|Year : 2022 | Volume
| Issue : 2 | Page : 124-131
Chemotherapy-Associated nausea and vomiting: A cross-sectional survey of occurrence and management patterns at jos university teaching hospital, Nigeria
Kelvin Mogesa Manyega, Benjamin Nasara Joseph, Okunlola Charity Rotkangmwa, Maxwell P Dapar
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmaceutical Sciences, University of Jos, Jos, Nigeria
|Date of Submission||24-Sep-2020|
|Date of Acceptance||02-Mar-2021|
|Date of Web Publication||6-Jul-2022|
Kelvin Mogesa Manyega
Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmaceutical Sciences, University of Jos, Jos
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: The management patterns for chemotherapy-associated nausea and vomiting (CANV) in Sub-Saharan African settings have not been previously reported. The objectives of this study were to describe the prescribing pattern of antiemetics for CANV, to assess their adherence to guidelines, and to determine the occurrence of CANV. Subjects and Methods: This was a cross-sectional study, with data extracted from the records of adult patients who received chemotherapy from 2015 to 2018 at Jos University Teaching Hospital, Nigeria. The National Comprehensive Cancer Network Harmonized Guidelines™ for Sub-Saharan Africa for Antiemesis Version 3.2018 was used to determine the extent of guideline adherence. Results: Records of 165 patients were analyzed. Majority of the patients (76.4%, n = 126) received moderate-to-high emetic risk intravenous (IV) chemotherapy. Out of 129 antiemetic prescriptions for acute-phase prophylaxis, ondansetron (75.2%), corticosteroids (61.2%), and promethazine (24.8%) were the most prescribed agents. In the delayed phase, 50 patients received prophylactic antiemetics in the order of corticosteroids, ondansetron, and promethazine at 74%, 34%, and 26%, respectively. Guideline adherence was low for the acute-phase (23.6%), delayed-phase (20.6%), and overall period (17.6%). Among inpatients (n = 85), occurrences of nausea were negligible, whereas acute vomiting (9%) and delayed vomiting (15%) levels were considerable. Not receiving highly emetogenic IV chemotherapy was associated with significantly lower odds for nausea or vomiting occurrence, odds ratio 0.228 (95% confidence interval 0.054–0.967). Conclusions: Antiemetic guideline adherence was low due to antiemetic under-prescribing. A few nausea and vomiting events were recorded predominantly among patients who received highly emetogenic IV chemotherapy.
| Abstract in French|| |
Contexte: Les schémas de prise en charge des nausées et vomissements associés à la chimiothérapie (CANV) en Afrique subsaharienne n'ont pas Été signalée précédemment. Les objectifs de cette étude étaient de décrire le schéma de prescription des antiémétiques pour le CANV, d'évaluer leur adhésion Aux lignes directrices et pour déterminer l'occurrence du CANV. Subjets et méthodes: Il s'agissait d'une étude transversale, avec des données extraites de Les dossiers des patients adultes ayant reçu une chimiothérapie de 2015 à 2018 à l'hôpital universitaire de Jos, au Nigéria. Le global national Cancer Network Harmonized Guidelines™ for Sub-Saharan Africa for Antiemesis Version 3.2018 a été utilisé pour déterminer l'étendue de la directive Adhérence. Résultats: Les dossiers de 165 patients ont été analysés. La majorité des patients (76,4 %, n = 126) ont présenté un risque émétique modéré à élevé Chimiothérapie intraveineuse (IV). Sur 129 prescriptions d'antiémétiques en prophylaxie de phase aiguë, ondansétron (75,2 %), corticoïdes (61,2 %), Et la prométhazine (24,8 %) étaient les agents les plus prescrits. Dans la phase retardée, 50 patients ont reçu des antiémétiques prophylactiques de l'ordre de Corticostéroïdes, ondansétron et prométhazine à 74 %, 34 % et 26 %, respectivement. Le respect des lignes directrices était faible pour la phase aiguë (23,6 %), Phase retardée (20,6 %) et période globale (17,6 %). Parmi les patients hospitalisés (n = 85), les occurrences de nausées étaient négligeables, alors que Les taux de vomissements (9 %) et de vomissements retardés (15 %) étaient considérables. Le fait de ne pas recevoir de chimiothérapie IV hautement émétisante était associé àProbabilités significativement plus faibles de survenue de nausées ou de vomissements, rapport de cotes 0,228 (intervalle de confiance à 95 % 0,054-0,967). Conclusions : Antiémétique Le respect des lignes directrices était faible en raison de la sous-prescription des antiémétiques. Quelques nausées et vomissements ont été enregistrés principalement chez les Patients ayant reçu une chimiothérapie IV hautement émétisante.
Mots-clés: Antiémétique, chimiothérapie, nausées, Nigéria, vomissements
Keywords: Antiemetic, chemotherapy, nausea, Nigeria, vomiting
|How to cite this article:|
Manyega KM, Joseph BN, Rotkangmwa OC, Dapar MP. Chemotherapy-Associated nausea and vomiting: A cross-sectional survey of occurrence and management patterns at jos university teaching hospital, Nigeria. Ann Afr Med 2022;21:124-31
|How to cite this URL:|
Manyega KM, Joseph BN, Rotkangmwa OC, Dapar MP. Chemotherapy-Associated nausea and vomiting: A cross-sectional survey of occurrence and management patterns at jos university teaching hospital, Nigeria. Ann Afr Med [serial online] 2022 [cited 2022 Dec 10];21:124-31. Available from: https://www.annalsafrmed.org/text.asp?2022/21/2/124/349968
| Introduction|| |
Chemotherapy-associated nausea and vomiting (CANV) is a commonly occurring adverse event that negatively impacts patients' quality of life. CANV occurs in the acute phase within 24-h postadministration of cancer chemotherapy or in the delayed phase, 2–5 days afterward. If poorly managed, CANV could lead to dehydration, electrolyte disturbances, and subsequent treatment delays with accumulating healthcare costs.
Depending on their emesis-inducing capacity, anticancer agents are classified into four categories namely highly emetogenic chemotherapy (HEC), moderately emetogenic chemotherapy (MEC), low emetogenic chemotherapy (LEC), and minimal emetic risk chemotherapy. Studies indicate that more than 90% of patients experience acute vomiting with HEC in the absence of antiemetic prophylaxis. Similarly, for MEC, LEC, and minimal emetic risk chemotherapy, the proportions of acute vomiting reported ranged from 30% to 90%, 10% to 30%, and <10%, respectively.
The overarching goal of CANV control is prevention. Antiemetic agents used for CANV prophylaxis include neurokinin-1 receptor antagonists (NK-1RAs) exemplified by aprepitant, 5-hydroxytryptamine 3 receptor antagonists (5-HT3RAs) like ondansetron, the atypical antipsychotic drug olanzapine, and corticosteroids. Guideline-recommended management of CANV entails administration of a three-drug combination of a 5-HT3RA, a corticosteroid, and an NK-1RA or olanzapine as acute-phase prophylaxis before administration of HEC. A two-drug combination of a 5-HT3RA and a corticosteroid is considered sufficient acute-phase prophylaxis for MEC, while a single antiemetic agent (5-HT3RA or corticosteroid) is adequate for LEC. Acute-phase regimens may be augmented by the administration of prophylactic antiemetics for 2 or more days in the delayed phase for patients receiving HEC, MEC,, or multiday chemotherapy regimens.
Research evidence suggests that guideline-recommended antiemetic management results in significantly better CANV control. Despite this, a considerable proportion of patients at risk of CANV do not receive optimal antiemetic management. Nonadherence to antiemetic-prescribing guidelines appears to be widespread. While a European multicenter prospective study reported under-prescribing of antiemetic agents, an American multicenter retrospective study reported overprescribing of antiemetic agents. There is a paucity of literature on adherence to CANV management guidelines in Nigeria. Findings of a survey of oncology professionals suggest that inadequate facilities and complexity of guideline information were barriers to implementation of guidelines. Therefore, the objectives of this study were to describe the prescribing pattern of antiemetics for CANV, to assess their adherence to guidelines, and to determine the occurrence of CANV.
| Subjects and Methods|| |
A cross-sectional study was carried out at Jos University Teaching Hospital (JUTH), Jos, Plateau State, Nigeria.
Ethical clearance (Ref: JUTH/DCS/ADM/127/XXVIII/1265) was obtained from the Institutional Health Research Committee of JUTH.
Records of all adult patients (≥18 years) who received at least one cycle of intravenous (IV) or oral chemotherapy from January 1, 2015, to December 31, 2018, were eligible for inclusion.
Data were manually abstracted from the medical records into a data collection pro forma. Data collected included patients' demographic data, baseline cancer clinical data, details of the chemotherapy regimen, antiemetic regimen, as well as occurrences of nausea and vomiting.
Chemotherapy agents prescribed were classified into IV single-day, IV multiday, or per-oral (PO) multiday, depending on the route and schedule of administration. Anticancer agents prescribed were classified according to the emetic risk classes following the criteria of the National Comprehensive Cancer Network (NCCN) Harmonized Guidelines™ for Sub-Saharan Africa for Antiemesis Version 3.2018 [Appendix 1].
Study definition of guideline adherence closely followed the NCCN Harmonized Guidelines™ for Sub-Saharan Africa for Antiemesis version 3.2018[Appendix 2]. Prescribing specific antiemetic doses was not required for guideline adherence in line with the practice established in previous research and to allow for comparison with the past studies., Prescriptions with the recommended antiemetics for the recommended days were considered guideline adherent. Patients for whom there was no indication for antiemesis and did not receive antiemetics were also counted as guideline adherent. Prescriptions lacking recommended antiemetics for the recommended days or those containing nonrecommended antiemetics were considered guideline nonadherent. Excessive antiemetic prescribing, defined as prescribing of antiemetics without indication, prescribing more antiemetic agents than recommended or prescribing antiemetics for longer than the recommended period, was considered guideline nonadherence. Overall period guideline adherence was achieved when a patient received guideline adherent antiemetic prescriptions on the recommended days of both the acute and delayed phases.
Nausea and/or vomiting were considered to have occurred only when they were recorded in the patient's file.
The sample size formula for proportions with a finite population correction was used to calculate sample size. Assuming the prevalence of antiemetic guideline adherence to be 50%, with a precision of 7.5% and 95% confidence level, a minimum sample size of 153 was required.
The Statistical Package for the Social Sciences (SPSS) version 23 (IBM Corporation, Armonk, New York, United States) was used for data management.
The prescribing pattern of antiemetics was determined by counting the number of patients who received specific antiemetics and their combinations for prophylaxis. Antiemetics prescribed were matched with emetic risk of chemotherapy prescribed to show the indications for the antiemetics.
Guideline adherence was determined by counting the number of patients who received guideline adherent antiemetic prescriptions as prophylaxis for the acute-phase, delayed-phase, and overall period.
The number of patients who experienced nausea and/or vomiting was counted for inpatients only. Outpatients were excluded from this analysis because they were not available for observation; thus, records of CANV occurrence in the hours following chemotherapy administration could not be found.
Corresponding percentages were computed for all the frequencies.
The association between the emetic risk of chemotherapy prescribed and CANV occurrence (any nausea or vomiting event) was determined. Association between guideline adherence and CANV occurrence was also determined. The Pearson's Chi-square test for independence or the Fisher's exact test was used as appropriate. A multivariate logistic regression model was built with CANV occurrence as the dependent variable, whereas overall period antiemetic guideline adherence (dichotomous), IV HEC (dichotomous), sex, and age were included as the independent variables. Statistical significance was achieved at a two-sided P < 0.05.
| Results|| |
A total population of 1418 patients had a presumed or confirmed cancer diagnosis, according to the records of the hospital within the study period. All of these were potential chemotherapy recipients. However, records of 706 patients could not be retrieved and only 712 records were available and assessed for eligibility. Of these, 547 did not receive chemotherapy and therefore were ineligible for inclusion in the study. Records of 165 patients who received chemotherapy were analyzed. [Table 1] shows demographic and clinical characteristics of the study participants.
|Table 1: Demographic and clinical characteristics of study patients (n=165)|
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Prophylactic antiemetic prescribing pattern
Out of the 165 patients analyzed, 129 patients (78.2%) and 50 patients (30%) received at least one prophylactic antiemetic agent in the acute-phase and delayed-phase, respectively. [Figure 1] shows the percentage distribution of individual antiemetic agents prescribed.
|Figure 1: Percentage distribution of antiemetic agents prescribed for acute phase and delayed phase chemotherapy-associated nausea and vomiting prophylaxis. Corticosteroids prescribed included dexamethasone, hydrocortisone and prednisolone|
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The combination of ondansetron and a corticosteroid was prescribed to 50 patients (38.8%) as antiemetic prophylaxis for the acute phase. Promethazine was prescribed with a corticosteroid to 21 patients (16.3%), whereas a three-drug combination of promethazine, a corticosteroid, and ondansetron was prescribed to five patients (3.9%) as acute-phase prophylaxis.
Among patients who received delayed-phase antiemetics (n = 50), the combination of promethazine and a corticosteroid was prescribed to 11 patients (22%) while five patients (10%) were prescribed for ondansetron with a corticosteroid.
Guideline adherence for chemotherapy-associated nausea and vomiting prophylaxis
The proportion of patients who received guideline adherent antiemetic prescriptions for prophylaxis was 23.6% (n = 39) for the acute-phase period, 20.6% (n = 34) for the delayed-phase period, and 17.6% (n = 29) for the overall period. Excessive antiemetic prescribing was observed in four patients (2.4%) in the acute phase and in three patients (1.8%) in the delayed phase. A total of 87 (64.0%) out of 136 patients who had an indication for delayed-phase antiemetic prophylaxis (single-day IV MEC or HEC; multiday IV MEC/HEC, minimal/LEC; multiday PO MEC/HEC) did not receive any antiemetics. Guideline adherence was high among patients who received IV or PO chemotherapy of minimal-to-low emetogenicity and low among patients who received IV or PO chemotherapy of moderate-to-high emetogenicity [Figure 2].
|Figure 2: Percent antiemetic guideline adherence by emetogenicity of prescribed chemotherapy agents and for the total study sample. IV = Intravenous, PO = Per-oral, MEC = Moderately emetogenic chemotherapy, HEC = Highly emetogenic chemotherapy, LEC = Low emetogenic chemotherapy, Minimal = Minimal emetic risk chemotherapy|
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Overall guideline adherence was 12.9% for the inpatient subgroup (n = 85) and 22.5% for the outpatient subgroup (n = 80).
The major reasons for guideline nonadherence in the acute phase were nonprescribing of NK-1RAs for patients who received single-day IV HEC or multiday IV MEC/HEC (n = 103, 62.4%); nonprescribing of corticosteroids for patients who received single-day IV MEC/HEC, multiday IV MEC/HEC (52 patients, 31.5%); nonprescribing of 5-HT3RAs for patients who received single-day IV HEC or MEC, IV multiday MEC/HEC, or multiday PO MEC/HEC (41 patients, 24.8%).
In the delayed phase, guideline nonadherence was majorly due to nonprescribing of NK-1RAs for 86 patients (52.1%) who received single-day IV HEC; nonprescribing of corticosteroids for patients who received single-day IV HEC or multiday IV MEC/HEC (73 patients, 44.2%); nonprescribing of 5-HT3RAs for patients who received multiday IV MEC/HEC or multiday PO MEC/HEC (n = 23, 13.9%); nonprescribing of either a corticosteroid or a 5-HT3RAs for 18 patients (10.9%) who received single-day IV MEC.
Chemotherapy-associated nausea and vomiting occurrence
Only inpatients (n = 85) were included for analysis of CANV occurrence. Seventeen patients (20%) experienced at least one episode of nausea or vomiting. Acute nausea occurred in four patients only (5%), while acute vomiting occurred in eight patients (9%). Delayed nausea occurred in two patients (2%), while delayed vomiting was present in 13 patients (15%). [Figure 3] shows the pattern of occurrence of various CANV categories. Receiving highly emetogenic IV chemotherapy was associated with higher CANV occurrence than receiving chemotherapy of other emetic risk classes (χ2 [1, N = 73] =5.0, P = 0.025). No association was found between overall guideline adherence and nonoccurrence of nausea or vomiting (P = 0.110, Fisher's exact test). On multivariate analysis, not receiving IV HEC was associated with significantly lower odds for CANV occurrence – odds ratio 0.228 (95% confidence interval 0.054–0.967; P = 0.045). Overall period guideline nonadherence was not significantly associated with CANV occurrence on multivariate analysis.
|Figure 3: Occurrence of chemotherapy-associated nausea and vomiting for in-patients (n = 85)|
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| Discussion|| |
In this study, the most prescribed antiemetic agents were ondansetron (75.2%), corticosteroids (61.2%), and promethazine (24.8%) for acute-phase prophylaxis; as well as corticosteroids (74%), ondansetron (34%), and promethazine (26%) for delayed-phase prophylaxis. Antiemetic guideline adherence was low for the acute-phase (23.6%), delayed-phase (20.6%), and overall periods (17.6%). Vomiting occurred in 9% and 15% of patients in the acute and delayed phases, respectively, while nausea occurrence both in the acute and delayed phases was very low (≤5%).
Despite the frequent prescribing of ondansetron and corticosteroids, a large proportion of patients did not receive these agents for acute- or delayed-phase prophylaxis, leading to low antiemetic guideline adherence and hence suboptimal CANV management. Observational studies carried out in India and South Korea have also reported higher prescribing rates for 5-HT3RAs and corticosteroids,, than those observed in the current study. Inadequate clinician knowledge on antiemetic prescribing is thought to have contributed to this difference. Promethazine prescribing in the current study was high despite lack of guideline recommendations to support its use for prophylaxis. Literature on prescribing of promethazine and other phenothiazines for CANV prophylaxis is scarce. Promethazine prescribing might have been high due to its relative low cost and availability as compared to other antiemetics.
The level of guideline adherence (17.6%) was low, indicating that transfer of guideline recommendations to practice was inadequate. Higher levels of guideline adherence ranging from 29% to 71% have been reported in the United States, Europe, and Iran.,,, Prescribing of NK-1RAs was relatively high in these studies and could have contributed to the observed difference in guideline adherence with the current study.
For patients who received single-day IV HEC or multiday IV MEC/HEC, guideline adherence and hence protection from CANV were very low because none of them were prescribed for NK-1RA or olanzapine. Aprepitant prescribing has been observed to be low in studies from Indian and Saudi Arabian tertiary centers, probably due to its high cost., Olanzapine has also been reported to be infrequently prescribed. From a general perspective, the cost of olanzapine at the study site was relatively high and could have contributed to its low prescribing rate.
Conversely, guideline adherence for patients who received chemotherapy of minimal or low emetogenicity, who have little or no requirement for antiemetic prescribing, was very high. Tavernier et al. reported similar findings from a prospective study conducted in France. Excessive prescribing of antiemetics in the current study was negligible unlike in reports from Japan and the United States where costly antiemetics were prescribed for patients who were receiving chemotherapy of low and minimal emetogenicity., Resources at the study site like other public hospitals in Sub-Saharan Africa tend to be scarce, hence the need to avoiding wasteful prescribing.
The proportion of patients who did not receive any antiemetic agent in the delayed phase despite having a clear indication for antiemesis was disproportionately high as compared to the acute phase. This shows that antiemetic prophylaxis for the delayed phase was neglected. A similar observation was made in an Italian multicenter prospective study where 30% of patients who needed antiemetics in the delayed phase did not receive any.
The occurrence of both acute and delayed nausea was very low (≤5%). Previous research has shown that nausea is highly occurring (42%) in patients receiving MEC and higher emetic risk chemotherapy who constituted the majority of patients in the current study. This study depended on archival records of clinicians' assessment notes to pick out nausea events. It is therefore possible that clinicians may have not probed for the presence of nausea in their patients, leading to under-reporting. A prospective study where nausea events will be recorded in real-time is required to confirm this observation.
In contrast to nausea, the occurrence of vomiting in both the acute and delayed phases was considerable and shows the extent of patient suffering as a result of CANV. Previous studies report similar levels of vomiting., As compared to nausea, vomiting was identified more frequently in the current study although literature shows that nausea is in fact more frequently occurring,,, further supporting the hypothesis that nausea was under-reported.
Patients receiving IV HEC experienced significantly more CANV than patients receiving other types of chemotherapy underscoring the need for appropriate antiemetic prophylaxis for this patient population. This observation is consistent with what has been reported in the past research.
Findings from this study suggest that antiemetic guideline adherence does not offer protection from CANV. However, prospective studies have shown that guideline adherence is associated with a significant reduction in CANV., This difference in findings could be explained by the retrospective cross-sectional design used in the current study, in which a large number of CANV events could have been missed precluding a proper assessment of the effect of guideline adherence. A prospective study is required to shed light on the effect of antiemetic guideline adherence on nausea and vomiting occurrence in a similar setting as the current study.
Strengths and weaknesses
This study shows a real-world picture of antiemetic management practices among patients receiving chemotherapy of all emetic risk classes used in practice including chemotherapy of low emetogenicity and PO chemotherapy which have not received adequate research attention. A weakness of this study was the inability to accurately determine the occurrence of nausea which could be attributed to the cross-sectional retrospective design. Prospective studies are needed to address this shortcoming.
| Conclusions|| |
The levels of guideline adherence in antiemetic management were low due to under-prescribing of 5-HT3RAs and corticosteroids, nonprescribing of NK-1RAs and olanzapine, and a neglect of antiemetic prophylaxis in the delayed phase. Notably, promethazine prescribing was frequent while excessive antiemetic prescribing was negligible. While vomiting occurrences were substantial, occurrences of acute and delayed nausea may have been under-reported. Strategies to enhance transfer of guideline recommendations to practice which include clinician education and use of chemotherapy order templates with prespecified antiemetics are needed to help improve management of CANV.
We acknowledge Mrs. Rifkatu Incham and Mr. Joro Christopher of the Health Records Department of JUTH for facilitating data collection. Pharm. Isaac Abah (Department of Pharmacy, JUTH) provided methodological support. The Faculty of Pharmaceutical Sciences headed by Prof. Ikoni Ogaji provided administrative support. Dr. Achei Beryl of the Ministry of Health, Kenya, is appreciated for assisting in reviewing and copy editing the final manuscript. Financial support in the form of research funds and university fees for Kelvin Manyega was provided by the Africa Centre of Excellence in Phytomedicine Research and Development (ACEPRD), University of Jos, Nigeria.
Financial support and sponsorship
This research was supported by a postgraduate studentship grant from the World Bank Sponsored ACEPRD, University of Jos, Nigeria.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]