Palonosetron is nonsuperior to ondansetron in acute phase but provides superior antiemetic control in delayed phase for pediatric patients administered highly emetogenic chemotherapy

2017 ◽  
Vol 65 (2) ◽  
pp. e26815 ◽  
Author(s):  
Juan Tan ◽  
Shan Wang ◽  
Xiaohua Liang ◽  
Chang-Chun Li ◽  
Jun Zhang ◽  
...  
Keyword(s):  
Acute Phase ◽  
Pediatric Patients ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Delayed Phase

scholarly journals Factors Associated With Chemotherapy-Induced Vomiting Control in Pediatric Patients Receiving Moderately or Highly Emetogenic Chemotherapy: A Pooled Analysis

2020 ◽  
Vol 38 (22) ◽  
pp. 2499-2509 ◽  
Author(s):  
L. Lee Dupuis ◽  
George A. Tomlinson ◽  
Annpey Pong ◽  
Lillian Sung ◽  
Kara Bickham
Keyword(s):  
Acute Phase ◽  
Pediatric Patients ◽  
Pooled Analysis ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Phase Duration ◽  
Factors Associated ◽  
Antiemetic Regimen ◽  
Chemotherapy Dose ◽  
Delayed Phase

PURPOSE To identify factors associated with chemotherapy-induced vomiting (CIV) control in pediatric patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC). MATERIALS AND METHODS An individual, patient‐level, pooled analysis was performed using data from five clinical trials of aprepitant or fosaprepitant in pediatric patients receiving HEC or MEC. The proportion of individuals who experienced no vomiting (complete CIV control) during the phase of interest was the primary study end point. The association of acute-phase complete CIV control (from first chemotherapy dose to 24 hours after the last chemotherapy dose of the chemotherapy block) with age, sex, race, cancer type, acute-phase duration, and antiemetic regimen was examined. Association of the same factors and acute-phase complete CIV control with complete CIV control in the delayed phase (end of acute phase until ≤ 96 hours later) was examined. RESULTS A total of 735 patients (mean age, 8.9 years; range, 0.3 to 17.9 years) were included in the acute-phase analysis. Acute-phase complete CIV control was less likely in older patients (relative risk [RR], 0.97 per year; 95% CI, 0.96 to 0.98 per year) and longer acute-phase duration (RR, 0.89 per day; 95% CI, 0.84 to 0.94 per day). Receipt of ondansetron plus aprepitant or fosaprepitant was associated with a higher likelihood of acute-phase complete CIV control versus ondansetron alone (RR, 1.28; 95% CI, 1.09 to 1.50). Delayed-phase complete CIV control was more likely in patients with acute-phase complete CIV control (RR, 1.19; 95% CI, 1.06 to 1.34) and in those who received aprepitant or fosaprepitant. CONCLUSION Younger age, shorter acute-phase duration, and antiemetic regimen were associated with acute-phase complete CIV control in pediatric patients receiving HEC or MEC. Acute-phase complete CIV control and antiemetic regimen were associated with delayed-phase complete CIV control.

scholarly journals Comparative study of fosaprepitant and aprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients

2021 ◽  
Author(s):  
Li Ting Yu ◽  
zhuo wang ◽  
fen zhou ◽  
Shuangshuang Shen ◽  
Shunguo Zhang ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Acute Phase ◽  
Pediatric Cancer ◽  
Rescue Medication ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic Chemotherapy ◽  
Phase 0 ◽  
Pediatric Cancer Patients ◽  
To Receive ◽  
Delayed Phase

Abstract Children aged 2-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-A (fosaprepitant) or arm-B (aprepitant). Children recruited to arm-A received intravenous ondansetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm-B received the same drugs as those given to children in arm-A, except that fosaprepitant was substituted with aprepitant. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy. Results: One hundred and eight patients were analyzed (55 in the fosaprepitant arm and 53 in the aprepitant arm). CR rates were higher in the fosaprepitant arm compared with the aprepitant arm during the acute phase (95 % vs 79 %, P =0.01< 0.05), delayed phase (71 % vs 66 %, P =0.89 ), and overall phase (69 % vs 57 %, P =0.18). Furthermore, the demand of rescue anti-emetics observed in fosaprepitant arm (7 %) has no difference with aprepitant arm (11 %). Conclusion: Addition of fosaprepitant to ondansetron and dexamethasone is more effective than aprepitant for the prevention of acute vomiting.

Efficacy of a Transdermal Granisetron Patch in Controlling Chemotherapy-Induced Nausea and Vomiting (CINV) in Hematologic Cancer Patients

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3045-3045
Author(s):  
Ruben Niesvizky ◽  
Ana Fernández Velasco ◽  
Doris S Wong ◽  
Deborah Braccia
Keyword(s):  
Cancer Patients ◽  
Acute Phase ◽  
Rescue Medication ◽  
Hematologic Malignancies ◽  
Emetogenic Chemotherapy ◽  
Response To Therapy ◽  
Patient Assessment ◽  
Highly Emetogenic Chemotherapy ◽  
Hematologic Cancer ◽  
Delayed Phase

Abstract Introduction: Multiday, highly emetogenic chemotherapy regimens are commonly used in the management of hematologic malignancies. Despite progress in prophylaxis, CINV, especially during the delayed phase, can remain a significant barrier to attaining planned chemotherapy dose on time for some patients. A granisetron transdermal system (GTS) has been shown to be as effective as oral granisetron in controlling CINV across multiple tumor types. This post-hoc analysis specifically examined the efficacy and safety of GTS in patients with hematologic malignancies. Methods: A randomized, phase 3 study has been published comparing GTS (7 day application) to oral granisetron (2 mg/day) in patients receiving either moderately or highly emetogenic chemotherapy for 3-5 days. Data for this analysis were limited to patients with a primary tumor diagnosis of lymphoma (n=51), leukemia (n=27), or multiple myeloma (n=5). The rates of complete control (CC; no vomiting, mild nausea, no rescue medication) and complete response (CR; no vomiting, no rescue medication) using either GTS or oral granisetron were compared during both the acute (first 24 hours) and delayed phase (days 2 to 5) following chemotherapy. Need for rescue medication and patient assessment of response to therapy with GTS were also compared. Results: 83 hematologic cancer patients (31 GTS, 52 oral granisetron) were included. The majority of patients received a non-cisplatin regimen with corticosteroids (59 patients; 71%). Patients received chemotherapy for 3 days (37; 45%) or 4 to 5 days (46 patients; 55%). During the acute phase of CINV, the CC rate of 94% and CR rate of 94% in the GTS group were similar to rates in the overall population (94% and 95%, respectively). There was no difference in CC and CR between GTS and oral granisetron in the acute phase (P=0.90 and 0.59, respectively). In the delayed phase, GTS resulted in CC in 87% and CR in 90%; compared with CC in 77% and CR in 81% of patients given oral granisetron (P=0.26 and 0.25, respectively). The use of rescue medication over the entire study period and patient assessment of overall response to therapy were not different between arms (P=0.60 and 0.92, respectively). GTS was well tolerated; the only treatment related adverse event was one case of mild constipation. Conclusion: This retrospective analysis suggests GTS may be an appropriate option for prevention of CINV in hematologic cancer patients. A trend toward improved control in the delayed phase was observed and further investigation of a benefit in delayed CINV for hematologic malignancies may be warranted. Disclosures Fernández Velasco: ProStrakan: Employment. Wong:ProStrakan: Employment. Braccia:ProStrakan: Employment.

Risk factors for chemotherapy-induced nausea in pediatric patients receiving highly emetogenic chemotherapy

2018 ◽  
Vol 66 (4) ◽  
pp. e27584 ◽  
Author(s):  
L. Lee Dupuis ◽  
Roy N. Tamura ◽  
Kara M. Kelly ◽  
Jeffrey P. Krischer ◽  
Anne-Marie Langevin ◽  
...  
Keyword(s):  
Risk Factors ◽  
Pediatric Patients ◽  
Emetogenic Chemotherapy ◽  
Highly Emetogenic 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]

Meta-analysis of trials comparing standard antiemetic treatment (SAT) with aprepitant containing antiemetic regimens (ACAR) for prevention of chemotherapy-induced nausea and vomiting (CINV).

2014 ◽  
Vol 32 (31_suppl) ◽  
pp. 171-171
Author(s):  
Neha Gupta ◽  
Hassan Hatoum ◽  
Omar Al Ustwani ◽  
Pongwut Danchaivijitr ◽  
Katy Wang ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Response To Treatment ◽  
Highly Emetogenic Chemotherapy ◽  
Antiemetic Treatment ◽  
Improved Outcomes ◽  
Score Method ◽  
American Society ◽  
Delayed Phase

171 Background: Various randomized controlled trials (RCTs) have shown improved outcomes with addition of aprepitant to standard antiemetic treatment (SAT) in preventing CINV. We conducted a meta-analysis to study the overall impact of ACAR in CINV prevention in adults. Methods: We searched Pubmed and Ovid databases, and American Society of Clinical Oncology meetings abstracts for RCTs using ACAR with SAT for CINV prevention in adult cancer patients (pts). Major study end points were complete response to treatment (CR; defined as no emesis and no use of rescue medications) in overall phase (OP; 0-120 hours of chemotherapy), acute phase (AP; 0-24 hours) and delayed phase (DP; 24-120 hours). Additionally, we assessed the control of nausea and toxicity profile (TP). Stouffer's Z-score method was used to calculate the overall effect. Results: 16 RCTs (5,547 pts) were included. 11 trials (3,314 pts) involved highly emetogenic chemotherapy (HEC) and 5 trials (2,233 pts) involved moderately emetogenic chemotherapy (MEC). ACAR increased CR in OP from 47% to 63% (OR=0.52, CI=0.46 to 0.58; p<0.001), in AP from 73% to 81% (p<0.01), and in DP from 51% to 66% (p<0.001). Significant increase in nausea control was seen in DP (p=0.03) but not in OP or AP. Incidence of various toxicities was statistically similar in both groups except slightly higher rate of fatigue (p=0.02) and hiccups (p<0.001), and lower rate of neutropenia (p=0.02) in ACAR. Conclusions: ACAR is effective in CINV due to both HEC and MEC in adult cancer pts. ACAR improves the control of emesis in all phases, and nausea in delayed phase only. With the exception of causing more fatigue & hiccups, and lesser neutropenia, overall TP of ACAR is similar to SAT.

scholarly journals Efficacy of Olanzapine Combined Therapy for Patients Receiving Highly Emetogenic Chemotherapy Resistant to Standard Antiemetic Therapy

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Masakazu Abe ◽  
Yuka Kasamatsu ◽  
Nobuhiro Kado ◽  
Shiho Kuji ◽  
Aki Tanaka ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Combined Therapy ◽  
Gynecologic Cancer ◽  
Emetogenic Chemotherapy ◽  
Antiemetic Therapy ◽  
Preventive Effect ◽  
Highly Emetogenic Chemotherapy ◽  
Oral Olanzapine ◽  
Phase 0 ◽  
Delayed Phase

Objective. Olanzapine is proved to be effective for chemotherapy induced nausea and vomiting (CINV). But its efficacy in combination with standard antiemetic therapy is unknown. The purpose of this study is to prove the preventive effect of olanzapine for the prevention of CINV caused by highly emetogenic chemotherapy when used with standard antiemetic therapy.Method. Gynecologic cancer patients receiving cisplatin-based chemotherapy who had grade 2 or 3 nausea in overall phase (0–120 h after chemotherapy) despite standard therapy were assigned to this study. From the next cycles to cycles in which patients developed grade 2 or 3 nausea, they received olanzapine with standard therapy. 5 mg oral olanzapine was administered for 7 days from the day before chemotherapy. The effectiveness of preventive administration of olanzapine was evaluated retrospectively. The primary endpoint was nausea control rate (grade 0 or 1) with olanzapine.Results. Fifty patients were evaluable. The nausea control rate with olanzapine was improved from 58% to 98% in acute phase (0–24 h after chemotherapy) and 2% to 94% in delayed phase (24–120 h after chemotherapy). In overall phase, the nausea control rate improved from 0% to 92%, and it was statistically significant (P<0.001).Conclusion. Preventive use of olanzapine combined with standard antiemetic therapy showed improvement in control of refractory nausea.

scholarly journals Efficacy, safety and feasibility of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric patients receiving moderately and highly emetogenic chemotherapy – results of a non-interventional observation study

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Semjon Willier ◽  
Karin Melanie Cabanillas Stanchi ◽  
Martina von Have ◽  
Vera Binder ◽  
Franziska Blaeschke ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pediatric Patients ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Observation Study ◽  
Highly Emetogenic Chemotherapy ◽  
Antiemetic Agent ◽  
Chemotherapy Administration ◽  
Antiemetic Prophylaxis

Abstract Background Chemotherapy-induced nausea and vomiting (CINV) belong among the most burdensome side effects in hemato-oncology. Mostly, a combination of ondansetron and dexamethasone is used as antiemetic prophylaxis in pediatric patients undergoing emetogenic chemotherapy. However, dexamethasone is prohibited in different pediatric chemotherapy protocols. Currently, data on the use of ondansetron with the new antiemetic agent fosaprepitant without dexamethasone is not available for pediatric patients. Methods In this non-interventional observation study, 79 pediatric patients with a median age of 8.0 years (range 0.5–17.9 years) who received a CINV prophylaxis regimen with either fosaprepitant (4 mg/kg; maximum 150 mg) and ondansetron (as 24-h continuous infusion) (n = 40; fosaprepitant group/FG) or ondansetron only (n = 39; control group/CG) during moderately or highly emetogenic chemotherapy were analyzed. The groups were analyzed and compared for frequency of vomiting, administered doses of on-demand antiemetic dimenhydrinate and adverse events during the acute (0-24 h after chemotherapy administration) and delayed (> 24 h–120 h) CINV phases. Results A total of 112 and 116 chemotherapy blocks were analyzed in the fosaprepitant and the control group, respectively. The emetogenic potential of the administered chemotherapy did not significantly differ (p = 0.8812) between the two cohorts. In the acute CINV phase, the percentage of patients experiencing vomiting (n = 26 patients) and the vomiting events were significantly higher (p = 0.0005 and p < 0.0001, respectively) in the CG (n = 26 patients (66.7%); 88 events) compared with the FG (n = 10 patients (25.0%); 37 events). In the delayed CINV phase, the percentage of patients experiencing vomiting and the vomiting events were also significantly higher (p = 0.0017 and p < 0.0001, respectively) in the CG (n = 31 patients (79.5%); 164 events) compared with the FG (n = 17 patients (42.5%); 103 events). Additionally, significantly more dimenhydrinate doses were administered in the CG compared with the FG patients (n = 322/n = 198; p < 0.0001). The occurrence of adverse events did not significantly differ between the two groups (p > 0.05). Conclusion Fosaprepitant (4.0 mg/kg) in addition to ondansetron, without application of dexamethasone, was well tolerated, safe, effective and superior to ondansetron only as CINV prophylaxis in pediatric patients during moderately and highly emetogenic chemotherapy.

Efficacy of triple antiemetic therapy (palonosetron, dexamethasone, aprepitant) for chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based, moderately emetogenic chemotherapy.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 226-226
Author(s):  
Toshimichi Miya ◽  
Kunihiko Kobayashi ◽  
Mitsunori Hino ◽  
Masahiro Ando ◽  
Susumu Takeuchi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Acute Phase ◽  
Rescue Medication ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Antiemetic Therapy ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Treatment ◽  
Severe Adverse Events ◽  
Delayed Phase

226 Background: Chemotherapy-induced nausea and vomiting (CINV) is a major adverse toxicity of cancer chemotherapy. Recommended treatments for prevention of CINV vary among guidelines, and optimal care for CINV caused by moderately emetogenic chemotherapy has not been established. This study assess efficacy and safety of triple antiemetic therapy consist palonosetron, dexamethasone and aprepitant for carboplatin-based chemotherapy. Methods: Chemotherapy-naïve patients with lung cancer scheduled for a first course of a carboplatin-containing regimen formed the study cohort. Patients were pretreated with antiemetic therapy consist palonosetron (0.75 mg, i.v.) and dexamethasone (9.9 mg, i.v.) on day 1, and aprepitant (125 mg, p.o.) on day 1 followed by 80 mg on days 2 and 3. Primary endpoint was the proportion of patients who did not experience vomiting and did not require rescue medication (complete response (CR)) in the acute phase (0-24 h), late phase (24-168 h) and overall. Secondary endpoint was the proportion of patients who experienced no vomiting episodes and no more than mild nausea without the need for rescue medication (complete control (CC)). Results: Prevalence of a CR during the acute phase, delayed phase, and overall was 100%, 91.9% and 91.9%, whereas that of CC was 100%, 84.4% and 84.4%, respectively. Most common adverse events were mild constipation; severe adverse events related to antiemetic treatment were not observed. Prevalence of a CR during the acute phase, delayed phase, and overall was 100%, 91.9% and 91.9%, whereas that of CC was 100%, 84.4% and 84.4%, respectively. Most common adverse events were mild constipation; severe adverse events related to antiemetic treatment were not observed. Conclusions: Triple antiemetic therapy comprising palonosetron, dexamethasone and aprepitant shows excellent effects in preventing CINV in patients receiving a carboplatin-containing regimen. Clinical trial information: UMIN000017877.

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