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1.
Anticancer Res ; 46(1): 395-405, 2026 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-41469110

RESUMO

BACKGROUND/AIM: This study investigated the efficacy and safety of olanzapine and aprepitant in preventing chemotherapy-induced nausea and vomiting in patients with hepatocellular carcinoma (HCC) undergoing cisplatin-based hepatic arterial infusion chemotherapy (HAIC). PATIENTS AND METHODS: This single-center, non-randomized, prospective study included patients with HCC receiving cisplatin-HAIC between December 2020 and February 2023. In the first treatment session, patients without diabetes mellitus received granisetron and olanzapine (GRA+OLA), and those with diabetes received granisetron monotherapy (GRA). The primary endpoint was the complete response (CR, no vomiting or rescue medications) rate in the GRA+OLA group. In the second session, aprepitant was added if complete control (CC, CR plus no severe nausea) was not achieved during the first treatment. Secondary endpoints were rates of CC and total control (TC, CR plus no nausea), changes in liver function, and toxicity in each medication group. RESULTS: The CR rate in the GRA+OLA group (n=7) was 85.7% (90% confidence interval=47.9-99.3%), which is numerically but not statistically significantly higher than the rate in the GRA group (n=9, 66.7%; p=0.59). Aprepitant was added in two cases, both of which achieved TC. No grade ≥3 treatment-related adverse events were observed. CONCLUSION: Olanzapine and/or aprepitant with granisetron may be effective and safe as an antiemetic therapy in cisplatin-HAIC.


Assuntos
Antieméticos , Protocolos de Quimioterapia Combinada Antineoplásica , Aprepitanto , Carcinoma Hepatocelular , Cisplatino , Neoplasias Hepáticas , Náusea , Olanzapina , Vômito , Humanos , Olanzapina/uso terapêutico , Olanzapina/efeitos adversos , Olanzapina/administração & dosagem , Aprepitanto/uso terapêutico , Aprepitanto/administração & dosagem , Aprepitanto/efeitos adversos , Cisplatino/efeitos adversos , Cisplatino/administração & dosagem , Neoplasias Hepáticas/tratamento farmacológico , Masculino , Carcinoma Hepatocelular/tratamento farmacológico , Feminino , Pessoa de Meia-Idade , Náusea/induzido quimicamente , Náusea/prevenção & controle , Náusea/tratamento farmacológico , Estudos Prospectivos , Vômito/induzido quimicamente , Vômito/prevenção & controle , Vômito/tratamento farmacológico , Antieméticos/uso terapêutico , Antieméticos/efeitos adversos , Antieméticos/administração & dosagem , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Granisetron/uso terapêutico , Granisetron/administração & dosagem , Adulto , Resultado do Tratamento
2.
Clin Transl Oncol ; 28(1): 14-22, 2026 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-40627319

RESUMO

Emesis is a common complication in patients with gastric cancer (GC), resulting from both tumor progression and adverse events of antineoplastic therapies. It is estimated that up to 70% of patients experience nausea and vomiting, significantly impacting quality of life. Symptoms can lead to dehydration, malnutrition, fatigue, and emotional disturbances like anxiety and depression. Etiological factors fall into two categories. First, neoplasia-related mechanisms-gastric outlet obstruction, gastroparesis due to autonomic dysfunction, invasion of adjacent structures, presence of peritoneal carcinomatosis or malignant ascites-contribute to gastric emptying disorders. Second, antineoplastic treatments-including chemotherapy, radiotherapy, and targeted therapies-carry an inherent inducing emesis risk and can cause acute, delayed, anticipatory, breakthrough, or refractory emesis. International guidelines from the American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), Multinational Association of Supportive Care in Cancer (MASCC), and National Comprehensive Cancer Network (NCCN) recommend combination regimens that include 5-hydroxytryptamine type 3 receptor antagonist (anti-5-HT3), dexamethasone, neurokinin-1 receptor antagonists (anti-NK1), and, occasionally, olanzapine. Prophylaxis should be tailored to the emetic risk of the treatment and the individual characteristics of the patient, like age, sex, and pharmacogenomic factors. Pharmacological strategies should be complemented with non-pharmacological interventions to enhance therapeutic efficacy and alleviate symptoms. This consensus guide from the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) highlights the importance of multidisciplinary and individualized approaches to managing emesis associated with GC. Evidence-based therapeutic algorithms are essential to achieving these goals.


Assuntos
Antieméticos , Antineoplásicos , Neoplasias Gástricas , Vômito , Humanos , Neoplasias Gástricas/complicações , Neoplasias Gástricas/tratamento farmacológico , Neoplasias Gástricas/terapia , Vômito/prevenção & controle , Vômito/etiologia , Vômito/induzido quimicamente , Vômito/terapia , Antieméticos/uso terapêutico , Consenso , Medicina Baseada em Evidências , Antineoplásicos/efeitos adversos
3.
Cancer Chemother Pharmacol ; 95(1): 119, 2025 Dec 03.
Artigo em Inglês | MEDLINE | ID: mdl-41335238

RESUMO

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a common gastrointestinal side effect in cancer treatment. 6-gingerol, a bioactive component of ginger, demonstrates efficacy in attenuating CINV. This study aimed to explore the effects of 6-gingerol on inhibiting ferroptosis and to clarify its potential antiemetic mechanisms in a cisplatin-induced rat pica model. METHODS: We established the rat pica model by intraperitoneal injection of cisplatin (6 mg/kg). The histopathological damage in gastrointestinal (GI) tissues was assessed by hematoxylin-eosin staining. The levels of serum IL-6, IL-1ß, TNF-α, and hepcidin were measured by ELISA. The occurrence of ferroptosis was confirmed by measuring the levels of ROS, GSH, SOD, MDA, and iron in GI tissues. Furthermore, iron deposition was visualized with Perls + DAB staining, and the lipid peroxidation product 4-HNE was detected via immunohistochemistry. The expression levels of iron homeostasis-related proteins in GI tissues were examined by western blotting. RESULTS: The results showed that 6-gingerol improved pica behavior and mitigated GI inflammation in cisplatin-treated rats. Additionally, 6-gingerol mitigated oxidative stress, lipid peroxidation, and reduced iron accumulation. Molecular docking analysis showed that iron homeostasis-related proteins (TfR1, DMT1, ferritin, Fpn, and hepcidin) might be the potential regulatory targets of 6-gingerol. Mechanistically, 6-gingerol restored iron homeostasis by downregulating the expression levels of TfR1 and DMT1 to reduce iron uptake and transport, and upregulating the expression levels of ferritin and Fpn to enhance iron storage and export. CONCLUSION: Overall, this study indicates that regulating iron homeostasis to inhibit ferroptosis is related to the therapeutic effect of 6-gingerol against CINV.


Assuntos
Antieméticos , Antineoplásicos , Catecóis , Álcoois Graxos , Ferroptose , Ferro , Náusea , Vômito , Animais , Catecóis/farmacologia , Catecóis/uso terapêutico , Ferroptose/efeitos dos fármacos , Álcoois Graxos/farmacologia , Álcoois Graxos/uso terapêutico , Ferro/metabolismo , Ratos , Cisplatino/efeitos adversos , Cisplatino/toxicidade , Masculino , Homeostase/efeitos dos fármacos , Ratos Sprague-Dawley , Vômito/induzido quimicamente , Vômito/tratamento farmacológico , Vômito/prevenção & controle , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Náusea/prevenção & controle , Antineoplásicos/efeitos adversos , Antineoplásicos/toxicidade , Antieméticos/farmacologia , Estresse Oxidativo/efeitos dos fármacos , Modelos Animais de Doenças , Peroxidação de Lipídeos/efeitos dos fármacos
4.
Medicine (Baltimore) ; 104(52): e46778, 2025 Dec 26.
Artigo em Inglês | MEDLINE | ID: mdl-41466018

RESUMO

BACKGROUND: Standardized chemotherapy-induced nausea and vomiting (CINV) prevention in HEC is critical, yet NK1RAs remain inaccessible for some patients due to cost and availability. Our prior study demonstrated HXZQ + 5HT3RAs + dexamethasone's superior efficacy; this phase III trial aimed to validate this regimen. METHOD: This multicenter, double-blind, randomized phase III trial (10 hospitals, Southwest China; March 2023-August 2024) assigned patients to group HX (HXZQ + 5HT3RA + dexamethasone) or group C (control). Primary endpoints: mean No CINV Days (NCDs) during the full cycle and complete control (CC) rate beyond the risk period. Secondary endpoints: safety, CC rate during the risk period, mean no nausea days and life function. RESULTS: A total of 166 patients were enrolled and 139 patients completed the study, 73 in group HX and 66 in group C. The mean NCDs was significantly better in group HX (17.92 ±â€…4.06) than that in group C (15.26 ±â€…5.91, P = .002). Group HX showed better NCDs in acute, delayed and the period beyond the risk phases than group C, with a higher CC rate of CINV beyond the risk phase (80.8% vs 60.6%, P = .009). The mean no nausea days in group HX was significantly better than that in group C (18.26 vs 15.45, P = .001). Group HX also showed a trend to better functional living index-emesis score, but only achieved the significance during the period beyond the risk phase. CONCLUSION: HXZQ in combination with a 5-HT3 receptor antagonist and dexamethasone is safe and feasible for preventing CINV due to 3-day cisplatin-containing HEC throughout the whole cycle.


Assuntos
Antieméticos , Antineoplásicos , Cisplatino , Medicamentos de Ervas Chinesas , Náusea , Vômito , Humanos , Náusea/induzido quimicamente , Náusea/prevenção & controle , Náusea/tratamento farmacológico , Feminino , Vômito/induzido quimicamente , Vômito/prevenção & controle , Vômito/tratamento farmacológico , Masculino , Método Duplo-Cego , Pessoa de Meia-Idade , Cisplatino/efeitos adversos , Cisplatino/administração & dosagem , Antieméticos/administração & dosagem , Antieméticos/uso terapêutico , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/uso terapêutico , Adulto , Antineoplásicos/efeitos adversos , Dexametasona/administração & dosagem , Dexametasona/uso terapêutico , Idoso , China
5.
Cancer Chemother Pharmacol ; 95(1): 114, 2025 Nov 24.
Artigo em Inglês | MEDLINE | ID: mdl-41284044

RESUMO

PURPOSE: Chemotherapy-Induced Nausea and Vomiting (CINV) has a significant negative impact on cancer chemotherapy and patients' quality of life (QOL). Purpose of this study is to establish the safety, tolerability and pharmacokinetics of novel Ondansetron Extended Release Injectable Suspension (OERIS) through preclinical and clinical studies. Antiemetic medications, especially 5-HT3 antagonists like ondansetron, granisetron, neurokinin1 antagonists (aprepitant, fosaprepitant etc.) have proven to be effective in the prevention and control of CINV. However, ondansetron is currently available as oral tablet/solutions or IM/IV formulations requiring multiple dosing 3-5 days during chemotherapy. Novel OERIS formulation is developed with an aim to provide a single dose treatment strategy for an effective prophylaxis of acute and delayed phases of CINV. METHODS: Preclinical studies in rats and dogs viz. maximum tolerated dose, sub-acute toxicity and pharmacokinetic studies were conducted to support safety and pharmacokinetic assessments and before initiating human studies. Subsequently, a Phase I study was conducted in 24 healthy male human volunteers to evaluate safety, tolerability and pharmacokinetics. Study involves 4 arms with 6 subjects in each arm administered with either one of the 3 doses of OERIS (35, 70 and 100 mg, IM) or reference (24 mg, IV in 3 divided doses). RESULTS: No Observed Adverse Effect Level (NOAEL) was found to be 150 mg/kg, i.m. in rats, which is approximately 160 times that of recommended ondansetron human dose (0.15 mg/kg, i.v.). Phase I study of OERIS demonstrated optimal PK exposures for efficacy up to 5-days within therapeutic window along with good safety (no QT prolongation and no hypokalemia) and tolerability (no injection site reactions) in healthy subjects at a dose of 100 mg. CONCLUSION: OERIS is a promising, convenient, safe anti-emetic therapy effective for acute and delayed phases (lasts for 5-days) of CINV in patients receiving chemotherapy with a single dose. TRIAL REGISTRATION: The trial is registered at Clinical Trial Registry of India (CTRI) with registration number: CTRI/2022/07/043886 (Registered on: 11/07/2022).


Assuntos
Antieméticos , Náusea , Ondansetron , Vômito , Ondansetron/farmacocinética , Ondansetron/administração & dosagem , Ondansetron/efeitos adversos , Masculino , Humanos , Animais , Antieméticos/farmacocinética , Antieméticos/administração & dosagem , Antieméticos/efeitos adversos , Ratos , Vômito/induzido quimicamente , Vômito/prevenção & controle , Adulto , Náusea/induzido quimicamente , Náusea/prevenção & controle , Náusea/tratamento farmacológico , Cães , Preparações de Ação Retardada/farmacocinética , Preparações de Ação Retardada/administração & dosagem , Pessoa de Meia-Idade , Dose Máxima Tolerável , Suspensões , Adulto Jovem , Ratos Sprague-Dawley , Feminino , Antineoplásicos/efeitos adversos
6.
Int J Clin Oncol ; 30(12): 2464-2473, 2025 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-41091406

RESUMO

BACKGROUND: Guideline-consistent prophylaxis is more effective in managing chemotherapy-induced nausea and vomiting than non-guideline approaches. However, the extent to which patients undergoing anticancer treatment receive guideline-recommended antiemetic therapy in real-world clinical practice remains unclear. This study evaluated the real-world patterns of antiemetic therapy among patients undergoing high emetic risk chemotherapy (HEC) and carboplatin-based moderate emetic risk chemotherapy (MEC) according to cancer type and treatment regimen and identified factors associated with antiemetic use. METHODS: We used health service utilization data linked to hospital-based cancer registries from 601 hospitals in Japan. Data from patients aged ≥ 18 years diagnosed with cancer in 2020 and 2021 and treated with intravenous HEC or carboplatin-based MEC were analyzed. The percentage of patients prescribed antiemetics was calculated. A multilevel mixed-effects logistic regression was performed to identify factors associated with antiemetic therapy. RESULTS: A total of 157,705 patients were analyzed (HEC: 100,163; MEC: 57, 542). Triple-drug antiemetics (an NK1 receptor antagonist, a 5-HT3 receptor antagonist, and dexamethasone) were prescribed to 70.6% and 71.9% of patients undergoing HEC and MEC, respectively. In the HEC group, 8.9% received olanzapine in addition to triple-drug antiemetics. Antiemetic therapy varied by cancer type and regimen. In multilevel analysis, odds of receiving triple-drug antiemetics were the highest in small-cell lung cancer (OR = 3.065) for HEC and in endometrial cancer (OR = 1.324) for MEC. CONCLUSION: Antiemetic therapy for patients receiving HEC or carboplatin-based MEC varies by cancer type and treatment regimen. Future research should explore reasons for and barriers to non-adherence to guidelines.


Assuntos
Antieméticos , Protocolos de Quimioterapia Combinada Antineoplásica , Carboplatina , Fidelidade a Diretrizes , Náusea , Neoplasias , Vômito , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carboplatina/efeitos adversos , Carboplatina/administração & dosagem , Fidelidade a Diretrizes/estatística & dados numéricos , Japão , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Náusea/prevenção & controle , Neoplasias/tratamento farmacológico , Guias de Prática Clínica como Assunto , Vômito/induzido quimicamente , Vômito/tratamento farmacológico , Vômito/prevenção & controle
7.
Support Care Cancer ; 33(9): 777, 2025 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-40788411

RESUMO

PURPOSE: Conditioning with high-dose melphalan (MEL) followed by autologous stem cell transplantation (ASCT) is the standard treatment for multiple myeloma (MM). The optimal regimen to prevent chemotherapy-induced nausea and vomiting (CINV) is unclear. We aimed to retrospectively evaluate the antiemetic effect and safety of a four-drug intensive regimen including olanzapine (OLA) on CINV in MM patients receiving MEL/ASCT. METHODS: MEL (200 mg/m2) was administered on day 1, followed by ASCT on day 3. Patients were classified into the standard group (palonosetron and dexamethasone on day 1, and aprepitant on day 1-3), and the intensive antiemetic regimen (IAR) group (palonosetron on day 1, dexamethasone on day 1-2, and aprepitant, and OLA on day 1-5). The primary endpoint was defined as no vomiting and no rescue medications (complete response) in the delayed phase (day 2-5). RESULTS: There were no significant differences in baseline characteristics between the OLA (n = 68) and standard (n = 54) groups. The complete response rate in the IAR group was significantly higher in the delayed phase (52.9% vs. 31.4%, p < 0.05). Multivariate analysis revealed that the IAR was associated with the complete response rate (OR, 2.34; 95% CI, 1.09-5.00; p = 0.028). The incidence of nausea (grade 3) in the delayed phase was lower in the IAR group (44.1% vs. 75.9%, p < 0.001). CONCLUSION: The four-drug intensive regimen including OLA may improve the antiemetic effect on delayed CINV while also ensuring safety in MM patients undergoing MEL/ASCT.


Assuntos
Antieméticos , Benzodiazepinas , Melfalan , Mieloma Múltiplo , Náusea , Transplante de Células-Tronco , Vômito , Humanos , Mieloma Múltiplo/terapia , Mieloma Múltiplo/tratamento farmacológico , Antieméticos/uso terapêutico , Antieméticos/administração & dosagem , Antieméticos/efeitos adversos , Masculino , Feminino , Olanzapina , Melfalan/administração & dosagem , Melfalan/efeitos adversos , Melfalan/uso terapêutico , Pessoa de Meia-Idade , Estudos Retrospectivos , Náusea/induzido quimicamente , Náusea/prevenção & controle , Náusea/tratamento farmacológico , Vômito/induzido quimicamente , Vômito/prevenção & controle , Vômito/tratamento farmacológico , Idoso , Dexametasona/administração & dosagem , Dexametasona/uso terapêutico , Benzodiazepinas/uso terapêutico , Benzodiazepinas/administração & dosagem , Benzodiazepinas/efeitos adversos , Transplante Autólogo , Aprepitanto , Palonossetrom , Adulto , Antineoplásicos Alquilantes/administração & dosagem , Antineoplásicos Alquilantes/efeitos adversos , Antineoplásicos Alquilantes/uso terapêutico , Transplante de Células-Tronco/métodos , Quimioterapia Combinada , Morfolinas/administração & dosagem , Morfolinas/uso terapêutico , Quinuclidinas/administração & dosagem , Quinuclidinas/uso terapêutico , Isoquinolinas/administração & dosagem , Isoquinolinas/uso terapêutico
8.
BMC Med ; 23(1): 501, 2025 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-40866861

RESUMO

BACKGROUND: This phase I trial aimed to assess the pharmacokinetics (PK), safety, and preliminary efficacy of a single dose of HR20013 (mixed formulation of fosrolapitant and palonosetron) plus dexamethasone in patients with malignant solid tumors. METHODS: Solid tumor patients who were naive to cisplatin-based chemotherapy and scheduled to receive the single-day cisplatin-based chemotherapy were enrolled. Patients would receive a single intravenous infusion of HR20013 (Day 1) before cisplatin-based chemotherapy, alongside oral dexamethasone (Day 1, 12 mg, once a day; Day 2-4, 3.75 mg, twice a day). Primary endpoints were PK parameters of fosrolapitant, rolapitant, M19 (a major active metabolite of rolapitant), palonosetron, and dexamethasone. RESULTS: Twenty-four patients were enrolled, and 22 received study treatment. Fosrolapitant reached maximum plasma concentration (Cmax) immediately at the end of the infusion of HR20013 (1 h), followed by a short terminal phase, and it was completely hydrolyzed into rolapitant. Mean elimination half-lives of rolapitant and palonosetron were 188.2 and 51.5 h, respectively. M19 reached Cmax at approximately 166.2 h. After a single oral administration of dexamethasone at 12 mg, when combined with HR20013, dexamethasone reached Cmax at approximately 1.5 h, with a mean Cmax of 106.0 ng/mL. Treatment-related adverse events occurred in 54.5% of patients, with constipation (22.7%), increased blood pressure (18.2%), abdominal distension (13.6%), injection site reaction (9.1%), and increased neutrophil count (9.1%) being most common. Complete response rates (no emesis/rescue therapy) were 90.9% at the overall phase (0-120 h) and 86.4% at the beyond delayed phase (120-168 h). CONCLUSIONS: HR20013 plus dexamethasone had a favorable PK profile, manageable safety, and durable antiemetic efficacy. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05465681.


Assuntos
Antieméticos , Cisplatino , Dexametasona , Isoquinolinas , Neoplasias , Pirróis , Quinuclidinas , Humanos , Dexametasona/administração & dosagem , Dexametasona/farmacocinética , Dexametasona/efeitos adversos , Dexametasona/uso terapêutico , Masculino , Feminino , Pessoa de Meia-Idade , Palonossetrom/farmacocinética , Palonossetrom/administração & dosagem , Cisplatino/efeitos adversos , Cisplatino/administração & dosagem , Cisplatino/uso terapêutico , Neoplasias/tratamento farmacológico , Antieméticos/farmacocinética , Antieméticos/administração & dosagem , Antieméticos/efeitos adversos , Antieméticos/uso terapêutico , Adulto , Idoso , Isoquinolinas/farmacocinética , Isoquinolinas/administração & dosagem , Isoquinolinas/efeitos adversos , Vômito/induzido quimicamente , Vômito/prevenção & controle , Pirróis/farmacocinética , Pirróis/administração & dosagem , Pirróis/efeitos adversos , Náusea/induzido quimicamente , Quinuclidinas/farmacocinética , Quinuclidinas/administração & dosagem , Quinuclidinas/efeitos adversos , Antineoplásicos/efeitos adversos , Resultado do Tratamento , Morfolinas
10.
Anticancer Res ; 45(9): 3605-3616, 2025 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-40876984

RESUMO

BACKGROUND/AIM: This study aimed to investigate the efficacy of olanzapine, an antiemetic agent used to prevent chemotherapy-induced nausea and vomiting (CINV), at 5 and 10 mg/day, by chemotherapy emetogenic risk, and to evaluate the efficacy of low dose olanzapine at 2.5 mg/day. MATERIALS AND METHODS: PubMed and Web of Science were searched to identify studies evaluating the efficacy of olanzapine in CINV prevention from database inception up to August 31, 2023. The primary endpoints were complete response (CR, defined as no emesis and no rescue) rates in acute, delayed, and overall phases. Additionally, data on the efficacy of 2.5 mg/day olanzapine were evaluated. RESULTS: A total of 24 studies were included in the meta-analysis. The CR rates in acute, delayed, and overall phases were 91% [95% confidence interval (CI)=88-94%], 76% (95%CI=71-80%), and 72% (95%CI=67-77%), respectively. Subgroup analysis in studies on highly emetogenic chemotherapy (HEC) revealed the CR rates in acute, delayed, and overall phases were not significantly different between 5 and 10 mg/day olanzapine. Conversely, the CR rates in delayed and overall phases were significantly better with 5 mg/day olanzapine in studies on moderately emetogenic chemotherapy (MEC) (p =0.03 and p=0.04, respectively). Evaluation of olanzapine at 2.5 mg/day suggested that it is effective in CINV prevention. CONCLUSION: Olanzapine was effective at both 5 and 10 mg/day in patients receiving HEC or MEC; its efficacy was not dose-dependent. Reduced olanzapin dose at 2.5 mg/day could be considered as an option for the management of CINV.


Assuntos
Antieméticos , Antineoplásicos , Náusea , Olanzapina , Vômito , Humanos , Olanzapina/uso terapêutico , Olanzapina/administração & dosagem , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Náusea/prevenção & controle , Vômito/induzido quimicamente , Vômito/tratamento farmacológico , Vômito/prevenção & controle , Antieméticos/uso terapêutico , Antieméticos/administração & dosagem , Antineoplásicos/efeitos adversos , Relação Dose-Resposta a Droga , Resultado do Tratamento
11.
BMC Gastroenterol ; 25(1): 577, 2025 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-40790551

RESUMO

BACKGROUND AND OBJECTIVES: Transcatheter arterial chemoembolization (TACE) is a fundamental treatment for unresectable hepatocellular carcinoma despite its tendency to induce postembolization syndrome (PES), which can negatively impact the quality of life and treatment outcomes of patients. This study aimed to evaluate the efficacy of prophylactic dexamethasone in reducing PES following TACE. METHODS: A thorough search across major databases was conducted to identify studies investigating the prophylactic use of dexamethasone in preventing and reducing PES. Efficacy was evaluated via a meta-analysis utilizing a random-effects model to determine the risk ratio (RR) and 95% confidence intervals (CIs), focusing on PES symptoms, including abdominal pain, fever, nausea, and vomiting. RESULTS: Among 406 meticulously reviewed studies, 5, encompassing a patient cohort of 400 individuals, were included in the final analysis. The results revealed a significant reduction in the overall incidence of abdominal pain (RR = 0.61; 95% CI: 0.51-0.75; P < 0.001), fever (RR = 0.46; 95% CI: 0.35-0.60; P < 0.001), and nausea and vomiting (RR = 0.57; 95% CI: 0.43-0.76; P < 0.001) using dexamethasone prophylactically. CONCLUSION: This meta-analysis suggested that the prophylactic administration of dexamethasone effectively prevents and reduces PES, significantly reducing the incidence of key symptoms, including abdominal pain, fever, nausea, and vomiting.


Assuntos
Antieméticos , Carcinoma Hepatocelular , Quimioembolização Terapêutica , Dexametasona , Neoplasias Hepáticas , Humanos , Quimioembolização Terapêutica/efeitos adversos , Carcinoma Hepatocelular/terapia , Dexametasona/uso terapêutico , Neoplasias Hepáticas/terapia , Vômito/prevenção & controle , Vômito/etiologia , Náusea/prevenção & controle , Náusea/etiologia , Dor Abdominal/prevenção & controle , Dor Abdominal/etiologia , Febre/prevenção & controle , Febre/etiologia , Síndrome , Antieméticos/uso terapêutico
12.
Clin J Oncol Nurs ; 29(4): 313-320, 2025 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-40794588

RESUMO

BACKGROUND: Chemotherapy can contribute to chemotherapy-induced nausea and vomiting (CINV). The use of acupressure is a nonpharmacologic method to counteract general nausea and vomiting. OBJECTIVES: The primary end point was to determine whether there were any differences in CINV episodes between patients receiving acupressure at two different acupressure points. METHODS: Patients (N = 509) were randomized between acupressure at the Pericardium 6 point and the Triple Warmer 5 point. Patients reported data in a structured diary for 10 days and health-related quality of life using a questionnaire on days 1 and 10. FINDINGS: Regardless of group, 70 patients reported having decreased global health status after the first chemotherapy treatment. There was no difference in the occurrence or intensity of CINV between acupressure applied at the two different points. Antiemetic prophylaxis remains the most important method of counteracting CINV.


Assuntos
Acupressão , Antineoplásicos , Náusea , Neoplasias , Vômito , Humanos , Acupressão/métodos , Feminino , Masculino , Pessoa de Meia-Idade , Vômito/induzido quimicamente , Vômito/terapia , Vômito/prevenção & controle , Náusea/induzido quimicamente , Náusea/terapia , Náusea/prevenção & controle , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Neoplasias/tratamento farmacológico , Adulto , Idoso , Qualidade de Vida , Inquéritos e Questionários
13.
Future Oncol ; 21(21): 2823-2833, 2025 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-40782019

RESUMO

AIM: Because no conclusive data demonstrate superiority among NK1 receptor antagonists (RA), existing antiemetic guidelines regard them as interchangeable. This individual patient data (IPD) meta-analysis compared the efficacy of NEPA (netupitant/fosnetupitant) and aprepitant/fosaprepitant-based regimens in preventing chemotherapy-induced nausea and vomiting (CINV). MATERIALS & METHODS: Head-to-head comparative studies published between 2003 and 2022 that evaluated antiemetic prophylaxis of aprepitant or fosaprepitant versus oral or intravenous (IV) NEPA in patients with various cancers receiving highly (HEC) or moderately emetogenic chemotherapy (MEC) were identified through a literature search. We combined individual patient data to assess complete response (no emesis/no rescue medication) and no significant nausea using a two-stage approach. RESULTS: A total of six studies involving 2,767 patients were included evaluating NEPA plus dexamethasone versus aprepitant/fosaprepitant plus any 5-HT3RA plus dexamethasone for patients with cancer receiving HEC/MEC. Complete response and no significant nausea rates were similar during the acute (0-24 h) phase but NEPA showed significantly higher rates than aprepitant during the delayed ( > 24-120 h) and overall (0-120 h) phases and on Days 3-5 following chemotherapy. CONCLUSION: Improved CINV prevention was observed with NEPA-based regimens, particularly during Days 3-5, highlighting its potential for managing prolonged nausea and vomiting associated with emerging anticancer targeted therapies.


This study examined two types of medicine to help cancer patients feel less sick during chemotherapy. Both types try to stop nausea and vomiting. One kind is called NEPA, and the other is called aprepitant. Both include drugs taken by mouth or given through an IV. All patients also took other common medicines to help with side effects. The researchers looked at six studies with a total of 2,767 patients. They wanted to see which medicine worked better. On the first day of chemotherapy, both types worked about the same. But in the days after chemotherapy, NEPA worked better. It helped prevent vomiting and more severe nausea. It also meant fewer people needed extra medicine to feel better. This improvement was true from day 2 to day 5 after treatment. The study shows that NEPA may give better long-term relief from chemotherapy side effects, which may be especially helpful for patients who are using newer cancer drugs that can cause longer-lasting nausea.


Assuntos
Antieméticos , Antineoplásicos , Protocolos de Quimioterapia Combinada Antineoplásica , Aprepitanto , Náusea , Neoplasias , Piridinas , Vômito , Humanos , Antieméticos/uso terapêutico , Antieméticos/administração & dosagem , Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Aprepitanto/uso terapêutico , Aprepitanto/administração & dosagem , Dexametasona/uso terapêutico , Dexametasona/administração & dosagem , Combinação de Medicamentos , Morfolinas , Náusea/prevenção & controle , Náusea/induzido quimicamente , Neoplasias/tratamento farmacológico , Piridinas/administração & dosagem , Piridinas/uso terapêutico , Resultado do Tratamento , Vômito/prevenção & controle , Vômito/induzido quimicamente , Piperazinas , Benzenoacetamidas
14.
J Pain Symptom Manage ; 70(6): 557-568.e1, 2025 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-40876663

RESUMO

BACKGROUNDS: Evidence shows that megestrol acetate (MA) is a potential antiemetic for preventing chemotherapy-induced nausea and vomiting (CINV). No persuasive clinical trials have been performed to validate the efficacy and safety of MA. Here we designed a randomized controlled trial to assess the efficacy of palonosetron plus MA versus palonosetron plus dexamethasone (DEX) in preventing CINV following moderately emetogenic chemotherapy (MEC) regimens. METHODS: This was a multicenter, randomized, single-blinded, crossover, clinical trial practiced in three medical centers. The eligible patients were recruited to the DEX-MA and MA-DEX groups using a computer-generated random number table. Briefly, the DEX-MA group received palonosetron and DEX for the first chemotherapy cycle and then received palonosetron and MA for the second cycle. The MA-DEX group received the antiemetic treatment in the reverse order. Evaluating patients' efficacy and quality of life (QOL) with these two antiemetic regimens. The primary endpoint was complete response (CR). This trial has been registered with the Chinese Clinical Trial Register (ChiCTR2000037447). RESULTS: Ninety-two patients were enrolled between June 2020 and July 2023, and 86 were eventually evaluated in the study. Forty-one patients were randomized in the DEX-MA group and forty-five in the MA-DEX group. Of all subjects, 51.1% were male, and 48.9% were female. complete response (CR) rates showed no significant difference in the acute phase (0-24 h) (DEX vs. MA, 81.4% vs. 82.6%, P = 0.843), delayed phase (24-120 h) (DEX vs. MA, 81.4% vs. 82.6%, P = 0.843), or overall phase (DEX vs. MA, 72.1% vs. 73.3%, P = 0.864). The QOL showed significant differences in dyspnea symptoms (P = 0.002) and appetite loss symptoms (P = 0.039). This result implied that MA led to less dyspnea, appetite loss, and a better QOL after chemotherapy. CONCLUSIONS: MA may have equivalent efficacy to DEX in the prevention of moderately emetogenic regimen CINV, and no obvious side events occurred. Compared with DEX, MA can significantly improve QOL, especially in decreasing dyspnea and appetite loss. An extension phase III study is going on to validate this observation.


Assuntos
Antieméticos , Antineoplásicos , Dexametasona , Acetato de Megestrol , Náusea , Palonossetrom , Vômito , Humanos , Dexametasona/uso terapêutico , Dexametasona/administração & dosagem , Palonossetrom/uso terapêutico , Vômito/induzido quimicamente , Vômito/prevenção & controle , Náusea/induzido quimicamente , Náusea/prevenção & controle , Antieméticos/uso terapêutico , Masculino , Estudos Cross-Over , Feminino , Pessoa de Meia-Idade , Adulto , Método Simples-Cego , Quimioterapia Combinada , Acetato de Megestrol/uso terapêutico , Acetato de Megestrol/administração & dosagem , Antineoplásicos/efeitos adversos , Qualidade de Vida , Idoso , Resultado do Tratamento
15.
Drugs ; 85(11): 1493-1497, 2025 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-40991189

RESUMO

Fosrolapitant/palonosetron (Ritanine®; ®) is a fixed-dose combination of fosrolapitant, a novel neurokinin-1 (NK-1) receptor antagonist prodrug, and palonosetron, a second generation 5-hydroxytryptamine-3 (5-HT3) receptor antagonist. It is being developed by Fujian Shengdi Pharmaceutical as a preventative treatment of chemotherapy-induced nausea and vomiting. On the 29th of May 2025, fosrolapitant/palonosetron received its first approval in China for the prevention of acute and delayed nausea and vomiting caused by highly emetogenic chemotherapy in adults. This article summarizes the milestones in the development of fosrolapitant/palonosetron leading to this first approval in chemotherapy-induced nausea and vomiting.


Assuntos
Antieméticos , Isoquinolinas , Náusea , Antagonistas dos Receptores de Neurocinina-1 , Palonossetrom , Quinuclidinas , Antagonistas do Receptor 5-HT3 de Serotonina , Vômito , Humanos , Palonossetrom/uso terapêutico , Palonossetrom/administração & dosagem , Palonossetrom/farmacologia , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Náusea/prevenção & controle , Antieméticos/uso terapêutico , Antieméticos/farmacologia , Antieméticos/administração & dosagem , Vômito/induzido quimicamente , Vômito/tratamento farmacológico , Vômito/prevenção & controle , Aprovação de Drogas , Antagonistas dos Receptores de Neurocinina-1/uso terapêutico , Antagonistas dos Receptores de Neurocinina-1/farmacologia , Antagonistas dos Receptores de Neurocinina-1/administração & dosagem , Combinação de Medicamentos , Antineoplásicos/efeitos adversos , Quinuclidinas/administração & dosagem , Antagonistas do Receptor 5-HT3 de Serotonina/uso terapêutico , Antagonistas do Receptor 5-HT3 de Serotonina/administração & dosagem , Antagonistas do Receptor 5-HT3 de Serotonina/farmacologia
16.
Front Med ; 19(4): 600-611, 2025 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-40616753

RESUMO

Chemotherapy-induced nausea and vomiting (CINV) is common in patients receiving moderately or highly emetogenic chemotherapy and is caused by the activation of peripheral and central nervous system pathways, with the neurokinin-1 receptor playing a central role in delayed CINV. Neurokinin-1 receptor antagonists (NK1RAs) in combination with other antiemetic agents are recommended in international and Chinese guidelines for the prevention of acute and delayed CINV. Therefore, a summary of current data for NK1RAs would be of great clinical utility. This article summarizes the available clinical and real-world data on the use of NK1RAs in CINV prophylaxis, with a focus on evidence from China, where three NK1RAs, aprepitant, fosaprepitant and netupitant, are currently approved. NK1RAs have demonstrated efficacy and favorable safety in the prevention of acute and delayed CINV. Further research is required to determine the optimal use of these drugs and to identify strategies for CINV management in specific patient populations.


Assuntos
Antieméticos , Antineoplásicos , Náusea , Antagonistas dos Receptores de Neurocinina-1 , Vômito , Humanos , Vômito/induzido quimicamente , Vômito/tratamento farmacológico , Vômito/prevenção & controle , Antagonistas dos Receptores de Neurocinina-1/uso terapêutico , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Náusea/prevenção & controle , Antieméticos/uso terapêutico , Antineoplásicos/efeitos adversos , Aprepitanto/uso terapêutico , Morfolinas/uso terapêutico
17.
BMC Pharmacol Toxicol ; 26(1): 126, 2025 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-40598638

RESUMO

PURPOSE: We aimed to compare the efficacy and safety of fosaprepitant plus triple therapy versus triple therapy alone, in terms of both routine and delayed regimen, in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving three-day cisplatin-based treatment. METHODS: In a prospective randomized controlled trial, patients undergoing three-day cisplatin-based chemotherapy (25mg/m2/day) received fosaprepitant plus triple therapy or triple therapy alone on day 1 (routine regimen). For the evaluation of the delayed regimen, the administration of fosaprepitant and/or olanzapine was delayed for 1 day. Efficacy and safety in overall phase (OP) were evaluated within 5 days after initiation of chemotherapy. RESULTS: Fosaprepitant plus triple therapy achieved a higher total protection (TP) rate during OP than triple therapy alone (56.9% vs. 40.4%; P = 0.018). Fosaprepitant plus triple therapy also produced a higher TP rate than triple therapy alone during delay phase (DP) (57.8% vs. 40.4%; P = 0.012) but not during acute phase (AP) (88.2% vs. 86.5%; P = 0.714). In addition, fosaprepitant plus triple therapy achieved higher complete response (CR) rates than triple therapy alone during DP, but not during AP. The delayed regimen appeared to have produced higher TP and CR rates than the routine regimen, but the differences were not statistically significant. The Kaplan-Meier curves showed that fosaprepitant plus triple therapy delayed the first vomiting. CONCLUSIONS: Fosaprepitant plus triple therapy demonstrated superiority over triple therapy alone for CINV control in patients receiving three-day cisplatin-based treatment. CLINICAL TRIALS REGISTRATION: This trial was registered in the China Clinical Trials Registry on December 8, 2020 (chiCTR2000040675).


Assuntos
Antieméticos , Antineoplásicos , Cisplatino , Morfolinas , Náusea , Vômito , Humanos , Cisplatino/efeitos adversos , Cisplatino/administração & dosagem , Náusea/induzido quimicamente , Náusea/prevenção & controle , Vômito/induzido quimicamente , Vômito/prevenção & controle , Feminino , Masculino , Pessoa de Meia-Idade , Antieméticos/uso terapêutico , Antieméticos/administração & dosagem , Antieméticos/efeitos adversos , Adulto , Antineoplásicos/efeitos adversos , Morfolinas/uso terapêutico , Morfolinas/efeitos adversos , Estudos Prospectivos , Idoso , Quimioterapia Combinada , Olanzapina/uso terapêutico , Olanzapina/administração & dosagem
18.
Medicine (Baltimore) ; 104(28): e43210, 2025 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-40660584

RESUMO

NEPA has demonstrated superiority in preventing chemotherapy-induced nausea and vomiting (CINV) compared to palonestron and non-inferiority compared to aprepitant/granisetron. However, despite the application of NEPA in previous studies, grade (Gr) 2 or higher CINV was reported in 20% to 30% of cases. The aim of this study was to investigate the efficacy of NEPA for CINV prevention in Korean cancer patients treated with highly emetogenic chemotherapy (HEC), and to evaluate the usefulness of adding olanzapine in cases experiencing Gr 2 or higher CINV in previous cycles. A retrospective cohort study was conducted on cancer patients treated with HEC and CINV prophylaxis using NEPA. If Gr 2 or higher CINV occurred, olanzapine 5 mg/day was administered for 5 days. The primary endpoint was the incidence of Gr 2 or higher CINV during cycle 1. Secondary endpoints included the efficacy of olanzapine addition and the identification of risk factors for Gr 2 or higher CINV. 142 patients were analyzed. The median age was 66.0 years, and males were 54.2%. Tumor sites included biliary tract (44%), genitourinary (27%), and breast (9%). HEC regimens included cisplatin < 50 mg/m2 (49%), cisplatin ≥ 50 mg/m2 (20%), carboplatin (18%), and doxorubicin (12%). The incidence of Gr 2 or higher CINV was 23% (33/142), and the incidence of all-grade CINV was 58% (82/142). Among those with Gr 2 or higher CINV, 82% (27/33) were treated with olanzapine combination without dose modification of HEC, and 74% (20/27) improved to Gr 1 CINV. This study showed that NEPA was comparably effective in Korean patients treated with HEC and demonstrated the efficacy of olanzapine combination therapy. Further studies are needed to confirm CINV prophylaxis strategies, either through initial combination with olanzapine in high-risk CINV patients or by adding olanzapine in patients with prior Gr2 or higher CINV.


Assuntos
Antieméticos , Antineoplásicos , Náusea , Neoplasias , Olanzapina , Vômito , Humanos , Masculino , Olanzapina/uso terapêutico , Olanzapina/administração & dosagem , Feminino , Náusea/induzido quimicamente , Náusea/prevenção & controle , Estudos Retrospectivos , Vômito/induzido quimicamente , Vômito/prevenção & controle , Antieméticos/uso terapêutico , Antieméticos/administração & dosagem , Idoso , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Antineoplásicos/efeitos adversos , República da Coreia , Quimioterapia Combinada , Adulto , Resultado do Tratamento
19.
J Clin Pharmacol ; 65(11): 1587-1597, 2025 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-40528496

RESUMO

This study aims to compare the efficacy and safety of different 5-HT3 receptor antagonists as monotherapy for nausea and vomiting in patients undergoing surgery or chemotherapy. A thorough search of various electronic databases was conducted to determine the randomized controlled trials comparing the efficacy and safety of different 5-HT3 receptor antagonists as monotherapy for preventing nausea and vomiting in patients undergoing surgery or chemotherapy. Primary outcomes included nausea, vomiting, and adverse events. A network meta-analysis was performed to compare each outcome. Seventeen trials were included in this study. For the control of nausea, palonosetron was the optimal choice among 5-HT3 receptor antagonists (surface under the cumulative ranking curve, SUCRA = 86.95%), regardless of whether the patients were undergoing surgery (SUCRA = 82.04%) or chemotherapy (SUCRA = 71.63%). As for controlling vomiting, palonosetron was still the optimal choice among different 5-HT3 receptor antagonists (SUCRA = 80.87%). In surgical patients, granisetron was the most effective in controlling vomiting (SUCRA = 88.04%). When considering the drug doses, palonosetron 0.25 mg was the optimal regimen for controlling both nausea and vomiting. In terms of safety, palonosetron 0.25 mg and granisetron 3 mg were the safest regimens among different 5-HT3 receptor antagonists. Among the various 5-HT3 receptor antagonists, palonosetron at a dosage of 0.25 mg emerged as the optimal choice for chemotherapy patients, while granisetron at a dosage of 3 mg proved to be the best option for surgical patients, taking into account both efficacy and safety. The study protocol was registered with PROSPERO (CRD42024552117).


Assuntos
Antieméticos , Náusea , Náusea e Vômito Pós-Operatórios , Antagonistas do Receptor 5-HT3 de Serotonina , Vômito , Humanos , Antieméticos/uso terapêutico , Antieméticos/efeitos adversos , Antieméticos/administração & dosagem , Antineoplásicos/efeitos adversos , Granisetron/uso terapêutico , Granisetron/efeitos adversos , Náusea/prevenção & controle , Palonossetrom/uso terapêutico , Palonossetrom/efeitos adversos , Náusea e Vômito Pós-Operatórios/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Antagonistas do Receptor 5-HT3 de Serotonina/uso terapêutico , Antagonistas do Receptor 5-HT3 de Serotonina/efeitos adversos , Antagonistas do Receptor 5-HT3 de Serotonina/administração & dosagem , Vômito/prevenção & controle
20.
Support Care Cancer ; 33(7): 622, 2025 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-40553393

RESUMO

PURPOSE: Most antiemetic studies have been conducted in patients with solid tumors receiving single-dose chemotherapy. A research gap leaves healthcare providers without clear guidance on effective antiemetic regimens and schedules for patients with hematologic malignancies undergoing high-dose multiday chemotherapy. This literature search identified antiemetic studies and assessed efficacy outcomes in the hematology setting, and specifically in patients receiving high-dose chemotherapy prior to hematopoietic stem cell transplantation (HSCT). METHODS: A literature review of both PubMed and Embase was performed for published studies evaluating antiemetic regimens including an NK1 receptor antagonist (RA) and/or a 5HT-3RA with/without dexamethasone in the hematology setting. Key features of all studies are reviewed, and antiemetic efficacy is summarized specifically for studies in which patients received high-dose chemotherapy prior to HSCT. RESULTS: Twenty-two of an initial 926 identified publications met the predefined inclusion criteria. The studies were heterogenous, with varying characteristics pertaining to randomization, control groups, size, cancer types, chemotherapies, antiemetics, and assessments, making cross-study comparisons and conclusions difficult. The range of response rates was wide with numerous studies showing complete response, no emesis or no nausea rates of less than 50%. Response rates were highest when an NK1 RA regimen was administered; however, an NK1 RA was underutilized and only administered in two-thirds of the studies. CONCLUSION: The results reflect a significant clinical problem in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with hematologic malignancies. The scarcity and heterogeneity of studies highlight challenges inherent in this area. This underscores a pressing need for rigorous randomized trials in hematology and HSCT assessing treatment-related CINV and effectiveness of antiemetic regimens.


Assuntos
Antieméticos , Antineoplásicos , Neoplasias Hematológicas , Transplante de Células-Tronco Hematopoéticas , Náusea , Vômito , Humanos , Neoplasias Hematológicas/tratamento farmacológico , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas/métodos , Antieméticos/uso terapêutico , Antieméticos/administração & dosagem , Vômito/induzido quimicamente , Vômito/prevenção & controle , Vômito/tratamento farmacológico , Náusea/induzido quimicamente , Náusea/prevenção & controle , Náusea/tratamento farmacológico , Antineoplásicos/efeitos adversos , Antineoplásicos/administração & dosagem , Antineoplásicos/uso terapêutico , Dexametasona/uso terapêutico , Dexametasona/administração & dosagem , Antagonistas dos Receptores de Neurocinina-1/uso terapêutico , Antagonistas do Receptor 5-HT3 de Serotonina/uso terapêutico
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