| dc.contributor.advisor | Griesinger, Frank Prof. Dr. | |
| dc.contributor.author | Wenleder, Stefan | |
| dc.date.accessioned | 2021-07-09T10:00:26Z | |
| dc.date.available | 2021-07-28T00:50:08Z | |
| dc.date.issued | 2021-07-09 | |
| dc.identifier.uri | http://hdl.handle.net/21.11130/00-1735-0000-0008-589F-3 | |
| dc.identifier.uri | http://dx.doi.org/10.53846/goediss-8704 | |
| dc.identifier.uri | http://dx.doi.org/10.53846/goediss-8704 | |
| dc.language.iso | deu | de |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | |
| dc.subject.ddc | 610 | de |
| dc.title | CHALLENGE-Studie: Morphometrisches Tumoransprechen in Korrelation mit bildgebenden Verfahren (Spiral-CT und PET) bei Patienten mit NSCLC IIIA/B unter Induktionstherapie | de |
| dc.type | doctoralThesis | de |
| dc.title.translated | CHALLENGE Trial: Morphometric tumor response correlated with imaging (CT and PET-scan) in induction therapy in patients with NSCLC IIIA/B | de |
| dc.contributor.referee | Rieken, Stefan Prof. Dr. | |
| dc.date.examination | 2021-07-21 | |
| dc.description.abstracteng | CHALLENGE Trial: Morphometric tumor response correlated with imaging (CT and PET-scan) in induction therapy in patients with NSCLC IIIA/B.
Introduction: In 2004 we started a phase II trial with induction therapy platinum/gemcitabine based chemotherapy and the tyrosine kinase inhibitor erlotinib in unselected subjects with the aim to identify molecular markers for a response to this regime.
Methods: The study was a prospective, multi-center, open label, exploratory phase II trial to find with morphometry the pathological response rate (pRR). The subjects received an induction therapy with erlotinib 150 mg/d for 42 days and afterwards three weeks of three times a cycle of gemcitabine (1250 mg/m2 on days 1 and 8) and cisplatin (80 mg/m2 on day 1). Subjects showing complete remission, partial remission or stable disease in induction therapy received a combination of chemotherapy with erlotinib. After chemotherapy surgery of the primary tumor and lymph nodes was performed. Afterwards radiotherapy was applied on the tumor, lymph nodes and mediastinum.
Results: 54 subjects were prescreened and 16 patients were included in the main trial. Combination of erlotinib and gemcitabine/cisplatin was well tolerated, surgery was feasible after induction therapy in 12 of 16 patients. 7 of 12 patients had a major pathological response. Correlating morphometry and imaging procedures showed in 12 non-responding patients in 2. Restaging 4 x stable disease and one partial remission. 7 responding patients showed 5 x partial remission and 2 x stable disease. Median overall survival was 14,2 months at a range from 3,3 to 168,4 months. Five year survival was 18,8 %. 2 of 16 patients had an EGFR mutation. These patients had an overall survival with 72,8 and 49,7 months. The trial had to be terminated early because of slow recruitment.
Conclusion: In an era when EGFR-mutations in NSCLC were not known in detail, we tried to identify groups who would benefit from erlotinib induction. The trial showed that neoadjuvant chemotherapy is an alternative to adjuvant systemic treatment. The intercalated concept with chemotherapy and tyrosine kinase inhibitor was feasible. Our data show that histological and clinical response do not always lead to the same results. Due to small study population no general conclusions can be made. | de |
| dc.contributor.coReferee | Schön, Margarete Prof. Dr. | |
| dc.subject.ger | CHALLENGE | de |
| dc.subject.ger | Tumoransprechen | de |
| dc.subject.ger | Induktionstherapie | de |
| dc.subject.ger | NSCLC | de |
| dc.subject.eng | CHALLENGE | de |
| dc.subject.eng | Induction therapy | de |
| dc.subject.eng | Erlotinib | de |
| dc.subject.eng | NSCLC | de |
| dc.identifier.urn | urn:nbn:de:gbv:7-21.11130/00-1735-0000-0008-589F-3-3 | |
| dc.affiliation.institute | Medizinische Fakultät | de |
| dc.subject.gokfull | Innere Medizin - Allgemein- und Gesamtdarstellungen (PPN619875747) | de |
| dc.description.embargoed | 2021-07-28 | |
| dc.identifier.ppn | 1762640198 | |