Chemotherapy-induced Nausea/vomiting Research Articles

Comparison between Palonosetron and Ondansetron in Prevention of Chemotherapy Induced Nausea Vomiting

Background: Chemotherapy induced nausea and vomiting (CINV) is the commonest and the most incapacitating experience of thepatient undergoing cancer chemotherapy. Poorly controlled CINV sometimes make patients to refuse further treatment. This study aimed to compare the efficacy and safety of Palonosetron and Ondansetron in preventing CINV during cancer chemotherapy. Methods:This randomized controlled trial was conducted in the Department of Pharmacology and Therapeutics of Sylhet MAG Osmani Medical College from January 2021 to December 2021. There were 190patients enrolled initially; 14 patients from both groups withdraw themselves. Finally, 91 patients of Palonosetron and 85 patients of Ondansetron treated were recruited. The Palonosetron group were treated with Palonosetron at 0.25 mg and the Ondansetron group were treated with Ondansetron 8.0 mg intravenously, 30min before chemotherapy. After that Palonosetron 0.5 mg single time and Ondansetron 8.0 mg orally three times a day were given and total follow-up period was seven days. Episode of nausea and vomiting graded according to the guideline “Common Terminology Criteria for Adverse Events (CTCAE)”, version 4.0, which was published by the US Department of Health and Human Services (National Institute of Health and National Cancer Institute). Result: The groups were matched for the age (p = 0.263), gender (p = 0.630), body weight (p = 0.846),site of malignancy (p = 0.375), and drugsused for chemotherapeutic (p = 0.301) in both study groups. Palonosetron treated patients experienced significant lower episode of nausea in day-1 (p = <0.001) and day-2 (p = 0.025), and in case vomiting in day-1 (p = 0.026) compared to Ondansetron. Significantly higher number of patients of Palonosetron compared to Ondansetron treated group showed complete response in both acute phase (p = 0.026), delayed phase (p = 0.036) and finally in overall phase (p = 0.014). Only four patients experienced with treatment failure in Ondansetron treated group. Observed adverse effects were in low intensity and not caused to stop the treatment procedure. Conclusion: Palonosetron was found to be more efficacious and well tolerated in preventing acute, delayed and overall phase of chemotherapy induced nausea and vomiting in this study.

Prevention and management of acute toxicities from conditioning regimens during hematopoietic stem cell transplantation.

Hematopoietic stem cell transplantation (HSCT) remains the only curative option for several hematological malignancies. Its use has continued to grow, with an estimated 23,500 transplants performed annually in the United States alone. The acute toxicities that occur from conditioning chemotherapy can impact the peri-transplant period and have substantial implications on patients' tolerability and outcomes, irrespective of the treatment of their disease. Chemotherapy-induced nausea vomiting (CINV), mucositis, transplant-associated thrombotic microangiopathy (TA-TMA), and sinusoidal obstruction syndrome, also known as a veno-occlusive disease (SOS/VOD) can all have significant implications for patients. These acute complications begin with the start of conditioning chemotherapy and add to potential toxicity for patients throughout the early post-transplant period, from Day +30 for CINV, mucositis, and SOS, and which can continue through at least Day +100 with the onset of TA-TMA. These toxicities must be prevented and managed appropriately. This review will summarize the literature surrounding them and guide their management.

LBA97 Olanzapine for the prevention of chemotherapy induced nausea vomiting in patients receiving moderately emetogenic chemotherapeutic (MEC) regimens: Results of a prospective triple blinded phase III multicentric study (OMEC)

LBA97 Olanzapine for the prevention of chemotherapy induced nausea vomiting in patients receiving moderately emetogenic chemotherapeutic (MEC) regimens: Results of a prospective triple blinded phase III multicentric study (OMEC)

Vitamin D status in breast cancer cases following chemotherapy: A pre and post observational study in a tertiary hospital in Yogyakarta, Indonesia.

To observe pre- and post-treatment vitamin D level and its association with treatment and concomitant factors in breast cancer patients treated with chemotherapy. We performed a pre-post observational analysis that nested in an ongoing prospective cohort study of breast cancer patients at Dr. Sardjito General Hospital, Yogyakarta, Indonesia. 136 subjects were recruited from the main study. Information on subjects' socio-demographic characteristics clinical status, and tumour profile was assessed at baseline. Number of chemotherapy cycles and chemotherapy-induced nausea vomiting (CINV) were also recorded. Vitamin D concentration was measured using ELISA methods at baseline and post-treatment. Vitamin D level of <20 ng/ml and <12 ng/ml were defined as deficiency and severe deficiency. Correlation between socio-demographic and clinical profile with baseline vitamin D was tested using Spearman correlation. Paired t-test was used to evaluate changes in post-treatment vitamin D concentration. The odds ratio for a subject to experience post-treatment vitamin D decrease was assessed based on number of chemotherapy cycles and CINV severity. The mean vitamin D level before chemotherapy was very low (8.80±3.64 ng/ml) in the whole panel. Higher AST level were associated with lower vitamin D level at baseline (r = -0.188, p = 0.028). Severe deficiency was found in 82.4% subjects at baseline and the rate increased to 89.0% after chemotherapy. Eighty-five cases showed a decrease level whereas 51 showed a slight improvement. Overall, a significant decrease of the vitamin D level was observed after chemotherapy (median change 3.13±4.03 ng/ml, p <0.001). Subjects who received >6 cycles of chemotherapy were less likely to experience a decreased level of post-treatment vitamin D (OR = 0.436, 95% CI = 0.196-0.968, p = 0.039). Indonesian breast cancer patients showed pre-existing severe vitamin D deficiency and deterioration of vitamin D after chemotherapy. Future research is needed to explore its implication towards patients' survival in the local setting. Evidence-based approach also needs to be taken to address this modifiable condition, including increasing awareness of the importance of maintaining vitamin D sufficiency both in patients and the general population.

Effectiveness of NEPA, an oral fixed-dose combination of NEtupitant and PAlonosetron in the prevention of chemotherapy-induced nausea-vomiting in patient receiving highly emetogenic chemotherapy regimens.

e24090 Background: Patients receiving Highly Emetogenic chemotherapy (HEC) are &gt; 90% risk of nausea-vomiting due to the drug's emetogenic potential and patient-related factors such as young age, female gender, low/no alcohol, H/O morning sickness and use of alternative medications. The current study was designed to assess the effectiveness of NEPA in patients receiving HEC in a real-world setting in India. Methods: An open-label, single-arm, prospective study among chemonaive patients was conducted across six centers from April 2019 to December 2021 after approval from each institutional ethics committee (CTRI/2020/02/023586). Complete response and treatment-emergent adverse events were the primary endpoints. Secondary endpoints included completion protection, complete control and severity of nausea. Results: HEC regimens were prescribed in 289 of the 360 patients enrolled in the study. Most common HEC regimen was Anthracycline-Cyclophosphamide (44.2%) followed by Paclitaxel-Carboplatin (17.9%). Average age of study population was 52.8±9.8 yrs. with male: female ratio of 1:2.1. Hypertension (17.6%) and diabetes (12.4%) were common comorbidities. Complete response in acute, delayed and overall phases were 94.4%, 94.8%, and 92.7% respectively. In overall phase, complete protection and complete control was 86.8% and 77.5% respectively. Mild, moderate and severe nausea were reported in 11.7%, 7.6%, and 2.4%, patients respectively. Adverse events were seen in 10(3.4%) patients, with leg pain being the most common 3(0.8%). One serious adverse event, unrelated to the study drug was reported. Conclusions: NEPA was effective and well tolerated in patients on a HEC regimen in the acute, delayed and overall phases with a completed response rate of &gt; 90%. Clinical trial information: CTRI/2020/02/023586. [Table: see text]

A retrospective study on chemotherapy-induced nausea and vomiting in highly/moderately emetogenic chemotherapy: incidence and prescribing practice.

Chemotherapy-induced nausea vomiting (CINV) is a common and significant problem in oncology patients and rated as one of cancer chemotherapy's most distressing side effects. The objectives of this study are to describe the incidence of CINV in highly and moderately emetogenic chemotherapy-treated patients and the prescribing pattern of CINV prophylaxis. This retrospective, cross-sectional single-center study randomly collected data on demographics, CINV episodes, and prescribing patterns for adult oncology patients receiving intravenous highly or moderately emetogenic chemotherapy (HEC/MEC) between January and December 2019. A total of 419 randomly selected records of HEC/MEC recipients with 2388 total chemotherapy cycles were included. The mean age was 53.6 ± 12.6years old. The majority was female (66%), Malay (54.4%), diagnosed with cancer stage IV (47.7%), and with no comorbidities (47%). All patients were prescribed with IV granisetron and dexamethasone before chemotherapy for acute prevention, whereas dexamethasone and metoclopramide were prescribed for delayed prevention. Aprepitant was not routinely prescribed for the prevention of CINV. CINV incidence was 57% in the studied population and 20% in the total cycle. This study found a significant association between CINV incidence with performance status and cisplatin-based chemotherapy (OR = 3.071, CI = 1.515-6.223, p = 0.002; OR = 4.587, CI = 1.739-12.099, p = 0.02, respectively). CINV incidence was rather high per patient but relatively low per cycle. Most patients were prescribed with dual regimen antiemetic prophylaxis. This study provides evidence that there was suboptimal use of recommended agents for CINV, and there is a clear need for further improvements in CINV management.

Effectiveness of the ayurvedic cannabis tincture in minimizing the side effect of chemotherapy induced nausea vomiting in breast cancer patient: A case report

Effectiveness of the ayurvedic cannabis tincture in minimizing the side effect of chemotherapy induced nausea vomiting in breast cancer patient: A case report

The effectiveness of NEPA in the prevention of chemotherapy-induced nausea vomiting among chemo naive patients in an Indian setting

BackgroundChemotherapy induced nausea- vomiting (CINV) is considered as the most common, feared and most troublesome side effect of chemotherapy. NEPA (NEtupitant 300 mg + PAlonosetron 0.50 mg) is the first commercially available oral fixed-dose combination (FDC) of two active antiemetic agents in India. The present study was planned to evaluate the effectiveness of NEPA in the real world setting of India.MethodsThis was a multicentric retrospective study conducted in two centers in India. The data of all chemonaive patients, who were prescribed NEPA was analyzed. Effectiveness i.e. complete response and complete protection in controlling overall, acute and delayed phase was analyzed.ResultsA total of 329 patients were enrolled in the study. 260 received highly emetogenic chemotherapy (HEC) regimen and 69 received moderately emetogenic chemotherapy (MEC) regimen. Among all the enrolled patients, complete response in acute, delayed and overall phase was 93, 85.71 and 85.41% respectively; and completed protection was 88.44, 81.76 and 80.54% respectively. Those who received HEC regimen, the completed response and complete protection in overall phase was 84.61 and 79.61% respectively and those who received MEC regimen the completed response and complete control in overall phase was 84.05 and 84.05% respectively.ConclusionA single oral dose of NEPA targeting dual pathways showed effective control of nausea-vomiting in patients on the HEC and MEC regimens and had good control over nausea-vomiting in acute, delayed and overall phase of nausea-vomiting.

Prevalence of breakthrough chemotherapy-induced nausea vomiting in patients on highly emetogenic chemotherapy: A Single-center observational study

Prevalence of breakthrough chemotherapy-induced nausea vomiting in patients on highly emetogenic chemotherapy: A Single-center observational study

Efficacy of Antiemetic Regimens for Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting in Patients of Breast Cancer Receiving Highly Emetogenic Chemotherapy

Abstract Background: Chemotherapy is fraught with serious and troublesome adverse effects, of which nausea and vomiting appears earliest and is the most disturbing. Therefore, this study was planned to investigate the antiemetic drug regimens used for chemotherapy-induced nausea vomiting (CINV) in patients with breast cancer receiving highly emetogenic chemotherapy (HEC). Subjects and Methods: An observational follow-up study was conducted to assess the efficacy of antiemetic regimens in breast cancer patients receiving HEC. A total of 71 newly diagnosed patients with breast cancer were included in the study. Patients were assessed for nausea by the visual analog scale, and a history of emetic episodes and need for rescue medication were recorded at 0 h, 6 h, 24 h, 48 h, and 120 h post-chemotherapy till three cycles. Results: The patients were prescribed a combination of ondansetron and dexamethasone (n = 23, n = 17, and n = 13 in first, second, and third cycle, respectively) or a combination of aprepitant, ondansetron, and dexamethasone (n = 48, n = 54 and n = 56 in the first, second, and third cycle, respectively). The intensity of nausea was higher for the patients who were prescribed ondansetron and dexamethasone regimen as compared to patients prescribed aprepitant additionally. Complete response, i.e., no emesis and no rescue medication, was higher in triple-drug regimen (52% vs. 0.4%, 63% vs. 17.6%, and 69% vs. 23% in three cycles, respectively). Conclusion: The control of CINV was better with a combination of aprepitant, ondansetron, and dexamethasone as compared to a regimen without aprepitant.

Aprepitant in weekly cisplatin with radiation in head and neck cancer: Is it required?

e24122 Background: Weekly cisplatin below 50 mg/m2 has lower emetogenic potential than 100 mg/m2 3weekly regimen. There is limited data on the utility of Aprepitant with weekly cisplatin used in radiation in head and neck squamous cell cancer (HNSCC). Methods: We conducted a phase 3 randomized trial in locally advanced HNSCC patients who were treated with definitive chemoradiation either with cisplatin or cisplatin-nimotuzumab. 5HT3 inhibitor and steroids +/- aprepitant were used as antiemetic prophylaxis as per physician discretion. The current analysis is focussed on studying the impact of aprepitant on nausea and vomiting. Fischer’s exact test was used to compare the chemotherapy induced nausea vomiting (CINV) rates between aprepitant and non-aprepitant groups. Binary logistic regression analysis was used to calculate the odds of CINV with the use of aprepitant. Results: Data on CINV is available for 524/536 patients. Nausea was present in 251 (47.9%) patients while vomiting was seen in 155 (29.6%) patients. Aprepitant, 5HT3 antagonist and dexamethasone were administered to 265 (50.86%), while 256 received 5HT3 antagonist and dexamethasone. Among patients receiving aprepitant, nausea was present in 112 (42.3%), while there was no nausea in 153 (57.7%) patients (p = 0.011). Vomiting with aprepitant was seen in 71 (26.8%) patients while 194 (73.2%) had no vomiting (p = 0.151). Adjusted odds ratio for use of aprepitant containing antiemetic prophylaxis in prevention of CINV were 1.585 (1.116-2.249;p = 0.010) and 1.328 (0.904-1.951;p = 0.149) as depicted in the table. Conclusions: Use of aprepitant significantly decreases nausea and is needed for weekly cisplatin regimens used in radiation in head and neck cancers. [Table: see text]

A modified olanzapine-based anti-emetic regimen for the control of nausea and vomiting in patients receiving weekly cisplatin.

Background There is limited data on specific antiemetic protocols for control of chemotherapy-induced nausea/vomiting (CINV) caused by weekly cisplatin regimens. Olanzapine is an active agent against CINV and may offer better control of nausea compared to aprepitant/fosaprepitant-based regimens. The usual antiemetic dose of olanzapine (10mg for four days) causes problems with drowsiness. A lower dose may be as effective with lesser side effects in patients receiving weekly cisplatin. Objective To assess the control of nausea, vomiting, and occurrence of side effects with a modified olanzapine-based antiemetic regimen among patients with carcinoma of the cervix receiving concurrent cisplatin with pelvic radiotherapy. Setting Tertiary cancer hospital in Southern India. Methods We used a modified regimen "mini-OPD", oral olanzapine (5mg) days 1 and 2, intravenous palonosetron (0.25mg) and dexamethasone (12mg) on day 1 of cisplatin administration in patients with carcinoma of the cervix receiving concurrent chemoradiotherapy with weekly cisplatin (40mg/m2/week). At our centre, these patients remained inpatients throughout chemoradiotherapy. CINV-related outcomes were captured in the patients' records by the treating physician in the subsequent week (up to 6 times per patient depending on the number of cycles). We audited these records to calculate the complete response (CR defined as no emetic episodes and no use of rescue medication) rate. Main outcome measure Grades of nausea, vomiting, and drowsiness as per CTCAE v4.0. Results Data of 65 patients (median age: 48years) who received mini-OPD regimen (median doses of cisplatin/patient: 4) was available. The CR rate was 55%. Considering all cycles together (217 weekly assessment points), "no nausea" target was attained in 125 (58%) assessments and "no vomiting" in 168 (77%). There were no significant side effects. Conclusions The mini-OPD regimen is an inexpensive, non-toxic and effective regimen for the prevention of CINV in patients receiving weekly cisplatin concurrent with pelvic radiotherapy.

Randomized, double-blind, placebo-controlled study of aprepitant versus two dosages of olanzapine with ondansetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving high-emetogenic chemotherapy.

We assessed the efficacy of aprepitant (APR) or 10 or 5mg OLN (OLN10 or OLN5) plus ondansetron and dexamethasone for chemotherapy-induced nausea/vomiting (CINV) prophylaxis in patients receiving high-emetogenic chemotherapy (HEC). Patients who received doxorubicin + cyclophosphamide or cisplatin were given intravenous ondansetron and dexamethasone prior to chemotherapy and oral dexamethasone on days 2-4 and randomized 1:1:1 to receive APR125 on day 1 and APR80 on days 2-3 or OLN10 or OLN5 on days 1-4. Matched placebo controls were used. The primary endpoint was no nausea in ≤ 120h. Secondary endpoints included CINV severity, complete response (CR) rate, adverse effects (AE), and quality of life. Of 141 patients, 104 received AC and 37 received cisplatin. The no-nausea rates were 33% (APR), 43.2% (OLN10; p = 0.24), and 37% (OLN5; p = 0.87). Grades 2-4 nausea were experienced by fewer patients for OLN10 than for APR (24-120h, 8.7% vs. 27.7%, respectively; p = 0.02; overall period, 19.6% vs. 40.4%, respectively; p = 0.03). The median visual analog scale nausea score from 24 to 120h was significantly lower for OLN10 (2.3) than for APR (1.2, p = 0.03). The degrees of vomiting, CR, and AE were similar between the APR and OLN10 groups. CINV was similar between the OLN5 and APR groups. Nausea was less severe for OLN10 than for APR in patients receiving HEC, but other measures were similar. CINV prevention efficacy was comparable between OLN5 and APR.

The efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.

To evaluate the efficacy and safety of the addition of olanzapine to ondansetron and dexamethasone for chemotherapy-induced nausea vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy (HEC). In this randomized, double-blind, placebo-controlled, crossover study, we randomly assigned chemotherapy-naïve patients receiving HEC to receive olanzapine or placebo in addition to ondansetron and dexamethasone. All subjects were crossed over to another treatment arm on second-cycle chemotherapy. The primary endpoint was complete response (CR) rate defined as no vomiting and no use of rescue drugs. At the first cycle, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (68.7% vs. 25.0%, p < 0.001), acute phase (0-24h) (75.0% vs. 31.2%, p < 0.001) and delayed phase (24-120h) (68.7% vs. 43.7%, p = 0.038). After crossover, there were significantly more patients with CR in the olanzapine group than in the placebo group in overall phase (67.2% vs. 25.0%, p < 0.001), acute phase (71.9% vs. 32.8%, p < 0.001) and delayed phase (67.2% vs. 37.5%, p < 0.001). In crossover analysis, the olanzapine group had significantly lower mean nausea (1.28 vs. 3.05, p < 0.001) and fatigue (3.5 vs. 4.58, p < 0.001) scores but higher mean appetite (2.5 vs. 1.55, p = 0.003) and sleepiness (3.26 vs. 2.2, p < 0.001) scores. There were no grade 3 and 4 anti-emetic-drug-related toxicities. Mean QT interval changes did not different between two groups (-4.30 vs. -1.86, p = 0.69). The addition of olanzapine to ondansetron and dexamethasone significantly improved CINV prevention and was safe in patients receiving HEC.

ON8 CHEMOTHERAPY INDUCED NAUSEA VOMITING: VALIDATION OF RISK SCORING ALGORITHM IN PATIENTS WITH GYNECOLOGICAL AND GASTROINTESTINAL CANCERS

The study aims to prospectively evaluate the risk scoring algorithm of Chemotherapy induced nausea-vomiting (CINV) in patients undergoing chemotherapy. All patients with Gynecological and Gastrointestinal cancers receiving chemotherapy are recruited after obtaining informed-consent. Patients are followed-up on Day-1 and Day-5 to record any evidences of acute and delayed CINV respectively through phone calls. Prior to every cycle of chemotherapy, the scoring-systems are applied to stratify patients into low and high-risk groups. Logistic-regression modelling is applied to compare the risk for grade 2 or greater CINV between patients considered to be at high and low risk. To assess the external-validity of each system, an area under the receiver-operating characteristic curve-(AUROC) analysis is performed. The CINV outcomes data from a total of 104 patients (until March 2019) over 326-cycles of chemotherapy was collected. The incidence of acute and delayed CINV was 42.7% and 76.4% respectively. Major significant risk-factors included younger patient age, platinum/anthracycline-based chemotherapy, low alcohol consumption, previous history of morning sickness and nausea/emetic episodes prior to chemotherapy. Both acute and delayed scoring systems had good predictive accuracy when applied to the external validation sample (acute-AUROC: 0.75; 95% CI: 0.69 to 0.80; delayed-AUROC: 0.71; 95% CI: 0.65 to 0.78). Patients identified by the scoring systems to be at high-risk were 3.8 (p = 0.005) and 6.6 (p = 0.002) times more likely to develop grade-2 or greater acute and delayed-CINV respectively. The present research establishes that the scoring-systems can precisely classify the patients at high-risk for acute and delayed CINV. Further, the data collected until October 2019 will be analyzed and presented at the conference.

THE EFFECT OF ACUPRESSURE WRISTBAND ON NAUSEA VOMITING IN BREAST CANCER PATIENTS WHO RECEIVED CHEMOTHERAPY

Chemotherapy is one of the therapies for cancer patients that cause some side effects, one of them is nausea and vomiting. Nausea and vomiting are still felt by patients even though they take antiemetics. Nausea dan vomiting can cause fluid and electrolyte imbalance. The aim of this study was to analysis the effect of combination acupressure wristband and antiemetic among chemotherapy induced nausea vomiting (CINV) on breast cancer patients. This research used quasi experimental research method, with a pre-post test with the control group. The sampling techniques was consecutive sampling with 25 respondents both in intervention group and control group. In the intervention group had received an acupressure wristband. CINV measured on the second day until fourth day after chemotherapy. Nausea and vomiting score were measured twice a day by a telemonitoring methode by Rhodes Index Nausea, Vomiting and Retching (INVR) questionaire. Data were analyzed by paired t-test, independent t-test, Wilcoxon test and Mann Whitney. The result of this study showed that acupressure wristband significantly reduce the chemotherapy induced nausea and vomit (p value = 0.000). The use of acupressure wristband combined with antiemetic therapy can significantly decrease chemotherapy induced nausea and vomiting in breast cancer patients. Acupressure wristband recommended for consideration nursing intervention in treating breast cancer patients who experience nausea and vomiting.

Comparative Study of Ondansetron Verses Palonosetron in Cisplatin Induced Nausea Vomiting

Objective: Nausea and vomiting can adversely affect the life of a patient with cancer both during and after chemotherapy. A common side effect of Cisplatin regimens is severe nausea and vomiting. Cisplatin based regimens for cancer is categorized as highly emetogenic chemotherapy. There is considerable progress in the control of nausea and vomiting from those early days but there is still paucity of data on antiemetic regimens for patients undergoing multiday Cisplatin based regimens. Palonosetron differs from first-generation 5HT3 antagonists. It has a longer half-life and a 100-times greater binding affinity to the 5HT3 receptor. This prospective study was designed to compare the efficacy of antiemetics Ondansetron and Palonosetron to prevent Chemotherapy induced nausea vomiting (CINV) in cancer patients on Cisplatin regimens. Material and Methods: A prospective randomised study was conducted at the department of Oncology at a tertiary care centre. A total of 40 chemotherapy naïve patients were enrolled in the study; 20 each in the ondansetron and palonosetron groups. All patients received Cisplatin in a dose of at least 50 mg /sq meter of body-surface area. The severity of nausea was recorded and vomiting was recorded in terms of number, frequency and time to rescue medication. Results: Of 40 patients with cancer placed on chemotherapeutic regimens containing Cisplatin 20 were placed in the Ondansetron arm and 20 were placed in the Palonosetron arm. Mean age in Ondansetron group was 54±13.84 and in Palonosetron group was56±11.93. Out of 20 patients in ondansetron group mean vomiting was 6.4 times while in Palonosetron it was 4.2. In Ondansetron group 14 (70%) showed response to Ondansetron while in Palonosetron 16 (80%) showed response. There was no response to treatment in 6 (30%) in Ondansetron and 4 (20%) in Palonosetron. Palonosetron given daily from Day 1 up to Day 5 of chemotherapy significantly reduced the incidence of nausea on. Conclusion: The overall complete response (CR) rates of Palonosetron were slightly higher than the Ondansetron. Palonosetron can reduced the incidence and severity of nausea and vomiting who are on Cisplatin therapy as compared to Ondansetron

Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial

Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy; however, most studies focus on solid malignancies and single-day regimens. A randomized, double-blinded, placebo-controlled trial was conducted to compare the addition of olanzapine to triplet therapy (fosaprepitant, ondansetron, dexamethasone [FOND-O]) versus triplet therapy alone (FOND) in preventing CINV in hematology patients receiving single-day and multiple-day highly emetogenic chemotherapy and hematopoietic cell transplant (HCT) regimens (NCT02635984).The primary objective of this study was to compare complete response (CR; no emesis and minimal nausea, <25 mm on a 100-mm visual analog scale) during the overall assessment period (chemotherapy days plus 5 days after). Secondary objectives were the number of emesis, number of rescue medications, percent achieving minimal nausea, and percent achieving complete protection (CP; no emesis, rescue antiemetic, or significant nausea), all of which are reported as acute (chemotherapy days), delayed (5 days after chemotherapy), and overall phases. Olanzapine 10 mg or matching placebo were given on each chemotherapy day and 3 days after. Adults with hematologic malignancy receiving HCT regimens of melphalan, BEAM (carmustine, etoposide, cytarabine, melphalan), busulfan (Bu)/cyclophosphamide (Cy), Bu/fludarabine (Flu), Bu/melphalan, FluCy, FluCy-total body irradiation (TBI), etoposide-TBI, and ICE (ifosfamide, carboplatin, etoposide) or 7+3 chemotherapy regimens were included. An estimated 98 patients were required using alpha = .05 and 80% power.No significant differences existed in baseline characteristics between FOND-O (n = 51) and FOND (n = 50) arms. Mean duration of olanzapine was 7.7 days (range, 4 to 11). Discontinuation for possible adverse events occurred in 3 placebo and 0 olanzapine patients. CR was significantly higher for FOND-O in overall (55% versus 26%, P = .003) and delayed (60.8% versus 30%, P = .001) but not acute (P = .13) phases. Significantly more patients receiving FOND-O achieved no more than minimal nausea in overall (P = .001) and delayed phases (P = .0002), as well as fewer overall mean emesis counts (P = .005). CP rates were not different in any assessment phase (P ≥ .05 each). Within the HCT subgroup (n = 64), the CR, CP, and no significant nausea rates were significantly better for FONDO-O in overall and delayed phases (all P < .05). Analysis within the HCT subgroup revealed significant improvement in outcomes in delayed and overall phases with FOND-O in the autologous but not allogeneic cohort.Addition of olanzapine to an NK-1–based triplet antiemetic regimen significantly improved clinically relevant outcomes in the HCT population.

Efficacy of the oral neurokinin-1 receptor antagonist aprepitant for nausea and vomiting induced by cisplatin and carboplatin in Japanese patients with gynecological cancer.

This study was conducted to evaluate the efficacy and the difference in effects of the oral neurokinin-1(NK-1) receptor antagonist aprepitant for chemotherapy-induced nausea/vomiting (CINV) in Japanese patients with gynecological cancer receiving highly emetogenic (cisplatin) and moderately emetogenic (carboplatin) chemotherapy. Aprepitant was added during the second course of chemotherapy in Japanese patients with grade≥2 (Common Terminology Criteria for Adverse Events, version 3.0) nausea and vomiting during the first course despite receiving antiemetic therapy (a first-generation 5-hydroxytryptamine 3 receptor antagonist + dexamethasone), and in patients who requested stronger antiemetic therapy despite only having grade 1 nausea and vomiting. The incidence of nausea and vomiting was compared between the first and second courses in each group. Ninety-six (55.5%) out of 173 patients received add-on therapy with aprepitant. There was a significant increase in the complete response (CR: no vomiting or salvage therapy) rate in the patients receiving aprepitant, with marked improvement being confirmed for delayed CINV. Stratified analysis showed that patients with delayed CINV treated with carboplatin had a significantly higher CR rate, while patients with both acute and delayed CINV treated with cisplatin had significantly higher CR rates. There was a positive correlation between the incidence of nausea and the incidence of vomiting in the patients treated with aprepitant. The oral NK-1 receptor antagonist aprepitant could be effective for both acute and delayed CINV with cisplatin and for delayed CINV with carboplatin in Japanese gynecological cancer patients.

Factors associated with neurokinin-1 receptor antagonist use among commercially insured cancer patients receiving highly emetogenic chemotherapy.

24 Background: Neurokinin-1 receptor antagonists (NK1RA) reduce chemotherapy-induced nausea/vomiting (CINV) among patients undergoing highly emetogenic chemotherapy (HEC). We evaluated factors associated with the use of NK1RA in patients treated with HEC. Methods: We performed a retrospective cohort study using Truven Health Marketscan to identify subjects who initiated HEC (doxorubicin or cisplatin) between 2009 and 2013, and concurrently received a NK1RA. Multivariable logistic regression was used, to determine the association of clinical and demographic factors and NK1RA use. Results: Of 32,004 subjects with cancer who were treated with either doxorubicin or cisplatin-containing regimens, 11,325 (33.3%) did not receive an NK1RA. From 2009 to 2013, NK1RA use increased from 53.2% to 73.5% (p &lt; 0.0001). Compared to non-users, NK1RA users were more frequently treated with cisplatin-based regimens (67.9% vs. 32.1%, p &lt; 0.0001), had in-network claims (66.7% vs. 33.3%, p &lt; 0.0001), were younger, and without other comorbidities. Multivariate analysis demonstrated that NK1RA use was more likely with cisplatin compared to doxorubicin (OR = 1.71, 95% CI 1.62-1.81) and with female compared to male patients (OR = 1.75, 95% CI 1.65-1.84). In-network claims (OR 1.26, 95% CI 1.16-1.36) and comprehensive benefit plans (OR = 1.14, 95% CI 1.04-1.25) were associated with increased NK1RA use, compared to out-of network claims and preferred provider organizations (PPO), respectively. Age ≥ 65 years (OR = 0.64, 95% CI 0.5-0.69) and increased comorbidities (comorbidity score of 1: OR 0.88, 95% CI 0.83-0.94; score of 2- OR 0.61, 95% CI 0.56-0.67) versus a score of 0 were associated with decreased NK1RA use. Conclusions: A substantial proportion of patients receiving HEC do not receive NK1RA, and type of insurance coverage was associated with receipt.