First-line chemo plus necitumumab improves overall survival in advanced NSCLC
Adding necitumumab to standard chemotherapy in a first-line setting significantly improves overall survival in patients with stage IV nonsmall cell lung cancer (NSCLC), a study has shown. However, results for progression-free survival (PFS) and objective response rate (ORR) are not statistically significant.
The investigators performed a comprehensive literature search according to the prespecified inclusion and exclusion criteria and extracted data on overall survival, PFS, ORR, and adverse events. They also conducted a meta-analysis to obtain pooled hazard ratios (HRs) and corresponding 95 percent confidence intervals (CIs) for time-to-event data and pooled odds ratio (ORs) with 95 percent CIs for dichotomous outcomes.
Four randomized clinical trials, involving 2,071 patients overall, were included in the meta-analysis. Pooled results revealed a significant improvement for overall survival (HR, 0.87, 95 percent CI, 0.79–0.95; p=0.004) with the combination of chemotherapy and necitumumab in patients with advanced NSCLC. There was no statistically significant improvement seen for PFS (HR, 0.83, 95 percent CI, 0.69–1.01; p=0.06) and ORR (OR, 1.46, 95 percent CI, 0.90–2.38; p=0.13).
In subgroup analysis, the combination therapy conferred no benefit in overall survival and ORR in patients with nonsquamous NSCLC. Moreover, those with advanced NSCLC who received necitumumab were at highest risk of developing a skin rash (OR, 14.50, 95 percent CI, 3.16–66.43; p=0.0006) and hypomagnesaemia (OR, 2.77, 95 percent CI, 2.23–3.45; p<0.00001). These patients also had a 55-percent (95 percent CI, 1.28–1.87; p<0.00001) greater risk of developing any grade ≥3 adverse event.