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Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomised evidence.

ABSTRACT: BACKGROUND:Nausea can be particularly prominent during the delayed period. Therefore, we performed a meta-analysis of the available randomised evidence to assess the average effect of palonosetron plus one-day dexamethasone (DEX; also called the DEX-sparing strategy) compared with palonosetron plus 3-day DEX for control of chemotherapy-induced nausea and vomiting (CINV), focusing on delayed nausea. METHODS:Eligible studies were identified through MEDLINE, Embase, and CENTRAL. Data on acute and delayed CINV were collected. Efficacy end points were complete response (CR; no vomiting, and no use of rescue medication), complete protection (CP; CR plus no clinically significant nausea), and total control (TC; CR plus no nausea) during the delayed period (days 2-5 after chemotherapy initiation). All randomised studies comparing palonosetron plus single-dose DEX (with or without another active agent) on day 1 followed by either no further DEX or additional DEX doses (both alone or in combination with another active agent) qualified. RESULTS:Of 864 citations screened, 8 studies with 1970 patients were included in the meta-analysis. During the delayed period, the combined odds ratio (OR) for all comparisons was 0.92 (95% confidence interval [CI], 0.76-1.12) for CR, 0.85 (95% CI, 0.71-1.03) for CP, and 0.92 (95% CI, 0.77-1.11) for TC in patients undergoing moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide-containing chemotherapy (AC). The absolute risk difference (RD) computations for all end points in the delayed period did not exceed the threshold of -?4% (range, -?1% to -?4%). The effect was similar in subgroups defined by various study design parameters. The absolute RD computations in the acute period did not exceed the threshold of 1% (range, 0 to 1%). For one-day vs. 3-day DEX, numbers needed to be treated in order for one additional patient to not experience CR, CP and TC over the delayed period were 100, 25 and 50, respectively. CONCLUSIONS:This meta-analysis demonstrates that DEX-sparing regimens do not cause any significant loss in protection against not only vomiting but also nausea induced by single-day MEC or AC during the delayed period. These data should lead clinicians to optimise use of prophylactic DEX in clinical practice.

SUBMITTER: Celio L

PROVIDER: S-EPMC6937643 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomised evidence.

Celio Luigi L Bonizzoni Erminio E Zattarin Emma E Codega Paolo P de Braud Filippo F Aapro Matti M

BMC cancer 20191230 1

<h4>Background</h4>Nausea can be particularly prominent during the delayed period. Therefore, we performed a meta-analysis of the available randomised evidence to assess the average effect of palonosetron plus one-day dexamethasone (DEX; also called the DEX-sparing strategy) compared with palonosetron plus 3-day DEX for control of chemotherapy-induced nausea and vomiting (CINV), focusing on delayed nausea.<h4>Methods</h4>Eligible studies were identified through MEDLINE, Embase, and CENTRAL. Data ...[more]

PMID: 31888544

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Project description:BackgroundFor the prevention of chemotherapy-induced nausea and vomiting (CINV) during the delayed phase (24-120 hours) after moderately emetogenic chemotherapy (MEC), the use of 3-day dexamethasone (DEX) is often recommended. This study compared the efficacy and safety of two DEX-sparing regimens with 3-day DEX, focusing on delayed nausea.Patients and methodsThis open-label, randomized, phase III study was designed to demonstrate noninferiority of two DEX-sparing regimens: ondansetron + DEX on day 1 + metoclopramide on days 2-3 (MCP arm), and palonosetron + DEX on day 1 (PAL arm) versus ondansetron on day 1 + DEX on days 1-3 (DEX arm) in chemotherapy-naïve patients receiving MEC. Primary efficacy endpoint was total control (TC; no emetic episodes, no use of rescue medication, no nausea) in the delayed phase. Noninferiority was defined as a lower 95% CI greater than the noninferiority margin set at -20%. Secondary endpoints included no vomiting, no rescue medication, no (significant) nausea, impact of CINV on quality of life, and antiemetics-associated side effects.ResultsTreatment arms were comparable for 189 patients analyzed: predominantly male (55.7%), median age 65.0 years, colorectal cancer (85.7%), and oxaliplatin-based chemotherapy (81.5%). MCP demonstrated noninferiority to DEX for delayed TC (MCP 56.1% vs. DEX 50.0%; 95% CI, -11.3%, 23.5%). PAL also demonstrated noninferiority to DEX (PAL 55.6% vs. DEX 50.0%; 95% CI, -12.0%, 23.2%). There were no statistically significant differences for all secondary endpoints between treatment arms.ConclusionThis study showed that DEX-sparing regimens are noninferior to multiple-day DEX in terms of delayed TC rate in patients undergoing MEC. ClinicalTrials.gov identifier. NCT02135510.Implications for practiceChemotherapy-induced nausea and vomiting (CINV) in the delayed phase (24-120 hours after chemotherapy) remains one of the most troublesome adverse effects associated with cancer treatment. In particular, delayed nausea is often poorly controlled. The role of dexamethasone (DEX) in the prevention of delayed nausea after moderately emetogenic chemotherapy (MEC) is controversial. This study is the first to include nausea assessment as a part of the primary study outcome to better gauge the effectiveness of CINV control and patients' experience. Results show that a DEX-sparing strategy does not result in any significant loss of overall antiemetic control: DEX-sparing strategies incorporating palonosetron or multiple-day metoclopramide are safe and at least as effective as standard treatment with a 3-day DEX regimen with ondansetron in controlling delayed CINV-and nausea in particular-following MEC.

Project description:BACKGROUND:The current antiemetic prophylaxis for patients treated with highly emetogenic chemotherapy (HEC) included the olanzapine-based triplet and neurokinin-1 receptor antagonists (NK-1RAs)-based triplet. However, which one shows better antiemetic effect remained unclear. MATERIALS AND METHODS:We systematically reviewed 43 trials, involving 16,609 patients with HEC, which compared the following antiemetics at therapeutic dose range for the treatment of chemotherapy-induced nausea and vomiting: olanzapine, aprepitant, casopitant, fosaprepitant, netupitant, and rolapitant. The main outcomes were the proportion of patients who achieved no nausea, complete response (CR), and drug-related adverse events. A Bayesian network meta-analysis was performed. RESULTS:Olanzapine-based triple regimens showed significantly better no-nausea rate in overall phase and delayed phase than aprepitant-based triplet (odds ratios 3.18, 3.00, respectively), casopitant-based triplet (3.78, 4.12, respectively), fosaprepitant-based triplet (3.08, 4.10, respectively), rolapitant-based triplet (3.45, 3.20, respectively), and conventional duplex regimens (4.66, 4.38, respectively). CRs of olanzapine-based triplet were roughly equal to different NK-1RAs-based triplet but better than the conventional duplet. Moreover, no significant drug-related adverse events were observed in olanzapine-based triple regimens when compared with NK-1RAs-based triple regimens and duplex regimens. Additionally, the costs of olanzapine-based regimens were obviously much lower than the NK-1RA-based regimens. CONCLUSION:Olanzapine-based triplet stood out in terms of nausea control and drug price but represented no significant difference of CRs in comparison with NK-1RAs-based triplet. Olanzapine-based triple regimens should be an optional antiemetic choice for patients with HEC, especially those suffering from delayed phase nausea. IMPLICATIONS FOR PRACTICE:According to the results of this study, olanzapine-based triple antiemetic regimens were superior in both overall and delayed-phase nausea control when compared with various neurokinin-1 receptor antagonists-based triple regimens in patients with highly emetogenic chemotherapy (HEC). Olanzapine-based triplet was outstanding in terms of nausea control and drug price. For cancer patients with HEC, especially those suffering from delayed-phase nausea, olanzapine-based triple regimens should be an optional antiemetic choice.

Dataset Information

Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomised evidence.

Publications

Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomised evidence.

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