Onkologie · 2006
Aprepitant as salvage therapy in patients with chemotherapy-induced nausea and emesis refractory to prophylaxis with 5-HT(3) antagonists and dexamethasone.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Oechsle Karin, Müller Martin R, Hartmann Jörg T, Kanz Lothar, Bokemeyer Carsten
Аннотация
BACKGROUND: Despite prophylaxis with 5-HT(3) antagonists and dexamethasone, nausea/emesis are common chemotherapy- induced toxicities. The aim of this trial was to evaluate the efficacy of adding the NK1 antagonist aprepitant in patients refractory to standard prophylaxis.
PATIENTS AND METHODS: Patients with significant nausea/vomiting despite prophylaxis with 5-HT(3) antagonists and dexamethasone were eligible. Aprepitant was added to the same antiemetic regimen used during previous cycles.
RESULTS: 34 patients received 92 cycles of chemotherapy with aprepitant which was applied orally at 125 mg on day 1 and 80 mg on days 2 and 3. All patients were refractory to standard antiemetic prophylaxis during cisplatin-based (n = 12) or other chemotherapy (n = 22). With the addition of aprepitant, all patients reported subjective improvement. The number of patients with nausea for >4 days decreased from 24 (71%) to 4 (12%) (p < 0.001), and the number of those with emesis for >2 days decreased from 26 (77%) to 0 (0%) (p < 0.001). In 12 patients receiving aprepitant for >2 cycles (3-8) the efficacy was maintained. No toxicity possibly related to aprepitant was observed.
CONCLUSION: Aprepitant demonstrated significant activity in patients with nausea/vomiting refractory to prophylaxis with 5-HT(3) antagonists and dexamethasone.
PATIENTS AND METHODS: Patients with significant nausea/vomiting despite prophylaxis with 5-HT(3) antagonists and dexamethasone were eligible. Aprepitant was added to the same antiemetic regimen used during previous cycles.
RESULTS: 34 patients received 92 cycles of chemotherapy with aprepitant which was applied orally at 125 mg on day 1 and 80 mg on days 2 and 3. All patients were refractory to standard antiemetic prophylaxis during cisplatin-based (n = 12) or other chemotherapy (n = 22). With the addition of aprepitant, all patients reported subjective improvement. The number of patients with nausea for >4 days decreased from 24 (71%) to 4 (12%) (p < 0.001), and the number of those with emesis for >2 days decreased from 26 (77%) to 0 (0%) (p < 0.001). In 12 patients receiving aprepitant for >2 cycles (3-8) the efficacy was maintained. No toxicity possibly related to aprepitant was observed.
CONCLUSION: Aprepitant demonstrated significant activity in patients with nausea/vomiting refractory to prophylaxis with 5-HT(3) antagonists and dexamethasone.