A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy

The risk factors affecting chemotherapy-induced nausea and vomiting (CINV) includes antiemetic premedication time pattern, and this study investigates the capability of enhancing this in breast cancer patients receiving high emetogenic chemotherapy (HEC). Furthermore, this observational research was implemented at the oncology unit of Dr. Soetomo General Hospital Surabaya over a three-month period involving 69 female patients. The results showed unspecific antiemetic premedication timing in comparison to those with recommended timeframes, was connected with greater occurrence of both acute nausea in all cycles of chemotherapy (p<0.05), and acute vomiting in second and third cycles (p<0.05) but not in the first cycle (p=0.49). However, specific time administration of antiemetic treatment was linked with lower incidence of delayed nausea in all cycles (p<0.05), and less delayed vomiting in second and third cycles (p<0.05) but not in first cycle (p=0.10). These findings indicate specific time administration of antiemetic drugs causes significant advantages in mitigating CINV among breast cancer patients treated with emetogenic chemotherapy, and significantly lessened the occurrence of acute and delayed nausea and vomiting.Keywords: Antiemetic premedication timing, breast cancer, CINV, nausea and vomiting Analisis Waktu Pemberian Premedikasi Antiemetik terhadap Kejadian Mual Muntah pada Pasien Kanker Payudara yang Mendapatkan Kemoterapi AbstrakKemoterapi dapat menginduksi mual muntah (chemotherapy-induced nausea and vomiting, CINV) yang dipengaruhi oleh beberapa faktor. Salah satu faktornya adalah waktu pemberian premedikasi antiemetik yang dapat meningkatkan kejadian CINV pada pasien kanker payudara yang menerima kemoterapi. Studi ini menganalisis waktu pemberian premedikasi antiemetik terhadap kejadian mual dan muntah yang terjadi pada pasien kanker payudara yang mendapatkan kemoterapi dengan tingkat emetogenik yang tinggi. Penelitian ini merupakan penelitian observasional prospektif dilakukan di Poli Onkologi Satu Atap RSUD Dr. Soetomo Surabaya selama periode pengambilan data tiga bulan dan melibatkan 69 wanita kanker payudara yang mendapat kemoterapi dengan tingkat emetogenik yang tinggi. Pemberian premedikasi antiemetik dengan waktu yang tidak spesifik, meningkatkan kejadian mual akut pada semua siklus dengan p<0,05 dan pada kejadian muntah akut pada siklus kedua dan ketiga (p<0,05), namun tidak pada siklus pertama kemoterapi (p=0,49). Pemberian premedikasi antiemetik dengan waktu spesifik dapat menurunkan kejadian mual tertunda di siklus pertama hingga ketiga (p<0,05) dan pada kejadian muntah tertunda pada siklus kedua dan ketiga (p<0,05), namun tidak pada siklus pertama (p=0,10). Penelitian ini memberikan bukti bahwa premedikasi antiemetik yang diberikan dengan waktu spesifik memberikan manfaat dalam mengurangi kejadian CINV yang berpotensi pada pasien kanker payudara yang mendapatkan kemoterapi dengan tingkat emetogenik tinggi. Kata kunci: CINV, kanker payudara, mual dan muntah, waktu pemberian premedikasi antiemetik

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

Journal of Clinical Oncology ◽

10.1200/jco.2005.09.050 ◽

2005 ◽

Vol 23 (12) ◽

pp. 2822-2830 ◽

Cited By ~ 322

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.

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