Chemotherapy with cetuximab versus chemotherapy alone for chemotherapy-naive advanced non-small cell lung cancer.

摘要: Background In advanced non-small cell lung cancer (NSCLC), the effectiveness of standard cytotoxic chemotherapy seems to have reached a 'plateau', and there is continuous need for new treatments further improve prognosis. Cetuximab monoclonal antibody targeted at epidermal growth factor receptor (EGFR) signalling pathway. Basically, it designed inhibit metastasis among other biological processes cancer. In combination with chemotherapy, has been evaluated as first-line treatment NSCLC in some randomised controlled trials (RCTs), inconsistent results. Objectives To evaluate efficacy toxicity plus cetuximab, compared alone, (NSCLC) previously untreated or (EGFR)-targeted drugs. Search methods We systematically searched Cochrane Lung Cancer Review Group's Specialized Register (from inception 17 December 2013), Central Controlled Trials (CENTRAL) (The Library 2013, Issue 12), MEDLINE (accessed through PubMed, 1966 EMBASE (1980 ClinicalTrials.gov World Health Organization (WHO) International Clinical Trials Registry Platform 2013). We also handsearched proceedings related from American Society Oncology European Society Medical (2000 checked reference lists all eligible primary studies review articles for additional potentially studies. Selection criteria Eligible were RCTs that cetuximab same NSCLC, EGFR-targeted drugs, measured least one following: overall survival, progression-free one-year survival rate, objective response quality life, serious adverse events. Data collection analysis We used methodological procedures expected by The Collaboration. extracted following data each study: publication details, participant characteristics, regimens intervention control arms, outcome measures effect size, information study. effects on dichotomous time-to-event outcomes risk ratio (RR) hazard (HR), 95% confidence intervals (CIs), respectively. conducted meta-analyses Manager 5 using random-effects model. employed Mantel-Haenszel method combine RRs inverse-variance HRs. Main results We included four trials, containing 2018 patients. subjects mostly white people (female: 26% 56%), median age 58 66 years. About half them had histologically proven adenocarcinoma. Of patients, 83% 99% their status using the Eastern Cooperative Group performance status, score 0 1 (which usually considered physically "fit"). All provided events, two (1901 patients) investigating life well. bias was low high outcomes, mainly due lack blinding. Compared improved (10.5 months versus 8.9 months; HR 0.87, CI 0.79 0.96), rate (45% 40%; RR 1.13, 1.02 1.25), (30% 23%; 1.31, 1.14 1.51). difference limit statistical significance (4.9 4.4 0.91, 0.83 1.00). No significant between arms reported relevant studies. Patients group experienced more acneiform rash (11.2% 0.3%; 37.36, 10.66 130.95), hypomagnesemia (5.3% 0.8%; 6.57, 1.13 38.12), infusion reaction (3.9% 1.1%; 3.50, 1.76 6.94), diarrhoea (4.8% 2.3%; 2.10, 1.26 3.48), hypokalaemia (6.3% 3.6%; 1.74, 2.99), febrile neutropenia (10.6% 7.6%; 1.40, 1.10 1.77), leukopenia (58.1% 42.7%; 1.36, 1.17 1.58) than did those group. events not reach significance. According reports original studies, generally manageable. There no cetuximab-related deaths. The evidence but most secondary outcomes. Authors' conclusions The better alone improving while inducing higher rates reportedly manageable events.