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

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 (intentionto-treat) population; toxicity was manageable and consistent with the overall population.

Necitumumab plus platinum-based chemotherapy versus chemotherapy alone as first-line treatment for stage IV non-small cell lung cancer: a meta-analysis based on randomized controlled trials

“…As shown in Figure 1, 8 articles based on 4 RCTs involving 2,074 patients (NC group, 1,060; CA group, 1,014) were selected for this meta-analysis (5,12,(14)(15)(16)(21)(22)(23). Five articles were from the phase III SQUIRE trial, among which Reck's study analyzed the tolerability and quality of life (21), Paz-Ares L's study analyzed the safety and efficacy outcomes of EGFR-expression patients (5), Reck's other study paid more attention to a German subgroup (22), Paz-Ares L's other study focused on east Asian patients, and one focused on the anticancer effectiveness based on OS, PFS, ORR, and DCR with toxicity based on AEs (15). The indicators they analyzed were different, so we analyzed several articles.…”

Advancing the Management of Non-small Cell Lung Cancer

“…The survival benefit was more pronounced in the German SQUIRE subpopulation with EGFR-expressing tumours than in the overall (intention-to-treat) population (HR 0.59, p=0.026). 62 In another subpopulation of patients with EGFR protein expression, OS for EGFR >0 patients was significantly longer in the necitumumab plus gemcitabine-cisplatin group than in with advanced non-squamous cell NSCLC. 64 The trial was prematurely closed due to an increased number of fatal thromboembolic events in patients in whom necitumumab had been added to cisplatin.…”

Drug Delivery Opportunities in Esophageal Cancer: Current Treatments and Future Prospects

“…Given that EGFR upregulation is common in many cancer types, there are several FDA-approved monoclonal antibody therapies in clinical use across multiple malignancies. These include: cetuximab for the treatment of both metastatic colorectal and squamous cell cancers, panitumumab for metastatic colorectal cancer, nimotuzumab for gliomas and head/neck cancer, and necitumumab for the treatment of nonsmall cell lung cancer . However, there are no currently approved therapies for treatment of esophageal cancer .…”