Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy

Ithimakin, Suthinee; Theeratrakul, Pathra; Laocharoenkiat, Apirom; Nimmannit, Akarin; Akewanlop, Charuwan; Soparattanapaisarn, Nopadol; Techawattanawanna, Sirisopa; Korphaisarn, Krittiya; Danchaivijitr, Pongwut

doi:10.1007/s00520-020-05380-6

Cited by 24 publications

(23 citation statements)

References 16 publications

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“…NCCN panel recommends an olanzapine-containing three-drug regimen with palanosetron and dexamethasone, since; there was no large clinical trial available for the other 5-HT3 antagonists (2). 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).…”

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confidence: 74%

Olanzapine: is it enough for CINV prevention?

2020

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supporting

confidence: 74%

Olanzapine: is it enough for CINV prevention?

2020

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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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Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy

Cited by 24 publications

References 16 publications

Olanzapine: is it enough for CINV prevention?

Olanzapine: is it enough for CINV prevention?

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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