Targettherapie des NSCLC: Studien
| BR.21 | NSCLC, inoperabel, Erlotinib nach Chemotherapie |
| TRUST | NSCLC, inoperabel, Erlotinib nach Chemotherapie |
| SATURN | NSCLC, inoperabel, Erlotinib nach Chemotherapie |
| EURTAG | Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations, weiße Patienten |
| OPTIMAL | Phase III, randomized, open-label study of first-line erlotinib versus gemcitabine/carboplatin in patients with EGFR-activating mutation-positive (EGFR Act Mut+) advanced non-small cell lung cancer (NSCLC), asiatische Patienten. Phase III, randomized, open-label study of first-line erlotinib versus gemcitabine/carboplatin in patients with EGFR-activating mutation-positive (EGFR Act Mut+) advanced non-small cell lung cancer (NSCLC). Chinesische Patienten. PFS Erlitinib 13,7M, Gemzitabine-Carboplatin 4,6M. |
| TITAN | NSCLC, inoperabel, Erlotinib v Chemotherapie, 337 Pat. second Line |
| Innovations | Randomized phase II trial of erlotinib (E)/bevacizumab (B) compared with cisplatin (P)/gemcitabine (G) plus B in first-line treatment of advanced nonsquamous (NS) non-small cell lung cancer (NSCLC). |
| FastAct-2 | GC-Erlotinib besser als GC-Placebo |
| Ensure | |
| RADIANT | Eine postoperative Behandlung mit Erlotinib nach kompletter Resektion ERFR-exprimierender NSCLC verbessert das DFS nicht(10). |
| IMPACT | Postoperativ Gefitinib v. Cisplatin-Vinorelbine, Stadium II-IIIA, mit EGFR Mutation (13) |
| INTEREST | NSCLC, inoperabel, Platin-vorbehandelt: Gefitinib (Iressa) oder Docetaxel |
| IPASS | NSCLC, inoperabel,Carboplatin - Taxol v Gefitinib, 1217 asiatische Pat. first Line |
| V-15-32 | NSCLC, inoperabel, Docetaxel v Gefitinib, 489 asiatische Pat. second Line |
| First Signal | Iressa v Cisplatin-Gemzitabine, Korea |
| WJTOG 3405 | |
| NEJSG 002 | |
| IMPRESS | Second Line, Cisplatin - Pemetrexed +- Gefitinib |
| IFUM | IRESSA Follow-Up Measure study (9). Phase IV, single-arm, 106 metastasiertes EGFR-mutiertes NSCLC. Europäer. IRESSA® 250mg. ORR 70%, DoR 8.3 months, Disease Control Rate 90.6%, PFS 9.7 M, OS 19.2M |
| REASON | Nicht interventionelle Anwendungsstudie. 4243 Patienten aus 149 deutschen Zentren. 431 EGFR mutiert. Mutation im Exon 19 hatten nach Gefitinib ein signifikant längeres überleben. |
| NeoIntercal | EGFR-mutiertes NSCLC: Induktion mit Gefitinib. Dann Taxan-Platin -Gefitinib. OP ev. PORT. Studie rekrutiert. |
| LUX-Lung 3 | |
| LUX-Lung 6 | |
| LUX-Lung 7 | Afatinib versus Gefitinib first line bei EGFR-M+ Bronchialkarzinom |
| LUX-Lung 8 | Afatinib (GILOTRIF®) verlängert gegenüber Erlotinib (Tarceva®) das progressionsfreie Überleben und das Gesamtüberleben einer second-line Therapie bei fortgeschrittenen, EGFR-positiver Plattenepithelkarzinomen des Bronchus. |
| Profil 1007 | fortgeschrittenes ALK - positives NSCLC |
| Profil 1014 | First Line, fortgeschrittenes ALK - positives NSCLC, Critozinib versus Carboplatin - Pemetrexed |
| SWOG 1300 | Second Line, Pemetrexed +- Critozinib |
| ALEX | Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung Cancer |
| ALTA-1L | Brigatinib versus Crizotinib in ALK-positive non-small-cell lung cancer |
| AVAiL | Bevacizumab beim fortgeschrittenen NSCLC (nicht SCC) ergibt keine Verlängerung der Überlebenszeit. |
| Stadium IIIb, IV: Carboplatin/Paclitaxel +- Bevacizumab(Avastin). Mit Avastin ist das Überleben signifikant höher. | |
| CALGB-8433 | Carboplatin/Paclitaxel +- Bevacizumab (5) |
| RTOG 8808 | Carboplatin/Paclitaxel +- Bevacizumab (6) |
| JO25567 | Erlotinib alone or with bevacizumab as first-line |
Teil von
Erlotinib versus docetaxel or pemetrexed as second line therapy in patients with advanced non small cell lung cancer and poor prognosis: Efficacy and safety results from phase III TITAN study.
Chicago Multidisciplinary Symposium in Thoracic Oncology 9-11.12.2010, Chicago, abstr LBOA5.
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Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma.
NEJM 361(2009):947–957.
3.) Maruyama R, et al.:
Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non–small-cell lung cancer.
JCO 26(2008):4244–4252.
4.) Douillard JY, et al., for the Adjuvant Navelbine International Trialist Association:
Impact of postoperative radiation therapy on survival in patients with complete resection and stage I, II, or IIIA non–small-cell lung cancer treated with adjuvant chemotherapy: The adjuvant Navelbine International Trialist Association (ANITA) randomized trial.
IJROBP 72(2008):695–701.
5.) Dillman RO, et al:
Improved survival in stage III non-small-cell lung cancer: Seven-year follow-up of cancer and leukemia group B (CALGB) 8433 trial.
JNCI 88(1996):1210-1215
6.) Sause W, Kolesar P, Taylor S IV, et al:
Final results of phase III trial in regionally advanced unresectable non-small cell lung cancer: Radiation Therapy Oncology Group, Eastern Cooperative Oncology Group, and Southwest Oncology Group.
Chest 117(2000):358-364
7.) Bradley J, Paulus R, Komaki R, et al.:
A randomized phase III comparison of standard-dose (60 Gy) versus high-dose (74 Gy) conformal chemoradiotherapy +/- cetuximab for stage IIIa/IIIb non-small cell lung cancer: Preliminary findings on radiation dose in RTOG 0617.
53. ASTRO-Kongress, Miami 2.-6.10.2011
8.) Spigel DR, et al.:
JCO 29(2011) Suppl, Abstract 7505
9.) Douillard J-Y, Ostoros G, Cobo M, et al.:
First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study.
Br J Cancer 2014;110:55–62
10.) Kelly K, et al.:
Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non–Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial.
JCO 2015;34:4007-4014; DOI 10.1200/JCO.2015.61.8918.
11.) Rittmeyer A Barlesi F, et al.:
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial.
Lancet 2017; 389: 255–65.
12.) J-C Soria, et al. for the FLAURA Investigators:
Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer.
N Engl J Med 2018;378:113-25.
DOI: 10.1056/NEJMoa1713137
13.) Tada H, et al. for the West Japan Oncology Group:
Randomized Phase III Study of Gefitinib Versus Cisplatin Plus Vinorelbine for Patients With Resected Stage II-IIIA Non–Small-Cell Lung Cancer With EGFR Mutation (IMPACT).
J Clin Oncol 2022;40:231-241
