A randomized pilot study comparing aprepitant to olanzapine for treatment of chemotherapy-induced nausea and vomiting

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9633-9633 ◽  
Author(s):  
N. M. Shumway ◽  
S. E. Terrazzino ◽  
C. B. Jones
Keyword(s):  
Pilot Study ◽  
Daily Diary ◽  
Cost Savings ◽  
Complete Response ◽  
Similar Efficacy ◽  
Nausea And Vomiting ◽  
Potential Cost ◽  
Double Blind ◽  
Acute Period ◽  
Grade 3

9633 Background: Chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) is prevalent. The NK1antagonist, aprepitant (APR), has been shown to decrease CINV and with increased use, cost of supportive care is rising. Recent studies have shown that olanzapine (OLN) is safe and effective for CINV when used in combination with dexamethasone and palonosetron. We conducted a randomized, double-blind, placebo controlled pilot study to evaluate the use of OLN compared to APR for prevention of CINV in patients receiving HEC. Methods: Chemotherapy naïve patients receiving HEC were randomized to an APR containing arm or an OLN containing arm [see Table ] for the first 2 cycles of treatment. Patients recorded episodes of emesis and use of rescue meds using a daily diary and symptoms using the M.D. Anderson Symptom Inventory(MDASI). 18 patients consented to the protocol and 17/18 (OLN=8, APR=9) patients were evaluable (1 lost daily diary) with a median age 60 (range 24–71) 11/18 were females. Results: Chemo regimens for OLN group included (AC=50%, cisplatin=25%, ABVD=25%, and ifos=25%) and for APR (AC=55%, cisplatin=33%, and ABVD=11%) For both cycles (C1+C2) the complete response (CR=no emesis, no rescue) during the anticipatory period (D-2, D-1) was 87.5% in the OLN group compared to 77.8% in the APR group. Acute period (D1) CR rates were 75% in OLN vs. 44% in the APR group. Delayed (D2–4) CR rates were 62.5% in OLN vs. 55.6% in the APR group. Rates of nausea (score ≥ 1 on scale of 0–10, MDASI) were 25% OLN vs. 22.2% APR for anticipatory period, 62.5% OLN vs. 44.4% APR for acute period, and 62.5% OLN vs. 66.7% APR for delayed period. There were no grade 3 /4 toxicities. Conclusions: OLN containing antiemetic regimens were well tolerated and offered similar efficacy as APR containing regimens in preventing CINV in patients receiving HEC. Larger studies are needed to evaluate non-inferiority and potential cost savings of OLN containing regimens. [Table: see text] No significant financial relationships to disclose.

scholarly journals The Efficacy, Safety, and Cost Benefit of Olanzapine versus Aprepitant in Highly Emetogenic Chemotherapy: A Pilot Study from South India

2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
Govind Babu ◽  
Smitha Carol Saldanha ◽  
Lakshmaiah Kuntegowdanahalli Chinnagiriyappa ◽  
Linu Abraham Jacob ◽  
Suresh Babu Mallekavu ◽  
...  
Keyword(s):  
Pilot Study ◽  
South India ◽  
Cost Benefit ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Highly Emetogenic Chemotherapy ◽  
Acute Period ◽  
Significant Difference ◽  
Grade 3

Background. The efficacy, safety, and cost benefit of olanzapine (OLN) when compared to aprepitant (APR) in the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) were evaluated. Methods. A prospective pilot study was done in chemotherapy-naive patients receiving HEC to compare OLN versus APR along with palonosetron and dexamethasone. 100 patients consented to the protocol and were randomized and evaluated for Complete Response (CR) (no emesis, no rescue). Results. CR was 86% for the acute period, 86% for the delayed period, and 80% for the overall period in 50 patients receiving the APD regimen. CR was 84% for the acute period, 88% for the delayed period, and 78% for the overall period for 50 patients receiving the OPD regimen. Patients without nausea were APD: 88% acute, 84% delayed, and 84% overall, and OPD: 84% acute, 88% delayed, and 84% overall. There were no significant grade 3 or 4 toxicities. OPD was comparable to APD in the control of CINV. Conclusion. In this study, there was no significant difference between olanzapine and aprepitant in preventing CINV with highly emetogenic chemotherapy. Olanzapine may thus be used as a potential, safe, and cost beneficial alternative to prevent nausea and vomiting in HEC.

Olanzapine for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC): Alliance A221301, a randomized, double-blind, placebo-controlled trial.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 176-176 ◽  
Author(s):  
Rudolph M. Navari ◽  
Rui Qin ◽  
Kathryn Jean Ruddy ◽  
Heshan Liu ◽  
Steven Francis Powell ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Controlled Trial ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Secondary Endpoint ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Grade 3

176 Background: The purpose of the study was to determine the effectiveness of olanzapine (OLN) for the prevention of nausea and vomiting in patients receiving highly emetogenic chemotherapy (HEC). Methods: A randomized, double-blind, phase III trial was performed in chemotherapy-naïve patients receiving cisplatin, > 70 mg/m2, or cyclophosphamide-anthracycline-based chemotherapy, comparing OLN to placebo in combination with aprepitant (APR), a 5-HT3 receptor antagonist (5-HT3), and dexamethasone (DEX). The OLN regimen was 10 mg of oral OLN, 125 mg APR, a 5-HT3, and oral DEX 12 mg pre-chemotherapy, day 1, and 10 mg/day of oral OLN and 8 mg DEX on days 2-4 post-chemotherapy plus 80 mg APR on days 2, 3 post-chemotherapy. The placebo (PLA) regimen was oral placebo, pre-chemotherapy, day 1, and on days 2-4 post-chemotherapy; the APR, 5-HT3, and DEX pre- and post-chemotherapy were identical to that used in the OLN regimen. Fosaprepitant (150 mg IV), day 1 was allowed for substitution for the oral aprepitant. Palonosetron, ondansetron, or granisetron were the permitted 5-HT3 options. Nausea was measured on a 0-10 visual analogue scale, with 0 being “no nausea at all” and 10 being “nausea as bad as it can be”. No nausea was the primary endpoint and, complete response (no emesis and no use of rescue medications) was a secondary endpoint. Results: 401 patients (202 OLN, 199 PLA) were enrolled in the study. The proportion of patients who had no nausea was significantly greater for the OLN regimen compared to the PLA regimen for the acute period (24h post-chemotherapy) (74% vs. 45%, p < 0.0006), for the delayed period ( 24-120 h post-chemotherapy) (43% vs. 26%, p < 0.0006), and for the overall period (0-120 h) (39% vs. 22%, p < 0.0006). Complete response was significantly improved for the OLN patients compared to PLA patients for the acute (85% vs. 65%, p < 0.0001), the delayed (67% vs. 53%, p < 0.0078), and the overall periods (64% vs. 41%, p < 0.0001). There were no grade 3 or 4 toxicities. Conclusions: No nausea, the primary endpoint, and complete response, a secondary endpoint, were significantly improved with OLN, compared to PLA. Clinical trial information: NCT02116530.

Is there a preferred dose of palonosetron? Results of an abstracted data (AD) meta-analysis (MA) of all eight randomized double-blind (RDB) studies and the impact on guideline considerations

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9636-9636
Author(s):  
H. Raftopoulos ◽  
E. Bria ◽  
R. Gralla ◽  
M. Lesser ◽  
B. Napolitano ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Complete Response ◽  
Similar Efficacy ◽  
Dose Finding ◽  
Double Blind ◽  
Significant Toxicity ◽  
Agent Selection ◽  
Secondary Endpoints ◽  
Grade 3 ◽  
The Impact

9636 Background: Controversy continues whether there should be a guideline-preferred 5-HT3 antagonist. Large trials with palonosetron (palo) 0.25 mg demonstrated advantages over earlier 5-HT3 agents in preventing emesis with chemotherapy (chemo). Guideline groups have not consistently adopted palo as the preferred 5HT3 agent since these trials omitted the recommended addition of dexamethasone (dex). A recent 1100 patient RDB trial (Yoshizawa, ESMO 2008) found superiority for palo 0.75 mg + dex versus granisetron 3 mg + dex. Both palo and granisetron are approved at varying doses in different countries. This abstracted-data MA was conducted to see if this palo dosing yields differences. If not, results from randomized trials at either dose can aid practice and guideline committees in 5-HT3 agent selection. Methods: A literature search and colleague inquiry identified RDB trials that included treatment arms with 0.25 mg and 0.75 mg of palo. MA primary endpoint: Complete Response (CR - no vomiting, no rescue) over days 1–5 after chemo. Secondary endpoints: 1)Acute CR (day 1), 2)Delayed CR (days 2 - 5), 3) Grade 3–4 toxicities. Data were abstracted and checked by at least 2 reviewers. CMA software v2 (Biostat, NJ) was used to calculate relative risk ratios (palo 0.75 vs palo 0.25) with 95% confidence intervals (CI). Results: 8 trials with 1926 patients included all RDB studies with these palo doses - 4 with HEC and 4 with MEC (6 with IV and 2 with oral palo). The Cochrane Q test indicated no heterogeneity (het) for overall and delayed CR; het seen in the acute setting was accounted for by the 2 smaller dose-finding studies. No significant toxicity differences were found. Conclusions: Palo doses of 0.25 mg or 0.75 mg yield very similar efficacy and safety with both HEC and MEC in this literature-based MA. Results with either dose can aid in practice and guideline considerations for all chemo groups studied. [Table: see text] [Table: see text]

A prospective multicenter, single blinded, randomized phase III trial to compare the efficacy of ramosetron, aprepitant and dexamethasone with ondansetron, aprepitant, and dexamethasone for preventing chemotherapy-induced nausea and vomiting: KCSG PC10-21.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9633-9633
Author(s):  
Hyo Jung Kim ◽  
Eun-Kee Song ◽  
Jun Suk Kim ◽  
Jin Seok Ahn ◽  
Hwan Jung Yun ◽  
...  
Keyword(s):  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Combination Regimen ◽  
Highly Emetogenic Chemotherapy ◽  
Acute Period ◽  
Intention To Treat ◽  
Grade 3 ◽  
To Receive

9633 Background: Combination of aprepitant, 5-HT3 receptor antagonist and steroid improve complete response (CR) of chemotherapy induced nausea and vomiting (CINV). But until now, there was no information whether ramosetron is as effective as other 5-HT3receptor antagonists for the combination regimen. Therefore, we compared a ramosetron, aprepitant and dexamethasone (RAD) with ondansetron, aprepitant and dexamethasone (OAD) to establish the non-inferiority of RAD in controlling highly emetogenic chemotherapy induced nausea and vomiting. Methods: A total of 334 patients with malignant disease who were scheduled to receive highly emetogenic chemotherapy were randomized to RAD or OAD. Aprepitant (125 mg day 1; 80 mg day 2, 3) and dexamethasone (12 mg day 1; 8 mg day 2-4) were administered to both group. Intravenous ramosetron (0.3mg day 1) or ondansetron (16mg day1) was given to RAD or OAD, respectively. Patients recorded vomiting and nausea (VAS score) on the diary. The primary end point was CR (no vomiting or retching and no rescue medication) rate in the acute period (chemotherapy day 1). The non-inferiority margin was defined as -15% differences. Results: 299 patients (RAD 143, OAD 156) were eligible for the efficacy analyses of modified intention-to-treat. Median age and sex were 60 (IQR 52 – 66) and 61 (51.5 – 68, p=0.54), 90 Male/66 Female and 114 Male/29 Female (p<0.0001) in RAD and OAD, respectively. There were no significant differences between two groups on the other baseline characteristics. The CR rates of RAD vs OAD were 84.6% vs 77.6% (95% C.I. -0.4 – 14.5%) at acute period, 69.5% vs 62.6% (-2.1 – 16.0%) at delayed period (days 2-5), and 66.7% vs 58.1% (-0.6 – 17.8%) at overall period. Median nausea score at acute period were 4 (IQR 2 – 5) and 3 (2-5, p=0.14) in RAD and OAD, respectively. There were no grade 3 or 4 toxicities. Conclusions: RAD regimen is as effective and tolerable as OAD antiemetic combination for the prevention of CINV in patients receiving highly emetogenic chemotherapy. Ramosetron could be considered as one of the best partners for aprepitant. Clinical trial information: NCT01536691.

scholarly journals Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Renu Sinha ◽  
Dilip Shende ◽  
Souvik Maitra ◽  
Neeraj Kumar ◽  
Bikash Ranjan Ray ◽  
...  
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Strabismus Surgery ◽  
Nausea And Vomiting ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Oculocardiac Reflex ◽  
Significant Difference

Aim.Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV) in children undergoing elective strabismus surgery.Methods.A total of 136 children (1–15 years) were included. Children received either granisetron (40 mcg/kg) [group G] or combination of granisetron (40 mcg/kg) and dexamethasone (150 mcg/kg) [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen.Results.The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68) of children in group G and 76.9% (50/65) of children in group GD, which was comparable statistically (p=0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46). Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex.Conclusion.Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial wasCTRI/2009/091/001000.

Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study)

2017 ◽  
Vol 35 (31) ◽  
pp. 3558-3565 ◽  
Author(s):  
Lingyun Zhang ◽  
Xiujuan Qu ◽  
Yuee Teng ◽  
Jing Shi ◽  
Ping Yu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Highly Emetogenic Chemotherapy ◽  
Double Blind ◽  
Phase Iii Trial ◽  
Delayed Nausea

Purpose We examined the efficacy and safety of thalidomide (THD) for the prevention of delayed nausea and vomiting in patients who received highly emetogenic chemotherapy (HEC). Patients and Methods In a randomized, double-blind, active-controlled, phase III trial, chemotherapy-naive patients with cancer who were scheduled to receive HEC that contained cisplatin or cyclophosphamide-doxorubicin/epirubincin ≥ 50 mg/m2 regimens were randomly assigned to a THD group (100 mg twice daily on days 1 to 5) or placebo group, both with palonosetron (0.25 mg on day 1) and dexamethasone (12 mg on day 1; 8 mg on days 2 to 4). Primary end point was complete response to vomiting—no emesis or use of rescue medication—in the delayed phase (25 to 120 h). Nausea and anorexia on days 1 to 5 were evaluated by the 4-point Likert scale (0, no symptoms; 3, severe). Quality of life was assessed by the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days −1 and 6. Results Of 656 patients, 638 were evaluable: 317 in the THD group and 321 in the control group. Compared with placebo, delayed and overall (0 to 120 h) complete response rates to vomiting were significantly higher with THD: 76.9% versus 61.7% ( P < .001) and 66.1% versus 53.3% ( P = .001), respectively. Rates of no nausea were also higher in the THD group (delayed: 47.3% v 33.3%; P < .001; overall: 41% v 29.6%; P = .003), and mean scores of anorexia were lower overall (0.44 ± 0.717 v 0.64 ± 0.844; P = .003). Adverse effects were mild to moderate. The THD group had increased sedation, dizziness, constipation, and dry mouth, but experienced better quality of life after chemotherapy. Conclusion Thalidomide combined with palonosetron and dexamethasone significantly improved HEC-induced delayed nausea and vomiting prevention in chemotherapy-naive patients.

Olanzapine versus aprepitant in the prevention of chemotherapy induced nausea and vomiting (CINV) in breast cancer patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21670-e21670
Author(s):  
S Mukesh ◽  
Sathya M ◽  
Akshay Jk
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Rescue Therapy ◽  
Antipsychotic Agents ◽  
Complete Response ◽  
Breast Cancer Patients ◽  
Acute Period ◽  
Prior Use ◽  
Grade 3 ◽  
Ecog Ps

e21670 Background: Olanzapine has been shown to be a safe and effective agent for the prevention of CINV. This study aims to compare olanzapine with aprepitant in the prevention of CINV. Methods: This study included breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 chemotherapy. Female patient; age, ≥ 18; chemotherapy naïve; no nausea/ vomiting in the past 24 hours were included. Patients with seizure disorder, brain metastasis, prior use of antipsychotic agents and hypersensitivity to olanzapine were excluded. Patients were randomized into two groups. Olanzapine group received tab olanzapine 10 mg on day 1 to 3. Aprepitant group received tab.aprepitant 125mg on day 1 and 80mg on days 2-3. Both groups received inj palnosteron 0.25mg, inj dexamethasone 8mg on day 1. Use of rescue therapy for nausea or vomiting was permitted. The primary end point of the study was complete response (CR) for nausea that is no nausea in the acute (within 24 hours), delayed (days 2-5), and overall periods (0-120 hours). Secondary endpoint was CR for vomiting and no use of rescue drugs in all periods. Beginning with the first day of chemotherapy and daily through day 5, patients were asked to record daily episodes of nausea using a visual analogue scale from 0 to 10, with 0 indicating no nausea and 10 indicating a maximal level of nausea. They were asked to record daily episodes of vomiting (number and time) and the utilization of rescue therapy. Results: A total of 84 patients (42 in each arm) were evaluated and consented for the study. The median age 48 years; range 29-80; ECOG PS - 0, 1. CR for nausea was 84% for the acute period , 58% for the delayed period and 56% for the overall period for the olanzapine group. CR for nausea in aprepitant group was 69% acute period, 55% delayed period, and 55% for the overall period. CR for vomiting was 91% acute; 74% delayed; 70% overall period for olanzapine group. CR for vomiting in aprepitant group was 91% acute; 83% delayed; 83% overall period. There were no Grade 3 /4 toxicities. Conclusions: Olanzapine is better in the prevention of nausea. However aprepitant is better in the prevention of vomiting. Combination of these two agents needs to be studied in future studies.

A phase 2 trial of lenvatinib 18 mg versus 14 mg once daily (QD) in combination with everolimus (5 mg QD) in renal cell carcinoma (RCC) after 1 prior VEGF-targeted treatment.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. TPS707-TPS707
Author(s):  
Hilary Glen ◽  
Javier Puente ◽  
Daniel Yick Chin Heng ◽  
Sun Young Rha ◽  
Di Li ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Final Analysis ◽  
The United States ◽  
Similar Efficacy ◽  
P Value ◽  
Phase 2 ◽  
Double Blind ◽  
Phase 2 Study ◽  
Grade 3

TPS707 Background: Based on findings from a randomized phase 2 study (Study 205), lenvatinib (LEN) + everolimus (EVE) was approved in the United States and European Union for patients (pts) with advanced RCC following 1 prior anti-angiogenic therapy. In that study, LEN 18 mg QD + EVE 5 mg QD significantly prolonged progression-free survival (PFS) compared with either monotherapy. In the LEN+EVE cohort, grades 3 and 4 treatment-emergent adverse events (TEAEs) occurred in 71% of pts. We report the design of an ongoing, multicenter, randomized, double-blind, phase 2 study (Study 218) to evaluate if a lower LEN starting dosage regimen provides similar efficacy with a better safety profile than LEN 18 mg + EVE 5 mg (NCT03173560). Methods: Eligible pts are aged ≥ 18 years with advanced clear cell RCC, 1 prior anti-VEGF therapy, ≥ 1 measurable target lesion per RECIST 1.1, a KPS score of ≥ 70, and prior nivolumab is allowed. Pts will receive LEN 18 mg or 14 mg QD + EVE 5 mg QD in 28-day cycles until disease progression, unacceptable toxicity, or withdrawal of consent. The LEN 14-mg dose will be escalated to 18 mg if no intolerable grade 2, or any grade ≥ 3 TEAEs requiring dose reduction occur in cycle 1. The primary endpoints are objective response rate (ORR) at week 24 (ORR24W) and the proportion of pts with intolerable grade 2 and any grade ≥ 3 TEAEs within 24 wks after randomization. Secondary endpoints include PFS and ORR. An estimated 306 pts will be randomized. Sample size is based on detecting noninferiority (NI) of ORR24W and superiority of the primary safety endpoint. Two interim analyses (IA) will be performed when 150 and 200 pts have completed 24 wks of follow-up or discontinue earlier. Each analysis will test NI and futility of the LEN 14-mg arm ORR24W vs the 18-mg arm ORR24W. An O’Brien-Fleming boundary will be used for NI. If the 1-sided P-value is ≤ 0.005 at the first IA, ≤ 0.014 at the second IA, or ≤ 0.045 at the final analysis, then NI in ORR24W will be claimed. If the futility boundary is crossed (ie, 1-sided P-value is ≥ 0.776 at the first IA or ≥ 0.207 at the second IA), then futility will be claimed. Clinical trial information: NCT03173560.

Combination of olanzapine and aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11577-11577
Author(s):  
Mukesh Shanthilal ◽  
Sathya M ◽  
Akshay Jk
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Rescue Therapy ◽  
Complete Response ◽  
Controlled Study ◽  
Combination Group ◽  
Breast Cancer Patients ◽  
Combination Strategy ◽  
Acute Period ◽  
Grade 3

11577 Background: Olanzapine and Aprepitant have been shown to be a safe and effective agent for the prevention of CINV. This study aims to compare Olanzapine, Aprepitant and their combination in the prevention of CINV. Methods: Prospective randomized controlled study in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 chemotherapy. Female patient; age, ≥ 18; chemotherapy naïve; were included. Patients with seizure disorder, brain metastasis were excluded. Olanzapine group received Tablet Olanzapine 10 mg on day 1 to 3. Aprepitant group received Tablet. Aprepitant 125mg on day 1, 80mg on days 2-3. The combination group received Aprepitant 125mg on day 1, 80mg on days 2-3 and Olanzapine 10mg on day 1. All groups received Palnosteron 0.25mg and Dexamethasone 8mg on day 1. The primary end point of the study was complete response (CR) for nausea that is no nausea in the acute, delayed and overall periods. Secondary endpoint was CR for vomiting and no use of rescue drugs in all periods. Beginning with the first day of chemotherapy and daily through day 5, patients were asked to record daily episodes of nausea using a visual analogue scale from 0 to 10, with 0 indicating no nausea and 10 indicating a maximal level of nausea. They were asked to record daily episodes of vomiting (number and time) and the utilization of rescue therapy. Results: A total of 141 patients were evaluated and consented for the study. The median age was 47 years; range 29-80; CR for nausea in the acute period (within 24 hours) was 83%, 63.8% and 78.7% (p=0.078); for the delayed period (days 2-5) 59.6%, 55.3% and 63.8% (p=0.702); for the overall period (0-120 hours) 57.4%, 53.2% and 59.6% (p=0.817) for the Olanzapine, Aprepitant and combination arm respectively. CR for vomiting in the acute period was 91.5%, 91.5% and 97.9.7% (p=0.344); for the delayed period 74.5%, 85.1% and 97.9% (p=0.005); for the overall period 70.2%, 85.1% and 97.9% (p=0.001) for the Olanzapine, Aprepitant and combination arm respectively. There were no Grade 3/4 toxicities. Conclusions: The combination strategy shows trend towards better prevention of CINV. Clinical trial information: CTRI/2017/12/010864.

scholarly journals Addition of Dexamethasone to Prophylactic Granisetron in Children Undergoing Ocular Surgeries – A Randomised Controlled Double-Blind Trial

2021 ◽  
Vol 8 (01) ◽  
pp. 12-16
Author(s):  
Koilada Shiv Kumar ◽  
Rajan Anand ◽  
Debasis Bagchi
Keyword(s):  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Fisher Exact Test ◽  
Double Blind ◽  
Exact Test ◽  
Paediatric Age ◽  
Randomised Controlled ◽  
Post Operative Nausea

BACKGROUND Postoperative nausea and vomiting are highly prevalent after ophthalmic surgeries in the paediatric age group. In this randomised, double-blind prospective clinical trial, we studied and compared the efficacy of granisetron and combination of granisetron with dexamethasone to prevent postoperative nausea and vomiting after paediatric ocular surgeries. METHODS Sixty paediatric patients (06 - 12 yrs. of age) undergoing elective ocular surgeries were randomly allocated to one of the two groups of 30 patients each. Group (G) received granisetron 40 mcg kg–1 intravenously as a bolus before induction of anaesthesia. Group (G + d) received granisetron 40 mcg kg–1 & dexamethasone 0.1 mg kg–1 intravenously as a bolus before induction. Student t-test, Fisher exact test were used wherever applicable for statistical analysis using SPSS version 15.0. RESULTS A complete response (defined as no post-operative nausea and vomiting and no need for another rescue antiemetic) was achieved in 63.3 % of patients who received granisetron alone and in 96.7 % of patients who received granisetron plus dexamethasone. We found nil difference in complications between the two groups. CONCLUSIONS We found that addition of dexamethasone to granisetron is more effective and beneficial than granisetron alone in preventing postoperative emesis in 1st 24 hours. KEYWORDS Post-Operative Nausea and Vomiting, Anaesthesia, Granisetron, Dexamethasone

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