Intercalated erlotinib–eribulin ‘feasible’ without added efficacy

Jun 25 2014

By Lynda Williams, Senior medwireNews Reporter

Erlotinib can be intercalated with the anti-tubule agent eribulin mesylate for patients with advanced non-small-cell lung cancer (NSCLC) but it is unlikely to increase treatment efficacy in those without epidermal growth factor receptor (EGFR) activating mutations, research suggests.

The study, published in the Annals of Oncology, shows similar outcomes in the 63 patients randomly assigned to receive eribulin mesylate 2.0 mg/m² on day 1 with erlotinib 150 mg on days 2 to 16 (21-day regimen) and the 60 patients who received eribulin mesylate 1.4 mg/m² on days 1 and 8 with erlotinib 150 mg on days 15 to 28 (28-day regimen).

All patients had disease progression after receiving at least one platinum-based doublet chemotherapy but no previous EGFR–tyrosine kinase inhibitor (EGFR–TKI) treatment.

The primary endpoint of the trial was the objective response rate and this did not significantly differ between patients given the 21-day and 28-day regimens, at 13% versus 17%, report Tony Mok, from The Chinese University of Hong Kong, and co-authors.

The 21-day and 28-day regimens were also comparable with regard to disease control rates (48 vs 63%) and both median overall survival (7.6 vs 8.5 months) and progression-free survival (3.5 vs 3.8 months).

Analysis showed that sequential administration of erlotinib did not alter the pharmacokinetic profile of eribulin mesylate and both regimens were considered to be well tolerated. The most common grade 3 or more severe side effects were neutropaenia, fatigue and dyspnoea.

Mok et al say that while the study met the predefined criteria for the feasibility of intercalated treatment, the outcomes suggest similar efficacy to phase II trial results for eribulin given alone, with an objective response rate of 10.0%.

“Our findings suggest that addition of the EGFR-TKI erlotinib does not improve the treatment

outcome of eribulin in these patients (no selection by biomarker status) with advanced NSCLC”, the authors write.

“This may best be explained by the fact that most of the patients in this study did not harbour activating EGFR mutations”, they add, noting that the significance of these mutations was unclear when the study was designed.

Mok and team therefore conclude: “Future investigation should explore the combination in patients with EGFR mutant disease in comparison with single-agent EGFR-TKI.”

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