Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Hilbe, W; Pall, G; Kocher, F; Pircher, A; Zabernigg, A; Schmid, T; Schumacher, M; Jamnig, H; Fiegl, M; Gächter, A; Freund, M; Kendler, D; Manzl, C; Zelger, B; Popper, H; Wöll, E.
Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study).
PLoS One. 2015; 10(5):e0125364-e0125364
Doi: 10.1371/journal.pone.0125364
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- Co-Autor*innen der Med Uni Graz
- Popper Helmuth
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- Abstract:
- Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles. Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m2 d1+2) and docetaxel (75 mg/m2 d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m2 d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST. 40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months. Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected. EU Clinical Trials Register; Eudract-Nr: 2006-004639-31.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Antineoplastic Combined Chemotherapy Protocols - administration & dosage
- Carcinoma, Non-Small-Cell Lung - drug therapy
- Cetuximab - administration & dosage
- Cisplatin - administration & dosage
- Drug Administration Schedule -
- Female -
- Humans -
- Induction Chemotherapy - methods
- Lung Neoplasms - drug therapy
- Male -
- Middle Aged -
- Neoplasm Staging -
- Survival Analysis -
- Taxoids - administration & dosage
- Treatment Outcome -