Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial

Celio, Luigi; Denaro, A.; Agustoni, Francesco; Bajetta, Emilio

doi:10.1016/j.suponc.2011.06.007

Cited by 19 publications

(8 citation statements)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The results of these trials suggest that with the administration of palonosetron during an MEC regimen, CINV can be controlled by 1 day of steroid administration. Moreover, Celio et al performed a subgroup analysis [ 19 ]. Multivariate analysis determined that age younger than 50 years was a risk factor for CINV.…”

Section: Discussionmentioning

confidence: 99%

Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy

Kosaka

Tanino

Sengoku

et al. 2015

Support Care Cancer

View full text Add to dashboard Cite

PurposeDexamethasone, plus a 5-HT3 receptor antagonist and an NK-1 receptor antagonist are recommended for controlling the chemotherapy-induced nausea and vomiting (CINV) of highly emetogenic chemotherapy. Several days of dexamethasone are effective for CINV; however, dexamethasone also has side effects. The purpose of this trial was to investigate whether the use of a second-generation 5-HT3 receptor antagonist and an NK-1 receptor antagonist could allow a reduced dose of dexamethasone for breast cancer patients receiving highly emetogenic chemotherapy.MethodsEighty breast cancer patients who received an anthracycline-cyclophosphamide combination regimen were enrolled. The patients were randomized to arm A (dexamethasone days 1–3) and arm B (dexamethasone day 1). The primary endpoint was complete response (CR) (no emetic episodes and no rescue medication) during the overall phase (days 1–5). The secondary endpoints were the CR during the delayed phase (days 2–5), complete control (CC) (no emetic episodes, no rescue medication, and no more than mild nausea) during the overall phase, and the safety of this antiemetic therapy.ResultsThere were no significant differences in the rates of CR and CC between arm A and B as follows: CR overall phase—arm A: 82.9 %, 90 % confidence interval [CI] 71.3–90.5 % vs arm B: 82.1 %, 90 % CI 70.0–90.0 %; p = 1.00; CR delayed phase—arm A: 87.8 %, 90 % CI 77.0–93.9 % vs arm B: 94.9 %, 90 % CI 85.6–98.3 %; p = 0.43; CC overall phase—arm A: 48.8 %, 90 % CI 36.4–61.3 % vs arm B: 61.5 %, 90 % CI 48.4–73.2 %; p = 0.27. There were very few adverse events and no severe adverse events associated with this antiemetic therapy.ConclusionsThe results suggest that the antiemetic effect provided by dexamethasone administered for 3 days can be obtained by dexamethasone administered for 1 day.

show abstract

Section: Discussionmentioning

confidence: 99%

Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy

Kosaka

Tanino

Sengoku

et al. 2015

Support Care Cancer

View full text Add to dashboard Cite

show abstract

“…The decision by one provider to use palonosetron on day 1 and dexamethasone on days 1-4 instead of using granisetron on day 1, plus dexamethasone on days 1-4, plus aprepitant on days 1-3, for HEC was a reasonable alternative to the institutional guidelines. Previously reported studies support, by cross-study comparisons, that palonosetron might give similar protection as does aprepitant plus granisetron [18][19][20].…”

Section: Discussionmentioning

confidence: 73%

Antiemetic prescribing practices using a computerized physician order entry system.

Kadakia

Leal

Seisler

et al. 2013

JCO

View full text Add to dashboard Cite

e17538 Background: Adherence to guideline-consistent chemotherapy-induced nausea and vomiting (CINV) prophylaxis is suboptimal. The primary aim of this study was to evaluate the magnitude of compliance to institutional guideline-directed antiemetic prophylaxis using a computerized physician order entry system at a single tertiary care institution. A nurse survey was also performed to evaluate how oncology practices, within a cooperative group, manage clinician orders for the prevention of CINV. Methods: The electronic medical records of 100 consecutive patients were evaluated. The primary endpoint was the incidence of compliance to provide all aspects of institutional guideline-directed antiemetic prophylaxis for acute (Day 1) and delayed (Days 2-4) CINV for patients receiving high, moderate, low, and minimally-emetogenic chemotherapy (HEC/MEC/LEC/MinEC). Noncompliance was declared if a recommended antiemetic was not prescribed per the guidelines or if additional antiemetics were prescribed. Descriptive analyses were performed on the convenience sample. Logistic regression was applied to determine the association of potential factors with noncompliance. Results: The incidence of compliance on Days 1-4 was 94%. Half of the noncompliant events occurred on Day 1 alone and involved the omission of pre-chemotherapy prochlorperazine in patients receiving LEC (3 of 6, 50%). There was a high-degree of compliance to institutional guidelines for delayed CINV (97%). Patients receiving doxorubicin/cyclophosphamide were numerically less likely to receive institutional guideline-directed antiemetic prophylaxis, compared to patients receiving other chemotherapy regimens (OR: 0.24 (0.04, 1.36), p-value: 0.05). No other factors were significantly predictive for compliance. The nurse survey demonstrated significant variability amongst the involved institutions, with regards to antiemetic prescribing practices. Conclusions: Computerized physician order entry is associated with impressive adherence to clinician prescribing practices, according to institutional guideline-directed antiemetic prophylaxis, for preventing acute and delayed CINV.

show abstract

“…Nine studies, [8,10,15–21] with 1968 cases were included in our meta-analysis (The flowchart was presented in PRISMA Flow Diagram). Three trials [22–24] were excluded because of repetitive data. Considering the heterogeneity and progress of chemotherapy and treatment options, 1 trial [25] was excluded.…”

Section: Resultsmentioning

confidence: 99%

Dexamethasone-sparing regimen is an effective and safe alternative in overall antiemetic protection

Xie

Ren

et al. 2019

Medicine

View full text Add to dashboard Cite

Objective:We performed a meta-analyisis to evaluate the efficacy of maintenance dexamethasone against acute or delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately or highly emetic risk chemotherapy regimen.Methods:PubMed, Embase, and Cochrane Library were searched for eligible studies. Data comparing maintenance dexamethasone with single-dose dexamethasone during the acute, delayed, and overall phase of CINV were extracted. Overall risk ratio (RR) was used to estimate the efficacy and adverse effects.Results:Nine studies were included. In delayed phase, maintenance dexamethasone has similar efficacy to single-dose dexamethasone for no emetic episodes (RR, 1.06; 95% confidence interval [CI], 1.00–1.14), complete response (RR, 1.04; 95% CI, 0.98–1.11), complete control (RR, 1.07; 95% CI, 0.98–1.16), and total control (RR, 1.06; 95% CI, 0.91–1.23). In overall phase, maintenance dexamethasone has similar efficacy to single-dose dexamethasone for no emetic episodes (RR, 1.02; 95% CI, 0.94–1.11), complete response (RR, 1.02; 95% CI, 0.95 -1.09), complete control (RR, 1.03; 95% CI, 0.94–1.13), total control (RR, 1.05; 95% CI, 0.90–1.23), and no rescue medication (RR, 1.07; 95% CI, 0.97–1.19). Maintenance dexamethasone was only superior to single-dose dexamethasone for no rescue medication during delayed phase (RR, 1.10; 95% CI, 1.01–1.21, P = .034). The incidence of hiccup was observed higher in maintenance dexamethasone group (RR = 3.16, 95% CI, 1.12–8.92).Conclusion:The single-dose dexamethasone regimen offers high and similar overall control of symptoms as the maintenance dexamethasone regimen in this population. Multiple-day dexamethasone was suitable for patients who used rescue medication during the delayed phase.

show abstract

Palonosetron Plus 1-Day Dexamethasone for the Prevention of Nausea and Vomiting Due to Moderately Emetogenic Chemotherapy: Effect of Established Risk Factors on Treatment Outcome in a Phase III Trial

Cited by 19 publications

References 11 publications

Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy

Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy

Antiemetic prescribing practices using a computerized physician order entry system.

Dexamethasone-sparing regimen is an effective and safe alternative in overall antiemetic protection

Contact Info

Product

Resources

About