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First-Line EGFR TKI beim inoperablen NSCLC mit EGFR-aktivirenden Mutationen

allgemeines 1. Generation: Erlotinib, Gefitinib 2. Generation: Afatinib, Dacomitinib 3. Generation: Osimertinib, wirksam auch bei T790M in Exon 20 Mutation
Mutationen Exon 18: G719X Exon 19: del/Ins Exon 20: + T790M Exon 21: L858R L861Q
Studien Ergebnisse von 7 prospektiven, randomisierten Phase III-Studien inoperables NSCLC mit EGFR-aktivirenden Mutationen First-Line EGFR TKI und Platin-basierte Chemotherapie
Ergebnis
Quelle Studie Therapie Patienten Response PFS OS
Mok (1) IPASS Gefitinib 132 71,2%* 9,5M* 21,6M
Chemotherapy 129 47,3% 6,3 M 21,9M
Lee(2) First-SIGNAL Gefitinib 22 84,6%* 8,4M 30,6M
Chemotherapy 6 37,5 % 6,7 M 26,5 M
Maemondo(3) NEJSG002 Gefitinib 114 73,7 %* 10,8 M* 30,5 M
Chemotherapy 110 30,7% 5,4 M 23,6 M
Mitsudomi (4,5) WJTOG 3405 Gefitinib 86 62,1%* 9,2 M* 35,5 M
Chemotherapy 86 32,2 % 6,3 M 38,8 M
Zhou(6) OPTIMAL (CTONG-0802) Erlotinib 82 82,9 % * 13,1 M* N/R
Chemotherapy 72 36,1 % 4,6 M N/R
Rosell(7) EURTAC Erlotinib 86 55 % * 9,7 M* N/R
Chemotherapy 87 11% 5,2 M N/R
Yang (8) LUX-Lung 3 Afatinib 230 56,1% 11,1 M * N/R
Chemotherapy 115 22,6 % 6,0 M N/R

N/R: nicht erreicht
*: signifikant
IPASS Iressa Pan-Asia Study
First-SIGNALFirst-Line Single-Agent Iressa Versus Gemcitabine and Cisplatin Trial in Never-Smokers With Adenocarcinoma of the Lung
NEJSG002 A Phase III Trial Comparing Gefitinib to Carboplatin CBDCA Plus Paclitaxel TXL as the First-Line Treatment for Advanced Non-Small-Cell Lung Cancer NSCLC With EGFR Mutations
WJTOG 3405 West Japan Thoracic Oncology Group 3405; Randomized Phase III Trial Comparing Gefitinib With Cisplatin Plus Docetaxel as the First-Line Treatment for Patients With Non-Small-Cell Lung Cancer Harboring Mutations of the Epidermal Growth Factor Receptor
OPTIMAL (CTONG-0802) Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer
EURTAC European Tarceva erlotinib versus Chemotherapy
LUX-Lung 3 A Randomized, Open-Label, Phase III Study of Afatinib Versus Pemetrexed and Cisplatin as First-Line Treatment for Patients With Advanced Adenocarcinoma of the Lung Harboring EGFR-Activating Mutations
Quellen 1. Mok TS, et al:
Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma.
N Engl J Med 361(2009):947-957

2.) Han JY, et al:
First-SIGNAL: First-line single-agent iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung.
J Clin Oncol 30(2012):1122-1128

3.) Maemondo M, et al:
Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR.
N Engl J Med 362(2010):2380-2388

4.) Mitsudomi T, et al:
Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): An open label, randomised phase 3 trial.
Lancet Oncol 11(2010):121-128

5.) Mitsudomi T, et al:
Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor (EGFR).
J Clin Oncol 30(2012):485s, (suppl; abstr 7521)

6.) Zhou C, et al:
Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): A multicentre, open-label, randomised, phase 3 study.
Lancet Oncol 12(2011):735-742

7.) Rosell R, et al:
Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): A multicentre, open-label, randomised phase 3 trial.
Lancet Oncol 13(2012):239-246

8.) Yang JC-H, et al:
LUX-Lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations.
J Clin Oncol 30(2012):480s, (suppl; abstr LBA7500)

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Impressum .....................................................................................Zuletzt geändert am 03.08.2013 9:51