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The Kobe Journal of Medical Sciences Jul 2017Albumin-bound paclitaxel (Abraxane®, nab-paclitaxel) is not recommended to be administered concurrently or sequentially with other drugs due to concern for instability....
Albumin-bound paclitaxel (Abraxane®, nab-paclitaxel) is not recommended to be administered concurrently or sequentially with other drugs due to concern for instability. The need to administer drugs separately increases infusion time. We evaluated the compatibility and stability of solutions containing nab-paclitaxel and other drugs, including gemcitabine hydrochloride, carboplatin, dexamethasone sodium phosphate, granisetron hydrochloride, and palonosetron hydrochloride. We visually examined changes in appearance, pH, and concentration of the mixed solutions of nab-paclitaxel and other drugs for up to 24 h. Concentration was measured using high-performance liquid chromatography (HPLC). The appearance and pH of the mixed solutions did not change for up to 24 h. The change in concentration up to 24 h was within 2%. The chromatogram did not change until 8 h. The results showed that the physical compatibility and chemical stability of nab-paclitaxel were not influenced when it was combined with other drugs until 8 h. This study suggests that nab-paclitaxel could be administered in a mixture or sequentially with other drugs to reduce administration time.
Topics: Albumins; Antineoplastic Combined Chemotherapy Protocols; Chromatography, High Pressure Liquid; Deoxycytidine; Drug Combinations; Drug Incompatibility; Drug Stability; Female; Granisetron; Humans; Infusions, Intravenous; Male; Paclitaxel; Risk Factors; Gemcitabine
PubMed: 29434168
DOI: No ID Found -
Supportive Care in Cancer : Official... May 2017Chemotherapy-induced nausea (CIN) has a significant negative impact on the quality of life of cancer patients. The use of 5-hydroxytryptamine-3 (5-HT) receptor... (Review)
Review
Chemotherapy-induced nausea (CIN) has a significant negative impact on the quality of life of cancer patients. The use of 5-hydroxytryptamine-3 (5-HT) receptor antagonists (RAs) has reduced the risk of vomiting, but (except for palonosetron) their effect on nausea, especially delayed nausea, is limited. This article reviews the role of NKRAs when combined with 5-HTRA-dexamethasone in CIN prophylaxis. Aprepitant has not shown consistent superiority over a two-drug (ondansetron-dexamethasone) combination in nausea control after cisplatin- or anthracycline-cyclophosphamide (AC)-based highly emetogenic chemotherapy (HEC). Recently, dexamethasone and dexamethasone-metoclopramide were demonstrated to be non-inferior to aprepitant and aprepitant-dexamethasone, respectively, for the control of delayed nausea after HEC (AC/cisplatin), and are now recognized in the guidelines. The potential impact of the new NKRAs rolapitant and netupitant (oral fixed combination with palonosetron, as NEPA) in CIN prophylaxis is discussed. While the clinical significance of the effect on nausea of the rolapitant-granisetron-dexamethasone combination after cisplatin is not conclusive, rolapitant addition showed no improvement in nausea prophylaxis after AC or moderately emetogenic chemotherapy (MEC). NEPA was superior to palonosetron in the control of nausea after HEC (AC/cisplatin). Moreover, the efficacy of NEPA in nausea control was maintained over multiple cycles of HEC/MEC. Recently, NKRAs have been challenged by olanzapine, with olanzapine showing superior efficacy in nausea prevention after HEC. Fixed antiemetic combinations (such as NEPA) or new antiemetics with a long half-life that may be given once per chemotherapy cycle (rolapitant or NEPA) may improve patient compliance with antiemetic treatment.
Topics: Antiemetics; Antineoplastic Agents; Humans; Nausea; Neurokinin-1 Receptor Antagonists; Quality of Life; Vomiting
PubMed: 28108820
DOI: 10.1007/s00520-017-3585-z -
Supportive Care in Cancer : Official... Dec 2023Chemotherapy-induced nausea and vomiting (CINV) are common adverse events in patients undergoing emetogenic chemotherapy. Palonosetron, a second-generation... (Meta-Analysis)
Meta-Analysis
PURPOSE
Chemotherapy-induced nausea and vomiting (CINV) are common adverse events in patients undergoing emetogenic chemotherapy. Palonosetron, a second-generation 5-hydroxytryptamine-3 receptor antagonist (5-HT3 RA), has demonstrated non-inferiority to first-generation 5-HT3 RAs for CINV in pediatric patients. Although palonosetron has a long half-life and prolonged antiemetic action, its efficacy against delayed CINV in pediatric patients is not well understood. Therefore, this meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy of palonosetron for delayed CINV in pediatric patients.
METHODS
A literature search of MEDLINE/PubMed, Embase, Cochrane Library, and Web of Science databases was performed. A meta-analysis was performed using forest plots, and risk ratios (RRs) and 95% confidence intervals (CIs) were calculated. A funnel plot was constructed to explore publication bias.
RESULTS
The literature search retrieved 842 records, of which 23 full-text articles were assessed, including six RCTs. Meta-analysis of four RCTs that reported on the complete response (CR: defined as no emesis and no rescue medication) rate for delayed CINV revealed that palonosetron was statistically superior to first-generation 5-HT3 RAs (RR = 1.21 [95% CI 1.09-1.35]; p < 0.01). Although the number of studies included was small, no publication bias was observed in the funnel plots. In addition, the CR rate for overall and acute CINV was also significantly higher for palonosetron (RR = 1.25 [95% CI 1.01-1.54]; p = 0.04 and RR = 1.06 [95% CI 1.01-1.12]; p = 0.03, respectively).
CONCLUSION
Palonosetron is effective in the prophylaxis of delayed CINV in pediatric patients.
Topics: Humans; Child; Palonosetron; Isoquinolines; Quinuclidines; Nausea; Antiemetics; Vomiting; Antineoplastic Agents; Serotonin 5-HT3 Receptor Antagonists
PubMed: 38145979
DOI: 10.1007/s00520-023-08283-4 -
Medicine Dec 2023A multimodal therapeutic strategy for preventing postoperative nausea and vomiting (PONV) benefits moderate- and high-risk surgical patients. We compared the efficacy of... (Randomized Controlled Trial)
Randomized Controlled Trial
Comparison of the antiemetic efficacy of a combination of midazolam with ramosetron and midazolam with palonosetron for postoperative nausea and vomiting prophylaxis in laparoscopic cholecystectomy.
BACKGROUND
A multimodal therapeutic strategy for preventing postoperative nausea and vomiting (PONV) benefits moderate- and high-risk surgical patients. We compared the efficacy of a combination of midazolam and ramosetron and a combination of midazolam and palonosetron for PONV prophylaxis in patients scheduled for laparoscopic cholecystectomy.
METHODS
We enrolled 68 patients aged 20 to 65 years undergoing laparoscopic cholecystectomy. Patients were randomly allocated to the midazolam 0.05 mg/kg with ramosetron 0.3 mg (MR) or midazolam 0.05 mg/kg with palonosetron 0.075 mg (MP) groups. The incidence of PONV, severity of nausea, use of rescue antiemetics, and pain severity were evaluated at 2, 24, and 48 hours after surgery.
RESULTS
The incidence (38.2% vs 5.9%) and severity of postoperative nausea were significantly lower in the MP group at 2 hours after surgery (P < .05). There were no significant differences in the incidence of vomiting, use of rescue antiemetics, or pain severity between the 2 groups.
CONCLUSION
The combination of midazolam with palonosetron significantly decreased the incidence and severity of postoperative nausea compared with midazolam combined with ramosetron, especially in the early postoperative phase (0-2 hours) in patients undergoing laparoscopic cholecystectomy.
Topics: Humans; Antiemetics; Palonosetron; Postoperative Nausea and Vomiting; Midazolam; Cholecystectomy, Laparoscopic; Double-Blind Method; Benzimidazoles
PubMed: 38206711
DOI: 10.1097/MD.0000000000036824 -
Anesthesia, Essays and Researches 2016Postoperative nausea and vomiting (PONV) is a common occurrence after laparoscopic surgeries. A number of pharmacological agents (antihistamines, butyrophenones,...
BACKGROUND
Postoperative nausea and vomiting (PONV) is a common occurrence after laparoscopic surgeries. A number of pharmacological agents (antihistamines, butyrophenones, dopamine receptor antagonists) have been tried of which the 5-hydroxytryptamine type 3 receptor antagonists are devoid of most side effects and highly effective in prevention and treatment of PONV. Thus, we evaluated the effectiveness of granisetron and palonosetron in prevention of PONV after laparoscopic surgeries under general anesthesia.
AIMS
We conducted a study to evaluate the effectiveness of granisetron and palonosetron, to compare the duration of action and side effects if any, in patients undergoing elective laparoscopic surgery under general anesthesia.
SETTINGS AND DESIGN
This was a prospective, randomized, double-blinded, comparative study. Sixty patients (18-65 years of age) of the American Society of Anesthesiologists Grade I and II undergoing elective laparoscopic surgeries were considered.
MATERIALS AND METHODS
They were randomly allocated into one of the two groups (Group G and Group P) of thirty patients each. Group G received injection granisetron 0.05 mg/kg; Group P received injection palonosetron 1.5 mcg/kg intravenous bolus 30 min before the induction of anesthesia.
STATISTICAL TESTS
All statistical analyses were performed using the SPSS statistical package version 18.0 (Chicago: SPSS Inc). Two independent sample -test was used for quantitative data, and the χ or Fisher's exact test was used for qualitative data. A difference was regarded as statistically significant at a < 0.05.
RESULTS
The need for rescue antiemetic was significantly lower in Group P in the 24-72 h postoperative period (ρ - 0.007). The PONV score was significantly less in Group P in the same period (ρ - 0.008). The incidence of side effects was statistically insignificant in both the groups (ρ - 0.999).
CONCLUSION
Prophylactic therapy with palonosetron is more effective than granisetron in the prevention of PONV after laparoscopic surgeries under general anesthesia.
PubMed: 27746523
DOI: 10.4103/0259-1162.191121 -
Current Radiopharmaceuticals 2024To investigate the mechanism of nausea and vomiting after TACE, and analyze the efficacy and safety of palonosetron hydrochloride in the prevention of nausea and...
PURPOSE
To investigate the mechanism of nausea and vomiting after TACE, and analyze the efficacy and safety of palonosetron hydrochloride in the prevention of nausea and vomiting after TACE.
METHODS
The data of 221 patients who underwent TACE in the Department of Intervention Therapy from August 2018 to August 2020 were collected. The patients were divided into two groups: those who did not use palonosetron hydrochloride before TACE (TACE group, N=116); and those who used palonosetron hydrochloride before TACE (TACE+palonosetron group, N=105). Primary study endpoint: The control rate of nausea and vomiting in the two groups at 0-24 h (acute), 24-120 h (delayed), and 0-120 h. Secondary Study Endpoints: Adverse events of palonosetron hydrochloride.
RESULTS
TACE group vs TACE+palonosetron group: 0-24 h, 74 vs. 44 patients with nausea (63.8% vs. 41.9%); 24-120 h, 50 vs. 16 patients with nausea (43.1% vs. 15.2%); 0-120 h after TACE, 81 vs. 50 patients with nausea (69.8% vs. 47.6%). 0-24 h, 52 vs. 26 patients with vomiting (44.8% vs. 24.8%); 24-120 h, 24 vs. 8 patients with vomiting (20.7% vs. 7.6%); 0-120 h after TACE, 64 vs. 26 patients with vomiting (55.2% vs. 24.8%). The incidence of nausea and vomiting after TACE was significantly lower in the TACE+palonosetron group than in the TACE group (p < 0.05).
CONCLUSION
Palonosetron hydrochloride can significantly reduce the incidence of nausea and vomiting in patients after TACE, with exact effect and high safety.
Topics: Humans; Palonosetron; Male; Female; Retrospective Studies; Aged; Middle Aged; Nausea; Vomiting; Antiemetics; Chemoembolization, Therapeutic; Treatment Outcome; Aged, 80 and over
PubMed: 38037910
DOI: 10.2174/0118744710261186231026062257 -
Future Oncology (London, England) Mar 2019Chemotherapy-induced nausea and vomiting diminishes quality of life and increases healthcare resource use. This retrospective medical records analysis evaluated... (Comparative Study)
Comparative Study
AIM
Chemotherapy-induced nausea and vomiting diminishes quality of life and increases healthcare resource use. This retrospective medical records analysis evaluated hydration requirements with emetogenic chemotherapy.
PATIENTS & METHODS
Cancer patients received moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC), and antiemetics palonosetron or granisetron extended-release subcutaneous (GERSC), neurokinin 1 receptor antagonist and dexamethasone. Unscheduled hydration event rates were determined.
RESULTS
For 186 patients (92 palonosetron, 94 GERSC) overall, mean hydration rate was significantly higher with palonosetron (0.6 vs 0.2; p = 0.0005). Proportion of patients with ≥1 hydration event was significantly higher with palonosetron overall (54 vs 33%; p = 0.0033) and in cycles 2-4 and the HEC subgroup.
CONCLUSION
GERSC within a three-drug antiemetic regimen may reduce unscheduled hydration requirements with MEC or HEC.
Topics: Adult; Aged; Aged, 80 and over; Antiemetics; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Delayed-Action Preparations; Dexamethasone; Female; Fluid Therapy; Granisetron; Humans; Male; Middle Aged; Morpholines; Nausea; Neoplasms; Neurokinin-1 Receptor Antagonists; Palonosetron; Retrospective Studies; Serotonin 5-HT3 Receptor Antagonists; Vomiting; Young Adult
PubMed: 30499739
DOI: 10.2217/fon-2018-0787 -
European Journal of Pharmaceutical... May 2021Palonosetron hydrochloride is a specific 5-HT3 receptor antagonist, used to prevent chemotherapy-induced nausea and vomiting (CINV), and is a known chemical entity... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
Palonosetron hydrochloride is a specific 5-HT3 receptor antagonist, used to prevent chemotherapy-induced nausea and vomiting (CINV), and is a known chemical entity currently registered in the oral and IV forms in several countries worldwide.
METHODS
Single-center, single-dose, 3-treatment, open-label, randomized, 3-period, phase-I cross-over study, conducted in 18 individuals (16 males and 2 females). The primary objective was to assess the pharmacokinetic profile of Palonosetron 0.25, 0.5 and 0.75mg, after a single, oral administration in Chinese male and female healthy volunteers.
RESULTS
After administration of a single oral dose of 0.25mg, 0.5mg, or 0.75mg palonosetron in Chinese male and female healthy subjects, plasma palonosetron concentrations reached maximum values (C) of 673 ± 151 pg/mL, 1330 ± 258 pg/mL, and 1990 ± 490 pg/mL, respectively, at 3-5 h (t). The plasma elimination half-life for 0.25, 0.5 and 0.75 mg of palonosetron was 41.8±9.72 hours, 44.6±8.59 hours and 42.3±8.51 hours, respectively. Single oral doses of 0.25mg, 0.5mg, or 0.75mg palonosetron were safe and well tolerated among all the 18 subjects involved.
CONCLUSIONS
The PK of palonosetron was found to be linear in the dose range of 0.25 to 0.75 mg. Oral palonosetron in doses up to 0.75 mg was well tolerated in healthy Chinese subjects. The PK and safety data obtained from this study were similar to previous phase I studies with IV palonosetron.
Topics: Antiemetics; China; Cross-Over Studies; Female; Healthy Volunteers; Humans; Isoquinolines; Male; Palonosetron; Quinuclidines; Vomiting
PubMed: 33581259
DOI: 10.1016/j.ejps.2021.105752 -
Hong Kong Medical Journal = Xianggang... Feb 2023This post-hoc analysis retrospectively assessed data from two recent studies of antiemetic regimens for chemotherapy-induced nausea and vomiting (CINV). The primary...
INTRODUCTION
This post-hoc analysis retrospectively assessed data from two recent studies of antiemetic regimens for chemotherapy-induced nausea and vomiting (CINV). The primary objective was to compare olanzapine-based versus netupitant/palonosetron (NEPA)-based regimens in terms of controlling CINV during cycle 1 of doxorubicin/cyclophosphamide (AC) chemotherapy; secondary objectives were to assess quality of life (QOL) and emesis outcomes over four cycles of AC.
METHODS
This study included 120 Chinese patients with early-stage breast cancer who were receiving AC; 60 patients received the olanzapine-based antiemetic regimen, whereas 60 patients received the NEPA-based antiemetic regimen. The olanzapine-based regimen comprised aprepitant, ondansetron, dexamethasone, and olanzapine; the NEPA-based regimen comprised NEPA and dexamethasone. Patient outcomes were compared in terms of emesis control and QOL.
RESULTS
During cycle 1 of AC, the olanzapine group exhibited a higher rate of 'no use of rescue therapy' in the acute phase (olanzapine vs NEPA: 96.7% vs 85.0%, P=0.0225). No parameters differed between groups in the delayed phase. The olanzapine group had significantly higher rates of 'no use of rescue therapy' (91.7% vs 76.7%, P=0.0244) and 'no significant nausea' (91.7% vs 78.3%, P=0.0408) in the overall phase. There were no differences in QOL between groups. Multiple cycle assessment revealed that the NEPA group had higher rates of total control in the acute phase (cycles 2 and 4) and the overall phase (cycles 3 and 4).
CONCLUSION
These results do not conclusively support the superiority of either regimen for patients with breast cancer who are receiving AC.
Topics: Humans; Female; Antiemetics; Palonosetron; Olanzapine; Quality of Life; Retrospective Studies; Dexamethasone; Vomiting; Nausea; Breast Neoplasms; Antineoplastic Agents
PubMed: 36810240
DOI: 10.12809/hkmj209182 -
Expert Opinion on Pharmacotherapy Jul 2017Chemotherapy-induced nausea and vomiting (CINV) has a negative impact on the lives of subjects receiving chemotherapy. In 2009, the second generation 5-HT-receptor... (Review)
Review
Chemotherapy-induced nausea and vomiting (CINV) has a negative impact on the lives of subjects receiving chemotherapy. In 2009, the second generation 5-HT-receptor antagonist, palonosetron, which is longer-acting than granisetron, was shown, as part of dual therapy with dexamethasone, to be superior to intravenous granisetron in the delayed phase of CINV. Area covered: In an attempt to maintain plasma levels of granisetron during the delayed phase of CINV, longer-acting preparations of granisetron have been manufactured. In addition to comparing intravenous/oral granisetron with palonosetron, this review considers the new longer-acting preparations of granisetron (transdermal and subcutanous) with emphasis on whether they are effective in the delayed phase of CINV. Expert opinion: Comparison of intravenous/oral granisetron and palonosetron, as part of triple therapy against the delayed phase of CINV, do not give clear-cut results as to non-inferiority or superiority of either agent. Subcutaneous granisetron is more convenient to use than transdermal granisetron, and has been shown to be non-inferior to palonosetron, as part of dual therapy, in the treatment of the acute and delayed phases of CINV. At present, it seems likely that there will be ongoing roles for intravenous and subcutaneous granisetron in CINV, but further data is required to ascertain the future of transdermal granisetron.
Topics: Administration, Cutaneous; Antiemetics; Antineoplastic Agents; Clinical Trials as Topic; Dexamethasone; Granisetron; Humans; Isoquinolines; Nausea; Palonosetron; Quinuclidines; Vomiting
PubMed: 28612633
DOI: 10.1080/14656566.2017.1342809