Randomised Phase 2 study of maintenance linsitinib (OSI-906) in combination with erlotinib compared with placebo plus erlotinib after platinum-based chemotherapy in patients with advanced non-small cell lung cancer.

Autor:	Ciuleanu, Tudor-Eliade, Ahmed, Samreen, Kim, Joo-Hang, Mezger, Jörg, Park, Keunchil, Thomas, Michael, Chen, Jihong, Poondru, Srinivasu, VanTornout, Jan M, Whitcomb, Debbie, Blackhall, Fiona, Mezger, Jörg
Předmět:	PLACEBOS PLATINUM compounds ANTINEOPLASTIC agents CELL receptors DRUG therapy COMPARATIVE studies HETEROCYCLIC compounds LUNG cancer IMIDAZOLES LUNG tumors RESEARCH methodology MEDICAL cooperation RESEARCH STATISTICAL sampling EVALUATION research RANDOMIZED controlled trials KAPLAN-Meier estimator THERAPEUTICS
Zdroj:	British Journal of Cancer; 9/5/2017, Vol. 117 Issue 6, p757-766, 10p, 5 Charts, 1 Map
Abstrakt:	Background: Maintenance therapy is important in advanced/metastatic non-small cell lung cancer (NSCLC). Erlotinib as switch maintenance following platinum-based chemotherapy increases survival. Cross-talk between the epidermal growth factor receptor and insulin-like growth factor receptor (IGFR) pathways mediate resistance to individual receptor blockade. This study compared maintenance linsitinib plus erlotinib vs erlotinib plus placebo in patients with NSCLC.Methods: In this Phase II randomised trial, patients without progression following four cycles of first-line platinum-based chemotherapy (N=205) received continuous schedule maintenance oral linsitinib 150 mg or placebo BID combined with erlotinib 150 mg QD for 21-day cycles. The primary endpoint was progression-free survival (PFS).Results: The study was unblinded early due to linsitinib non-superiority. No difference was found between the two treatment groups in median PFS of 125 days linsitinib vs 129 days placebo (P=0.601); no difference in overall survival (OS) was observed. Tolerability was similar, although in the linsitinib group, treatment-related adverse events and discontinuations were more frequent. No drug-drug interaction was implicated.Conclusions: Linsitinib maintenance therapy added to erlotinib did not improve PFS or OS in non-progressing NSCLC patients. This highlights the need for robust biomarkers of response for combinations that incorporate IGFR-targeted therapies in maintenance or other therapeutic settings. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
Externí odkaz:	Zobrazit plný text záznamu Full text from SpringerLink