Erlotinib and bevacizumab versus cisplatin, gemcitabine and bevacizumab in unselected nonsquamous nonsmall cell lung cancer.

Abstract

Erlotinib with bevacizumab showed promising activity in recurrent nonsquamous (NS) nonsmall cell lung cancer (NSCLC). The INNOVATIONS study was designed to assess in first-line treatment of unselected cisplatin-eligible patients this combination compared to cisplatin, gemcitabine and bevacizumab. Stage IIIB/IV patients with NS-NSCLC were randomised on erlotinib (150 mg daily) and bevacizumab (15 mg·kg(-1) on day 1, every 3 weeks) (EB) until progression, or cisplatin (80 mg·m(-2) on day 1, every 3 weeks) and gemcitabine (1250 mg·m(-2) on days 1 and 8, every 3 weeks) up to six cycles and bevacizumab (15 mg·kg(-1) on day 1, every 3 weeks) (PGB) until progression. 224 patients were randomised (EB n=111, PGB n=113). The response rate (12% versus 36%; p<0.0001), progression-free survival (median 3.5 versus 6.9 months; hazard ratio (HR) 1.85, 95% CI 1.39-2.45; p<0.0001) and overall survival (median 12.6 versus 17.8 months; HR 1.41, 95% CI 1.01-1.97; p=0.04) clearly favoured PGB. In patients with epidermal growth factor receptor mutations (n=32), response rate, progression-free survival and overall survival were not superior with EB. Platinum-based combination chemotherapy remains the standard of care in first-line treatment of unselected NS-NSCLC. Molecular targeted approaches strongly mandate appropriate testing and patient selection.

• Authors: Michael Thomas, Jürgen Fischer, Stefan Andreas, Cornelius Kortsik, Christian Grah, Monika Serke, Michael von Eiff, Christian Witt, Jens Kollmeier, Ernst Müller, Michael Schenk, Michael Schröder, Matthias Villalobos, Niels Reinmuth, Roland Penzel, Philipp Schnabel, Thomas Acker, Alexander Reuss, Martin Wolf, ABC-Lung Cancer Group
• Journal: The European respiratory journal (Eur Respir J) Vol. 46 Issue 1 Pg. 219-29 (Jul 2015) ISSN: 1399-3003 [Electronic] England
• PMID: 25792638 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright ©ERS 2015.

Chemical References

• Deoxycytidine
• Bevacizumab
• Erlotinib Hydrochloride
• ErbB Receptors
• Cisplatin
• Gemcitabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Bevacizumab (administration & dosage)
• Carcinoma, Non-Small-Cell Lung (drug therapy)
• Cisplatin (administration & dosage)
• DNA Mutational Analysis
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Disease Progression
• Disease-Free Survival
• ErbB Receptors (genetics)
• Erlotinib Hydrochloride (administration & dosage)
• Female
• Humans
• Lung Neoplasms (drug therapy)
• Male
• Middle Aged
• Mutation
• Proportional Hazards Models
• Treatment Outcome
• Gemcitabine