase III trials. Most recently, a pooled analysis of the LUX-Lung
3 and LUX-Lung 5 trials revealed a survival benefit for afatinib
compared to cisplatin-based chemotherapy in patients with
common mutations, albeit the significant survival benefit
was limited to patients with exon 19 deletions. As part of
the INSIGHT study, data on first-line therapy were available
for 184 patients with advanced mutation-positive NSCLC.
Combining all treatment lines, EGFR tyrosine kinase inhibitors
were administered to 80.4% of the patients. Thus treatment
strategies for patients with EGFR mutation-positive tumors in
cancer centers of Central Europe are similar to those of other
countries. The data of the INSIGHT study were obtained from
major cancer centers in the region and might not necessarily
reflect the overall situation of testing and treatment on the
various country levels. Thus country-based data are necessary.
In this context, implementation of lung cancer registries in the
various countries will be of great help.