The efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy

Vimolchalao, Veerisa; Sakdejayont, Siwat; Wongchanapai, Ploytuangporn; Sukprakun, Shama; Angspatt, Pattama; Thawinwisan, Wilai; Chenaksara, Piyachut; Sriuranpong, Virote; Vinayanuwatikun, Chanida; Parinyanitikun, Napa; Poovorawan, Nattaya; Tanasanvimon, Suebpong

doi:10.1007/s10147-019-01570-3

Cited by 12 publications

(11 citation statements)

References 23 publications

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“…Eleven studies ( 28 – 34 , 36 – 39 ) are randomized controlled experiments; one study ( 35 )is a prospective control study; and nine studies ( 28 – 31 , 33 , 34 , 37 – 39 ) compared 5 or 10 mg olanzapine with placebo, while three studies ( 32 , 35 , 36 ) compared the four-drug regimen with standard regimen; and 12 studies differed in the drugs used in the concurrent antiemetic regimens: a corticosteroid, 5-HT3 receptor antagonist, and NK1 receptor antagonist in seven studies ( 28 – 32 , 36 , 39 ) and a corticosteroid and 5-HT3 receptor antagonist in five studies ( 33 – 35 , 37 , 38 ).…”

Section: Resultsmentioning

confidence: 99%

“…All 12 studies reported a CR to antiemetic therapy and defined CR as no vomiting and no rescue; eleven studies (28)(29)(30)(32)(33)(34)(35)(36)(37)(38)(39) reported a CC to antiemetic therapy and defined CC as no nausea and no emesis. No studies evaluated the bioavailability of the olanzapine in their articles.…”

Section: Included Studiesmentioning

confidence: 99%

“…reported the use of 5 mg olanzapine to prevent CINV; five studies(31,32,(37)(38)(39)(40)(41) included HEC patients; two studies (29, 33)included MEC patients; and five studies (28, 30, 34-36) included HEC and MEC patients. Of the five studies involving both HEC and MEC, only three studies (34-36) reported the results of HEC and MEC separately, and two studies were not enough for subgroup analysis; eight studies (28, 29, 31-35, 37) reported adverse reactions including sedation, Table 2 provides the procedures of each study to evaluate the sedative effect of olanzapine; 11 studies (28-34, 36-39) are randomized controlled experiments; 1 study (35) is a prospective control study…”

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The Balance Between the Effectiveness and Safety for Chemotherapy-Induced Nausea and Vomiting of Different Doses of Olanzapine (10 mg Versus 5 mg): A Systematic Review and Meta-Analysis

et al. 2021

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IntroductionThe aim of this study is to rigorously review the efficacy and safety of olanzapine in chemotherapy-induced nausea and vomiting (CINV) settings including (1) at 5- and 10-mg doses, and (2) the setting of highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).MethodsEmbase, Pubmed, and Cochrane Library were searched from the establishment of the database through April 18, 2021. The primary efficacy endpoints were the rate of complete response (CR; no emesis and no rescue), 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 complete control (CC, no nausea, and no emesis), for each phase. Safety endpoints were the rate of somnolence, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) criteria. The Mantel–Haenszel, random, or fixed-effect 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.ResultNine studies reported the use of 10 mg olanzapine to prevent CINV; three studies reported the use of 5 mg olanzapine to prevent CINV. When olanzapine was administered at 10 mg for HEC patients, the six endpoints were statistically and clinically better than the control group. For MEC patients, four out of six endpoints were better than the control group. When olanzapine is administered at 5 mg for MEC patients, four endpoints have statistical and clinical advantages. The sedative effects of 10 and 5 mg olanzapine were statistically more significant than those of the control group. The sedative effect of the 10-mg olanzapine group was more significant than that of the 5-mg olanzapine group, both statistically and clinically.Conclusion5 mg olanzapine may be as effective as 10 mg olanzapine for patients with HEC and MEC, and its sedative effect is lower than 10 mg olanzapine. Fewer studies on 5 mg olanzapine have led to uncertain data. In the future, more randomized controlled trials of 5 mg olanzapine are needed to study the balance between the effectiveness and safety of olanzapine.

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Section: Resultsmentioning

confidence: 99%

Section: Included Studiesmentioning

confidence: 99%

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confidence: 99%

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The Balance Between the Effectiveness and Safety for Chemotherapy-Induced Nausea and Vomiting of Different Doses of Olanzapine (10 mg Versus 5 mg): A Systematic Review and Meta-Analysis

et al. 2021

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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

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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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“…However, since the 2016 review, many clinical trials using olanzapine for CINV have been started, completed, and published-in many cases, citing the paucity of literature at the time as support for initiating their trial and the need for further research in this setting (13)(14)(15).…”

Section: Introductionmentioning

confidence: 99%

Secondary and cumulative meta-analysis of olanzapine for antiemetic prophylaxis for chemotherapy-induced nausea and vomiting: do we still need to study its effectiveness?

et al. 2021

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Background: Olanzapine has been found to have antiemetic properties due to its ability to inhibit multiple serotonergic, dopaminergic, alpha-1 adrenergic and histamine receptors. In 2016, a meta-analysis of 10 randomized controlled trials (RCTs) on olanzapine in the prophylactic setting found olanzapine to be more efficacious than other standard antiemetics in the prophylactic setting. However, since the review, many clinical trials using olanzapine for chemotherapy-induced nausea and vomiting (CINV) have been published-in many cases, contending that further trials would further help elucidate the efficacy of olanzapine for CINV given the continued paucity of literature. The primary aim of this study is to conduct a secondary, cumulative meta-analysis to assess the impact of the most recent trials on the published effect estimate of olanzapine and ultimately determine whether trials published since 2016 have significantly changed the summary estimate.Methods: As reported previously, a literature search was conducted up until 2015, of Ovid Medline, Embase and the Cochrane Central Register of Controlled Trials; 10 RCTs with a total of over 1,000 patients were included, that compared olanzapine to other antiemetics in the prophylactic setting, which reported on at least one of two endpoints-no emesis and no nausea. The Mantel-Haenszel, random-effects analysis model was used to compute cumulative risk ratios (RR) and their accompanying 95% confidence intervals (CIs).Results: For the endpoint of emetic control, the cumulative meta-analysis shows that the summary effect did not change noticeably with the inclusion of the most recent trials. In the acute phase, the RR shifted from 1.07 before 2011 to 1.10 after 2015, even after the inclusion of 7 trials. Similar small changes were noted in the delayed and overall phases. For the endpoint of nausea control, the cumulative meta-analysis does show a significant visual change in summary effect, except for nausea control in the acute phase. In the delayed

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The efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy

Cited by 12 publications

References 23 publications

The Balance Between the Effectiveness and Safety for Chemotherapy-Induced Nausea and Vomiting of Different Doses of Olanzapine (10 mg Versus 5 mg): A Systematic Review and Meta-Analysis

The Balance Between the Effectiveness and Safety for Chemotherapy-Induced Nausea and Vomiting of Different Doses of Olanzapine (10 mg Versus 5 mg): A Systematic Review and Meta-Analysis

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

Secondary and cumulative meta-analysis of olanzapine for antiemetic prophylaxis for chemotherapy-induced nausea and vomiting: do we still need to study its effectiveness?

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