Faculty Opinions recommendation of Aprepitant versus dexamethasone for preventing chemotherapy-induced delayed emesis in patients with breast cancer: a randomized double-blind study.

2013 ◽  
Author(s):  
Ana Maria Gonzalez-Angulo
Keyword(s):  
Breast Cancer ◽  
Blind Study ◽  
Double Blind Study ◽  
Delayed Emesis ◽  
Double Blind

Aprepitant Versus Dexamethasone for Preventing Chemotherapy-Induced Delayed Emesis in Patients With Breast Cancer: A Randomized Double-Blind Study

2014 ◽  
Vol 32 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Fausto Roila ◽  
Benedetta Ruggeri ◽  
Enzo Ballatori ◽  
Albano Del Favero ◽  
Maurizio Tonato
Keyword(s):  
Breast Cancer ◽  
Response Rates ◽  
Complete Response ◽  
Similar Efficacy ◽  
Blind Study ◽  
Double Blind Study ◽  
Delayed Emesis ◽  
Double Blind ◽  
Acute Emesis ◽  
Antiemetic Prophylaxis

PurposeA combination of aprepitant, a 5-HT3 receptor antagonist, and dexamethasone is recommended for the prophylaxis of acute or delayed emesis induced by chemotherapy containing anthracyclines plus cyclophosphamide in patients with breast cancer. The aim of this study was to verify whether dexamethasone is superior to aprepitant in preventing delayed emesis in patients receiving the same prophylaxis for acute emesis.Patients and MethodsA randomized double-blind study comparing aprepitant versus dexamethasone was completed in chemotherapy-naive patients with breast cancer treated with anthracyclines plus cyclophosphamide. Before chemotherapy, all patients were treated with intravenous palonosetron 0.25 mg, dexamethasone 8 mg, and oral aprepitant 125 mg. On days 2 and 3, patients randomly received oral dexamethasone 4 mg twice per day or aprepitant 80 mg once per day. Primary end point was rate of complete response (ie, no vomiting or rescue treatment) from days 2 to 5 after chemotherapy.ResultsOf 580 enrolled patients, 551 were evaluable: 273 received dexamethasone, and 278 received aprepitant. Day 1 complete response rates were similar: 87.6% for dexamethasone and 84.9% for aprepitant (P < .39). From days 2 to 5, complete response rates were the same with both antiemetic prophylaxes (79.5%; P < 1.00), as were results of secondary end points (ie, complete protection, total control, no vomiting, no nausea, score of Functional Living Index–Emesis; P < .24). Incidences of insomnia (2.9% v 0.4%; P < .02) and heartburn (8.1% v 3.6%; P < .03) were significantly greater with dexamethasone on days 2 to 5.ConclusionIn patients with breast cancer treated with anthracycline plus cyclophosphamide chemotherapy and receiving the same antiemetic prophylaxis for acute emesis, dexamethasone was not superior to aprepitant but instead had similar efficacy and toxicity in preventing delayed emesis.

scholarly journals PF-05280014 (a trastuzumab biosimilar) plus paclitaxel compared with reference trastuzumab plus paclitaxel for HER2-positive metastatic breast cancer: a randomised, double-blind study

2018 ◽  
Vol 120 (2) ◽  
pp. 172-182 ◽  
Author(s):  
Mark D. Pegram ◽  
Igor Bondarenko ◽  
Marina Moreira Costa Zorzetto ◽  
Sachin Hingmire ◽  
Hirotaka Iwase ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Metastatic Breast ◽  
Blind Study ◽  
Double Blind Study ◽  
Her2 Positive ◽  
Double Blind

Thoracic Paravertebral Block for Breast Cancer Surgery: A Randomized Double-Blind Study

2007 ◽  
Vol 105 (6) ◽  
pp. 1848-1851 ◽  
Author(s):  
Jytte F. Moller ◽  
Lone Nikolajsen ◽  
Svein Aage Rodt ◽  
Hanne Ronning ◽  
Palle S. Carlsson
Keyword(s):  
Breast Cancer ◽  
Cancer Surgery ◽  
Paravertebral Block ◽  
Blind Study ◽  
Breast Cancer Surgery ◽  
Double Blind Study ◽  
Double Blind ◽  
Thoracic Paravertebral Block

scholarly journals Aprepitant versus metoclopramide, both combined with dexamethasone, for the prevention of cisplatin-induced delayed emesis: a randomized, double-blind study

2015 ◽  
Vol 26 (6) ◽  
pp. 1248-1253 ◽  
Author(s):  
F. Roila ◽  
B. Ruggeri ◽  
E. Ballatori ◽  
S. Fatigoni ◽  
C. Caserta ◽  
...  
Keyword(s):  
Blind Study ◽  
Double Blind Study ◽  
Delayed Emesis ◽  
Double Blind

Aprepitant (AP) versus dexamethasone (D) for preventing delayed emesis induced by anthracyclines plus cyclophosphamide (A+C) chemotherapy (CT) in breast cancer patients (pts): A double-blind, multicenter, randomized study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9614-9614 ◽  
Author(s):  
Fausto Roila ◽  
Enzo Ballatori ◽  
Alessandra Fabi ◽  
Sonia Fatigoni ◽  
Silvana Chiara ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Study ◽  
Complete Response ◽  
Similar Efficacy ◽  
Double Blind Study ◽  
Delayed Emesis ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Acute Emesis ◽  
Antiemetic Prophylaxis

9614 Background: A combination of AP + a 5-HT3 receptor antagonist + D and AP alone is recommended, respectively, for the prophylaxis of acute and delayed emesis induced by A+C CT in breast cancer pts. In the registrative study the role of AP in delayed emesis was not defined because prophylaxis of acute emesis was different between the two arms, and the superiority of AP on delayed emesis could be the consequence of a dependent effect on the different results achieved in acute phase. Aim of this study was to compare the efficacy of AP versus D in preventing delayed emesis in pts receiving the same prophylaxis of acute emesis. Methods: A randomized double-blind study comparing AP versus D was completed in naive breast cancer pts treated with A+C. Before CT, all pts were treated with intravenous palonosetron 0.25 mg and D 8 mg, and oral AP 125 mg. On days 2 and 3 pts randomly received D 4 mg bid or AP 80 mg qd. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) from days 2 - 5 after CT. Results: From September 2009 to July 2012, 580 pts were enrolled; 551 were fully evaluated, 273 in arm D and 278 in arm AP. Day 1 complete response rates were similar: 239/273 (87.6%) in D arm and 236/278 (84.9%) in AP arm. From day 2-5, complete response was the same with both antiemetic prophylaxes (79.5%), and all secondary endpoints (complete protection, total control, no vomiting, no nausea, score of FLIE) assumed similar values. During the delayed phase, incidence of insomnia (2.9% vs. 0.4%) and heartburn (8.1% vs. 3.6%) was significantly superior in D arm. Conclusions: In breast cancer pts submitted to A+C CT and receiving the same antiemetic prophylaxis for acute emesis, D and AP present similar efficacy and toxicity. Clinical trial information: NCT 00869973.

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