Fosaprepitant Shows Efficacy for Non-AC Chemotherapy Patients

Fosaprepitant may reduce delayed-phase nausea and vomiting symptoms after non-anthracycline and cyclophosphamide-based chemotherapy

  • Date: 12 Oct 2015
  • Author: Lynda Williams, Senior medwireNews Reporter
  • Topic: Supportive Measures

medwireNews: Patients undergoing moderately emetogenic, non-anthracycline and cyclophosphamide (non-AC)-based chemotherapy benefit from the addition of a single dose of neurokinin-1 (NK1) receptor antagonist fosaprepitant to their anti-emetic regimen, double-blind phase III trial results indicate.

The drug has previously been demonstrated to prevent acute- and delayed-phase chemotherapy-induced nausea and vomiting (CINV) in patients given highly emetogenic and AC-based treatment, explain Cindy Weinstein, from Merck & Co Inc in Kenilworth, New Jersey, USA, and co-workers.

Now, they report in the Annals of Oncology that, 78.9% of 502 patients randomly assigned to receive fosaprepitant 150 mg on day 1 of non-AC moderately emetogenic chemotherapy (MEC) alongside ondansetron and dexamethasone achieved a complete response, defined as no vomiting or need for rescue medication during the delayed phase.

This was a significantly higher complete response than the 68.5% rate in the group of 498 patients given placebo plus the serotonin 5-HT3 receptor antagonist and steroid therapy.

The fosaprepitant-treated patients were also significantly more likely to achieve an overall complete response than the controls (77.1 vs 66.9%), although the two groups had a comparable rate of complete response in the acute phase (93.2 vs 91.0%).

“This may be attributed in part to a higher than expected [complete response] rate… in the acute phase of the control group compared with that of previous studies”, Weinstein et al comment.

Nevertheless, there was a significant improvement achieved in rates of no vomiting for the acute, delayed and overall phases of treatment with fosaprepitant therapy compared with placebo, as well as an increased time to first vomiting episode.

And patients given fosaprepitant were significantly more likely to experience no CINV impact on their daily life, as measured by the Functional Living Index-Emesis total score, at 81.0% versus 75.5%.

Finally, the adverse event profile for both treatment groups was “generally typical of a population receiving emetogenic chemotherapy”, the authors say. Three (0.6%) patients given fosaprepitant experienced infusion-site thrombophlebitis compared with none of the placebo group.

“While these findings indicate that a single-dose fosaprepitant regimen can potentially offer the convenience of completing all antiemetic treatment prior to MEC initiation in a single day, the study was not designed to evaluate treatment differences among subgroups across the full heterogeneity of the MEC population”, the researchers note.

They therefore recommend further research to “fine-tune future antiemetic guidelines within the heterogeneous MEC population (eg, exploring differences between carboplatin and non-carboplatin-containing regimens and between single- versus multiday antiemetic regimen).”

Reference

Weinstein C, Jordan K, Green S, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol 2015; Advance online publication 8 October. doi: 10.1093/annonc/mdv482

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