scholarly journals Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer After Moderately Emetogenic Chemotherapy

2005 ◽  
Vol 23 (12) ◽  
pp. 2822-2830 ◽  
Author(s):  
David G. Warr ◽  
Paul J. Hesketh ◽  
Richard J. Gralla ◽  
Hyman B. Muss ◽  
Jørn Herrstedt ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Rescue Therapy ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Self Report ◽  
Moderately Emetogenic Chemotherapy ◽  
Breast Cancer Patients ◽  
End Point ◽  
Control Regimen

Purpose This is the first study in which the NK1-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Patients and Methods Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index–Emesis questionnaire. Results Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. Conclusion The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.

scholarly journals Effectiveness of antiemetics in control of antineoplastic chemotherapy-induced emesis at home

2014 ◽  
Vol 27 (5) ◽  
pp. 412-418 ◽  
Author(s):  
Marielly Cunha Castro ◽  
Suely Amorim de Araújo ◽  
Thaís Rezende Mendes ◽  
Glauciane Silva Vilarinho ◽  
Maria Angélica Oliveira Mendonça
Keyword(s):  
Breast Cancer ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Moderately Emetogenic Chemotherapy ◽  
Medical Prescription ◽  
Acute Emesis ◽  
Antineoplastic Chemotherapy ◽  
At Home

Objective Evaluating if antiemetics are effective in the prevention or treatment at home, of chemotherapy-induced emesis. Methods In total, were included 42 women with breast cancer in moderately emetogenic chemotherapy, using dexamethasone/ondansetron before each cycle. The frequency of nausea and vomiting was obtained by applying the instrument in the pre-chemotherapy period, and 24h, 48h, 72h and 96h after chemotherapy. The use of antiemetics was considered in accordance with adherence to medical prescription. Results All patients (n = 42, 100%) reported emesis at some point. Only five cases (11.9%) were anticipatory. In the first 24 hours (acute emesis), 38 (90.5%)ayed), emesis was reported by all despite the regular use (n = 20, 47.6%) or not (n = 22, 52.4%) of antiemetics (ondansetron, dexamethasone and metoclopramide/or dimenhydrinate). Conclusion Antiemetics were not effective in the prevention or treatment at home, of chemotherapy-induced emesis.

Olanzapine versus aprepitant in the prevention of chemotherapy induced nausea and vomiting (CINV) in breast cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21670-e21670
Author(s):  
S Mukesh ◽  
Sathya M ◽  
Akshay Jk
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Rescue Therapy ◽  
Antipsychotic Agents ◽  
Complete Response ◽  
Breast Cancer Patients ◽  
Acute Period ◽  
Prior Use ◽  
Grade 3 ◽  
Ecog Ps

e21670 Background: Olanzapine has been shown to be a safe and effective agent for the prevention of CINV. This study aims to compare olanzapine with aprepitant in the prevention of CINV. Methods: This study included breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 chemotherapy. Female patient; age, ≥ 18; chemotherapy naïve; no nausea/ vomiting in the past 24 hours were included. Patients with seizure disorder, brain metastasis, prior use of antipsychotic agents and hypersensitivity to olanzapine were excluded. Patients were randomized into two groups. Olanzapine group received tab olanzapine 10 mg on day 1 to 3. Aprepitant group received tab.aprepitant 125mg on day 1 and 80mg on days 2-3. Both groups received inj palnosteron 0.25mg, inj dexamethasone 8mg on day 1. Use of rescue therapy for nausea or vomiting was permitted. The primary end point of the study was complete response (CR) for nausea that is no nausea in the acute (within 24 hours), delayed (days 2-5), and overall periods (0-120 hours). Secondary endpoint was CR for vomiting and no use of rescue drugs in all periods. Beginning with the first day of chemotherapy and daily through day 5, patients were asked to record daily episodes of nausea using a visual analogue scale from 0 to 10, with 0 indicating no nausea and 10 indicating a maximal level of nausea. They were asked to record daily episodes of vomiting (number and time) and the utilization of rescue therapy. Results: A total of 84 patients (42 in each arm) were evaluated and consented for the study. The median age 48 years; range 29-80; ECOG PS - 0, 1. CR for nausea was 84% for the acute period , 58% for the delayed period and 56% for the overall period for the olanzapine group. CR for nausea in aprepitant group was 69% acute period, 55% delayed period, and 55% for the overall period. CR for vomiting was 91% acute; 74% delayed; 70% overall period for olanzapine group. CR for vomiting in aprepitant group was 91% acute; 83% delayed; 83% overall period. There were no Grade 3 /4 toxicities. Conclusions: Olanzapine is better in the prevention of nausea. However aprepitant is better in the prevention of vomiting. Combination of these two agents needs to be studied in future studies.

Combination of olanzapine and aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11577-11577
Author(s):  
Mukesh Shanthilal ◽  
Sathya M ◽  
Akshay Jk
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Rescue Therapy ◽  
Complete Response ◽  
Controlled Study ◽  
Combination Group ◽  
Breast Cancer Patients ◽  
Combination Strategy ◽  
Acute Period ◽  
Grade 3

11577 Background: Olanzapine and Aprepitant have been shown to be a safe and effective agent for the prevention of CINV. This study aims to compare Olanzapine, Aprepitant and their combination in the prevention of CINV. Methods: Prospective randomized controlled study in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 chemotherapy. Female patient; age, ≥ 18; chemotherapy naïve; were included. Patients with seizure disorder, brain metastasis were excluded. Olanzapine group received Tablet Olanzapine 10 mg on day 1 to 3. Aprepitant group received Tablet. Aprepitant 125mg on day 1, 80mg on days 2-3. The combination group received Aprepitant 125mg on day 1, 80mg on days 2-3 and Olanzapine 10mg on day 1. All groups received Palnosteron 0.25mg and Dexamethasone 8mg on day 1. The primary end point of the study was complete response (CR) for nausea that is no nausea in the acute, delayed and overall periods. Secondary endpoint was CR for vomiting and no use of rescue drugs in all periods. Beginning with the first day of chemotherapy and daily through day 5, patients were asked to record daily episodes of nausea using a visual analogue scale from 0 to 10, with 0 indicating no nausea and 10 indicating a maximal level of nausea. They were asked to record daily episodes of vomiting (number and time) and the utilization of rescue therapy. Results: A total of 141 patients were evaluated and consented for the study. The median age was 47 years; range 29-80; CR for nausea in the acute period (within 24 hours) was 83%, 63.8% and 78.7% (p=0.078); for the delayed period (days 2-5) 59.6%, 55.3% and 63.8% (p=0.702); for the overall period (0-120 hours) 57.4%, 53.2% and 59.6% (p=0.817) for the Olanzapine, Aprepitant and combination arm respectively. CR for vomiting in the acute period was 91.5%, 91.5% and 97.9.7% (p=0.344); for the delayed period 74.5%, 85.1% and 97.9% (p=0.005); for the overall period 70.2%, 85.1% and 97.9% (p=0.001) for the Olanzapine, Aprepitant and combination arm respectively. There were no Grade 3/4 toxicities. Conclusions: The combination strategy shows trend towards better prevention of CINV. Clinical trial information: CTRI/2017/12/010864.

Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9626-9626
Author(s):  
J. A. Boice ◽  
H. Schmoll ◽  
C. Brown ◽  
A. Taylor
Keyword(s):  
Rescue Medication ◽  
Medication Use ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Double Blind Study ◽  
Double Blind ◽  
Therapy Regimen ◽  
Control Regimen

9626 Background: Aprepitant (A) has been shown in a previous trial to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving cyclophosphamide and anthracycline. This study assessed A in patients with a variety of tumors receiving a broad range of MEC regimens. Methods: This Phase III, randomized, gender-stratified, double-blind, trial enrolled female and male patients ≥18 years old with confirmed malignancies naïve to MEC or highly emetogenic chemotherapy and scheduled to receive a single dose of 1 or more MEC agent. Patients received A triple-therapy regimen (A 125 mg, ondansetron [O] 8 mg b.i.d., and dexamethasone [D] 12 mg on Day 1 of chemotherapy, A 80 mg q.d. on Days 2–3) or a control regimen (O 8 mg b.i.d. and D 20 mg on Day 1, and O 8 mg q12h on Days 2–3) all administered orally. Episodes of vomiting, nausea, and rescue medication use were recorded in a patient diary. Tolerability was assessed by physical and lab examinations, and adverse event (AE) reporting. Primary and key secondary efficacy endpoints were proportions of patients with No Vomiting and Complete Response (no vomiting and no rescue medication use), respectively, during the 120 hours postchemotherapy. Results: Among 848 randomized patients, 77% were female while 52, 20, 13, and 5% of patients had breast, colorectal, lung, or ovarian cancer, respectively. Significantly more patients in the A group achieved No Vomiting and Complete Response (a difference of 14.1 &12.4 percentage points vs. control, respectively). The incidences of AEs were generally similar in the aprepitant (61.9%) and control groups (66.5%). Conclusions: The aprepitant regimen provided superior efficacy over the control regimen in the treatment of CINV in a broad range of patients receiving MEC in both No Vomiting and Complete Response endpoints. Aprepitant was generally well tolerated. [Table: see text] [Table: see text]

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

2016 ◽  
Vol 4 (1) ◽  
pp. 20-25
Author(s):  
Bruno Vincenzi ◽  
Anna Maria Frezza ◽  
Marianna Silletta ◽  
Emanuela Dell’Aquila ◽  
Giovanna Catania ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lung Cancer ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Moderately Emetogenic Chemotherapy ◽  
Receptor Antagonists ◽  
Number Of Patients ◽  
Constant Dose ◽  
Grade 3 ◽  
Type 3

Background Despite the efficacy of prophylaxis with serotonin type 3 (5-HT3) 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-HT3 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

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