A randomized study of olanzapine-containing versus standard antiemetic regimens for the prevention of chemotherapy-induced nausea and vomiting in Chinese breast cancer patients

Abstract

Objectives Chemotherapy-induced nausea and vomiting (CINV) are distressing symptoms. This randomized study evaluated the antiemetic efficacies of standard antiemetic regimen with/without olanzapine. Patients and methods Eligible patients were chemotherapy-naive Chinese breast cancer patients who were planned for (neo)adjuvant doxorubicin/cyclophosphamide. Antiemetic regimen for all studied population included aprepitant, ondansetron and dexamethasone; patients were randomized to Olanzapine (with olanzapine) or Standard arms (without olanzapine). Patients filled in self-reported diaries and completed visual analogue scales for nausea, as well as Functional Living Index-Emesis questionnaires. Blood profiles including fasting glucose and lipids were monitored. Results 120 patients were randomized. In Cycle 1 doxorubicin/cyclophosphamide, the Olanzapine arm had significantly higher rates of “Complete Response” than the Standard arm: 65.0% vs 38.3% in the overall period (p = 0.0035), 70.0% vs 51.7% in the acute period (p = 0.0397) and 92.9% vs 74.2% in the delayed period (p = 0.0254). Olanzapine arm also had significantly higher rates of “No significant nausea” and “No nausea” during all 3 time-frames and better QOL. Similar findings were also revealed throughout multiple cycles. Pre-study abnormalities in glucose and lipids occurred in 39.7% and 34.2% of the studied population respectively; there were no differences in these parameters between the two arms at end-of-study assessment. Conclusion The addition of olanzapine to standard aprepitant-based antiemetic regimen provides clinically meaningful improvement in controlling CINV. This was associated with a positive impact on QOL and tolerable toxicity profiles among Chinese breast cancer patients receiving doxorubicin/cyclophosphamide chemotherapy. Further studies on metabolic profiles of breast cancer patients are warranted.

Olanzapine for the prophylaxis and rescue of chemotherapy-induced nausea and vomiting: a systematic review, meta-analysis, cumulative meta-analysis and fragility assessment of the literature

“…Three studies reported on olanzapine for the rescue of breakthrough CINV [ 42 – 44 ]; 22 studies reported on olanzapine in the prophylactic setting [ 45 – 66 ]. Only seven studies (one reporting on rescue of breakthrough CINV, and six reporting on prophylactic CINV) had no corresponding full-text articles [ 42 , 48 , 53 , 55 , 56 , 60 , 61 ].…”

“…Among the adult prophylactic studies, 15 reported exclusively on HEC patients [ 46 , 49 – 52 , 55 , 56 , 58 , 60 – 66 ], three exclusively on MEC patients [ 53 , 57 , 59 ], and three on a patient population that consists of both HEC and MEC patients [ 45 , 47 , 54 ]. Eight studies compared olanzapine to a double-blind placebo-controlled regimen [ 47 , 52 , 59 , 62 – 66 ] and thirteen used an opened controlled study design—nine studies used a control arm with antiemetics different from the antiemetics in the investigational (olanzapine-containing) arm [ 46 , 49 , 51 , 53 , 55 , 56 , 58 , 60 , 61 ] and four used a control arm with the same antiemetics as in the investigational (olanzapine-containing) arm except for olanzapine [ 45 , 50 , 54 , 57 ]. 17 adult prophylactic studies used 10 mg doses of olanzapine [ 45 , 46 , 49 – 59 , 61 , 62 , 65 , 66 ], and 3 studies used 5 mg [ 47 , 60 , 63 ]; 1 used a mix of 5 mg and 10 mg [ 64 ] (Table 1 ).…”

“…17 adult prophylactic studies used 10 mg doses of olanzapine [ 45 , 46 , 49 – 59 , 61 , 62 , 65 , 66 ], and 3 studies used 5 mg [ 47 , 60 , 63 ]; 1 used a mix of 5 mg and 10 mg [ 64 ] (Table 1 ).…”

Engineering of Doxorubicin-Encapsulating and TRAIL-Conjugated Poly(RGD) Proteinoid Nanocapsules for Drug Delivery Applications

“…Doxorubicin hydrochloride (Dox), a chemotherapeutic drug, which intercalates with DNA, is used for a wide range of cancer treatments [ 4 , 5 ], however it is associated with severe side effects, e.g., cardiac damage, vomiting, bone marrow suppression, tissue damage at the site of injection, and myelosuppression, which prevent it from being the prominent first choice [ 6 , 7 ]. Tumor necrosis factor (TNF)-related apoptosis-inducing ligand (TRAIL), a protein considered as a promising candidate for treatment owing to its selective apoptotic effect on cancer cells [ 8 , 9 ], is not therapeutically effective, as IV administration leads to insufficient amount at the target site due to rapid degradation in vivo.…”

The incidence of nausea and vomiting in cancer patients in Greek clinical practice: A longitudinal study

“…For assessing quality of life Functional Living Index-Emesis [ 2 , 10 ], EORTC QLQ-C30, SF-36 [ 11 ] and FACT-G [ 1 ] were used. More recent studies have examined the efficacy of newer antiemetics in controlling chemotherapy-induced nausea and vomiting and their impact on quality of life [ 13 , 14 ].…”