A randomised, placebo-controlled, double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy

Tanioka, Miki; Kitao, Akihito; Matsumoto, Koji; Shibata, Nobuto; Yamaguchi, Satoshi; Fujiwara, Kiyoshi; Minami, Hironobu; Katakami, Nobuyuki; Morita, Shunji; Negoro, Shunichi

doi:10.1038/bjc.2013.400

Cited by 61 publications

(68 citation statements)

References 26 publications

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“…The addition of aprepitant to standard antiemetic regimens yielded absolute benefits of 14% for the measure of no emesis in the overall phase16, 19 and for the CR rate in the overall phase20 in carboplatin‐treated patients. Smaller studies have produced inconsistent results for the benefit of aprepitant in patients administered carboplatin therapy 21, 22, 23. Data on netupitant also suggest a similar benefit based on measures of no emesis and CR in the overall phase with historical controls used for comparison 17, 24.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of the neurokinin‐1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin‐based chemotherapy

Hesketh

Schnadig

Schwartzberg

et al. 2016

Cancer

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BACKGROUNDRolapitant, a novel neurokinin‐1 receptor antagonist, provided effective protection against chemotherapy‐induced nausea and vomiting (CINV) in a randomized, double‐blind phase 3 trial of patients receiving moderately emetogenic chemotherapy or an anthracycline and cyclophosphamide regimen. The current analysis explored the efficacy and safety of rolapitant in preventing CINV in a subgroup of patients receiving carboplatin.METHODSPatients were randomized 1:1 to receive oral rolapitant (180 mg) or a placebo 1 to 2 hours before chemotherapy administration; all patients received oral granisetron (2 mg) on days 1 to 3 and oral dexamethasone (20 mg) on day 1. A post hoc analysis examined the subgroup of patients receiving carboplatin in cycle 1. The efficacy endpoints were as follows: complete response (CR), no emesis, no nausea, no significant nausea, complete protection, time to first emesis or use of rescue medication, and no impact on daily life.RESULTSIn the subgroup administered carboplatin‐based chemotherapy (n = 401), a significantly higher proportion of patients in the rolapitant group versus the control group achieved a CR in the overall phase (0‐120 hours; 80.2% vs 64.6%; P < .001) and in the delayed phase (>24‐120 hours; 82.3% vs 65.6%; P < .001) after chemotherapy administration. Superior responses were also observed by the measures of no emesis, no nausea, and complete protection in the overall and delayed phases and by the time to first emesis or use of rescue medication. The incidence of treatment‐emergent adverse events was similar for the rolapitant and control groups.CONCLUSIONSRolapitant provided superior CINV protection to patients receiving carboplatin‐based chemotherapy in comparison with the control. These results support rolapitant use as part of the antiemetic regimen in carboplatin‐treated patients. Cancer 2016;122:2418–2425. © 2016 American Cancer Society.

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Section: Discussionmentioning

confidence: 99%

Efficacy of the neurokinin‐1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin‐based chemotherapy

Hesketh

Schnadig

Schwartzberg

et al. 2016

Cancer

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“…The aprepitant group showed a better overall CR of 80.3% compared with that of 67.2% for the control group. Tanioka et al (2013) reported on a randomized study of aprepitant in women receiving MEC comprising mainly a carboplatin-or irinotecan-containing regimen. Prevalence of a CR overall was superior, but not significantly higher, in the aprepitant, granisetron and dexamethasone group than in the placebo, granisetron and dexamethasone group (aprepitant group, 62.2%; placebo group, 52.1%).…”

Section: Discussionmentioning

confidence: 99%

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

Miya

Kobayashi

Hino

et al. 2016

JCO

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Background: Chemotherapy-induced nausea and vomiting (CINV) is a major adverse toxicity of cancer chemotherapy. Recommended treatments for prevention of CINV vary among published guidelines, and optimal care for CINV caused by moderately emetogenic chemotherapy has not been established. This study assessed the efficacy and safety of triple antiemetic therapy comprising palonosetron, dexamethasone and aprepitant for carboplatin-based chemotherapy. Chemotherapy-naïve patients with lung cancer scheduled for a first course of a carboplatin-containing regimen formed the study cohort. Patients were pretreated with antiemetic therapy comprising palonosetron (0.75 mg, i.v.) and dexamethasone (9.9 mg, i.v.) on day 1, and aprepitant (125 mg, p.o.) on day 1 followed by 80 mg on days 2 and 3. Primary endpoint was the proportion of patients who did not experience vomiting and did not require rescue medication [complete response (CR)] in the acute phase (0-24 h), late phase (24-168 h) and overall. Secondary endpoint was the proportion of patients who experienced no vomiting episodes and no more than mild nausea without the need for rescue medication [complete control (CC)].Results: Prevalence of a CR during the acute phase, delayed phase, and overall was 100, 91.9 and 91.9%, whereas that of CC was 100, 84.4 and 84.4%, respectively. The most common adverse event was mild constipation; severe adverse events related to antiemetic treatment were not observed. Conclusion: Triple antiemetic therapy comprising palonosetron, dexamethasone and aprepitant shows excellent effects in the prevention of CINV in patients receiving a carboplatin-containing regimen.

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“…Studies have shown that combinations of new drugs such as palonosetron (serotonin receptor antagonist of the second generation) and aprepitant (NK-1 receptor antagonist) can offer a better protection. (10,11,15) Apart from drugs, complementary medicines and integrative practices can be associated with treatment such as herbal medicines, homeopathy, acupuncture, relaxation, aromatherapy and others. It is noteworthy that in addition to having these services provided, patients should be counseled regarding their effectiveness and encouraged to carry them out.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2014

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Objective: Evaluating if antiemetics are effective in the prevention or treatment at home, of chemotherapyinduced 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. ResumoObjetivo: Avaliar se antieméticos são eficazes na prevenção ou tratamento da emese induzida pela quimioterapia antineoplásica, em domicílio. Métodos: Foram incluídas 42 mulheres com câncer de mama, em quimioterapia moderadamente emetogênica, submetidas à dexametasona/ondansetrona antes de cada ciclo. A frequência de náuseas e vômitos foi obtida por instrumento aplicado nos tempos pré-quimioterapia e 24h, 48h, 72h e 96h pós-quimioterapia. O uso de antieméticos foi considerado conforme adesão à prescrição médica. Resultados: Todas as pacientes (n=42, 100%) relataram emese em algum momento. Apenas cinco casos (11,9%) foram antecipatórios. Nas primeiras 24h (emese aguda), 38 (90,5%) apresentaram náuseas associadas (n=20, 47,6%) ou não (n=18, 42,8%) a vômitos e, após este período (tardio), a emese foi referida por todas, apesar da utilização regular (n=20, 47,6%) ou não (n=22, 52,4%) de antieméticos (ondansetrona, dexametasona, metoclopramida e/ou dimenidrinato). Conclusão: Os antieméticos não foram eficazes na prevenção ou no tratamento da emese induzida pela quimioterapia, em domicílio.

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A randomised, placebo-controlled, double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy

Cited by 61 publications

References 26 publications

Efficacy of the neurokinin‐1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin‐based chemotherapy

Efficacy of the neurokinin‐1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin‐based chemotherapy

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

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

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