scholarly journals Efficacy and Safety of 5-Hydroxytryptamine-3 Receptor Antagonists (5-HT3 RAs) for The Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Patients: A Review

2021 ◽  
Vol 11 (1-s) ◽  
pp. 195-199
Author(s):  
Nisaurrahmah Nisaurrahmah ◽  
Oktavia Sri ◽  
Ifora Ifora
Keyword(s):  
Cancer Patients ◽  
Heart Rhythm ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Efficacy And Safety ◽  
Receptor Antagonists ◽  
Complete Control ◽  
Electrocardiogram Ecg ◽  
Ecg Abnormalities ◽  
Delayed Phase

Objective: This review provides an update review of the efficacy and safety of 5-hydroxytryptamine-3 receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting (CINV) in cancer patients. Methods: The information was collected from electronic scientific search engines from PubMed, Science Direct, Scopus, and Google Scholar. The publication dates covered were from 2010 to 2020. The primary endpoint was the percentage of patients who achieved a complete response (CR), complete control (CC), no nausea, no emesis, or no rescue medication.The secondary endpoint was the percentage of patients who experience constipation related to 5-HT RA constipation, headache, diarrhea, or dizziness, as well as changes in heart rhythm. Results: Fourteen articles were identified. Palonosetron has the same effectiveness as granisetron as but more effective than ondansetron in the delayed phase and overall. Adverse effects that often occur due to the use of palonosetron, granisetron, and ondansetron are constipation and headache. Some of the articles also mentioned that palonosetron does not cause changes in heart rhythm but granisetron and ondansetron do cause changes in the electrocardiogram (ECG) at certain doses. Conclusion: Palonosetron has the same effectiveness as granisetron, and more effective than ondansetron in delayed, and overall phases. The use of palonosetron, granisetron, and ondansetron cause constipation and headaches at all doses, palonosetron does not cause ECG abnormalities whereas granisetron and ondansetron cause ECG changes. Keywords: palonosetron, ondansetron, granisetron, 5-HT3 RAs, cancer, nausea, vomiting, CINV.

scholarly journals Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens

2015 ◽  
Vol 04 (01) ◽  
pp. 007-010 ◽  
Author(s):  
Sachin Hingmire ◽  
Nirmal Raut
Keyword(s):  
Rescue Medication ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Efficacy And Safety ◽  
Moderately Emetogenic Chemotherapy ◽  
Open Label ◽  
Highly Emetogenic Chemotherapy ◽  
Serious Adverse Events ◽  
Complete Control

Abstract Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian population with aprepitant containing regimens. Aims: The aim was to assess the Efficacy and Safety of Aprepitant for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy/moderately emetogenic chemotherapy (HEC/MEC) regimens. Settings and Design: Investigator initiated, multicentric, open-label, prospective, noncomparative, observational trial. Subjects and Methods: Triple drug regimen with aprepitant, palonosetron, and dexamethasaone administration was assessed for the prevention of CINV during acute, delayed, and the overall phase (OP) for HEC/MEC Regimens. The primary endpoint was complete response (CR; no emesis and no use of rescue medication) and the key secondary endpoint was the complete control (CC; no emesis, no rescue medication and no more than mild nausea) during the OP. Statistical Analysis Used: Perprotocol efficacy was analyzed for the first cycle with results represented in terms of CR/CC rates using descriptive statistics. Results: Seventy-five patients were included in the study with median age of 49.7 years and 89.7% being females. The CR rate (OP) for patients administered HEC or MEC regimens during the first cycle were 92% and 90.9%, respectively. Similarly, the CC rates (OP) were 75% and 90% for these regimens, respectively. 7 (9.2%) patients reported adverse drug reactions that were mild and transient with no reports of any serious adverse events. Conclusions: Use of aprepitant containing regimen for patients receiving HEC/MEC regimen resulted in significantly high CR and CC response rates, which further consolidate its potential role to improve patient quality of life and compliance to disease management.

Phase III study of APF530 versus ondansetron with a neurokinin 1 antagonist + corticosteroid in preventing highly emetogenic chemotherapy-induced nausea and vomiting: MAGIC trial.

2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 68-68
Author(s):  
Ian D. Schnadig ◽  
Richy Agajanian ◽  
Shaker R. Dakhil ◽  
Nashat Y. Gabrail ◽  
Robert E. Smith ◽  
...  
Keyword(s):  
Unmet Need ◽  
Complete Response ◽  
Drug Regimen ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Complete Control ◽  
Delayed Phase

68 Background: Managing chemotherapy-induced nausea and vomiting (CINV) associated with delayed ( > 24-120 h) highly emetogenic chemotherapy (HEC) is an unmet need. APF530, extended-release granisetron, provides sustained release over ≥ 5 days to prevent acute (0-24 h) and delayed CINV. This trial compared the efficacy and safety of APF530 in preventing CINV after HEC in a 3-drug regimen vs a standard 3-drug regimen with ondansetron (Ond). Methods: In this double-blind, multicenter study (NCT02106494), patients (pts) receiving single-day HEC (2011 ASCO guidelines) were randomized 1:1 to APF530 500 mg SC (10 mg granisetron) or Ond 0.15 mg/kg IV and stratified by cisplatin ( ≥ 50 mg/m2, yes/no). Pts were scheduled to receive concomitant dexamethasone (Dex) 12 mg IV + fosaprepitant (Fos) 150 mg IV on day 1 + PO Dex on days 2-4. The primary end point was delayed-phase complete response (CR) (no emesis, no rescue medication). Secondary end points included CR in acute and overall phases and complete control (CC; CR and no more than mild nausea) in acute, delayed, and overall phases. Treatment (tx) comparisons used chi-square test controlling for cisplatin. Adverse events (AEs) and injection-site reactions (ISRs) were assessed. Results: Modified intent-to-treat analysis included 902 pts (APF530, n = 450; Ond, n = 452) with baseline demographics balanced between tx groups. A significantly higher % of APF530 (65%) vs Ond (57%) pts had delayed-phase CR (P= .014). A significantly higher % of APF530 (61%) vs Ond (53%) pts had delayed-phase CC (P= .022, Table). CR and CC rates in acute and overall phases were numerically higher with APF530 vs Ond, but not statistically significant. APF530 was well tolerated. Most common AEs were ISRs, mostly mild or moderate. Conclusions: APF530 with Fos+Dex led to statistically higher CR and CC rates in delayed-phase CINV with HEC vs a standard 3-drug regimen of Ond with Fos+Dex. Clinical trial information: NCT02106494. [Table: see text]

scholarly journals Adding aprepitant to palonosetron does not decrease carboplatin-induced nausea and vomiting in patients with gynecologic cancer

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Yuko Watanabe ◽  
Yoshitaka Saito ◽  
Takashi Mitamura ◽  
Yoh Takekuma ◽  
Mitsuru Sugawara
Keyword(s):  
Cancer Patients ◽  
Combination Chemotherapy ◽  
Gynecologic Cancer ◽  
Area Under The Curve ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Expensive Drug ◽  
Significant Difference ◽  
Delayed Phase

Abstract Background Recently, aprepitant has been recommended in carboplatin-based regimens, but there are limited reports on the efficacy of administering aprepitant, palonosetron, and dexamethasone (DEX) in carboplatin-containing regimens. Moreover, because aprepitant is an expensive drug, confirming its effectiveness is very important from the medical cost perspective. In this study, we examined the efficacy of prophylactically administered aprepitant, palonosetron and DEX, in paclitaxel and carboplatin (TC) combination chemotherapy. Methods Patients with gynecologic cancer who were treated with paclitaxel (175 mg/m2) and carboplatin (area under the curve, AUC = 5–6) combination chemotherapy were retrospectively evaluated. The complete response (CR) rate, severity of nausea, and incidence of anorexia in the first course were compared between patients who did not receive aprepitant (control group) and those who received (aprepitant group). Results The 106 patients were divided into two groups, consisting of 52 and 54 the control and aprepitant groups, respectively, and the patient background showed no significant difference between both groups. The CR rate of the overall phase between the control and aprepitant groups was 73.1 vs. 74.1%, that in the acute phase was 98.1 vs. 100%, and in the delayed phase was 75.0 vs. 74.1%, respectively, without any significant difference. The severity of nausea and incidence of anorexia were also not significantly different between both groups. Conclusions The results of the study suggest that adding aprepitant to palonosetron and DEX does not prevent carboplatin-induced nausea and vomiting in gynecologic cancer patients. Therefore, adding aprepitant to palonosetron does not decrease carboplatin-induced nausea and vomiting in patients with gynecologic cancer.

scholarly journals Efficacy and safety of 5 mg olanzapine for nausea and vomiting management in cancer patients receiving carboplatin: integrated study of three prospective multicenter phase II trials

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Senri Yamamoto ◽  
Hirotoshi Iihara ◽  
Ryuji Uozumi ◽  
Hitoshi Kawazoe ◽  
Kazuki Tanaka ◽  
...  
Keyword(s):  
Risk Factors ◽  
Logistic Regression ◽  
Cancer Patients ◽  
Phase Ii ◽  
Low Dose ◽  
Nausea And Vomiting ◽  
Efficacy And Safety ◽  
Multivariable Logistic Regression ◽  
Related Risk ◽  
Total Control

Abstract Background The efficacy of olanzapine as an antiemetic agent in cancer chemotherapy has been demonstrated. However, few high-quality reports are available on the evaluation of olanzapine’s efficacy and safety at a low dose of 5 mg among patients treated with carboplatin regimens. Therefore, in this study, we investigated the efficacy and safety of 5 mg olanzapine for managing nausea and vomiting in cancer patients receiving carboplatin regimens and identified patient-related risk factors for carboplatin regimen-induced nausea and vomiting treated with 5 mg olanzapine. Methods Data were pooled for 140 patients from three multicenter, prospective, single-arm, open-label phase II studies evaluating the efficacy and safety of olanzapine for managing nausea and vomiting induced by carboplatin-based chemotherapy. Multivariable logistic regression analyses were performed to determine the patient-related risk factors. Results Regarding the endpoints of carboplatin regimen-induced nausea and vomiting control, the complete response, complete control, and total control rates during the overall study period were 87.9, 86.4, and 72.9%, respectively. No treatment-related adverse events of grade 3 or higher were observed. The multivariable logistic regression models revealed that only younger age was significantly associated with an increased risk of non-total control. Surprisingly, there was no significant difference in CINV control between the patients treated with or without neurokinin-1 receptor antagonist. Conclusions The findings suggest that antiemetic regimens containing low-dose (5 mg) olanzapine could be effective and safe for patients receiving carboplatin-based chemotherapy.

Active combination with aprepitant, palonosetron, and dexamethasone for preventing emesis of anthracycline-containing regimens in patients with breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19512-e19512
Author(s):  
Yoshie Nakayama ◽  
Yoshinori Ito ◽  
Shunji Takahashi ◽  
Kiyohiko Hatake
Keyword(s):  
Breast Cancer ◽  
Acute Phase ◽  
Medical Records ◽  
Complete Response ◽  
Highly Emetogenic Chemotherapy ◽  
Complete Control ◽  
Antiemetic Drugs ◽  
Number Of Patients ◽  
Phase 0 ◽  
Delayed Phase

e19512 Background: Anthracycline and cyclophoshamaide containing regimens for breast cancer are classified as highly emetogenic chemotherapy. Aprepitant (A), palonosetron (P), granisetron (G) or dexamethasone(D) are recommended as antiemetic drugs. However, it is uncertain which combination would be best effective. We have retrospectively examined the efficacy of these antiemetic drugs. Methods: We reviewed the medical records of 501 patients with breast cancer treated with anthracycline and cyclophoshamaide containing regimens between August, 2009 and September, 2010. The combination of GD were G: 3 mg on day1 (i.v.), 2 mg on days 2-6 (p.o.) and D: 16.5 mg on day1 (i.v.), 8mg on days 2-4 (p.o.). The AGD were A: 125 mg on day1 (i.v.), 80 mg on days 2-3 (p.o.), G: 3 mg on day1 (i.v.), 2 mg on days 2-6 (p.o.), and D: 13.2 mg on day1 (i.v.), 4 mg on days 2-4 (p.o.). The APD were A: 125 mg on day1 (i.v.), 80 mg on days 2-3 (p.o.), P: 0.75 mg on day1 ( i.v.), and D: 13.2 mg on day1 (i.v.), 4 mg on days 2-4 (p.o.). Results: The number of patients who were treated with GD, AGD, and APD were 170, 159, and 172, respectively. Complete response (CR) rate in acute phase (0-24h) or delayed phase (24-120h) and complete control (CC) rate in acute or delayed phase in each regimens were summarized in the table. AGD or APD was significantly superior to GD in CR rate of acute or delayed phase (P<0.01). Of note, CC rate of APD in acute phase was significantly superior to AGD (P<0.01). AGD or APD was significantly superior to GD in CC rate in delayed phase. Conclusions: The combination with APD was the most effective antiemetic therapy in patients who were treated with anthracycline and cyclophosphamide containing regimens. [Table: see text]

scholarly journals The addition of omeprazole to ondansetron for treating chemotherapy-induced nausea and vomiting in pediatric cancer patients

2018 ◽  
Vol 1 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo
Keyword(s):  
Placebo Group ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Controlled Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Significant Difference ◽  
Pediatric Cancer Patients

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.

scholarly journals Ramosetron hydrochloride for the prevention of cancer chemotherapy induced nausea and vomiting: The Indian experience

2014 ◽  
Vol 03 (02) ◽  
pp. 132-137 ◽  
Author(s):  
Jayesh J. Sanmukhani ◽  
Prafulla Pawar ◽  
Ravindra Mittal
Keyword(s):  
Adverse Events ◽  
Cancer Chemotherapy ◽  
Complete Response ◽  
Daily Basis ◽  
Nausea And Vomiting ◽  
Efficacy And Safety ◽  
Open Label ◽  
Entire Study ◽  
Ondansetron Hydrochloride ◽  
Delayed Nausea

Abstract Background: Despite the advent of 5-HT 3 antagonists, control of delayed gastrointestinal adverse events with cancer chemotherapy is still not optimal. This open label, active controlled, multicentric clinical trial was undertaken to assess the comparative efficacy and safety of ramosetron with ondansetron for the prevention of acute and delayed nausea and vomiting associated with emetogenic cancer chemotherapy in adult patients in India. Materials and Methods: Enrolled patients received treatment with ramosetron hydrochloride 0.1 mg or ondansetron hydrochloride 4 mg tablets once daily in the morning for 5 days starting 1 h before the start of chemotherapy. Severity grades of nausea and vomiting were recorded on a daily basis for a period of 5 days and complete response rate (CRR) and effective rate (ER) were calculated. Clinical adverse events were recorded and hematological and biochemical investigations were performed for safety assessment. Results: A total of 114 patients in ramosetron group and 100 patients in ondansetron group completed the study and were eligible for efficacy and safety analysis. CRR and ERs show that while ramosetron is non-inferior to ondansetron in the control of early nausea and vomiting (occurring during the first 24 h) after the treatment with emetogenic chemotherapy, it is superior to ondansetron in the control of delayed nausea and vomiting (occurring after the first 24 h). The proportion of patients achieving a cumulative complete response (for the entire study period) is significantly greater in ramosetron group as compared to ondansetron group (27.2% vs. 7.0%; P < 0.001). Ramosetron was well tolerated by all the study participants. Conclusions: Ramosetron is significantly more effective than ondansetron for the control of delayed nausea and vomiting induced by emetogenic cancer chemotherapy.

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