Abstract | OBJECTIVES: This is a single center, randomized, double-blind placebo-controlled study to evaluate the NK(1)-receptor antagonist, aprepitant, in Chinese breast cancer patients. The primary objective was to compare the efficacy of aprepitant-based antiemetic regimen and standard antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients who received moderately emetogenic chemotherapy. The secondary objective was to compare the patient-reported quality of life in these two groups of patients. PATIENTS AND METHODS: RESULTS: Of 127 patients randomized, 124 were assessable. For CINV in Cycle 1 AC, there was no significant difference in the proportion of patients with reported complete response, complete protection, total control, 'no vomiting', 'no significant nausea' and 'no nausea'. The requirement of rescue medication appears to be lesser in patients treated with the aprepitant-based regimen compared to those with the standard regimen (11% vs. 20%; P = 0.06). Assessment of FLIE revealed that while there was no difference in the nausea domain and the total score between the two groups; however, patients receiving standard antiemetic regimen had significantly worse quality of life in the vomiting domain (mean score [SD] = 23.99 [30.79]) when compared with those who received the aprepitant-based regimen (mean score [SD] = 3.40 [13.18]) (P = 0.0002). Both treatments were generally well tolerated. Patients treated with the aprepitant-based regimen had a significantly lower incidence of neutropenia (53.2% vs. 35.5%, P = 0.0468), grade >or= 3 neutropenia (21.0% vs. 45.2, P = 0.0042) and delay in subsequent cycle of chemotherapy (8.1% vs. 27.4%, P = 0.0048). CONCLUSION: The aprepitant regimen appears to reduce the requirement of rescue medication when compared with the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide, and is associated with a better quality of life during adjuvant AC chemotherapy.
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Authors | Winnie Yeo, F K F Mo, J J S Suen, W M Ho, S L Chan, W Lau, J Koh, W K Yeung, W H Kwan, K K C Lee, T S K Mok, A N Y Poon, K C Lam, E K Hui, B Zee |
Journal | Breast cancer research and treatment
(Breast Cancer Res Treat)
Vol. 113
Issue 3
Pg. 529-35
(Feb 2009)
ISSN: 1573-7217 [Electronic] Netherlands |
PMID | 18327706
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antiemetics
- Antineoplastic Agents
- Morpholines
- Aprepitant
- Ondansetron
- Dexamethasone
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Topics |
- Adult
- Aged
- Antiemetics
(administration & dosage)
- Antineoplastic Agents
(adverse effects)
- Aprepitant
- Breast Neoplasms
(drug therapy)
- Carcinoma, Ductal, Breast
(drug therapy)
- China
- Dexamethasone
(administration & dosage)
- Double-Blind Method
- Female
- Humans
- Middle Aged
- Morpholines
(administration & dosage)
- Nausea
(chemically induced, drug therapy)
- Ondansetron
(administration & dosage)
- Quality of Life
- Vomiting
(chemically induced, drug therapy)
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