Emetogenic Chemotherapy Regimens Research Articles

A nationwide double-blind phase III randomized clinical trial (RCT) of olanzapine vs. prochlorperazine for the treatment of refractory nausea in patients receiving moderately or highly emetogenic chemotherapy among NCI Community Oncology Research Program (NCORP) practices.

185 Background: Despite advances in antiemetics given during chemotherapy, nausea remains a clinically significant issue and greatly impairs quality of life (QOL). Current ASCO guidelines recommend olanzapine or prochlorperazine for refractory chemotherapy-induced nausea. However, there is a lack of direct empirical comparisons to establish their relative efficacy. Methods: The URCC NCORP Research Base and 21 NCORP practices enrolled 1,363 chemotherapy-naïve patients with breast cancer starting a high/moderate emetogenic chemotherapy regimen to this Phase III RCT (NCT03367572). Antiemetics were prescribed per ASCO guidelines. Screening occurred during Cycle 1, followed by randomization for Cycle 2. Those with ≥ moderate nausea (≥3 on a 1-7 scale) in Cycle 1 and willing to continue were randomized (1:1:1 ratio) into 3 arms (n=310): 1) ASCO regimen plus olanzapine (OLZ), 2) ASCO regimen plus prochlorperazine (PC), or 3) ASCO regimen plus placebo. Nausea was evaluated using a four-day home diary (4x daily), with the primary outcomes being changes in average (avg) and maximum (max) nausea. FACT-G measured QOL. Intent-to-treat primary analyses (ANOVA and Cohen’s Δ effect size) evaluated whether OLZ or PC improved nausea, testing between-arm differences in nausea change from Cycle 1 to 2 compared to placebo at a p=0.025 significance level corrected for 3 arms. Results: The median age was 50.7y, with 80.7% White/12.3% Black/5.8% Asian/4.2% Latino, and evenly distributed across groups. The change in avg nausea score was statistically significant for the OLZ (avg change = −1.07: Cohen’s Δ = 0.49) and PC arms (avg change = −0.94: Cohen’s Δ = 0.38) compared to the placebo (avg change = −0.50; p <0.001 vs OLZ, p = 0.01 vs PC). Similar but larger changes were noted for change in max nausea score in the OLZ (max change = −2.57: Cohen’s Δ = 0.86) and PC arms (max change = −2.01: Cohen’s Δ = 0.47) against the placebo (max change = −1.30; p <0.001 vs OLZ, p <0.01 vs PC). The OLZ arm had a clinically significant change in overall QOL from pre-chemo to Cycle 2 vs placebo (FACT-G mean difference = +4.91; p = 0.006) but the PC arm vs placebo did not (FACT-G mean difference = −0.87; p = 0.61). OLZ exhibited superiority over PC in terms of changes in max nausea (mean difference = −0.56; p = 0.023) and QOL (FACT-G mean difference = +5.80; p = 0.006), but not for avg nausea (mean difference = −0.13; p = 0.418). Conclusions: OLZ and PC, when added to ASCO guidelines, each significantly reduces refractory nausea. OLZ demonstrates superior max nausea control with clinically and statistically significant improvements in QOL. This study fills the gap in empirical comparisons and solidifies OLZ's position as a promising intervention for refractory nausea. Clinical trial information: NCT03367572 .

Olanzapine as Antiemetic Prophylaxis in Moderately Emetogenic Chemotherapy

The role of olanzapine has not been adequately evaluated in moderately emetogenic chemotherapy (MEC) regimens with or without neurokinin-1 receptor antagonists. To evaluate whether addition of olanzapine to an MEC regimen reduces nausea, vomiting, and use of nausea rescue medications among patients with solid malignant tumors. This multicenter, open-label phase 3 randomized clinical trial included patients aged 18 years or older with solid malignant tumors who were receiving oxaliplatin-, carboplatin-, or irinotecan-based chemotherapy. The trial was conducted at 3 institutes in India from March 26, 2019, to August 26, 2023; the final cutoff date for analysis was September 10, 2023. Patients were randomized 1:1 to dexamethasone, aprepitant, and palonosetron with olanzapine (experimental group) or without olanzapine (observation group). The experimental group received 10 mg of olanzapine orally once at night on days 1 through 3 of the chemotherapy regimen. The primary end point was complete response (CR), defined as the proportion of patients with no vomiting, no significant nausea (scored as <5 on a visual analog scale of 1 to 100), and no use of rescue medications for nausea. Secondary end points included the proportion of patients experiencing nausea and chemotherapy-induced nausea and vomiting (CINV), receiving rescue medications, and experiencing adverse events. A total of 560 patients (259 [64%] male; median age, 51 years [range, 19-80 years]) were randomized. The analysis included 544 patients with evaluable data (274 assigned to olanzapine and 270 to observation). Baseline characteristics were evenly matched between the 2 groups. The proportion of patients with CR was significantly greater in the group with (248 [91%]) than without (222 [82%]) olanzapine in the overall 120-hour treatment period (P = .005). Likewise, there were significant differences between the olanzapine and observation groups for nausea control (264 [96%] vs 234 [87%]; P < .001) and CINV (262 [96%] vs 245 [91%]; P = .02) during the overall assessment period, and the proportion of patients receiving rescue medications significantly increased in the observation group (30 [11%]) compared with the olanzapine group (11 [4%]) (P = .001). Grade 1 somnolence was reported by 27 patients (10%) following administration of chemotherapy and olanzapine and by no patients in the observation group. In this randomized clinical trial, the addition of olanzapine significantly improved CR rates as well as nausea and vomiting prevention rates in chemotherapy-naive patients who were receiving MEC regimens containing oxaliplatin, carboplatin, or irinotecan. These findings suggest that use of olanzapine should be considered as one of the standards of care in these chemotherapy regimens. Clinical Trials Registry-India (CTRI) Identifier: CTRI/2018/12/016643.

Two doses of fosaprepitant included prophylactic treatment for the three-day cisplatin-based chemotherapy induced nausea and vomiting

PurposeNeurokinin 1 receptor antagonists included prophylactic treatment was recommended for patients who receive one-day cisplatin chemotherapy. It is unclear whether the prolonged administration of fosaprepitant is effective for three-day cisplatin-based chemotherapy induced nausea and vomiting (CINV). We aim to explore the prophylactic antiemetic efficacy and safety of two doses of fosaprepitant included regimen in the patients receiving multiple-day cisplatin chemotherapy.MethodsThis randomized, parallel-group, open-labelled study was conducted in nine hospitals between February 2021 and February 2023. Patients diagnosed as lung cancer and chemotherapy naive were screened. Eligible participants were scheduled to be treated with highly emetogenic chemotherapy regimen which including three days of cisplatin. Then they were randomly divided into the experimental group (two doses of fosaprepitant, Group 2DF) and the control group (one dose of fosaprepitant, Group C). The primary endpoints included the safety and the average none CINV days (NCDs). This study was registered on the website of chictr.org.cn, number ChiCTR2100042665.ResultsOverall, 204 participants were randomly assigned, and 198 patients were analyzed. No statistical difference in adverse events was found between the two groups. All treatment-related adverse effects for fosaprepitant observed were of grade 1–2. The average NCDs of Group 2DF was significantly more than Group C (18.21 ± 3.40 days vs 16.14 ± 5.20 days, P = 0.001). Furthermore, the better life function score was achieved in Group 2DF according to FLIE questionnaire.ConclusionThe administration of two-dose fosaprepitant was safe and more effective than one dose in protecting patients from CINV induced by three-day cisplatin included chemotherapy.

Randomized Placebo-Controlled Trial of Topical Capsaicin for Delayed Chemotherapy-Induced Nausea and Vomiting.

We examined the efficacy of topical capsaicin in reducing delayed chemotherapy-induced nausea and vomiting (CINV). Adults on highly emetogenic chemotherapy regimens applied 2 g of capsaicin ointment (0.075%) or matching placebo four times a day to the abdomen for 5 days in addition to standard antiemetic regimen in this blinded randomized controlled trial. Patients were monitored for nausea and vomiting in the immediate (day 1), delayed (days 2-5), and extended phases (days 2-15). Self-reported incidence and daily episodes of CINV were compared between the groups. Onset, severity, need for rescue antiemetics, cumulative vomiting episodes, and safety were also compared. In total, 160 patients were enrolled. The final modified intention-to-treat population included 75 patients each in the capsaicin and placebo groups. Fewer patients experienced nausea (36.0% [n = 27] v 53.3% [n = 40]; P = .033) and vomiting (28.0% [n = 21] v 42.7% [n = 32]; P = .060) in the capsaicin arm during the delayed phase. During the extended phase, there was a significantly lower incidence of nausea (44% v 64.0%; P = .014) in the capsaicin arm. No difference in nausea (26.7% v 25.3%) or vomiting (22.7% v 18.7%) was evident in the immediate phase. The average daily episodes of nausea and vomiting were significantly fewer in the capsaicin arm during the delayed and extended phases. With capsaicin, no grade 3 nausea (9.3% v 0.0%; P = .007) was observed, and the time to first nausea and vomiting was significantly prolonged. There were no differences between the groups with respect to rescue antiemetics, unscheduled hospital visits, and adverse events. Topical capsaicin reduced the incidence of nausea and the average number of vomiting episodes during delayed and extended phases without increasing adverse effects.

Fire dragon cupping in prevention and treatment of chemotherapy-induced nausea and vomiting in breast cancer: a randomized controlled trial

To observe the clinical efficacy and safety of fire dragon cupping in prevention and treatment of chemotherapy-induced nausea and vomiting (CINV) in breast cancer. Sixty breast cancer patients receiving medium-high emetogenic chemotherapy regimen were randomly divided into an observation group (30 cases, 3 cases dropped out) and a control group (30 cases, 3 cases dropped out). In both groups, 5 mg tropisetron hydrochloride was given intravenously on the day of chemotherapy and 1st to 3rd days after chemotherapy. In the observation group, fire dragon cupping on the abdomen was applied on 1st, 3rd and 5th days after chemotherapy. The incidence of nausea, vomiting, loss of appetite, abdominal pain, abdominal distension, the severity of nausea, vomiting on 1st to 6th days after chemotherapy, and the duration of nausea, vomiting, loss of appetite were observed in the two groups. The self-rating anxiety scale (SAS) score, general comfort questionnaire scale (GCQ) score before and after treatment and remedy antiemetic medication were observed in the two groups, and the safety was evaluated. On 2nd to 6th days after chemotherapy, the number of patients with nausea, loss of appetite and abdominal distension and nausea scores in the observation group were lower than those in the control group (P<0.05). On 1st to 3rd days after chemotherapy, the number of patients with vomiting and vomiting scores in the observation group were lower than those in the control group (P<0.05). The duration of nausea, vomiting and loss of appetite in the observation group were shorter than those in the control group (P<0.05). In the observation group, there was no significant difference in SAS and GCQ scores before and after treatment (P>0.05). After treatment, the GCQ score in the control group was decreased compared with that before treatment (P<0.05). After treatment, there was no significant difference in SAS and GCQ scores between the two groups (P>0.05). There was no significant difference in the number of patients using remedy medication between the two groups (P>0.05). No adverse reaction occurred during treatment in both groups. Fire dragon cupping can effectively reduce the incidence of nausea, vomiting, loss of appetite and the severity of nausea, vomiting related to chemotherapy in breast cancer, and improve patient comfort, and have good safety.

Efficacy and Safety of Ginger on Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Chemotherapy-induced nausea and vomiting (CINV) is a prevalent and distressing side effect. Historically, ginger has been explored as a potential remedy for various ailments, including its potential efficacy against CINV. The aim of this study was to determine whether taking ginger supplements can relieve CINV. A comprehensive search was conducted across PubMed, EMBASE, Cochrane Library, and the Wanfang database. Randomized controlled trials meeting our inclusion criteria were analyzed. The primary outcomes were the incidence and severity of CINV. The protocol was registered on PROSPERO, and the number is CRD4202232104. Of the 35 randomized controlled trials analyzed, 22 trials employed ginger capsules as the primary intervention, whereas 13 studies evaluated the prophylactic effects of ginger-partitioned moxibustion. The outcomes indicated that combining ginger capsules with standard antiemetic agents can significantly reduce the incidence of grade 3 acute nausea (Risk Ratio [RR], 0.19; P < .001) and the incidence of high-grade overall vomiting (RR, 0.47; P = .01). Moreover, ginger-partitioned moxibustion can significantly alleviate the incidence of both mild (RR, 0.56; P = .001) and severe (RR, 0.39; P < .00001) vomiting. Only 2.8% of patients experienced dizziness after ginger-partitioned moxibustion. Our findings indicate that ginger capsules, when used alongside antiemetic drugs, enhance the management of severe CINV, particularly in highly emetogenic chemotherapy regimens. Based on our findings, we recommend initiating ginger supplements before chemotherapy, in conjunction with standard antiemetics, to reduce the severity of CINV. The promising results warrant more rigorous clinical trials to firmly establish the role of ginger in CINV management.

Generic Netupitant Plus Palonosetron and Dexamethasone for Prophylaxis of Chemotherapy-Induced Nausea and Vomiting (CINV) in Cancer Patients Receiving Highly or Moderately Emetogenic Chemotherapy: A Retrospective Study

Chemotherapy-induced nausea and vomiting (CINV) is a challenging adverse effect that is associated with deteriorating quality of life. Inhibiting neurokinin 1 and 5-hydroxytryptamine type 3 receptors involved in the major emesis pathways has significantly prevented CINV and is recommended as standard treatment in international antiemetic guidelines. This retrospective study was conducted to explore the efficacy of formulated netupitant (NE; 300 mg) and palonosetron (PA; 0.50mg) tablets with dexamethasone in patients receiving high and moderate emetogenic chemotherapy. A single dose of NE, PA, and dexamethasone was given 1 hour prior to the chemotherapy for 4 days. The key end-points were to assess complete response (CR), complete protection (CP), and complete control (CC) with no emesis, no nausea, and no use of rescue medication during acute (0–24 hours) and delayed phase (24–120 hours) of CINV. This study conducted on 212 patients showed overall rates of CR, CP, and CC as 97.5, 91.1, and 92.19%, respectively, in the acute phase and 95.09, 88.06, and 87.74% in a delayed phase. These patients underwent 1,387 cycles of chemotherapy involving both high emetogenic chemotherapy and moderate emetogenic chemotherapy regimens. A decrease in the rate of CR, CP, and CC from 93.47, 76.20, and 73.90% (acute phase) to 86.95, 69.67, and 67.37% (delayed phase) with highly emetogenic chemotherapy was observed, while the combination treatment achieved 100 CR, CP, and CC in both the acute and delayed phase with the moderately emetogenic chemotherapy regimen. Our study demonstrated the promising efficacy of the triple treatment with formulated NE and PA tablets in combination with dexamethasone in preventing and managing CINV in real-world settings.

Possibilities of prevention of nausea during cytostatic therapy: literature review and clinical cases

Chemotherapy-induced nausea and vomiting (CINV) is a side effect of cancer treatment, affecting up to 40% of patients. Nausea and vomiting are the most dangerous and also the most common side effects among patients undergoing chemotherapy. CINV remains one of the most worrisome syndromes associated with cancer therapy and can lead to dehydration, electrolyte imbalances, malnutrition, and metabolic disorders. Risk factors for developing CINV include the patient’s gender and age, a history of CINV, and the emetogenicity and timing of chemotherapy. Options for preventing CINV are 5-HT3 receptor antagonists (i.e., ondansetron, granisetron, palonosetron) in combination with corticosteroids (i.e., dexamethasone) or additionally in combination with NK1 receptor antagonists (i.e., aprepitant, fosaprepitant, netupitant, rolapitant). Palonosetron is a selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonist. The effectiveness of palonosetron for delayed nausea and vomiting is also supported by the results of three randomized trials that demonstrated no side effects of the simplified regimen with palonosetron and single dose dexamethasone for the control of CINV associated with moderately emetogenic chemotherapy or AC regimen. A clinical observation of the treatment of a young patient with breast cancer is given. After the first course of chemotherapy, the patient developed a rather serious complication in the form of vomiting, which required hospitalization for infusion therapy. The above clinical observation demonstrates the effectiveness of palonosetron in neo-adjuvant chemotherapy in a young patient, which made it possible to complete the entire course of treatment. After completion of neo-adjuvant chemotherapy, a radical operation was performed and a complete morphological response was noted.

Cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: Results of a phase II/III, placebo-controlled, randomised trial.

12019 Background: The aim of this multi-centre, randomised, placebo-controlled, phase II/III trial was to determine the efficacy of adding an oral THC/CBD (tetrahydrocannabinol/cannabidiol) cannabis extract in adults who experience CINV during moderate and highly emetogenic intravenous chemotherapy regimens despite guideline-consistent anti-emetic prophylaxis. The phase II crossover component has been published (Grimison et al, AnnOnc 2020). Here we report the definitive results from the combined phase II/III components with a planned sample size of 250 patients. Methods: For the definitive phase III component, participants were randomised 1:1 to receive, oral THC 2.5mg/CBD 2.5mg (Tilray TN-TC11M) capsules TDS days -1 to 5, or placebo (in addition to guideline-consistent anti-emetics including rescue medications) for cycles A, B and C. Primary endpoint was the difference in gaining a ‘complete response’ (no emesis and no use of rescue medications) during 0-120 hours from chemotherapy for cycle A. Results: Complete response was achieved in 24% and 8% with THC/CBD and placebo, respectively (absolute difference 16%, P-value 0.01). The study closed early due to slow accrual without knowledge of study outcomes, with a total of 147 patients recruited 2016-22 (pilot n=78, definitive n=69). Median age was 56 years (range 25 to 80), 78% were females, 39% reported historic cannabis use, 65% were treated with curative intent. Most common regimens were doxorubicin/cyclophosphamide (AC, 31%), and fluorouracil/oxaliplatin (FOLFOX, 17%), 97% received corticosteroid &amp; 5-HT3 antagonist, 80% received NK-1 antagonist, 10% received olanzapine. Efficacy and safety are shown in the table. No SAEs were attributed to THC/CBD. Conclusions: Oral THC/CBD was associated with a significant increase in the proportion of patients achieving a complete response in chemotherapy-induced nausea and vomiting and was well tolerated, representing an effective new treatment in the management of this condition. Future analyses will report quality of life and cost-effectiveness. Funding from NSW Government Dept of Health. Drug supply by Tilray. Clinical trial information: ACTRN12616001036404 . [Table: see text]

OLANZAPINE AS PROPHYLACTIC ANTIEMETIC IN BREAST CANCER PATIENTS: A PROSPECTIVE COMPARATIVE STUDY IN A TERTIARY CARE CENTRE

Context: Aims The prevention of chemotherapy induced nausea and vomiting (CINV) by olanzapine can improve patients adherence to treatment. and objectives: To study the efcacy of olanzapine as prophylactic antiemetic in parenteral highly emetogenic chemotherapy (HEC) regimen of breast cancer and to compare its side effects with aprepitant. Prospect Settings and Design: ive, comparative, open-label, non randomized study was conducted on 146 eligible breast cancer patients, equally distributed into aprepitant and olanzapine groups. The Methods and Material: Multinational Association of Supportive Care in Cancer (MASCC) Tool (MAT) and Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 was used for evaluation. Chi-square test and unpaired t test was applied to test for sta Statistical analysis used: tistical signicance using ©2021 GraphPad Prism. P value ≤ 0.05 was considered signicant. Data were represented using frequency distribution table and bar diagrams. Patients achieving Complete Response (CR, no emesis and no rescue me Results: dication) was signicantly higher in olanzapine treated group. Nausea was signicantly controlled but vomiting wasn't signicantly controlled with olanzapine when compared with aprepitant. Assessment of side effects showed signicantly increased sedation on day 2 on those receiving olanzapine in comparison to aprepitant. Conclusions: Olanzapine has signicant results in controlling CINV caused by parenteral HEC regimens when compared with aprepitant in acute, delayed and overall period with minimal increase in sedation

The Effectiveness of an Oral Fixed-Dose Combination of Netupitant and Palonosetron (NEPA) in Patients With Multiple Risk Factors for Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Observational Indian Study.

BackgroundFemale gender, young age, first chemotherapy cycle, and low alcohol intake have all been linked to an increased risk of nausea and vomiting from chemotherapy. We intended to see if netupitant and palonosetron (NEPA) could prevent chemotherapy-induced nausea and vomiting (CINV) in patients with risk factors such as age, gender, chemotherapy cycle number, and alcohol consumption history.MethodsIn this retrospective study, chemotherapy-naïve patients who were prescribed netupitant (300 mg) and palonosetron (0.50 mg) (NEPA) before the first cycle of chemotherapy were analyzed for overall, acute, and delayed phases of complete response (CR), complete protection (CP), and control.ResultsIn the acute phase (AP), delayed phase (DP), and overall phase (OP), complete response was 88.23%, 86.27%, and 86.27%, respectively; complete protection was 80.39%, 78.43%, and 76.47%, respectively; and complete control was 76.47%, 72.54%, and 70.58%, respectively, in the whole population (i.e., 51 patients). Complete response, protection, and control in the overall phase were achieved by 86.27%, 72.72%, and 68.18% of patients who received the highly emetogenic chemotherapy (HEC) regimen (i.e., 44 patients), respectively.ConclusionNEPA provided a consistent magnitude of benefit for patients who are at high risk, receiving HEC and moderately emetogenic chemotherapy (MEC), and having good control in the acute, delayed, and overall phases of CINV.

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]

Distinct Nausea Profiles Are Associated With Gastrointestinal Symptoms in Oncology Patients Receiving Chemotherapy.

Unrelieved chemotherapy-induced nausea (CIN) occurs 48% of patients undergoing chemotherapy and is one of the most debilitating symptoms that patients report. The aims of this study were to identify subgroups of patients with distinct CIN profiles and determine how these subgroups differed on demographic and clinical characteristics; severity, frequency, and distress of CIN; and the co-occurrence of common gastrointestinal symptoms. Patients (n = 1343) completed demographic questionnaire and Memorial Symptom Assessment Scale 6 times over 2 cycles of chemotherapy. Latent class analysis was used to identify subgroups of patients with distinct CIN profiles. Differences among these subgroups were evaluated using parametric and nonparametric statistics. Four distinct CIN profiles were identified: none (40.8%), increasing-decreasing (21.5%), decreasing (8.9%), and high (28.8%). Compared with the none class, patients in the high class were younger, had a lower annual household income, had child care responsibilities, had a lower Karnofsky Performance Status score and a higher Self-administered Comorbidity Questionnaire score, and were more likely to have received chemotherapy on a 14-day cycle and a highly emetogenic chemotherapy regimen. In addition, patients in the high class reported high occurrence rates for dry mouth, feeling bloated, diarrhea, lack of appetite, abdominal cramps, difficulty swallowing, mouth sores, weight loss, and change in the way food tastes. That 60% of the patients reported moderate to high CIN occurrence rates confirms that this unrelieved symptom is a significant clinical problem. Nurses need to evaluate patients' level of adherence to their antiemetic regimen and make appropriate referrals for physical therapy, psychological services, and dietary counseling.

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.

Assessment of the Adherence Rate of Acute Chemotherapy Induced Nausea and Vomiting Prophylaxis Regimens by Medical Team to NCCN Clinical Recommendations: Cross-Section Observation

Background: Chemotherapy induced nausea and vomiting (CINV) is still distressing adverse effect for patients. Thus, we conducted this study to assess the compliance of CINV prophylaxis patterns with NCCN guideline. Methods: 136 Patients with any kind of malignancy who undergoes chemotherapy in Shahid Ghazi hospital, Tabriz, Iran, were included in this study. Adherence rate to the NCCN guideline of antiemetic therapy for different emetogenic potential chemotherapy regimens was evaluated. Results: All patients received their prophylaxis 30 min before chemotherapy, which is completely adherent to guideline. Hematological malignancies were associated with higher adherence rate (P=0.032). For high and moderate emetic risk patients, dexamethasone and ondansetron were remarkably under-dosed, whereas Granisetron was over-dosed. Adherence rate to guideline in high and moderate and minimal emetic risk chemotherapy was 72.3%, 22.9% and 69.2% respectively. None of low emetic risk patients received guideline compliant prophylaxis. In all emetic risk levels, 50 (36.8%) patients received guideline adherent prophylaxis. Conclusion: As results indicated, adherence rate wasn’t optimal. Available dosage form of a medication has great impact on appropriate prescription. Thus, it is suggested for pharmaceutical companies to be informed about recent guidelines’ updates and subsequently produce proper dosage forms for different indications.

Evaluation of clinical outcomes and efficacy of palonosetron and granisetron in combination with dexamethasone in Egyptian patients receiving highly emetogenic chemotherapy

Chemotherapy-induced nausea and vomiting (CINV) is considered one of the most serious adverse events affecting chemotherapy-receiving cancer patients. It dramatically affects their food intake, nutritional status and more importantly their quality of life. We can observe CINV in highly emetogenic chemotherapy (HEC) such as adriamycin-cyclophosphamide combination (AC) in breast cancer patients and cisplatin-based regimens in other cancer types. This study aimed to evaluate the antiemetic efficacy of palonosetron (PALO) over granisetron (GRA) in combination with dexamethasone for multiple highly emetogenic chemotherapy drugs (HEC), especially in chemotherapy regimens in Egyptian breast cancer patients and cisplatin-based regimens in other diseases. An open-label randomized trial was carried out, including 115 patients receiving at least four cycles of highly emetogenic chemotherapy regimens. All patients received dexamethasone in combination with the 5-HT3 receptor antagonist. We recorded patients' clinical and biochemical characteristics and withdraw blood samples to monitor serum substance P and serotonin in correlation with chemotherapy-induced nausea and vomiting (CINV). We use the MASCC antiemetic tool in the acute phase (0-24hr) and delayed phase (24-120h) to evaluate patient outcomes in both stages after each chemotherapy cycle. In (PALO) group, only 7.84% of patients showed acute vomiting, and 11.76% showed acute nausea, whereas 43.75% of patients showed acute vomiting and 89.06% showed acute nausea in (GRA) group (P < 0.0001). For delayed CINV, 23.53% of patients showed delayed vomiting, and 47.06% showed delayed nausea in the (PALO) group, while 82.81% of patients showed delayed emesis, and 92.19% showed delayed nausea in (GRA) group (P < 0.0001). The study showed that PALO is a cost-effective choice when compared to GRA in CINV prevention as 45.10% of patients in (PALO) required additional rescue medications (Domperidone 10mg orally three times per day plus Trimebutine 200mg orally three times per week both for 5 days), while 95.24% in the (GRA) group used the same medications. Adverse events of both antiemetic drugs (PALO and GRA) include headaches and constipation and QTc prolongation reports, mostly mild to moderate, with relatively low rates among the two groups. Palonosetron, combined with dexamethasone, is more effective than granisetron and dexamethasone combination against both acute and delayed emesis induced by highly emetogenic chemotherapy (HEC) cisplatin-based protocols and the combination of cyclophosphamide and anthracyclines (AC). Medical team members should make more efforts, especially clinical pharmacy personnel, to monitor medications' effectiveness and help the medical team achieve a suitable and reliable care plan.

Incidence of chemotherapy-induced nausea and vomiting among cancer patients receiving moderately to highly emetogenic chemotherapy in cancer centers in Sichuan, China.

Nausea and vomiting are the most painful and feared side effects for patients during chemotherapy. Currently, most studies focus on the occurrence of CINV during the risk phase. We initiated this real-world study to understand the actual occurrence of CINV throughout all phases, to provide a basis to prevent CINV in patients during chemotherapy and improve their quality of life. This prospective real-world study was conducted at 17 major cancer centers in Sichuan, China. Cancer patients who were about to receive moderately/highly emetogenic chemotherapy were included in the study. Occurrences of nausea and vomiting were recorded using patient diaries, and physicians are responsible for recording patient clinical data. A total of 1,139 patients were included in this study between August 2018 and April 2019. In this study, the incidence of acute CINV was 55.3%, delayed CINV was 62.3%, and CINV beyond the risk period was 36%. All phases overall, the overall complete control (CC) rate of CINV was 30.1 and 32.1% for highly and moderately emetogenic chemotherapy regimens, respectively. The median CC time for CINV was 7days, but only 21.5% of these patients used antiemetic regimens according to the NCCN guideline. In the real world, the incidence of CINV is high in patients receiving chemotherapy, and nausea and vomiting may occur beyond the risk period; the low level of standardized antiemetic treatment in compliance with the guideline might have been the main reason for unsatisfactory prevention and control of CINV in this study.

Avoidable Acute Care Use Associated with Nausea and Vomiting Among Patients Receiving Highly Emetogenic Chemotherapy or Oxaliplatin.

Chemotherapy-induced nausea and vomiting (CINV) contributes to avoidable acute care, a metric now tracked in Medicare's oncology outcome measure. CINV is preventable, yet guidelines are often not followed. We sought to quantify acute care involving CINV and other avoidable toxicities after highly emetogenic chemotherapy (HEC) to identify excess risk and assess clinician adherence to antiemesis guidelines for HEC. We retrospectively evaluated U.S. electronic health records (2012-2018) using Medicare's OP-35 outcome measure to identify avoidable acute care involving any of 10 toxicities, including CINV, after HEC regimens relative to non-HEC. Antiemetic guideline adherence was defined as use ofneurokinin-1 (NKl) receptor antagonists Q5 (RAs) plus 5-hydroxytryptamine type 3 RA+ dexamethasone at HEC initiation. Among 17,609 patients receiving HEC, acute care rates associated with HEC chemotherapy included 32% cisplatin, 31% carboplatin, and 21% anthracycline/cyclosphospharnide (AC), with 76% meeting the criteria as avoidable events. Oxaliplatin rates were 29%. Avoidable acute care occurred 1.83 times (95% confidence interval, 1.76-1.91, p < .0001) as often after HEC versus non-HEC excluding oxaliplatin; CINV-related acute care occurred 2.29 times as often. Nonadherence to antiemesis guidelines occurred in 34% and 24% of cisplatin and AC courses, respectively, because of omission of a NKl RA. Patients treated with HEC regimens experienced high avoidable acute care use, 1.8 times the risk seen for other chemotherapy. Nonadherence to guideline-directed antiemetic prophylaxis highlights the need to ensure adherence to antiemetic guidelines, including the use of NKl RA in HEC. After survival, perhaps the most important goal in oncology is limiting avoidable acute care, a goal now used by Medicare to impact cancer reimbursement. This study found that patients treated with highly emetogenic chemotherapy (HEC) regimens had high rates of avoidable acute care use, 1.8 times the risk seen for other chemotherapy. A substantial proportion of the avoidable acute care involved chemotherapy-induced nausea and vomiting. Results showed that incomplete adherence to national antiemetic guidelines for HEC regimens primarily driven by omission of upfront neurokinin-1 receptor antagonist use, suggesting that improved adherence can meaningfully resolve this gap in quality and cost of care.

Antiemetic medication efficacy during EPOCH and R-EPOCH treatment.

This study aims to determine the adequacy of current institutional standard practice for CINV prophylaxis for EPOCH and R-EPOCH at The Ohio State University James Cancer Hospital. Single-center, retrospective analysis was performed including all patients receiving EPOCH or R-EPOCH chemotherapy for Non-Hodgkin's lymphomas from 1/1/2012 to 6/30/2017. The primary endpoint was rate of CINV events, which included usage of more than 50 percent of available doses of breakthrough antiemetics while inpatient, hospitalization due to CINV or related complications, or adjustments made to the CINV prophylactic or breakthrough regimen during current or subsequent cycles. Secondary endpoints included determining prescriber adherence to institutional standard CINV prophylaxis, characterization of adjustments to the antiemetic regimen following the incidence of CINV, and identification of high-risk patients that may benefit from additional CINV prophylaxis. Of 111 patients, 54 (48.6%) experienced CINV events with any cycle of EPOCH or R-EPOCH chemotherapy. Of those patients, 17 (31.5%) received institutional standard CINV prophylaxis at baseline, 8 (14.8%) received additional scheduled antiemetics, and 26 (48.1%) were prescribed additional breakthrough antiemetics with their first cycle of EPOCH or R-EPOCH. Younger age, diagnosis of anxiety, and previous susceptibility to nausea were significantly associated with CINV events. This study illustrates the inadequacy of current institutional standard for CINV prophylaxis for patients receiving EPOCH and R-EPOCH, highly emetogenic chemotherapy regimens. With nearly half of included patients experiencing CINV events, and most initially receiving more than our standard prophylaxis, changes to our standard antiemetics used with this chemotherapy regimen are needed.

Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type

BackgroundResults from a phase III, randomized, double-blind, active comparator-controlled, parallel-group trial evaluating fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) found that a single-day, triple-antiemetic fosaprepitant regimen resulted in a significantly higher proportion of patients achieving a complete response (CR; no vomiting or rescue medication use) in the delayed phase (25–120 h after chemotherapy initiation), compared with a 3-day control regimen (ClinicalTrials.gov, NCT01594749). As the risk for CINV is dependent on chemotherapy regimen and generally guided by tumor type, this post hoc analysis evaluated the efficacy and safety of this regimen by cancer subpopulations (gastrointestinal [GI] or colorectal, lung, breast, and gynecologic cancers).MethodsSubjects with confirmed cancer who were naive to highly and moderately emetogenic chemotherapy (HEC and MEC) and were scheduled to receive intravenous (IV) anthracycline-cyclophosphamide (AC)–based MEC on the first day of chemotherapy were randomly assigned to receive oral ondansetron and oral dexamethasone plus either a single IV dose of fosaprepitant 150 mg (fosaprepitant regimen) or placebo (control regimen). The primary efficacy end point was the proportion of subjects achieving CR in the delayed phase. CR rates in the overall and acute phases (0–120 h and 0–24 h after MEC initiation, respectively) were assessed as secondary end points. Safety and tolerability were also assessed.ResultsCR rates in the delayed phase favored the fosaprepitant regimen over the control regimen across the GI/colorectal, lung, breast, and gynecologic cancer subgroups (range, 6.2–22%); similar findings were observed for CR in the overall phase. CR in the acute phase was high for all groups (≥87%). The fosaprepitant regimen was well tolerated in all cancer subgroups.ConclusionsThis post hoc analysis indicated that a single-day fosaprepitant regimen was effective in preventing CINV in patients receiving MEC, regardless of cancer type.Trial registrationClinicalTrials.govNCT01594749, registered May 9, 2012.