Risk Factors For Chemotherapy-induced Nausea And Vomiting Research Articles

Abstract PO1-11-12: Factors associated with treatment failure for chemotherapy-induced nausea and vomiting (CINV) among breast cancer patients receiving adjuvant chemotherapy

Abstract Background Cancer patients often consider CINV as one of the most disturbing side effects of cytotoxic chemotherapy. Adriamycin and cyclophosphamide (AC), considered by many to be part of the standard adjuvant regimen for breast cancer patients, is highly emetogenic. Despite adopting optimal antiemetic prophylaxis, the control of CINV remains modest for some patients. Among Chinese breast cancer patients receiving adjuvant AC chemotherapy, the present analysis aims to determine the association of the number of risk factors for CINV with (i) likelihood of antiemetic treatment failure; (ii) time to first vomiting in 1st AC cycle. Methods: We retrieved data from three previously reported prospective antiemetic studies on patients who received AC, in whom different antiemetic regimens were administered. Treatment failure was defined as (i) not achieving CR (CR= no vomiting and no use of rescue medication over 120 hours after start of AC), or (ii) experiencing nausea (nausea VAS >/= 5mm during the 120 hours). Multivariate logistic regression models were applied to identify potential factors associated with the development of CINV. The Cochran–Armitage trend test was utilized to assess possible trends in the relationship between treatment failure and number of identified risk factors. The time-to-treatment failure curves, as classified by the number of identified factors in each subgroup, were evaluated using the Kaplan–Meier method. Results: Based on multivariate analysis of 303 breast cancer patients, not achieving CR was more likely among non-obese patients, not receiving guideline recommended prophylactic antiemetic regimens, history of motion sickness and history of vomiting in pregnancy. Experience of nausea was more likely in non-obese patients, not receiving guideline recommended prophylactic antiemetic regimens, and history of motion sickness. Treatment failure in terms of ‘no CR’ was associated with increased number of risk factors that an individual patient displayed; the figures increased from 18.8% for those with 0 risk factor to 94.1% for those with 4 risk factors (p < 0.0001). Treatment failure in terms of nausea was associated also with increased number of risk factors; the figures increased from 25.9% for those with 0 risk factor to 83.3% for patients with 3 risk factors (p < 0.0001). Time to first vomiting was significantly related to number of identified factors (p < 0.0001). Among patients who had 0, 1, 2 and 3 risk factors, the 24-hour rate of ‘no vomiting’ were 81.3%, 80.3%, 66.7%, 53.7% and 17.7%, respectively; similar trends were observed for analyses on 48-hour and 72-hour rates. Conclusions: The present study confirmed that reported risk factors for CINV in the literature were important in Chinese breast cancer patients receiving AC chemotherapy. Furthermore, patients who had more risk factors had increased likelihood of treatment failure and shorter time to first vomiting. Funding: Madam Diana Hon Fun Kong Donation for Cancer Research Citation Format: Winnie Yeo, Nicole Ngai, Horatio Yeo, Dong Lai, Elizabeth Pang, Carol Kwok, Thomas Lau, Frankie Mo. Factors associated with treatment failure for chemotherapy-induced nausea and vomiting (CINV) among breast cancer patients receiving adjuvant chemotherapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-11-12.

Risk Factors Associated with Chemotherapy-Induced Nausea and Vomiting Among Women with Breast Cancer Receiving Highly Emetogenic Chemotherapy: Individual Patient-Based Analysis of Three Prospective Antiemetic Trials.

Although risk factors related to chemotherapy-induced nausea and vomiting (CINV) have been identified in previous studies, only a few studies have evaluated the risk factors associated with contemporary antiemetic prophylaxis, including olanzapine/aprepitant- or NEPA-containing regimens. This study aimed to identify the risk factors associated with CINV development in Chinese breast cancer patients receiving doxorubicin and cyclophosphamide chemotherapy. Data from 304 patients enrolled in 3 previously reported prospective antiemetic studies were included. Multivariate logistic regression models were used to predict risk factors associated with CINV occurrence. Additionally, the likelihood of treatment failure in relation to the number of risk factors in individual patients was evaluated. Multivariate analysis of the entire study group revealed that obesity status (defined as body mass index/= 25.0 kg/m2) and the use of olanzapine/aprepitant- or NEPA-containing anti-emetic regimens were associated with a high likelihood, while a history of motion sickness was associated with a lower likelihood, complete response (CR), and "no nausea" in the overall phase. A history of vomiting during pregnancy was also associated with a lower likelihood of an overall CR. Patients with an increasing number of risk factors had a higher likelihood of treatment failure and shorter time to first vomiting. Those who did not achieve CR and "no nausea" in the first cycle were less likely to achieve these parameters in the subsequent cycle of chemotherapy. The present study confirmed previously reported risk factors for CINV in Chinese breast cancer patients receiving doxorubicin and cyclophosphamide. Further optimization of CINV control is required for patients with identifiable risk factors; olanzapine/aprepitant- or NEPA- containing prophylaxis are the preferred contemporary anti-emetics regimens for Chinese breast cancer patients undergoing doxorubicin and cyclophosphamide chemotherapy.

Aldehyde dehydrogenase 2 rs671 genetic polymorphisms are associated with chemotherapy-induced nausea and vomiting

To investigate the correlation between aldehyde dehydrogenase 2 (ALDH2) rs671 polymorphisms and chemotherapy-induced nausea and vomiting (CINV). A total of 90 Chinese patients with malignant tumors receiving chemotherapy for the first time were recruited in this study. The occurrence of CINV was observed within 120 h after treatment with docetaxel and cis-platinum chemotherapy (DP regimen). The data of the patients (including age, gender, tumor stage, habitual alcohol consumption, motion sickness, morning sickness, and average sleep time prior to chemotherapy) were collected through a questionnaire. ALDH2 rs671 polymorphisms of the patients were analyzed using a multiple single nucleotide polymorphism genotyping, and the Hardy-Weinberg equation was used for genetic linkage analysis. The correlations between the factors including ALDH2 rs671 polymorphisms and the occurrence of CINV were analyzed. The incidence of CINV was 48.9% among the patients receiving their first chemotherapy with DP regimen. Univariate analysis indicated that the genetic polymorphisms of ALDH2 rs671 were significantly correlated with the occurrence of CINV (P < 0.05). Multivariate logistic analysis indicated that ALDH2 rs671 mutation (OR: 3.019, 95% CI: 1.056-8.628, P < 0.05) and average sleep time prior to chemotherapy no longer than 6 h (OR: 2.807, 95% CI: 1.033-7.628, P < 0.05) were risk factors for CINV in patients with malignant tumors receiving the first chemotherapy with DP regimen. ALDH2 gene mutation at rs671 is a risk factor contributing to the occurrence of CINV, and understanding of the underlying mechanism may help to more effectively control the occurrence of CINV.

Fatores de risco relacionados a náuseas e vômitos induzidos por quimioterapia aguda e tardia em pediatria: análise multivariada

OBJECTIVES: This study aimed to characterize the clinical profile and the factors that predispose chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases. METHODS: A retrospective cohort study was conducted in a Brazilian hospital with pediatric patients under 18 years old receiving moderately or highly emetogenic chemotherapy. Thus, a descriptive analysis was performed to characterize this population, followed by univariate and multivariate analysis to evaluate the risk factors for CINV. In both phases, considering significant the variables with p-values <0.05. RESULTS: The median age was 6 and 71% of the patients included used highly emetogenic protocols. Furthermore, 41% and 76% did not have vomit in the acute and delayed phase, respectively. Through logistic regression, it is noted that patients with bone tumors and sarcomas have higher CINV in the acute phase (OR 10.0, 95%IC 1.1-88.9, p=0.039), while patients who do not have complete control in the acute phase are more likely to have CINV in the delayed phase (OR 11.8, 95%IC 1.1-130.5, p=0.044). CONCLUSION: These results suggest that bone tumors and sarcomas are associated with an increase in CINV in the acute phase. In addition, control in the acute phase is associated with a complete response in the delayed phase.

Chemotherapy-Induced Nausea and Vomiting in Breast Cancer Patients: A Multicenter Prospective Observational Study

Objective:This study aimed to assess the occurrence of chemotherapy-induced nausea and vomiting (CINV) in acute phase (24 h after chemotherapy) and delayed phase (2–5 days after chemotherapy) after standard antiemetic therapy and to explore the risk factors of CINV in the acute and delayed phases.Methods:This prospective and observational study analyzed the data of 400 breast cancer patients scheduled for chemotherapy in two hospitals. The self-report survey was developed to assess the occurrence of CINV and their associated factors. On day 2 and day 6 of chemotherapy, CINV was evaluated by the Multinational Association of Supportive Care in Cancer Antiemetic Tool (MAT). The incidence of acute and delayed CINV was expressed as frequency and percentage.Results:Among 400 patients, 29.8% and 23.5% experienced acute and delayed CINV, respectively. Logistic regression analysis showed that the risk factors associated with acute CINV included pain/insomnia, history of CINV, and highly emetogenic chemotherapy. The history of motion sickness (MS), history of CINV, number of chemotherapy cycles completed, and the incidence of acute CINV were significant risk factors for delayed CINV (all P < 0.05).Conclusions:The results of this study are helpful for nurses to identify high-risk patients with CINV, formulate effective treatment plans, and reduce the incidence of CINV.

Association of illness perception with chemotherapy-induced nausea and vomiting: a Turkish Oncology Group (TOG) study.

Chemotherapy-induced nausea and vomiting (CINV) may be linked to the psychological status of cancer patients. Therefore, the authors aimed to better understand the underlying risk factors for CINV using the Brief Illness Perception Questionnaire. A total of 238 patients were recruited during three cycles of chemotherapy. Patient, disease and treatment characteristics were noted at the onset of chemotherapy. The Brief Illness Perception Questionnaire was administered face-to-face prior to chemotherapy. The relationship between illness perceptions and CINV was analyzed using Spearman's rank correlation. Positive illness perception parameters, including personal and treatment control, were negatively correlated, whereas negative illness perception parameters, including consequences, timeline, identity, concern and emotions, were positively correlated with CINV after adjusting for age, sex and emetogenic potential of chemotherapy (p<0.001). Illness perception may be an underlying risk factor for CINV.

Abstract PS13-35: Evaluation of age as a risk factor for CINV in breast cancer patients: Post-hoc analysis of the German real-world AkyPRO study

Abstract Background: The primary objective of the prospective, non-interventional study (NIS) AkyPRO was the evaluation of quality of life (QoL) in adult cancer patients (pts) receiving NEPA as antiemetic prophylaxis. Secondary endpoints were efficacy and safety of NEPA. NEPA is administered as an oral fixed dose combination of 300 mg of the neurokinin-1-receptor antagonist - (NK1RA) netupitant and 0,5 mg of the 5-hydroxytryptamin-3-receptor antagonist (5-HT3RA) palonosetron once per chemotherapy cycle as primary prophylaxis for chemotherapy-induced nausea and vomiting (CINV) associated with moderately (MEC) or highly (HEC) emetogenic chemotherapy. In modern antiemetic guidelines, anthracycline/ cyclophosphamide (AC) - containing chemotherapy (AC-CT) is classified as HEC requiring triple antiemetic prophylaxis with a 5-HT3RA, a NK1RA and dexamethasone. Pts with breast cancer (BC) have additional risk factors for nausea and vomiting, like female sex and younger age, thus representing a high-risk group for CINV. Here, we present a post-hoc analysis of quality of life data and effectiveness of NEPA in the subgroup of BC pts in two age groups ≥ and &amp;lt; 60 years (y), who were treated with AC-CT in the AkyPRO NIS. Methods: The AkyPRO NIS has been conducted to evaluate quality of life and effectiveness of antiemetic prophylaxis with NEPA in cancer pts with various cancer entities receiving single day or two day MEC or HEC in a real life situation. Quality of life (QoL) was recorded by FLIE questionnaires. Effectiveness of NEPA as indicated by complete response (CR: no vomiting, no rescue medication), additional medication, and adverse events were recorded in patient diaries over three consecutive chemotherapy cycles. Patients and physicians documented overall antiemetic control on a 4-point scale (very good, good, satisfactory, poor). Results: In total, the AkyPro NIS enrolled 2,427 pts. 1,428 pts (65.7 %) had breast cancer. In this post hoc analysis 1,197 BC pts receiving AC-CT (83 % of all BC pts) were evaluated. 782 pts (65%) were &amp;lt;60y, 415 (35%) ≥ 60y old. Most pts received AC-CT in the adjuvant or neoadjuvant setting. Pts ≥ 60y reported a higher CR rate in the overall phase over 3 cycles (c1 88%, c2 90%, c3 88%) than pts &amp;lt;60y (c1 78%, c2, 78%, c77%). Pts ≥ 60y also experienced moderate or severe nausea less frequently, with the non-significant nausea (NSN) rate being 67, 67, 70% c1-c3 in these pts vs. 57, 59, 58% in c1-c3 in younger pts. QoL data confirmed this observation. Older pts reported more often to have no impact on daily life (NIDL) due to nausea (58-62% in c1-c3) than younger pts (50-54% in c1-c3). Comparison of patients’ and physicians’ perception of antiemetic treatment effectiveness revealed that in both groups the majority estimated the effectiveness of antiemetic prophylaxis with NEPA high and comparably well and good or very good. Conclusion: This real-life study confirmed the effectiveness of NEPA in preventing CINV in the subgroup of BC pts receiving AC-chemotherapy. Pts ≥ 60y experienced less CINV compared to pts &amp;lt;60y, confirming that younger age represents a risk factor for CINV and indicating that the choice of an adequate antiemetic prophylaxis is crucial in this group of pts. Citation Format: Joerg Schilling, Steffi Busch, Martin Hollaender, Gabriele Kaltenecker, Eberhard Müller, Thomas Resch, Angelika Till, Meinholf Karthaus. Evaluation of age as a risk factor for CINV in breast cancer patients: Post-hoc analysis of the German real-world AkyPRO study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-35.

Risk factors of chemotherapy-induced nausea and vomiting in patients with metastatic colorectal cancer: a prospective cohort study (YCOG1301).

Although the effectiveness of antiemetic therapy for colorectal cancer chemotherapy has improved with further drug development, some patients still suffer from chemotherapy-induced nausea and vomiting (CINV) even with only 5-hydroxytryptamine-3 receptor antagonist and dexamethasone. The present study investigated the risk factors of CINV in patients who received chemotherapy for colorectal cancer and clarified which patients need additional neurokinin 1 receptor antagonist. Patients with colorectal cancer receiving moderate-emetic-risk chemotherapy (MEC) were enrolled in this prospective single-arm study with intravenous palonosetron 0.75 mg and dexamethasone 9.9 mg before chemotherapy and with paroral dexamethasone 8 mg on days 2 and 3. The primary endpoint was the complete response (CR) rate for delayed-phase CINV. A total of 179 patients were eligible for this study. The delayed CR rate was 84.9% (152/179). There were no significant differences in any risk factors, but women with a low body mass index (BMI) (a combination of "female sex" and "BMI < 20") showed a significantly lower rate of CC (complete control) (odds ratio [OR] = 0.45, 95% confidence interval [CI] = 0.17-1.13; p = 0.039), and young patients with a low BMI (combination of "age < 65" and "BMI < 20") showed a significantly lower rate of CR (OR = 0.34, 95% CI = 0.13-0.88; p = 0.022) than the other patients. This study failed to identify any single risk factors associated with delayed CINV in patients who received chemotherapy for advanced colorectal cancer. However, combinations of "thin and women" or "young and thin patients" might be possible predictive conditions, thus, candidates for NK1 receptor antagonist administration in MEC. Further investigations are required to develop criteria for the supplementation of NK1 receptor antagonist.

Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study

BackgroundNEPA is an oral fixed-dose combination of netupitant, a new highly selective neurokinin-1 receptor antagonist, and palonosetron. This study was conducted to evaluate whether the efficacy of NEPA against chemotherapy-induced nausea and vomiting (CINV) in cycle 1 would be maintained over subsequent chemotherapy cycles in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide (AC). The study also describes the relationship between efficacy on day 1 through 5 (overall period) and control of CINV on day 6 through 21 (very late period) in each cycle.MethodsIn this multicentre, phase II study, patients received both NEPA and dexamethasone (12 mg intravenously) just before chemotherapy. The primary efficacy endpoint was overall complete response (CR; no emesis and no rescue medication use) in cycle 1. Sustained efficacy was evaluated during the subsequent cycles by calculating the rate of CR in cycles 2–4 and by assessing the probability of sustained CR over multiple cycles. The impact of both overall CR and risk factors for CINV on the control of very late events (vomiting and moderate-to-severe nausea) were also examined.ResultsOf the 149 patients enrolled in the study, 139 were evaluable for a total of 552 cycles; 97.8% completed all 4 cycles. The proportion of patients with an overall CR was 70.5% (90% CI, 64.1 to 76.9) in cycle 1, and this was maintained in subsequent cycles. The cumulative percentage of patients with a sustained CR over 4 cycles was 53%. NEPA was well tolerated across cycles. In each cycle, patients with CR experienced a significantly better control of very late CINV events than those who experienced no CR. Among the patients with CR, the only predictor for increased likelihood of developing very late CINV was pre-chemotherapy (anticipatory) nausea (adjusted odds ratio = 0.65–0.50 for no CINV events on cycles 3 and 4).ConclusionThe high anti-emetic efficacy seen with the NEPA regimen in the first cycle was maintained over multiple cycles of adjuvant AC for breast cancer. Preliminary evidence also suggests that patients achieving a CR during the overall period gain high protection even against very late CINV events in each chemotherapy cycle.Trial registrationThis trial was retrospectively registered at Clinicaltrials.gov identifier (NCT03862144) on 05/Mar/2019.

423P - Effectiveness of first-generation 5HT3 receptor antagonist plus dexamethasone plus aprepitant in controlling delayed chemotherapy-induced nausea and vomiting in patients with colorectal cancer: A propensity score-matched analysis

BackgroundDelayed chemotherapy-induced nausea and vomiting (CINV) is not well controlled in patients with colorectal cancer (CRC) treated with oxaliplatin (L-OHP)-based chemotherapy. Whether adding a neurokinin-1 receptor antagonist to a first-generation 5HT3 antagonist (1st-5HT3RA) and dexamethasone (DEX) is beneficial in patients on L-OHP-based chemotherapy is controversial. It is unclear whether palonosetron (PALO) or aprepitant (APR) is more effective in controlling delayed CINV. We, therefore, investigated whether PALO+DEX (PALO group) or 1st-5HT3RA+DEX+APR (APR group) was more effective in controlling delayed CINV, as well as risk factors for delayed CINV, in patients with CRC treated with L-OHP-based chemotherapy. MethodsWe pooled data from two prospective observational studies in Japan and one phase III clinical trial and compared the incidence of CINV between the PALO and APR groups using propensity score-matched analysis. Risk factors for CINV were identified using logistic regression models. ResultsAmong the 404 eligible patients, those in the PALO group showed a higher incidence of delayed CINV than those in the APR group (nausea: 43.4% vs. 32.4%, P = 0.061; vomiting: 12.5% vs. 4.4%, P = 0.017). The logistic regression analysis identified alcohol consumption, motion sickness, and PALO+DEX regimen as independent risk factors for delayed nausea, and female sex and PALO+DEX regimen as those for delayed vomiting. ConclusionsTreatment with the three antiemetics, including APR, was more effective in controlling delayed CINV than prophylactic treatment with the two antiemetics, including PALO. Thus, patients with CRC receiving L-OHP-based chemotherapy should be treated with three antiemetics, including APR. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

430P - Emetic risk of carboplatin plus pemetrexed is higher than that of carboplatin plus paclitaxel in patients with lung cancer: A propensity score-matched analysis

BackgroundThe emetogenic classification of antineoplastic agents has provided a framework for defining antiemetic treatment recommendations in international guidelines. The most widely used classification schema identified four emetic risk levels. However, information on the emetogenicity of each chemotherapeutic regimen is insufficient. We previously reported that the emetic risk of pemetrexed was higher than that of taxans. Risk factors for chemotherapy-induced nausea and vomiting (CINV) were also assessed in patients with lung cancer receiving carboplatin plus pemetrexed (CBDCA+PTX) or carboplatin plus paclitaxel (CBDCA+PEM), and the CINV incidence was compared between these two regimens. MethodsData were pooled from two prospective studies, and propensity score matching was used to compare the CINV incidence between CBDCA+PTX and CBDCA+PEM groups. Risk factors for CINV were identified using logistic regression models. The pattern of CINV occurrence was evaluated by 7-day patient diary for recording CINV after the commencement of chemotherapy. ResultsAmong 240 evaluable patients, the CINV incidence was higher in the CBDCA+PEM group than in the CBDCA+PTX group at the delayed phase (nausea: 51.1% vs. 36.2%, P = 0.040; vomiting: 23.4% vs. 14.9%, P = 0.138). The pattern of delayed CINV occurrence peaked on days 5 and 4 for CBDCA+PEM and CBDCA+PTX regimens, respectively. Logistic regression analysis identified younger age, female sex, no alcohol consumption, two antiemetics, and CBDCA+PEM regimen as independent risk factors associated with delayed nausea, and female sex and two antiemetics for delayed vomiting. ConclusionsThe emetic risk of CDBCA+PEM regimen was higher than that of CBDCA+PTX regimen. More aggressive antiemetic prophylaxis such as quadruple therapy, including olanzapine, may be considered in patients receiving CDBCA+PEM regimen. Legal entity responsible for the studyThe authors. FundingHas not received any funding. DisclosureAll authors have declared no conflicts of interest.

A Nationwide, Multicenter Registry Study of Antiemesis for Carboplatin-Based Chemotherapy-Induced Nausea and Vomiting in Japan.

BackgroundWe previously reported the results of a prospective study of chemotherapy‐induced nausea and vomiting (CINV) in a cohort of patients who received carboplatin‐based chemotherapy and were selected from a nationwide registry of those scheduled for moderately (MEC) or highly emetogenic chemotherapy (HEC) by the CINV Study Group of Japan. Of 1,910 previously registered patients (HEC: 1,195; MEC: 715), 400 patients received carboplatin‐based chemotherapy. The frequency of CINV was determined, and the risk factors for CINV were assessed.Materials and MethodsCINV data were collected from 7‐day diaries. Risk factors for CINV were identified using logistic regression models.ResultsOf 400 patients scheduled for carboplatin‐based chemotherapy, 267 patients received two antiemetics (5‐hydroxytryptamine‐3 receptor antagonist [5‐HT3 RA] and dexamethasone [DEX]), 118 patients received three antiemetics (5‐HT3 RA, DEX, and neurokinin‐1 receptor antagonist [NK1 RA]), and 15 were nonadherent to the treatment. In these patients, the CINV overall, acute, and delayed phase rates of complete response (CR), defined as no vomiting with no rescue medication, were 67.0%, 98.2%, and 67.5%, respectively. The rates of no nausea were 55.6%, 94.0%, and 56.1%, respectively, and those of no vomiting were 81.3%, 99.0%, and 81.8%, respectively. Older age was associated with a decreased non‐CR, whereas female sex, history of pregnancy‐related emesis, and dual antiemetic therapy were associated with an increased non‐CR during the overall period.ConclusionIn a clinical practice setting, in patients who received carboplatin‐based chemotherapy, adherence is quite high and appropriate antiemetic prophylaxis requires a triple antiemetic regimen including NK1 RA.Implications for PracticeFor patients receiving carboplatin‐based chemotherapy, triple antiemetic therapy with 5‐hydroxytryptamine‐3 receptor antagonist, dexamethasone, and neurokinin‐1 receptor antagonist should be given prophylactically regardless of risk factor status.

Risk Analysis for Chemotherapy-induced Nausea and Vomiting (CINV) in Patients Receiving FEC100 Treatment.

Risk factors for chemotherapy-induced nausea and vomiting (CINV) with anthracycline-containing regimen for breast cancer patients remain unknown. The risk factors for CINV with FEC100 were investigated. Data on CINV events and patient backgrounds of 180 patients were collected from the first cycle of FEC100 treatment. In this regimen, patients were administered various antiemetics (ADs). The combinations of ADs were classified into four categories, while body mass index (BMI) was stratified into three categories. Risk factors were selected based on patient characteristics and combination of ADs. Risks for CINV were analyzed by univariate and multivariate analyses. In the univariate analysis of nausea, BMI was a significant factor, while BMI and combination of ADs were significant in vomiting. In the multivariate analysis concerning nausea, BMI was a significant factor. In the analysis concerning vomiting, the combination of ADs and BMI were significant. BMI was the most important risk factor for nausea and vomiting, while the combination of ADs was for vomiting.

One-Day Versus Three-Day Dexamethasone in Combination with Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Individual Patient Data-Based Meta-Analysis.

A dexamethasone-sparing regimen consisting of palonosetron plus 1-day dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) has been studied previously. Here, we evaluate the noninferiority of the dexamethasone-sparing regimen in overall antiemetic control using a meta-analysis based on individual patient data (IPD). We conducted a systematic review for randomized trials reporting CINV outcomes for the comparison of palonosetron plus 1-day dexamethasone (d1 arm) versus the same regimen followed by dexamethasone on days 2-3 after chemotherapy (d3 arm) in chemotherapy-naïve adult patients undergoing either moderately emetogenic chemotherapy (MEC) or anthracycline plus cyclophosphamide (AC)-containing chemotherapy. PubMed and MEDLINE were searched electronically. A manual search was also conducted. The primary endpoint was complete response (CR; no emesis and no rescue medication) in the overall 5-day study period. The noninferiority margin was set at -8.0% (d1 arm-d3 arm). Five studies (n = 1,194) were eligible for analysis and all IPD was collected. In the overall study period, the d1 arm showed noninferiority to the d3 arm for CR as well as complete control (pooled risk difference in CR rate - 1.5%, 95% confidence interval [CI] -7.1 to 4.0%, I2 = 0%; in complete control rate - 2.4%, 95% CI -7.7 to 2.9%, I2 = 0%). There was no significant interaction between dexamethasone regimen and risk factors (type of chemotherapy, sex, age, and alcohol consumption). This IPD meta-analysis indicates that the dexamethasone-sparing regimen is not associated with a significant loss in overall antiemetic control in patients undergoing MEC or AC-containing chemotherapy, irrespective of known risk factors for CINV. Although dexamethasone in combination with other antiemetic agents has been used to prevent chemotherapy-induced nausea and vomiting (CINV), it is of clinical importance to minimize total dose of dexamethasone in patients undergoing multiple cycles of emetogenic chemotherapy. This individual-patient-data meta-analysis from five randomized controlled trials (1,194 patients) demonstrated a noninferiority of the dexamethasone-sparing regimen for complete response and complete control of CINV. The outcomes were comparable across patients with different characteristics. These findings thus help physicians minimize use of the steroid and further reduce the burden of dexamethasone-related side effects in patients undergoing multiple consecutive courses of emetogenic chemotherapy.

Abstract P1-11-07: Risk analysis for chemotherapy induced nausea and vomiting (CINV) in patients receiving FEC100 treatment

Abstract BACKGROUND: Anthracycline-containing regimens are standard treatment options in adjuvant and neoadjuvant chemotherapy in breast cancer. Chemotherapy-induced nausea and vomiting (CINV) is experienced frequently in patients receiving these regimens, but the risk factors for CINV are unknown. OBJECTIVE: The aim of this study was to investigate risk factors for CINV in anthracycline-containing regimens retrospectively. METHODS: Data were collected from the JONIE study, which was conducted in order to estimate the efficacy of zoledronic acid in a neoadjuvant setting from March 2010 to June 2012 (UMIN000003261). A total of 180 patients were recruited, and we used CINV data from the first cycle of FEC100 treatment and patient backgrounds. As the protocol regulation allowed the use of antiemetic drugs,in the first cycle of the FEC100 regimen, patients received various types of antiemetic agents, which we classified into four groups: Dexamethasone (DEX)+5-HT3 receptor antagonist (5-HT3)+neurokinin-1 receptor antagonist (NK1) (DEX+5-HT3+NK1) group; Dexamethasone (DEX)+5-HT3 receptor antagonist (5-HT3) (DEX+5HT3) group; Dexamethasone (DEX)+5-HT3 receptor antagonist (5-HT3)+dopamine receptor antagonist (DRA) (DEX+5HT3+DRA) group; and Dexamethasone (DEX)+5-HT3 receptor antagonist (5-HT3)+neurokinin-1 receptor antagonist (NK1)+ dopamine receptor antagonist (DRA) (DEX+5-HT3+NK1+DRA) group. Risk factors were selected from patient backgrounds and the combinations of antiemetic drugs. In patient backgrounds, the body mass index (BMI) was stratified into 3 categories: Less than 18.5 (underweight group); equal to or more than 18.5 but less than 25 (standard BMI group); and equal to or more than 25 (overweight group). The risks for CINV were analyzed by univariate and multivariate analyses. P values of less than 0.05 were defined as significant. RESULTS: In a univariate analysis of nausea, the body mass index (BMI) was the only significant factor (P&amp;lt;0.05). On the other hand, BMI and the combination of antiemetic drugs were significant factors in vomiting. (P&amp;lt;0.05 and 0.005, respectively). In a multivariate analysis of nausea, the P value for BMI was 0.02. The odds ratio for the underweight group was 7.745 (confidence interval: 2.171 to 27.634) compared with the standard BMI group. In a multivariate analysis of vomiting, BMI and the combination of antiemetic drugs were significant risk factors (P=0.025 and 0.023, respectively). The odds ratio for the underweight group was 3.481 (confidence interval: 1.183 to 10.241)compared with the standard BMI group. Furthermore, the odds ratios in the DEX+5-HT3+DRA and DEX+5HT3 groups were 5.005 (confidence interval: 1.543 to 16.239) and 4.178 (confidence interval: 1.428 to 12.222), respectively, compared with the DEX+5-HT3+NK1 group, which was consistent with the CINV guidelines in 2011. CONCLUSIONS: This study revealed that BMI was the most important risk factor for nausea, and that BMI and the combination of antiemetic drugs were risk factors for vomiting. Underweight-patients tend to have CINV in anthracycline-containing regimen. The DEX+5-HT3+NK1 group was the best antiemetic drug combination. These result show that following the CINV guideline treatment is mandatory in order to prevent CINV. Citation Format: Hayashi M, Nakazawa K, Hasegawa Y, Horiguchi J, Miura D, Ishikawa T, Takao S, Kim SJ, Yamagami K, Miyashita M, Konishi M, Shigeoka Y, Suzuki M, Taguchi T, Kubota T, Tanino Y, Yamada K, Kimura K, Akazawa K, Kohno N. Risk analysis for chemotherapy induced nausea and vomiting (CINV) in patients receiving FEC100 treatment [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-07.

Effects of Serum Sodium Concentrations on Nausea and Vomiting after Moderately Emetogenic Chemotherapy

Chemotherapy-induced nausea and vomiting (CINV) is the most unbearable adverse effect of chemotherapy. The antiemesis guidelines of the National Comprehensive Cancer Network indicate that hyponatremia is a risk factor for CINV, although the relationship between the incidence of CINV and hyponatremia has not been sufficiently studied. This two-center prospective observational study evaluated whether low serum sodium concentrations were a risk factor for CINV. The study included 34 patients who were scheduled to receive first-line carboplatin- or oxaliplatin-based chemotherapy for gynecological or colorectal cancers. Patient diaries were used to record the daily incidences of CINV events during a 5-day period. The patients were divided based on the median serum sodium concentration into a low Na+ group (<141 mEq/L) and a high Na+ group (≥141 mEq/L). The incidences of delayed nausea were 27.8% in the high Na+ group and 62.5% in the low Na+ group (p=0.042), with complete control rates (no vomiting, rescue medication, or grade 2 nausea) of 77.8% and 43.8%, respectively (p=0.042). The time to complete control failure in each group was analyzed using the Kaplan-Meier method, which revealed a significantly shorter time in the low Na+ group (p=0.03). Therefore, these results indicate that low serum sodium concentrations may increase the risk of CINV.

Acute chemotherapy-induced nausea and vomiting in children with cancer: Still waiting for a common consensus on treatment.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common treatment side-effects, and remains a significant concern, in children undergoing chemotherapy. Although adult patients receive chemotherapy regimens combined with appropriate standardized antiemetic treatment, children can receive markedly varying antiemetic treatments. A narrative review of CINV was performed regarding CINV definition, scoring system, prevention and treatment, specifically focussing on studies conducted with paediatric oncology patients. The review highlighted a lack of rigorously developed CINV scoring systems and standardized CINV pharmacological treatment for paediatric oncology patients. Different scoring systems were found to identify potential risk factors for CINV associated with the use of several different antiemetic drugs, however, few studies have been performed in children undergoing chemotherapy. Thus, CINV remains a distressing and partially controlled side-effect in the paediatric patient population. To reduce emesis and improve quality of life in paediatric oncology patients, standardized antiemetic treatment may be preferred, using a unique CINV scoring system that accounts for the emetogenic level of the chemotherapy regimen adopted and the children’s clinical characteristics.

Chemotherapy-Induced Nausea and Vomiting Mitigation With Music Interventions

Despite three decades of studies examining music interventions as a mitigant of chemotherapy-induced nausea and vomiting (CINV), to date, no systematic review of this literature exists. . PubMed, Scopus, PsycInfo®, CINAHL®, Cochrane Library, and Google Scholar were searched. Keywords for all databases were music, chemotherapy, and nausea. . All studies were appraised for methodology and results. . 10 studies met inclusion criteria for review. Sample sizes were generally small and nonrandomized. Locus of control for music selection was more often with the investigator rather than the participant. Few studies controlled for the emetogenicity of the chemotherapy administered, nor for known patient-specific risk factors for CINV. . The existing data have been largely generated by nurse scientists, and implications for nursing practice are many, because music interventions are low-cost, easily accessible, and without known adverse effects. However, this specific body of knowledge requires additional substantive inquiry to generate clinically relevant data.

Risk factors of CINV induced by CDDP in antiemetic triplet regimen including palonosetron or granisetron: TRIPLE study

Current antiemetic guidelines recommend antiemetic triplet regimen for cisplatin. Although several prior studies have identified risk factors for chemotherapy-induced nausea and vomiting (CINV), only a few have evaluated antiemetic triplet regimen, particularly with palonosetron. Therefore, the purpose of the present study was to confirm and compare the risk factors for CINV when using palonosetron or granisetron. A total of 825 patients in the phase III clinical trial on cisplatin regimen were evaluated (TRIPLE study). The primary endpoint was complete response (CR) rate in the overall period (0-120 h). All patients were evaluated for CINV risk factors. Using a post-hoc analysis, the impact of antiemetic treatment on CR was assessed, and odds ratio (OR) with 95% confidence intervals (CIs) for antiemetic treatment failure (TTF) were evaluated by using multivariate logistic regression models. CINV risk factors were also evaluated separately in each treatment group. The multivariate analysis revealed that female (OR: 2.572; 95% CI: 1.855-3.566), less than 60 years old (OR: 1.717; 95% CI: 1.252-2.355), the cisplatin dose (OR: 1.017; 95% CI: 1.001-1.033), and granisetron use (OR: 1.357; 95% CI: 1.013-1.817) were all significantly associated with TTF in the entire study group. Similarly, female and age were also identified as the risk factors associated with TTF in both groups (P < 0.0001). Kaplan-Meier plots of time to event classified each groups and revealed no significant difference between the groups for patients with zero risk factors (P = 0.353). For patients with one or more risk factors, those treated with palonosetron experienced significantly higher CR rates than granisetron (P = 0.049). This analysis confirmed several previously reported CINV risk factors when using triplet antiemetic regimen. Palonosetron might be preferred for patients with one or more risk factors. Clinical trial information:UMIN 000004863

Comprehensive study of risk factors for chemotherapy-induced nausea and vomiting in cancer patients receiving cisplatin-based chemotherapy: A TRIPLE pharmacogenomics study.

10091 Background: Chemotherapy-induced nausea and vomiting (CINV) is one of the most unpleasant adverse effects of chemotherapy. Resistance to prophylactic antiemetic treatment is problematic, with 30%–50% of patients experiencing unsatisfactory control. Younger age and female sex are well-known risk factors for CINV. Genetic polymorphisms are suggested to influence antiemetic treatment response. Methods: This study included a subset of patients previously enrolled in a randomised controlled trial. This study aimed to evaluate the role of pharmacogenomic polymorphisms relevant to antiemetic response in patients with cancer receiving cisplatin-based chemotherapy. The study’s efficacy endpoint was the proportion of patients with complete response (CR). The study endpoint was evaluated separately in the acute (CR0-24) and delayed (CR24-120) phases. Thirteen polymorphisms were genotyped, and the association of these genotypes with the efficacy of prophylactic antiemetics was then investigated. Confounding variables for CR were identified using stepwise multivariate logistic regression analysis. Age and sex were included as independent variables by the forced-entry method, and the stepwise method was used to select the pharmacogenomic factors for inclusion as independent variables. Results: In this genetic polymorphism association study, 156 patients with solid cancer were evaluated. Multivariate logistic regression analysis revealed that ERCC1 8092AA (odd ratio [OR]: 11.251; 95% confidence interval [CI]: 1.741–72.712, P = 0.011) and female sex (OR = 3.630; 95% CI = 1.138–11.578, P = 0.029) were significant predictors of CR0-24. No significant association of CR24-120 with pharmacogenomic polymorphisms was found via multivariate logistic regression analysis. Conclusions: ERCC1 polymorphism might be influenced the extent of CINV control in patients receiving cisplatin-based chemotherapy. Clinical trial information: 000009335.