Trial reportThe oncologist2026
Central nervous system symptom burden and clinical implications for antiemetic management with olanzapine in AC chemotherapy.
Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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20 authors.
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Abstract
backgroundOlanzapine 5 mg improves chemotherapy-induced nausea and vomiting (CINV) control in patients receiving anthracycline-cyclophosphamide (AC) chemotherapy, but sedation remains a concern. We evaluated whether central nervous system (CNS) symptom burden identifies patients at higher risk of poor CINV control. PATIENTS AND
methodsThis secondary analysis of the phase III JTOP-B trial included women with breast cancer receiving AC chemotherapy. Patients were randomized to olanzapine 5 mg or placebo plus standard triplet antiemetic therapy. Daily patient-reported sedation and concentration impairment were assessed for 5 days. CNS burden was evaluated using recurrent "Bad Days" (concurrent moderate/severe sedation and concentration impairment) and cumulative CNS burden scores. Associations between CNS symptom patterns and complete response (CR; no emesis and no rescue medication) during 0-120 hours were analyzed.
resultsAmong 480 patients, CR rates decreased with increasing CNS symptom severity in both groups. In the olanzapine group, CR rates decreased across increasing sedation (75.0%-51.6%) and concentration impairment (78.1%-48.6%). Concentration impairment more strongly identified patients with poor CINV control than sedation alone. Higher cumulative CNS burden and recurrent Bad Days were associated with lower CR rates, identifying a clinically vulnerable population. Olanzapine maintained higher CR rates than placebo across CNS symptom strata.
conclusionsCNS symptom burden was associated with suboptimal CINV control, while 5 mg of olanzapine maintained superior antiemetic efficacy across CNS symptom strata. Monitoring day-to-day CNS symptoms may help identify patients requiring closer observation or additional supportive care.
trial registrationJapan Registry of Clinical Trials Identifier: jRCT1031200134.
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