Open, randomized, multi-center phase II study comparing efficacy and tolerability of Erlotinib vs. Carboplatin/Vinorelbin in elderly patients (>70 years of age) with untreated non-small cell lung cancer.

Autor: Heigener DF; Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany. Electronic address: d.heigener@lungenclinic.de., Deppermann KM; Department of Pulmonology, HELIOS Klinikum Erfurt, Erfurt, Germany., Pawel JV; Department of Pulmonology, Asklepios Klinikum Gauting, Munich, Germany., Fischer JR; Department of Oncology, Klinik Löwenstein, Löwenstein, Germany., Kortsik C; Department of Pulmonology, Hildegardis Krankenhaus, Mainz, Germany., Bohnet S; Department of Pulmonology, Universitätsklinikum Schleswig Holstein Campus Lübeck, Member of the German Center for Lung Research (DZL), Lübeck, Germany., Eiff MV; Department of Internal Medicine, Malteser Hildegardis Krankenhaus Köln, Köln, Germany., Koester W; Department of Oncology, Kliniken Essen-Mitte Essen, Essen, Germany., Thomas M; Thoracic Oncology, Thoraxklinik of Heidelberg University, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany., Schnabel PA; Department of Pathology, Thoraxklinik of Heidelberg University, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany., Reck M; Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.
Jazyk: angličtina
Zdroj: Lung cancer (Amsterdam, Netherlands) [Lung Cancer] 2014 Apr; Vol. 84 (1), pp. 62-6. Date of Electronic Publication: 2014 Feb 03.
DOI: 10.1016/j.lungcan.2014.01.024
Abstrakt: Background: Targeting the epidermal-growth-factor-receptor (EGFR) in non-small cell lung cancer (NSCLC) is an established treatment option with less toxicity compared to conventional chemotherapy. This study was undertaken to determine whether Erlotinib is non-inferior compared to chemotherapy as a first-line therapy in unselected elderly patients.
Materials and Methods: Patients ≥ 70 years with untreated, metastatic NSCLC were randomized to Erlotinib (E), 150 mg/day or Carboplatin (AUC5) plus Vinorelbine (25mg/m(2) on days 1 and 8) every three weeks (CV). Primary endpoint was progression-free survival (PFS). After progression, crossover was strongly recommended. Secondary endpoints were duration of response, 1-year survival, overall survival (OS), response rate (RR), quality of life (FACT-L), assessment of comorbidities by simplified comorbidity score (SCS) and Charlsons' comorbidity score, safety and assessment of molecular markers.
Results: Between June 2006 and August 2008 284 pts were randomized to E (144) and CV (140). PFS was significantly inferior with E (median PFS 2.4 versus 4.6 months [HR 1.6, 75% CI 1.22-2.09, p: 0.0005]) as well as RR (7.8% v 28.3%, p: 0.0001). No significant difference in OS appeared (median E: 7.3 months versus CV: 8.4 months, HR: 1.24 [75% CI 0.9-1.71]). In never smokers PFS (median PFS: 3.7 v 4.3 m, E v CV, HR 0.72, 75% CI 0.35-1.48) and OS (median: 16.5 versus 17 months, HR 0.99 [75% CI 0.38-2.57]) were comparable. More skin toxicity and diarrhea was seen with E compared to more myelotoxicity, neurotoxicity and constipation with CV. Less severe adverse events were observed with E (81 v 102, E v CV).
Conclusion: CV had an increased efficacy compared with E in an unselected population of elderly patients with advanced NSCLC.
(Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)
Databáze: MEDLINE
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