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.

Abstract

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.

• Authors: D F Heigener, K M Deppermann, J V Pawel, J R Fischer, C Kortsik, S Bohnet, M V Eiff, W Koester, M Thomas, P A Schnabel, M Reck
• Journal: Lung cancer (Amsterdam, Netherlands) (Lung Cancer) Vol. 84 Issue 1 Pg. 62-6 (Apr 2014) ISSN: 1872-8332 [Electronic] Ireland
• PMID: 24560332 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Quinazolines
• Vinblastine
• Carboplatin
• Erlotinib Hydrochloride
• ErbB Receptors
• Vinorelbine

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carboplatin (administration & dosage)
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
• ErbB Receptors (genetics)
• Erlotinib Hydrochloride
• Female
• Humans
• Lung Neoplasms (drug therapy, mortality, pathology)
• Male
• Mutation
• Neoplasm Staging
• Quinazolines (administration & dosage, therapeutic use)
• Risk Factors
• Treatment Outcome
• Vinblastine (administration & dosage, analogs & derivatives)
• Vinorelbine