Efficacy of necitumumab recombinant human monoclonal antibody that blocks the ligand binding epidermal growth factor receptor (EGFR) in patients with squamous (SQ) non-small-cell lung cancer (NSCLC) ...has been confirmed in two randomized clinical trials (SQUIRE and JFCM). This study evaluated the association between efficacy and initial skin toxicity with necitumumab treatment by analyzing pooled data from two clinical trials (SQUIRE and JFCM).
Data of 635 patients with SQ-NSCLC (intent-to-treat population) treated with necitumumab plus gemcitabine and cisplatin (N + GC) were pooled from two clinical trials (SQUIRE and JFCM). The relationship between skin toxicities developed by the end of the second cycle and efficacy was evaluated. Efficacy endpoints included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Univariate and multivariate analyses were carried out for these endpoints.
OS and ORR were associated with skin toxicity, whereas PFS was not. Patients with grade ≥2 or grade 1 skin toxicity had significantly longer OS compared to patients without skin toxicity (grade 0) in the N + GC group median = 15.0 (grade ≥2); 12.7 (grade 1); 9.4 (grade 0) months; hazard ratio (HR) = 0.51 (grade ≥2 to grade 0); 95% confidence interval (CI) 0.40-0.64, P < 0.001 and HR = 0.64 (grade 1 to grade 0); 95% CI 0.52-0.80, P < 0.001. In multivariate analysis, OS was significantly associated with skin toxicity.
A significant association was found between necitumumab-induced skin toxicity and efficacy. These results are consistent with the previously reported association between other EGFR inhibitors-induced skin toxicity and efficacy.
•This is a pooled analysis to evaluate an association between necitumumab-induced skin toxicity and efficacy.•Skin toxicity was associated with OS and ORR.•Skin toxicity and performance status were associated with OS by multivariate analysis.•Skin toxicity was not associated with necitumumab trough concentration.•Prompt management of skin toxicity should be implemented for effective necitumumab treatment.
An abstract of a study by Sawada et al on the mutational analysis of primary tumors and single circulating tumor cells (CTC) captured by a novel dielectrophoretic microwell array system in metastatic ...breast cancer, oral cancer, and lung cancer patients is presented. The study involves CTC enrichment by density gradient centrifugation with RosetteSep, and samples were loaded into the cell entrapment chamber. Results of single CTC sequencing revealed that CTCs have various cancer related gene mutations, same mutations in three particular genes were detected among CTCs from multiple patients regardless of cancer types, from the results of comparison mutational analysis between primary tumor tissue and CTCs.
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