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BMC Pulmonary Medicine Jun 2023Appropriate monitoring and management of chemotherapy-induced nausea and vomiting (CINV) with prophylactic antiemetics is important for cancer patients. This study was...
OBJECTIVE
Appropriate monitoring and management of chemotherapy-induced nausea and vomiting (CINV) with prophylactic antiemetics is important for cancer patients. This study was performed to validate the clinical practice of antiemetic use with carboplatin-based chemotherapy in lung cancer patients in the Hokushin region (Toyama, Ishikawa, Fukui, and Nagano prefectures), Japan.
METHODS
We surveyed retrospective data of newly diagnosed and registered lung cancer patients initially treated with carboplatin-based chemotherapy in 21 principal hospitals in the Hokushin region linked with health insurance claims data between 2016 and 2017.
RESULTS
A total of 1082 lung cancer patients (861 [79.6%] men, 221 [20.4%] women; median age 69.4 years [range, 33-89 years]). All patients received antiemetic therapy, with 613 (56.7%) and 469 patients (43.3%) receiving 5-hydroxytryptamine-3 receptor antagonist/dexamethasone double regimen and 5-hydroxytryptamine-3 receptor antagonist/dexamethasone/neurokinin-1 receptor antagonist triple regimen, respectively. However, the rates of double regimen and use of palonosetron were higher in Toyama and Fukui prefectures. Thirty-nine patients (3.6%) changed from double to triple regimen, while 41 patients (3.8%) changed from triple to double regimen after the second cycle, but six of these returned to triple antiemetics in subsequent cycles.
CONCLUSION
Adherence to antiemetic guidelines in clinical practice was high in Hokushin region. However, rates of double and triple antiemetic regimens differed between the four prefectures. Simultaneous analysis of nationwide registry and insurance data was valuable for evaluating and comparing the differences in the status of antiemesis and management.
Topics: Male; Humans; Female; Aged; Antiemetics; Carboplatin; Retrospective Studies; Receptors, Serotonin, 5-HT3; Dexamethasone; Vomiting; Lung Neoplasms; Antineoplastic Combined Chemotherapy Protocols; Antineoplastic Agents
PubMed: 37365528
DOI: 10.1186/s12890-023-02524-2 -
Journal of Geriatric Oncology Jul 2023We recently demonstrated the non-inferiority of two dexamethasone (DEX)-sparing regimens with an oral fixed-combination of netupitant and palonosetron (NEPA) versus the... (Randomized Controlled Trial)
Randomized Controlled Trial
Dexamethasone-sparing regimens with NEPA (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting in older patients (>65 years) fit for cisplatin: A sub-analysis from a phase 3 study.
INTRODUCTION
We recently demonstrated the non-inferiority of two dexamethasone (DEX)-sparing regimens with an oral fixed-combination of netupitant and palonosetron (NEPA) versus the guideline-recommended DEX use for cisplatin-induced nausea and vomiting. Since prevention of chemotherapy-induced nausea and vomiting is critical in older patients, we retrospectively evaluated the efficacy of the DEX-sparing regimens in this subset.
MATERIALS AND METHODS
Chemo-naive patients aged >65 years treated with high-dose cisplatin (≥70 mg/m) were eligible. Patients received NEPA and DEX on day 1 and were randomized to receive either (1) no further DEX (DEX1), (2) oral low-dose DEX (4 mg) on days 2-3 (DEX3), or (3) the guideline-recommended standard DEX (4 mg twice daily) on days 2-4 (DEX4). The primary efficacy endpoint of the parent study was complete response (CR; no vomiting and no use of rescue medication) during the overall phase (days 1-5). No significant nausea (NSN; none or mild nausea) and the proportion of patients reporting no impact on daily life (NIDL) which was evaluated by the Functional Living Index-Emesis questionnaire on day 6 (overall combined score > 108), were secondary endpoints.
RESULTS
Among the 228 patients in the parent study, 107 were > 65 years. Similar CR rates [95% confidence intervals (CI)] were observed in patients over 65 years across treatment groups [DEX1: 75% (59.7-86.8%); DEX3: 80.6% (62.5-92.6%); DEX4: 75% (56.6-88.5%)] as well as versus the total study population. NSN rates were also similar in the older-patients across treatment groups (p = 0.480) but were higher compared with the total population. Similar rates of NIDL (95% CI) were reported in the older-patient subset across treatment groups [DEX1: 61.5% (44.6-76.6%); DEX3: 64.3% (44.1-81.4%); DEX4: 62.1% (42.3-79.3%); p = 1.0] during the overall phase, as well as versus total population. A similar proportion of older patients across treatment groups experienced DEX-related side effects.
DISCUSSION
This analysis shows that older-patients who are fit for cisplatin benefit from a simplified regimen of NEPA plus single-dose DEX with neither loss in antiemetic efficacy nor the adverse impact on patient daily functioning. The study was registered on ClinicalTrials.gov (identifier NCT04201769) on 17/12/2019 (retrospectively registered).
Topics: Humans; Aged; Cisplatin; Palonosetron; Retrospective Studies; Nausea; Antiemetics; Dexamethasone; Drug-Related Side Effects and Adverse Reactions; Antineoplastic Agents
PubMed: 37290207
DOI: 10.1016/j.jgo.2023.101537 -
Oncology 2023Dexamethasone (DEX)-sparing strategy with 5-hydroxytryptamine-3 receptor antagonist (5HT3RA) and aprepitant (APR), as triplet antiemetic prophylaxis, is associated with... (Observational Study)
Observational Study
INTRODUCTION
Dexamethasone (DEX)-sparing strategy with 5-hydroxytryptamine-3 receptor antagonist (5HT3RA) and aprepitant (APR), as triplet antiemetic prophylaxis, is associated with poor control of delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving carboplatin (CBDCA)-based chemotherapy. This study aimed to evaluate whether using palonosetron (PALO) as a 5HT3RA provides superior control with CINV than first-generation (1st) 5HT3RA in triplet antiemetic prophylaxis with a DEX-sparing strategy.
METHODS
Pooled patient-level data from a nationwide, multicenter, and prospective observational study were analyzed to compare the incidence of CINV between patients administered PALO and 1st 5HT3RA in combination with 1-day DEX and APR.
RESULTS
No significant differences were observed in the incidence of CINV, pattern of CINV, or severity of nausea by type of 5HT3RA in triplet antiemetic prophylaxis with DEX-sparing strategy. In both groups, the incidence of nausea gradually increased from day 3, peaked on day 4 or 5, and then declined slowly. The visual analog scale scores in the delayed phase remained high throughout the 7-day observation period.
CONCLUSION
Careful patient selection and symptom monitoring are needed when implementing the DEX-sparing strategy in triplet antiemetic prophylaxis for patients undergoing CBDCA-based chemotherapy. Furthermore, additional strategies may be needed to achieve better control of delayed CINV.
Topics: Humans; Aprepitant; Palonosetron; Antiemetics; Carboplatin; Dexamethasone; Isoquinolines; Quinuclidines; Nausea; Vomiting; Antineoplastic Combined Chemotherapy Protocols; Antineoplastic Agents
PubMed: 37276851
DOI: 10.1159/000531318 -
Farmacia Hospitalaria : Organo Oficial... 2023Latest MASCC/ESMO guidelines of the recommendations for the prophylaxis of acute and delayed emesis induced by moderately emetogenic chemotherapy was published in 2016... (Observational Study)
Observational Study
OBJECTIVE
Latest MASCC/ESMO guidelines of the recommendations for the prophylaxis of acute and delayed emesis induced by moderately emetogenic chemotherapy was published in 2016 incorporating anthracycline schemes as highly emetogenic chemotherapy (HEC), proposing triple antiemetic therapy to control nausea and vomiting. Likewise, they recommend triple therapy for carboplatin. The objectives of this study were to analyze the degree of concordance between guidelines and antiemetic prophylaxis used in the Chemotherapy Outpatient Unit in patients undergoing treatment with HEC and carboplatin, to evaluate its effectiveness and to determine the savings due to the use of netupitant/palonosetron (NEPA) oral (or) with intravenous (iv) dexamethasone (NEPAd) compared to iv Fosaprepitant with ondansetron and dexamethasone (FOD iv).
METHODS
Prospective observational study recording demographic variables, chemotherapy protocol, tumor location, patient emetogenic risk, antiemetic regimen prescribed, concordance with the MASCC/ESMO guideline, and effectiveness, evaluated by MASCC survey, use of rescue medication and visits to the Emergency Department or hospitalization due to emesis. A cost minimization pharmacoeconomic study was carried out.
RESULTS
61 patients were included; 70% women; median age 60.5. Platinum schemes were more frequent in period 1, being 87.5% compared to 67.6% in period 2. Anthracycline schemes were 21.6% and 10% respectively in each period. A 21.1% of the antiemetic regimens did not coincide with the MASCC/ESMO recommendations, being entirely in period 1. The score of the effectiveness questionnaires was total protection in 90.9% in acute nausea, from 100% in acute vomiting and delayed nausea, and 72.7% in delayed vomiting. The frequency of use of rescue medication was 18.7% in period 1 and was not necessary in period 2. No visits to the emergency room or admissions were detected in any of the periods.
CONCLUSIONS
Use of NEPAd led to a 28% reduction in costs with respect to the use of FOD. A high level of concordance was obtained in both periods between the latest published guideline and healthcare practice in our field. Surveys carried out on patients seem to suggest that both antiemetic therapies have similar effectiveness in clinical practice. The inclusion of NEPAd has led to a reduction in costs, positioning itself as an efficient option.
Topics: Female; Humans; Male; Middle Aged; Anthracyclines; Antibiotics, Antineoplastic; Antiemetics; Antineoplastic Agents; Carboplatin; Dexamethasone; Nausea; Vomiting; Prospective Studies
PubMed: 37268481
DOI: 10.1016/j.farma.2023.04.003 -
British Journal of Anaesthesia Aug 2023Approximately 25% of ambulatory surgery patients experience post-discharge nausea and vomiting (PDNV). We aimed to investigate whether palonosetron, a long-acting... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Approximately 25% of ambulatory surgery patients experience post-discharge nausea and vomiting (PDNV). We aimed to investigate whether palonosetron, a long-acting anti-emetic, decreases the incidence of PDNV in high-risk patients.
METHODS
In this prospective, randomised, double-blind, placebo-controlled trial, 170 male and female patients undergoing ambulatory surgery under general anaesthesia, with a high predicted risk for PDNV, were randomised to receive either palonosetron 75 μg i.v. (n=84) or normal saline (n=86) before discharge. During the first 3 postoperative days (PODs), we measured outcomes using a patient questionnaire. The primary outcome was the incidence of a complete response (no nausea, vomiting, or use of rescue medication) until POD 2. Secondary outcomes included the incidence of PDNV each day until POD 3.
RESULTS
The incidence of a complete response until POD 2 was 48% (n=32) in the palonosetron group and 36% (n=25) in the placebo group (odds ratio 1.69 [95% confidence interval: 0.85-3.37]; P=0.131). No significant difference in the incidence of PDNV was observed between the two groups on the day of surgery (47% vs 56%; P=0.31). Significant differences in the incidence of PDNV were found on POD 1 (18% vs 34%; P=0.033) and POD 2 (9% vs 27%; P=0.007). No differences were observed on POD 3 (15% vs 13%; P=0.700).
CONCLUSIONS
Compared with placebo, palonosetron did not reduce the overall incidence of post-discharge nausea and vomiting up to postoperative day 2. The lower incidence of post-discharge nausea and vomiting on poatoperative days 1 and 2 in the palonosetron group requires further investigation.
CLINICAL TRIAL REGISTRATION
EudraCT 2015-003956-32.
Topics: Humans; Male; Female; Palonosetron; Postoperative Nausea and Vomiting; Ambulatory Surgical Procedures; Prospective Studies; Patient Discharge; Aftercare; Antiemetics; Double-Blind Method
PubMed: 37246062
DOI: 10.1016/j.bja.2023.04.034 -
Advances in Therapy Jul 2023Chemotherapy-induced nausea and vomiting (CINV) is a recognized adverse outcome among patients with cancer. This retrospective study aimed to quantify the treatment...
INTRODUCTION
Chemotherapy-induced nausea and vomiting (CINV) is a recognized adverse outcome among patients with cancer. This retrospective study aimed to quantify the treatment outcomes, resource utilization, and costs associated with antiemetic use to prevent CINV in a broad US population who received cisplatin-based chemotherapy.
METHODS
Data from the STATinMED RWD Insights Database was collected from January 1, 2015 to December 31, 2020. Cohorts included any patients that had at least one claim for fosnetupitant + palonosetron (NEPA) or fosaprepitant + palonosetron (APPA) and evidence of initiating cisplatin-based chemotherapy. Logistic regression was used to evaluate nausea and vomiting visits within 14 days after chemotherapy, and generalized linear models were used to examine all-cause and CINV-related healthcare resource utilization (HCRU) and costs.
RESULTS
NEPA was associated with significantly lower rates of nausea and vomiting visits after chemotherapy (p = 0.0001), including 86% greater odds of nausea and vomiting events for APPA during the second week after chemotherapy (odds ratio [OR] = 1.86; p = 0.0003). The mean numbers of all-cause inpatient visits (p = 0.0195) and CINV-related inpatient and outpatient visits were lower among NEPA patients (p < 0.0001). These differences corresponded to 57% of NEPA patients and 67% of APPA patients having one or more inpatient visits (p = 0.0002). All-cause outpatient costs and CINV-related inpatient costs were also significantly lower for NEPA (p < 0.0001). The mean number of all-cause outpatient visits, all-cause inpatient costs, and CINV-related outpatient costs was not significantly different between groups (p > 0.05).
CONCLUSION
In this retrospective study based on claims data, NEPA was associated with lower rates of nausea and vomiting and lower CINV-related HCRU and costs compared to APPA following cisplatin-based chemotherapy. These results complement clinical trial data and published economic models supporting the use of NEPA as a safe, effective, and cost-saving antiemetic for patients undergoing chemotherapy.
Topics: Humans; Antiemetics; Cisplatin; Palonosetron; Retrospective Studies; Nausea; Vomiting; Neoplasms; Quinuclidines; Treatment Outcome; Gastrointestinal Agents; Delivery of Health Care; Antineoplastic Agents
PubMed: 37245189
DOI: 10.1007/s12325-023-02537-7 -
Biomedical Papers of the Medical... Jun 2023Postdischarge nausea and vomiting (PDNV) cause substantial pediatric morbidity with potentially serious postoperative complications. However, few studies have addressed... (Review)
Review
Postdischarge nausea and vomiting (PDNV) cause substantial pediatric morbidity with potentially serious postoperative complications. However, few studies have addressed PDNV prevention and treatment in pediatric patients. Here we searched the literature and processed it in a narrative review describing PDNV incidence, risk factors, and management in pediatric patients.. A successful strategy for reducing PDNV considers both the pharmacokinetics of the antiemetic agents and the principle of multimodal prophylaxis, utilizing agents of different pharmacologic classes. Since many highly effective antiemetic agents have relatively short half-lives, a different approach must be used to prevent PDNV. A combination of oral and intravenous medications with longer half-lives, such as palonosetron or aprepitant, can be used. In addition, we designed a prospective observational study with the primary objective of determining PDNV incidence. In our study group of 205 children, the overall PDNV incidence was 14.6% (30 of 205), including 21 children suffering from nausea and 9 suffering from vomiting.
Topics: Humans; Child; Antiemetics; Postoperative Nausea and Vomiting; Aftercare; Patient Discharge; Prospective Studies; Observational Studies as Topic
PubMed: 37222143
DOI: 10.5507/bp.2023.020 -
International Journal of Critical... 2023The incidence of postoperative nausea and vomiting (PONV) is quite high after laparoscopic surgeries. This study endeavors to compare the efficacy of the combination of...
A comparison of prophylactic antiemetic therapy with palonosetron and dexamethasone as single-agents or in combination in adult patients undergoing laparoscopic surgery: A randomized trial.
BACKGROUND
The incidence of postoperative nausea and vomiting (PONV) is quite high after laparoscopic surgeries. This study endeavors to compare the efficacy of the combination of palonosetron and dexamethasone with that of either drug alone in the prevention of PONV in patients undergoing laparoscopic surgeries.
METHODS
This randomized, parallel-group trial was done on ninety adults of American Society of Anesthesiologists Grade I and II patients aged 18-60 years undergoing laparoscopic surgeries under general anesthesia. The patients were randomly divided into three groups of thirty patients each. Group P ( = 30) received palonosetron 0.075 mg intravenously (iv), Group D ( = 30) received dexamethasone 8 mg iv and Group P + D ( = 30) received palonosetron 0.075 mg and dexamethasone 8 mg iv. The primary outcome was incidence of PONV in 24 h, and the secondary outcome was a number of rescue antiemetics required. To compare the proportions in the groups, unpaired -test, Mann-Whitney -test, Chi-square test, or Fisher's exact test was applied.
RESULTS
We found that the overall incidence of PONV was 46.7% in Group P, 50% in Group D, and 43.3% in Group P + D during the first 24 h. Rescue antiemetic was required in 27% of the patients in Group P and Group D compared to 23% of the patients in Group P + D and twice in 3% of the patients in Group P, 7% of the patients in Group D, and none in Group P + D which were not significant.
CONCLUSIONS
The combination therapy of palonosetron plus dexamethasone did not significantly reduce the incidence of PONV when compared with either drug alone.
PubMed: 37180300
DOI: 10.4103/ijciis.ijciis_150_20 -
British Journal of Anaesthesia Jul 2023Postoperative nausea and vomiting (PONV) has been identified as a big (very frequently encountered) little (not linked to life-threatening outcomes) problem. Traditional...
Postoperative nausea and vomiting (PONV) has been identified as a big (very frequently encountered) little (not linked to life-threatening outcomes) problem. Traditional drugs (dexamethasone, droperidol or similar drugs, serotonin receptor antagonists) each have significant but limited effect, leading to an increasing use of combination therapies. High-risk patients, often identified through use of risk scoring systems, remain with a significant residual risk despite combining up to three traditional drugs. A recent correspondence in this Journal proposes the use of up to five anti-emetic drugs to further minimise the risk. This disruptive strategy was supported by favourable initial results, absence of side-effects and lower acquisition costs of the added new drugs (aprepitant and palonosetron) because of their recent loss of patent protection. These results are provocative and hypothesis generating, but need confirmation and do not warrant immediate changes in clinical practice. The next steps will also necessitate wider implementation of protocols protecting patients from PONV and a search for additional drugs and techniques aimed at treating established PONV.
Topics: Humans; Postoperative Nausea and Vomiting; Antiemetics; Droperidol; Serotonin Antagonists; Risk Factors; Vomiting; Dexamethasone; Drug Therapy, Combination
PubMed: 37179157
DOI: 10.1016/j.bja.2023.04.004 -
Journal of Oncology Pharmacy Practice :... Mar 2024The purpose of this study was to investigate the efficacy and safety of netupitant/palonosetron (NEPA) for the prevention of chemotherapy-induced nausea and vomiting...
The purpose of this study was to investigate the efficacy and safety of netupitant/palonosetron (NEPA) for the prevention of chemotherapy-induced nausea and vomiting (CINV) for hematopoietic cell transplantation (HCT) patients receiving BEAM therapy. This phase II, prospective, intention-to-treat, single-center, single-arm study involved 43 adult patients who received NEPA and dexamethasone for the prevention of CINV due to BEAM conditioning chemotherapy. An interim analysis, performed after 13 patients, determined utility versus futility, and supported continuation to full enrollment. Descriptive statistics were used to report complete response (CR), complete protection, incidence of emesis, and administration of rescue agents. A Kaplan-Meier curve depicted time to first emesis and first rescue medication. Patients self-reported levels of daily nausea descriptively via a CINV Questionnaire. By study end, 13 of 43 patients achieved a CR with an average of 10.6 emesis-free days (SD 0.95) over the 11-day observation period, with no emetic events in any patient during the acute/chemotherapy phase. Nausea was well-controlled throughout the acute therapy phase (Day 1-6) and increased during the delayed phase (Day 7-11) with a peak mean level of 2.79/10 at Day 10. Aside from lower grade (≤2), headaches, constipation, and diarrhea were the most widely reported adverse effects. : The combination of NEPA and dexamethasone is safe and effective for the prevention of CINV in patients receiving BEAM conditioning therapy prior to HCT. The regimen demonstrated greater effectiveness in the acute phase versus the delayed phase, with low levels of nausea throughout the study period and complete emesis prevention during chemotherapy.
Topics: Adult; Humans; Palonosetron; Antiemetics; Prospective Studies; Vomiting; Nausea; Quinuclidines; Dexamethasone; Antineoplastic Agents; Cell Transplantation; Piperazines; Pyridines; Benzeneacetamides
PubMed: 37151021
DOI: 10.1177/10781552231173863