A randomized, double-blind, placebo-controlled study evaluating the efficacy of combination olanzapine, ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving doxorubicin plus cyclophosphamide

Tienchaiananda, Piyawan; Nipondhkit, Wipada; Maneenil, Kunlatida; Sa-nguansai, Sunatee; Payapwattanawong, Songwit; Laohavinij, Sudsawat; Maneechavakajorn, Jedzada

doi:10.21037/apm.2019.08.04

Cited by 30 publications

(27 citation statements)

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“…However, several phase II trials also supported the superiority efficacy in terms of nausea control by olanzapine 10 mg in combination with ondansetron plus dexamethasone when compared to the standard dose of aprepitant in combination (5,6). Our study also demonstrated the efficacy of olanzapine 10 mg in the three-drug regimen with ondansetron and dexamethasone in terms of the nausea control and the complete response rate in acute phase (7). Additionally, a systematic review of NK-1 receptor antagonist, 5-HT3 antagonist and dexamethasone revealed 72% complete response rate in the acute phase which was similar to 75% complete response rate in the acute phase from olanzapine, ondansetron and dexamethasone in our study (7,8).…”

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confidence: 74%

Olanzapine: is it enough for CINV prevention?

2020

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confidence: 74%

Olanzapine: is it enough for CINV prevention?

2020

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“…Studies on the role of olanzapine in the control of CINV and related meta-analyses [ [22] , [23] , [24] ] have led to the inclusion of this agent as antiemetic in more recent international guidelines. Since the early phase II studies [ [10] , [11] , [12] , 25 ], a number of randomized studies on olanzapine have been reported [ [13] , [14] , [15] , [16] , [17] , 26 , 27 ]. In the study reported by Wang et al., lung cancer patients who underwent gemcitabine and cisplatin therapy were being randomized to ondansetron with or without olanzapine; olanzapine-containing regimen was reported to be superior in controlling both acute and delayed CINV [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

“…In the study reported by Wang et al., lung cancer patients who underwent gemcitabine and cisplatin therapy were being randomized to ondansetron with or without olanzapine; olanzapine-containing regimen was reported to be superior in controlling both acute and delayed CINV [ 14 ]. When olanzapine was added to a backbone of 5HT3RA dexamethasone (administered for one or more days), a number of studies reported better control of CINV [ 13 , 15 , 26 , 27 ] while one did not show additional benefit with the agent [ 28 ]. Two other studies have compared the combination of olanzapine, ondansetron and dexamethasone with aprepitant, ondansetron and dexamethasone; both reported similar antiemetic efficacies between the two arms [ 16 , 17 ], and as such it has led Babu et al.…”

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confidence: 99%

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

Park

Lau

et al. 2020

The Breast

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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.

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“…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][63][64][65][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 (olanzapinecontaining) 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).…”

Section: Included Studiesmentioning

confidence: 99%

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

Chow

Herrstedt

Aapro

et al. 2021

Support Care Cancer

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Introduction The aim of this study is to rigorously review the efficacy and safety of olanzapine in defined hematology oncology settings including (1) the setting of highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) settings (2) at 5 mg and 10 mg doses, and (3) for response rates for use in the acute, delayed, and overall settings post-MEC and HEC. Methods Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched through April 23, 2020. The primary efficacy endpoints were the rate of complete response, in the acute (0-24 h post-chemotherapy), delayed (24-120 h post-chemotherapy), and overall (0-120 h post-chemotherapy) phases. The secondary efficacy endpoints were the rates of no nausea and no emesis, for each phase. Safety endpoints were the rate of no serious adverse events (i.e., no grade 3 or 4 toxicities), as assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria. The Mantel-Haenszel, random-effects analysis model was used to compute risk ratios and accompanying 95% confidence intervals for each endpoint. For endpoints that statistically favored one arm, absolute risk differences were computed to assess whether there is a 10% or greater difference, used as the threshold for clinical significance by MASCC/ESMO. Fragility indices were also calculated for each statistically significant endpoint, to quantitatively assess the robustness of the summary estimate. A cumulative meta-analysis was conducted for each efficacy meta-analysis with more than 5 studies, also using the Mantel-Haenszel random-effects analysis model. Results Three studies reported on olanzapine for the rescue of breakthrough chemotherapy-induced nausea and vomiting (CINV); 22 studies reported on olanzapine in the prophylactic setting. For studies reporting on HEC patients, olanzapinecontaining regimens were statistically and clinically superior in seven of nine efficacy endpoints in the prophylaxis setting. When olanzapine is administered at a 10-mg dose, it is statistically and clinically superior to control patients in eight of nine endpoints among adults. Olanzapine may be effective in the MEC setting and when administered at 5-mg doses, but the paucity of data leads to notable uncertainty. Conclusion Further RCTs are needed in the setting of MEC patients and administration of olanzapine at a lower 5-mg dose, which may be given to reduce the sedative effect of olanzapine at 10 mg.

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A randomized, double-blind, placebo-controlled study evaluating the efficacy of combination olanzapine, ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving doxorubicin plus cyclophosphamide

Cited by 30 publications

References 12 publications

Olanzapine: is it enough for CINV prevention?

Olanzapine: is it enough for CINV prevention?

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

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

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