Aprepitant, Granisetron, and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting After High-Dose Melphalan in Autologous Transplantation for Multiple Myeloma: Results of a Randomized, Placebo-Controlled Phase III Trial

Schmitt, Thomas; Goldschmidt, Hartmut; Neben, Kai; Freiberger, Anja; Hüsing, Johannes; Gronkowski, Martina; Thalheimer, M.; Pelzl, Le Hang; Mikus, Gerd; Burhenne, Jürgen; Ho, Anthony D.; Egerer, Gerlinde

doi:10.1200/jco.2013.55.0095

Cited by 79 publications

(62 citation statements)

References 32 publications

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“…The incidence of vomiting on POD1 was significantly less in all patients receiving aprepitant in different doses. However, although most chemotherapy-related antiemetic regimes used 125 mg oral aprepitant,20 there are no dose recommendations for the perioperative use of aprepitant. Most PONV-related trials have used oral doses ranging from 40 to 125 mg without major adverse effects, except for one study which reported dizziness with 125 mg in comparison with 80 mg 15.…”

Section: Discussionmentioning

confidence: 99%

Aprepitant for postoperative nausea and vomiting: a systematic review and meta-analysis

Singh

Borle

Rewari

et al. 2015

Postgraduate Medical Journal

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Postoperative nausea and vomiting (PONV) is an important clinical problem. Aprepitant is a relatively new agent for this condition which may be superior to other treatment. A systematic review was performed after searching a number of medical databases for controlled trials comparing aprepitant with conventional antiemetics published up to 25 April 2015 using the following keywords: 'Aprepitant for PONV', 'Aprepitant versus 5-HT3 antagonists' and 'NK-1 versus 5-HT3 for PONV'. The primary outcome for the pooled analysis was efficacy of aprepitant in preventing vomiting on postoperative day (POD) 1 and 2. 172 potentially relevant papers were identified of which 23 had suitable data. For the primary outcome, 14 papers had relevant data. On POD1, 227/2341 patients (9.7%) patients randomised to aprepitant had a vomiting episode compared with 496/2267 (21.9%) controls. On POD2, the rate of vomiting among patients receiving aprepitant was 6.8% compared with 12.8% for controls. The OR for vomiting compared with controls was 0.48 (95% CI 0.34 to 0.67) on POD1 and 0.54 (95% CI 0.40 to 0.72) on POD2. Aprepitant also demonstrated a better profile with a lower need for rescue antiemetic and a higher complete response. Efficacy for vomiting prevention was demonstrated for 40 mg, 80 mg and 125 mg without major adverse effects. For vomiting comparison there was significant unexplainable heterogeneity (67.9% and 71.5% for POD1 and POD2, respectively). We conclude that (1) aprepitant reduces the incidence of vomiting on both POD1 and POD2, but there is an unexplained heterogeneity which lowers the strength of the evidence; (2) complete freedom from PONV on POD1 is highest for aprepitant with minimum need for rescue; and (3) oral aprepitant (80 mg) provides an effective and safe sustained antivomiting effect.

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Section: Discussionmentioning

confidence: 99%

Aprepitant for postoperative nausea and vomiting: a systematic review and meta-analysis

Singh

Borle

Rewari

et al. 2015

Postgraduate Medical Journal

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“…[17][18][19][23][24][25][26][27] Recently, a randomized placebo controlled trial demonstrated the superiority of adding aprepitant to granisetron with dexamethasone for patients undergoing autologous HSCT for multiple myeloma. 13 Overall, the existing data supports the use of aprepitant during conditioning for autologous HSCT.…”

Section: Introductionmentioning

confidence: 81%

Fosaprepitant for the prevention of nausea and vomiting in patients receiving BEAM or high-dose melphalan before autologous hematopoietic stem cell transplant

Clark

Clemmons

Schaack

et al. 2015

J Oncol Pharm Pract

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“…Chemotherapy-induced nausea and vomiting (CINV) development after standard premedication (palonosetron and dexamethasone) and after the addition of aprepitant. genic chemotherapy [24,[33][34][35][36][37][38][39]. Moreover, a single oral dose of aprepitant administered prior to abdominal surgery was found to be effective in the prevention of postoperative nausea and vomiting [40].…”

Section: Discussionmentioning

confidence: 99%

“…Moreover, a single oral dose of aprepitant administered prior to abdominal surgery was found to be effective in the prevention of postoperative nausea and vomiting [40]. A number of phase III studies have compared the efficacy of a standard antiemetic regimen (5-HT 3 antagonist and dexamethasone) versus a similar regimen plus aprepitant in patients undergoing highly emetogenic chemotherapy [33,[36][37][38][39], showing a higher percentage of complete responses and an improvement in the complete response rate when aprepitant was added. In addition, differences between the aprepitant-containing and standard regimens seen in the first cycle persisted over multiple cycles, and repeated administration of aprepitant appeared to be well tolerated.…”

Section: Discussionmentioning

confidence: 99%

Aprepitant plus palonosetron as salvage therapy for CINV induced by moderately emetogenic chemotherapy in cancer patients

Vincenzi

Frezza

Silletta

et al. 2016

CBN

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Background Despite the efficacy of prophylaxis with serotonin type 3 (5-HT 3 ) receptor antagonists, nausea and vomiting are still among the most common chemotherapy-induced toxicities. The aim of this study was to evaluate the efficacy of adding aprepitant in patients with chemotherapy-induced nausea and vomiting (CINV) refractory to prophylaxis with 5-HT 3 receptor antagonists and dexamethasone. Patients and Methods Between January 2008 and November 2010, 51 patients (median age 59 years) with a variety of malignancies (breast cancer: 23; lung cancer: 12; sarcoma: 6; ovarian cancer: 3; other: 7) were enrolled. All patients were refractory to antiemetic therapy according to ASCO guidelines and developed at least grade 2 nausea and/or vomiting after the first chemotherapy course. Aprepitant was given at 125 mg on day 1 and 80 mg on days 2-3. Patients also received a single dose of palonosetron 250 µg on day 1 plus dexamethasone 12-20 mg at a constant dose. Results After addition of aprepitant, the number of patients with grade 3/4 nausea decreased from 31 (61%) to 4 (8%), and those with grade 2 nausea from 20 (39%) to 6 (12%) [both p<0.0001]. All patients received aprepitant for more then two courses (range 3-8) and efficacy was maintained during all chemotherapy cycles. Conclusions This study showed that aprepitant was effective as salvage therapy in patients with CINV refractory to prophylaxis with 5-HT 3 receptor antagonists and dexamethasone following platinum-or nonplatinum-based chemotherapy, and that the efficacy of aprepitant persists over multiple cycles.

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Aprepitant, Granisetron, and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting After High-Dose Melphalan in Autologous Transplantation for Multiple Myeloma: Results of a Randomized, Placebo-Controlled Phase III Trial

Abstract: The addition of aprepitant resulted in significantly less CINV and had a positive effect on quality of life.

Cited by 79 publications

References 32 publications

Aprepitant for postoperative nausea and vomiting: a systematic review and meta-analysis

Aprepitant for postoperative nausea and vomiting: a systematic review and meta-analysis

Fosaprepitant for the prevention of nausea and vomiting in patients receiving BEAM or high-dose melphalan before autologous hematopoietic stem cell transplant

Aprepitant plus palonosetron as salvage therapy for CINV induced by moderately emetogenic chemotherapy in cancer patients

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