08 Mar Fosaprepitant reduces chemoradiotherapy-induced emesis in patients treated for cervical cancer
MedicalResearch.com Interview with:
Dr Christina H Ruhlmann PhD
Department of Oncology
Odense University Hospital, Denmark
MedicalResearch.com: What is the background for this study?
Response: The background for the GAND-emesis study is the result of a phase II study in patients with gynecological cancer receiving fractionated radiotherapy and concomitant weekly cisplatin 40 mg/m2. In that study, patients received weekly antiemetic prophylaxis with palonosetron and prednisolone, and we found that 57% of patients were continuously free from emesis (sustained no emesis) during 5 weeks of treatment. We hypothesized that the addition of a NK1 receptor antagonist could increase the number of patients with sustained no emesis, and we therefore planned the GAND-emesis study: a multinational, randomised, placebo-controlled, double-blind study that has recently been published.
MedicalResearch.com: What are the main findings?
Response: In the GAND-emesis study we compared efficacy of weekly antiemetic prophylaxis with fosaprepitant, palonosetron, and dexamethasone to placebo, palonosetron, and dexamethasone during 5 weeks of radiotherapy and concomitant weekly cisplatin 40 mg/m2 for cervical cancer. The primary endpoint was sustained no emesis during 5 weeks of treatment (competing risk analysis). We found that the proportion of patients with sustained no emesis was 48.7% for the placebo group compared with 65.7% for the fosaprepitant group, and the treatments were well tolerated. To our knowledge, this is the first study to investigate the efficacy of a NK1 receptor antagonist during 5 weeks of chemoradiotherapy.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: According to antiemetic guidelines, patients receiving cisplatin at any dose should receive prophylaxis including a NK1 receptor antagonist, even that the low doses of cisplatin have not been investigated in phase III studies. The GAND-emesis study now provides evidence that patients treated with fractionated radiotherapy and weekly cisplatin 40 mg/m2 should receive antiemetic prophylaxis with a NK1 receptor antagonist, palonosetron, and dexamethasone.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Efficacy and safety of fosaprepitant for the prevention of nausea and emesis during 5 weeks of chemoradiotherapy for cervical cancer (the GAND-emesis study): a multinational, randomised, placebo-controlled, double-blind, phase 3 trial
Ruhlmann, Christina H et al.
The Lancet Oncology , Volume 0 , Issue 0 ,
Published Online: 04 March 2016
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Dr Christina H Ruhlmann PhD (2016). Fosaprepitant Reduced Chemotherapy Induced Nausea in Cervical Cancer