Necitumumab plus Gemcitabine and Cisplatin as First-Line Therapy in Patients with Stage IV EGFR- Expressing Squamous Non-Small-Cell Lung Cancer: German Subgroup Data from an Open-Label, Randomized Controlled Phase 3 Study (SQUIRE).

Abstract

BACKGROUND:

In the SQUIRE study, adding the anti-epidermal growth factor receptor (EGFR) IgG1 antibody necitumumab to first-line gemcitabine and cisplatin (GC + N) in advanced squamous non-small-cell lung cancer (sqNSCLC) significantly improved overall survival (OS); the safety profile was acceptable. We explored data for the German subpopulation (N = 96) of SQUIRE patients with EGFR-expressing tumors.

PATIENT AND METHODS:

Patients with stage IV sqNSCLC were randomized 1:1 to up to 6 cycles of open-label GC + N or GC alone. GC + N patients with no progression continued on necitumumab monotherapy until disease progression or intolerable toxicity. The primary endpoint was OS; the secondary endpoints included progression-free survival (PFS), safety and health-related quality of life (EQ-5D, Lung Cancer Symptom Scale (LCSS)).

RESULTS:

The 96 German SQUIRE patients with EGFR-expressing tumors (GC + N 42, GC 54) received a median of 4 GC cycles; the GC + N patients received 5 cycles of necitumumab. Adding necitumumab was associated with 41% risk reduction of death (hazard ratio (HR) 0.59, 95% confidence interval (CI) 0.37-0.94, p = 0.026) and 44% risk reduction of progression (HR 0.56, 95% CI 0.33-0.95, p = 0.029). Adverse events typically associated with EGFR antibody treatment (including rash, hypomagnesemia) were more common with GC + N. The time to deterioration of the EQ-5D and LCSS scores showed no notable differences between the treatment arms, except for appetite loss (delayed for GC + N).

CONCLUSION:

The survival benefit from adding necitumumab to first-line GC was more pronounced in the German SQUIRE subpopulation with EGFR-expressing tumors than in the overall (intention-to-treat) population; toxicity was manageable and consistent with the overall population.

• Authors: Martin Reck, Michael Thomas, Cornelia Kropf-Sanchen, Jörg Mezger, Mark A Socinski, Henrik Depenbrock, Victoria Soldatenkova, Jacqueline Brown, Thomas Krause, Nick Thatcher
• Journal: Oncology research and treatment (Oncol Res Treat) Vol. 39 Issue 9 Pg. 539-47 ( 2016) ISSN: 2296-5262 [Electronic] Switzerland
• PMID: 27614872 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2016 S. Karger GmbH, Freiburg.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Deoxycytidine
• necitumumab
• EGFR protein, human
• ErbB Receptors
• Cisplatin
• Gemcitabine

Topics

• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• ErbB Receptors (metabolism)
• Female
• Germany (epidemiology)
• Humans
• Lung Neoplasms (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Neoplasm Staging
• Prevalence
• Risk Factors
• Survival Rate
• Treatment Outcome
• Gemcitabine