Chemotherapy-induced Nausea Research Articles

Impact of dexamethasone on transplant-related mortality in pediatric patients: a multi-site, propensity score-weighted, retrospective assessment.

Dexamethasone use during hematopoietic cell transplant (HCT) conditioning varies between pediatric centers. This study aimed to estimate the difference in 1-year treatment-related mortality (TRM) between patients who did or did not receive dexamethasone during HCT conditioning. Secondary objectives were to estimate the difference between dexamethasone-exposed and dexamethasone-unexposed groups in 1-year event-free survival (EFS), time to neutrophil engraftment, acute graft-versus-host disease (aGVHD), and invasive fungal disease (IFD) at day + 100. This was a seven-site, international, retrospective cohort study. Patients < 18years old undergoing their first allogeneic or autologous myeloablative HCT for hematologic malignancy or aplastic anemia between January 1, 2012, and July 31, 2017, were included. To control for potential confounders, propensity score weighting was used to calculate the standardized mean difference for all endpoints. Among 242 patients, 140 received dexamethasone during HCT conditioning and 102 did not. TRM was unaffected by dexamethasone exposure (1.7%; 95% CI - 7.4, 10.2%). Between-group differences in secondary outcomes were small. However, dexamethasone exposure significantly increased possible, probable, and proven IFD incidence (9.0%, 95% CI 0.8, 17.3%). TRM is not increased in pediatric patients who receive dexamethasone during HCT conditioning. Clinicians should consider potential IFD risk when selecting chemotherapy-induced vomiting prophylaxis for pediatric HCT patients.

Prolonged administration of the granisetron transdermal delivery system reduces capecitabine plus oxaliplatin regimen induced nausea and vomiting

ObjectiveTo evaluate the safety and efficacy of the granisetron transdermal delivery system (GTDS) combined with Dexamethasone for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving Capecitabine plus Oxaliplatin (CapeOX) therapy.DesignOpen-label, prospective, multi-center phase II trial.SettingThree institutions.ParticipantsFifty-four patients scheduled to receive CapeOX chemotherapy.InterventionsParticipants received GTDS (3.1 mg applied to the upper arm 48 h before chemotherapy, replaced on day 5, and discarded on day 12) and Dexamethasone.Main outcome measuresThe primary endpoint was the complete control rate of CINV. Secondary endpoints included the duration of delayed complete control, complete control rate in the acute phase, safety, and quality of life.ResultsThe complete control rate for delayed CINV over the entire period (25–480 h) was 72.7% (95% CI 0.57–0.88). The duration of delayed complete control was 17.2 ± 4.5 days, with 51.5% of patients experiencing no nausea during the delayed phase. The complete control rate in the acute phase was 81.8% (95% CI 0.69–0.95). No serious adverse events related to the antiemetic regimen were reported.ConclusionProlonged administration of GTDS is safe and effective for preventing CINV in patients with gastrointestinal malignancies treated with CapeOX.Trial RegistrationClinicalTrials.gov registry (NCT05325190); registered on October 10, 2021.

The Gut Microbial Lipid Metabolite 14(15)-EpETE Inhibits Substance P Release by Targeting GCG/PKA Signaling to Relieve Cisplatin-Induced Nausea and Vomiting in Rats.

Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect related to activation of substance P (SP). SP activation can result from dysregulation of the gut-brain axis, and also from activation of protein kinase A signaling (PKA) signaling. In this study, we connected these factors in an attempt to unveil the mechanisms underlying CINV and develop new therapeutic strategies. Female rats were injected with cisplatin (Cis) to induce pica. Fecal samples were collected before/after injection, and subjected to lipid metabolomics analysis. In another portion of pica rats, the PKA inhibitor KT5720 was applied to investigate the involvement of PKA signaling in CINV, while fecal microbiota transplantation (FMT) was implemented to verify the therapeutic effect of the lipid metabolite 14(15)-EpETE. Pica symptoms were recorded, followed by ileal histological examination. The targeting relationship between 14(15)-EpETE and glucagon was determined by bioinformatics. SP and glucagon/PKA signaling in rat ileum, serum, and/or brain substantia nigra were detected by immunohistochemistry, enzyme-linked immunosorbent assay, and/or western blot. The results showed a significantly lower level of 14(15)-EpETE in rat feces after Cis injection. KT5720 treatment alleviated Cis-induced pica symptoms, ileal injury, SP content increase in the ileum, serum, and brain substantia nigra, and ileal PKA activation in rats. The ileal level of glucagon was elevated by Cis in rats. FMT exerted an effect similar to that of KT5720 treatment, relieving the Cis-induced changes, including ileal glucagon/PKA activation in rats. Our findings demonstrate that FMT restores 14(15)-EpETE production, which inhibits SP release by targeting GCG/PKA signaling, ultimately mitigating CINV.

Differences in severity of chemotherapy-induced nausea and vomiting between neoadjuvant and adjuvant chemotherapy in patients with breast cancer: analysis of data from two prospective observational studies.

We assessed the differences in chemotherapy-induced nausea and vomiting (CINV) severity in patients with breast cancer, receiving neoadjuvant chemotherapy (NAC) and adjuvant chemotherapy (AC). CINV severity in patients on anthracycline-based NAC (n = 203) and AC (n = 79) was assessed at baseline (C0) and after the first and fourth chemotherapy using a 10-point Likert scale. Group-by-time interaction term was used to evaluate the effect of the group on changes in CIN (cCIN) and CIV (cCIV) from C0 to the follow-up periods (C1, C4). If insignificant, group effects were analyzed without the interaction term. Subgroup analysis was performed based on age 50. In statistical analyses, sociodemographic and clinical variables that differed between groups were adjusted for. The effect of group by follow-up period was not significant in cCIN and cCIV. The AC group showed a significantly higher change in the severity of cCIN compared to the NAC group (estimated mean = 1.133, 95% CI = 0.104-2.161, p = 0.031), but there was no difference in cCIV. In those ≤ 50years, significant differences in cCIN severity (estimated mean = 1.294, 95% CI = 0.103-2.484, p = 0.033) were observed, but not in cCIV. In those > 50years, neither cCIN nor cCIV differed significantly between groups. NAC in breast cancer patients showed less severe CIN than adjuvant chemotherapy AC, but not in those over 50. Clinicians should recognize that the severity of CIN may vary across different chemotherapy settings and adjust their management accordingly. The clinical trial registration ( www. gov ) numbers were NCT01887925 (the registration date is from June 20, 2013, to November 27, 2015) and NCT02011815 (the registration date is from December 10, 2013, to September 22, 2019).

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 = &lt;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.

Gastrointestinal and Neuropsychological Symptoms Are Associated With Distinct Vomiting Profiles in Patients Receiving Chemotherapy.

To identify subgroups of patients with distinct chemotherapy-induced vomiting (CIV) profiles; determine how these subgroups differ on several demographic, clinical, and symptom characteristics; and evaluate factors associated with chemotherapy-induced nausea and CIV profiles. Adult patients (N = 1,338) receiving cancer chemotherapy. Data were collected on demographic, clinical, and symptom characteristics. Differences among subgroups of patients with distinct CIV profiles were evaluated using parametric and nonparametric tests. Three CIV profiles (None, Decreasing, and Increasing) were identified. Compared with the None class, Decreasing and Increasing classes were more likely to have lower household income and a higher comorbidity burden, as well as to report higher rates of dry mouth, nausea, diarrhea, depression, anxiety, sleep disturbance, morning fatigue, and pain interference. Clinicians need to assess common and distinct risk factors for CIV and chemotherapy-induced nausea.

After 20 Years of Treatment with Aprepitant for Chemotherapy-Induced Nausea and Vomiting, Should the Therapeutic Indications for Aprepitant be Expanded?

After 20 Years of Treatment with Aprepitant for Chemotherapy-Induced Nausea and Vomiting, Should the Therapeutic Indications for Aprepitant be Expanded?

The Effect of Progressive Relaxation Exercises on Fatigue, Nausea and Vomiting in Patients with Breast Cancer Receiving Chemotherapy

Objective: The research was designed experimentally to evaluate the effectiveness of progressive relaxation exercises (PRE) in the prevention of chemotherapy-induced fatigue, nausea and vomiting in patients diagnosed with breast cancer. Methods: 50 patients diagnosed with breast cancer received doxorubicin and taxane-based treatment who applied to the chemotherapy unit of a private hospital were participated in the study. 24 patients were included in the experimental group, and 26 patients were included in the control group, who were selected by simple random method and agreed to want to get in the research. The participants in the intevention group were provided with one-to-one relaxation training accompanied by Relaxation Exercises CD of the Turkish Psychological Association before the initiation of treatment. Data were collected using “Patient Identification Form”, “Piper Fatigue Scale (PFS)” and “Rhodes Index of Nausea, Vomiting and Retching (RINVR)” forms. Results: Most of the patients who attended in the research were married (76%) and the mean age was 52.72±10.17. A total of 54% of the participants received doxorubicin-based treatment and 46% of them was on taxane-based treatment. When we investigated the effect of PRE on fatigue, nausea and vomiting, it was found out that fatigue and “nausea, vomiting and retching (NVR) experience, occurrence and distress” scores on the day of treatment were significantly lower than those of the other five days, but there wasn’t difference in five-day symptom scores between the groups. Conclusion: It was concluded that PRE were not an effective approach in decreasing the symptoms of fatigue, nausea, vomiting in the research group patients with breast cancer and receiving chemotherapy.

Outcomes of chemotherapy-induced nausea and vomiting guideline adherence in pediatric and adult patients: a systematic review.

This study describes chemotherapy-induced nausea and vomiting (CINV) control rates in pediatric and adult patients who did or did not receive guideline-consistent CINV prophylaxis. We conducted a systematic literature review of studies published in 2000 or later that evaluated CINV control in patients receiving guideline-consistent vs. guideline-inconsistent CINV prophylaxis and reported at least one CINV-related patient outcome. Studies were excluded if the guideline evaluated was not publicly available or not developed by a professional organization. Over-prophylaxis was defined as antiemetic use recommended for a higher level of chemotherapy emetogenicity than a patient was receiving. We identified 7060 citations and retrieved 141 publications for full-text evaluation. Of these, 21 publications (14 prospective and seven retrospective studies) evaluating guidelines developed by six organizations were included. The terms used to describe CINV endpoints and definition of guideline-consistent CINV prophylaxis varied among studies. Included studies either did not address over-prophylaxis in their definition of guideline-consistent CINV prophylaxis (48%; 10/21) or defined it as guideline-inconsistent (38%; 8/21) or guideline-consistent (3/21; 14%). Eleven included studies (52%; 11/21) reported a clinically meaningful improvement in at least one CINV endpoint in patients receiving guideline-consistent CINV prophylaxis. Ten reported a statistically significant improvement. This evidence supports the use of guideline-consistent prophylaxis to optimize CINV control. Institutions caring for patients with cancer should systematically adapt CINV CPGs for local implementation and routinely evaluate CINV outcomes.

China guidelines on prevention and treatment of nausea and vomiting caused by antitumor therapies (2023 edition)

Epidemiologic data show that the incidence and mortality of cancer in China has been increasing, but the age-standardized mortality rate (ASMR) decreased. The descend trend in ASMR indicated that China has achieved remarkable results in the comprehensive prevention and control of cancer in recent decades through the risk factor control, cancer screening, early diagnosis and treatment, and standardization of diagnostic and therapeutic protocols. In recent years, new anti-tumor therapies and drugs have been developed, but nausea and vomiting are still common adverse event associated with many anti-tumor therapies and can negatively impact patients' quality of life and potentially limit the effectiveness of anti-tumor therapies. The experts from China Anti-Cancer Association Committee of Rehabilitation and Palliative Care, China Anti-Cancer Association Committee of Tumor Clinical Chemotherapy, China Anti-Cancer Association Committee of Neoplastic Supportive-care and Chinese Society of Clinical Oncology Committee of Supportive and Rehabilitative Care have integrated recent advances in the prevention and treatment of nausea and vomiting caused by anti-tumor therapy. Following the existing evidence in evidence-based medicine, referring to both domestic and international guidelines, and considering the clinical practice in China, the "Guidelines for China prevention and treatment of nausea and vomiting caused by antitumor therapies (2023 edition)," has been formulated, aiming to provide professional guidance for the prevention and treatment of chemotherapy-induced nausea and vomiting in anti-tumor therapy in China.

Acupoint Application Combined with Acupressure as an Adjunctive Therapy for Chemotherapy-induced Nausea and Vomiting.

Chemotherapy-induced nausea and vomiting (CINV) refers to the nausea and vomiting experienced by patients after the application of chemotherapy drugs, significantly affecting their quality of life and physical recovery, as well as increasing the pain of the patients. Basic medicine primarily focuses on acid suppression, gastric protection, and vomiting suppression, but there are still many patients with nausea and vomiting symptoms that cannot be alleviated. Traditional Chinese medicine (TCM) can effectively alleviate nausea and vomiting through acupoint stimulation and pressure, while also offering advantages such as simplicity, affordability, and fewer side effects. The aim of this article is to introduce the method of using acupoint application combined with acupressure as an adjunctive therapy for CINV, using the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) tablet scale as a questionnaire. The article details aspects such as acupoint selection, production, and the use of acupoint application, massage techniques, and operating procedures, all with the goal of ensuring the safety and efficacy of acupoint application combined with acupressure as an adjuvant therapy, thereby improving patients' clinical symptoms and quality of life.

The efficacy and safety of Xiao-Ban-Xia-Tang in the treatment of chemotherapy-induced nausea and vomiting: A systematic review and meta-analysis.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most frequent and critical side effects due to chemotherapeutics. In China, Xiao-Ban-Xia-Tang (XBXT) has already been applied extensively to prevent and treat CINV. However, there is limited testimony on the effectiveness and safety of this purpose, and there was no correlative systematic review. The aim of this review was to systematically evaluate the effectiveness and safety of XBXT in preventing and treating CINV. The systematic search was conducted in eight databases to acquire randomized controlled trials (RCTs) that appraised the effect of XBXT in treating CINV. The vomiting and nausea relief efficiency, eating efficiency, quality of life, and adverse reactions were explored for efficacy assessment. Bias risk was rated by manipulating the Cochrane risk of bias tool 2.0 (RoB 2). The retrieved investigations were analyzed by utilizing ReviewManager 5.4 and Stata 17.0. The quality of evidence was evaluated adopting the GRADE tool. A total of 16 clinical RCTs of XBXT in the treatment of CINV were incorporated into the investigation, with a total of 1246 participants. The meta-analysis showed that compared with conventional antiemetic drugs, XBXT and antiemetics improved the vomiting relief efficiency (RR 1.35, 95% confidence interval: 1.25-1.46, p < 0.00001), nausea relief efficiency (N = 367, RR 1.23, 95% CI: 1.09-1.38, p < 0.00001), and quality of life (RR = 1.37, 95% CI: 1.14-1.65, p = 0.0009) and reduced the adverse events (N = 370, RR 0.53, 95% CI: 0.29-0.96, p = 0.04). XBXT and DARAs raised eating efficiency compared with DARAs (N = 208, RR 1.30, 95% CI: 1.07-1.57, p = 0.007). The data existed as statistically significant, and the publication bias was identified as relatively low from the funnel plot and trim and fill analysis. In addition, sensitivity analysis demonstrated robust outcomes. The quality of evidence for each outcome ranged from moderate to high. There is some encouraging evidence that XBXT and antiemetics had better therapeutic effects and safety in treating CINV than antiemetic drugs alone. The quality assessment and low publication bias indicated that the overall criterion was scientific. Better research is required to verify the evidence designed with large-scale RCTs and rigorous methods.

Olanzapine Plus Triple Antiemetic Therapy for the Prevention of Carboplatin-Induced Nausea and Vomiting: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial.

We evaluated the efficacy and safety of antiemetic therapy with olanzapine, a neurokinin-1 receptor antagonist (RA), a 5-hydroxytryptamine-3 (5-HT3) RA, and dexamethasone for preventing chemotherapy-induced nausea and vomiting in patients receiving carboplatin-containing chemotherapy. Chemotherapy-naïve patients scheduled to receive carboplatin (AUC ≥5) were randomly assigned to receive either olanzapine 5 mg once daily (olanzapine group) or placebo (placebo group) in combination with aprepitant, a 5-HT3 RA, and dexamethasone. The primary end point was the complete response (CR; no vomiting and no rescue therapy) rate in the overall phase (0-120 hours). Secondary end points included the proportion of patients free of nausea and safety. In total, 355 patients (78.6% male, median age 72 years, 100% thoracic cancer), including 175 and 180 patients in the olanzapine and placebo groups, respectively, were evaluated. The overall CR rate was 86.9% in the olanzapine group versus 80.6% in the placebo group. The intergroup difference in the overall CR rate was 6.3% (95% CI, -1.3 to 13.9). The proportions of patients free of chemotherapy-induced nausea in the overall (88.6% in the olanzapine group v 75.0% in the placebo group) and delayed (89.7% v 75.6%, respectively) phases were significantly higher in the olanzapine group than in the placebo group (both P < .001). Somnolence was observed in 43 (24.6%) and 41 (22.9%) patients in the olanzapine and placebo groups, respectively, and no events were grade ≥3 in severity. The addition of olanzapine was not associated with a significant increase in the overall CR rate. Regarding the prevention of nausea, adding olanzapine provided better control in patients receiving carboplatin-containing chemotherapy, which needs further exploration.

The influence of psychosocial factors on first-time chemotherapy-induced nausea and vomiting: A prospective multicenter cohort study.

12135 Background: Previous studies have suggested that if cancer patients experience no chemotherapy-induced nausea and vomiting (CINV) or mild symptoms during their first chemotherapy cycle, they are less likely to experience CINV in subsequent cycles, suggesting that the optimal intervention time may be before the first chemotherapy cycle. Consequently, attention should be paid to relevant risk factors. Currently, there is a lack of data on psychosocial risk factors related to chemotherapy among cancer patients in China. Methods: This study was a multicenter, prospective cohort study that included cancer patients from seven hospitals' oncology departments who were scheduled to undergo their first chemotherapy cycle. The chemotherapy regimens administered were either highly or moderately emetogenic protocols. Demographic and baseline clinical characteristics were recorded by clinical oncologists. Participants were asked to complete the Distress Thermometer (DT), the Mini-Mental Adjustment to Cancer (Mini-MAC), and a risk factor questionnaire the day before chemotherapy, and to keep a daily diary describing their CINV experiencing for 21 days after chemotherapy. Results: Between October 2022 and November 2023, a total of 1100 cancer patients were enrolled in this study and 972 cancer patients completed all the questionnaires. A total of 64.1% reported CINV during the first chemotherapy cycle. In logistic regression analysis, CINV was predicted by higher PS score (OR=1.411, p=0.049), highly emetogenic regimens (OR=1.846, p=0.004), failure to follow anti-emetics guidelines (OR=2.323, p&lt;0.001), history of nausea/vomiting for other reasons(OR=1.817, p=0.001), lower number of hours slept before the night of chemotherapy (OR=8.987, p&lt;0.001), expectancy of CINV(OR=1.505, p=0.032), maladaptive coping (OR = 1.03, p = 0.024) and distress (OR = 1.157, p =0.021). Conclusions: Psychosocial factors significantly correlate with chemotherapy-induced nausea and vomiting (CINV) among Chinese cancer patients. These findings underscore the importance of integrating psychosocial assessments into the management of CINV, potentially improving treatment outcomes and patient experiences.

Neiguan (PC6) acupoint stimulation for preventing chemotherapy-induced nausea and vomiting: a cost-effective supplement in guideline-inconsistent chemotherapy-induced nausea and vomiting prophylaxis subgroup.

To assess the efficacy and safety of Neiguan (PC6) acupoint acustimulation in preventing chemotherapy-induced nausea and vomiting (CINV), especially for patients with guideline-inconsistent CINV prophylaxis (GICP) due to personal reasons METHODS: From January 2021 to December 2021, 373 patients suffered from solid malignancy were recruited according to the inclusion criteria. Complete response (no emesis and no rescue medication use) rate during the overall phase (0-120 h of each chemo-cycle) was the primary assessment of CINV control. The Functional Living Index-Emesis (FLIE) questionnaire was investigated among these patients as a secondary 'quality of life' objective to assess the impact of CINV on patients' daily life by recording score of nausea and vomiting. With acustimulation of Neiguan (PC6) acupuncture point through a portable, noninvasive and user-friendly device, in terms of complete response rate and scores in nausea/vomiting by FLIE questionnaire, patients achieve a better outcome in highly emetogenic chemotherapy (HEC) induced CINV, especially GICP subgroup. Meanwhile, analysis also demonstrated this tendency existed in other patients with HEC/GCCP (guideline consistent CINV prophylaxis) and moderate emetogenic chemotherapy, although the difference was not significant. Considering advantages of Neiguan (PC6) acustimulation such as noninvasive, covered by medical insurance and few side effects, we believe it would be an ideal auxiliary tool in CINV control, especially in patients who receive highly emetogenic chemo-protocol and are reluctant to GCCP for economic reasons.

Assessment of chemotherapy-induced nausea and vomiting in adult patients with hematopoietic stem-cell transplant at a tertiary care hospital.

e24098 Background: Chemotherapy induced nausea and vomiting (CINV) is prevalent and potentially treatment-limiting side effects in cancer patients.1 Nausea and vomiting are frequent and significantly affect cancer patients' daily functioning and health-related quality of life (HRQL). A patient who experienced nausea and vomiting showed to be affected by worse physical, cognitive, social functioning, and global quality of life in comparison to patients who don’t have nausea and vomiting. Methods: We conducted a prospective cohort observational study to assess the complete response (CR) and risk factor associated with nausea and vomiting among HSCT patients at King Fahad Medical City (KFMC). All adult patient underwent Bone Morrow Transplant (BMT) were included in the study. Data was collected prospectively during admission to the hospital and receive the conditioning regimen. Patients was interviewed by clinical pharmacist and assessed using MASCC Antiemesis Tool© (MAT) to assess the effectiveness of our regimen used to prevent nausea and vomiting during active chemotherapy days and delayed phase. Results: A total of 30 patients were enrolled in the study during a one year follow up from April 2021 to April 2022. Data analysis was done and revealed as follows; out of 30 patients enrolled 18 (60%) patients were female while 12 (40%) were male. Lymphomas including (Non-Hodgkin, and Hodgkin lymphomas) were the most common diagnosis included among patients 17 (56.6%). BEAM protocol was the most common conditioning regimen protocol used 13 (43.3%). Complete response (CR) was achieved in 13 (43.3%) patients during acute nausea and vomiting, while 17 (56.7%) patients weren’t being able to achieve CR. Furthermore, out of the 30 patients observed, 6 (20.0%) experienced delayed vomiting, while 19 (63.3%) experienced delayed nausea. Similarly, Complete response (CR) was achieved in 11 (36.7%) patients during delayed nausea and vomiting, while 19 (63.3%) patients weren’t being able to achieve Complete response (CR) respectively. Breakthrough medication for nausea and vomiting was needed in all patients who didn’t have to achieve CR 19 (63.3%) patients. There was no association between age, gender, conditioning regimen, and type of transplant and achieved CR among patients (P- value; &gt; 0.05). However, more breakthrough medication is needed when CR is not achieved (P- value; &lt; 0.05). Conclusions: At our institution, among hematopoietic transplant recipients receiving appropriate antiemetics, approximately half (50%) achieved complete response (CR) in preventing chemotherapy-induced vomiting (CINV). Age, gender, and transplant type were not significantly associated with increased CR failure, while the specific conditioning regimen did not show a statistically significant impact.

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.

An open-label randomized trial comparing addition of olanzapine 5 mg versus olanzapine 10 mg as anti-emetic to standard anti-emetic regime for doxorubicin or epirubicin and cyclophosphamide in breast cancer.

e12531 Background: Chemotherapy-induced nausea and vomiting (CINV) is an important therapy related side effects in the treatment of malignancies. Breast cancer patients receive a highly-emetogenic chemotherapy with Doxorubicin or Epirubicin and Cyclophosphamide. The addition of Olanzapine 10 mg is known to reduce acute and delayed CINV, however, Olanzapine 10 mg is associated with somnolence and fatigue. In this study, the proportion of complete response of CINV to Olanzapine 5 mg was compared to Olanzapine 10 mg that was added to standard antiemetic regime. Methods: This was an open-label randomized clinical trial comparing the effectiveness of Olanzapine 5 mg against Olanzapine 10 mg in preventing acute and delayed phases of CINV. This study was conducted at a tertiary care cancer centre in India between 2020 – 2021. The sample size was calculated 118 subjects that were allocated with simple randomization method. The primary outcome of CINV in acute and delayed phase were collected using the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool; the intensity of symptoms of nausea, retching and vomiting were assessed using the Rhodes index; the overall patient experience was assessed using the Edmonton Symptom Assessment Scale. The comparison of proportions of CINV in the two groups were compared using Chi-square test while intensity scores were compared using Wilcoxon rank-sum test. All p values &lt;0.05 were considered significant. Ethics approval was obtained from the Institutional Review Board. The trial was registered at the Clinical Trials Registry of India. Results: Of the118 patients randomized, 57 received Olanzapine 5 mg and 61 received Olanzapine 10 mg in addition to standard antiemetic regime. The overall complete response rate was 54.2% in acute phase and 72.0% in delayed phase. The complete response rate of Olanzapine 5 mg was 57.9% in acute phase and 91.2% in delayed phase. The complete response rate of Olanzapine 10 mg was 50.9% in acute phase and 54.1% in delayed phase. The nausea intensity score on day 5 after chemotherapy was significantly lower among those receiving Olanzapine 10 mg. However, there were no difference in the reduction retching and overall symptoms between the groups. In terms of side effect profile, those receiving Olanzapine 10 mg reported significantly higher grades of somnolence and fatigue. There was no difference in the occurrence of pain, depression, anxiety, shortness of beath, appetite and wellbeing. Conclusions: There was no difference in the effectiveness of Olanzapine 5 mg compared to Olanzapine 10 mg in the prevention of CINV. However, Olanzapine 10 mg was associated with higher proportions of somnolence and fatigue. Therefore, it is recommended that Olanzapine 5 mg may replace current antiemetic regimes that contain Olanzapine 10 mg. Clinical trial information: CTRI/2020/01/023076.

Cost-effectiveness of an oral THC: CBD cannabis extract for secondary prevention of refractory, chemotherapy-induced nausea and vomiting.

TPS11188 Background: The CannabisCINV trial showed the incorporation of a THC:CBD (tetrahydrocannabinol:cannabidiol) cannabis extract in addition to usual, guideline-recommended antiemetic prophylaxis, reduced the incidence of refractory chemotherapy-induced nausea and vomiting. The aim of this within-trial cost-effectiveness analysis was toassess the incremental costs and benefits of oral THC: CBD versus placebo, for preventing chemotherapy-induced nausea and vomiting. Methods: The analysis was performed from a health system perspective, using prospectively collected data from the CannabisCINV trial and linked Medicare data. The evaluation focused on the costs and benefits associated with oral THC: CBD cannabis extract versus placebo in addition to usual care, on complete response: defined as no emesis and no use of rescue medications during the overall treatment phase (0-120 h, cycle 1). The primary economic outcome was an incremental cost-effectiveness ratio (ICER) of achieving a complete response. One-way sensitivity analyses and non-parametric bootstrapping (with 1,000 replications) were conducted to assess the robustness of results. Results: Of 147 participants randomized, 60 of 73 assigned THC:CBD and 66 of 74 assigned placebo consented to Medicare data linkage. The incidence of complete response was higher for THC:CBD than placebo (24% vs 5%, absolute difference 19%, 95%CI 13 to 26%). The mean cost (AUD) of hospitalisation was $580 (SD $7,831) for the intervention group and $1,873 (SD $7,235) for placebo. The mean healthcare costs (AUD) were $1,464 (SD $4,667) for THC:CBD group and $2,725 (SD $9,237) for the placebo. The THC:CBD group had a mean total healthcare cost saving of $1,261 per patient (95% CI -$3,550 to $1029) compared with the placebo group. THC:CBD was less expensive and more effective than placebo (i.e. dominant), in the primary analysis, and over the range of pre-specified sensitivity analyses. Conclusions: This within-trial analysis indicates oral THC: CBD is cost-effective for the treatment of refractory, chemotherapy-induced nausea and vomiting from a health system perspective and supports reimbursement in this setting. The trial and economic evaluation were prospectively registered in the Australian and New Zealand. Clinical trial information: ACTRN12616001036404.

The Effect of CYP2C19*2 (rs4244285) and CYP17 (rs743572) SNPs on Adriamycin and Paclitaxel based Chemotherapy Outcomes in Breast Cancer Patients.

Cytochrome P450 (CYP) are phase I metabolizing enzymes involved in detoxification of chemotherapeutic agents. Among the CYP gene family, including CYP1A1, CYP1B1, CYP2C, CYP2D, CYP2E and CYP17, their significance in cancer susceptibility is well established. However, there remains limited understanding regarding the polymorphisms of CYP2C19*2 and CYP17 and their potential correlation with chemotherapy-induced toxicity reactions in breast cancer (BC) patients. In this study we intended to identify the association of CYP2C19*2 and CYP17 gene polymorphisms on drug response as well as toxicity reactions in BC patients undergoing adriamycin/paclitaxel based chemotherapy within Indian population. Two hundred BC patients receiving adriamycin and paclitaxel chemotherapy were enrolled in this study and chemotherapy induced hematological and non-hematological toxicity reactions were noted. The polymorphisms of CYP2C19*2 (681G>A) and CYP17 (34T>C) isoforms of cytochrome p 450 gene was studied by PCR and RFLP analysis. The univariate logistic regression analysis revealed significant associations between CYP2C19*2 (681 G>A) polymorphisms with hematological toxicities i.e., anemia (OR=9.77, 95% CI: 2.84-33.52; p=0.0003), neutropenia (OR=5.72, 95% CI: 1.75-18.68; p=0.003), febrile neutropenia (OR=4.29, 95% CI: 1.32-13.87; p=0.014) and thrombocytopenia (OR=5.86, 95% CI: 1.15-29.72); p=0.032) in BC patients. Additionally BC patients treated with adriamycin exhibited significant association between CYP2C19*2 polymorphism with chemotherapy induced nausea and vomiting (CINV) (OR=99.73, 95% CI: 5.70-174.64); p=0.001), fatigue (OR=83.29, 95% CI: 4.77-145.69); p=0.002), bodyache (OR=4.44, 95% CI: 1.24-15.91); p=0.021) and peripheral neuropathy (OR=12.00, 95% CI: 1.80-79.89); p=0.010. Furthermore, the regression analysis indicated an association between CYP17 with body ache (OR=2.77, 95% CI: 1.21-6.34; p=0.015) and peripheral neuropathy (OR=3.90, 95% CI: 1.59-9.53; p=0.002) in BC patients treated with paclitaxel chemotherapy. The findings obtained from this study illustrated significant association of CYP2C9*2 (681G>A) polymorphism with adreamicin based chemotherapy induced toxicities and CYP17 (34T>C) polymorphism with paclitaxel induced bodyache and peripheral neuropathy in BC patients.