Improving Guideline-Congruent Care for Chemotherapy-Induced Nausea and Vomiting Prophylaxis in Pediatric Oncology Patients

PURPOSE Chemotherapy-induced nausea and vomiting (CINV) is a very common side effect of pediatric cancer therapy. High-quality, evidence-based, pediatric-specific guidelines for prophylaxis and treatment of CINV are available. At many centers, guideline-concordant care is uncommon. We formed a multidisciplinary quality improvement team to implement guideline-concordant care for CINV prophylaxis at our center. We present the results following the first year of our interventions. METHODS We planned and implemented a multipronged approach in three key phases: (1) developing and publishing an acute CINV prophylaxis pathway, (2) education of providers, and (3) updating the computerized provider order entry system. We used iterative, sequential Plan-Do-Study-Act cycles and behavioral economic strategies to improve adherence to guideline-concordant CINV prophylaxis. We focused on aprepitant usage as a key area for improvement. RESULTS At the beginning of the study period, < 50% of patients were receiving guideline-concordant CINV prophylaxis and < 15% of eligible patients were receiving aprepitant. After 1 year, more than 60% of patients were receiving guideline-concordant care and 50% of eligible patients were receiving aprepitant. CONCLUSION We describe the development and implementation of a standardized pathway for prevention of acute CINV in pediatric oncology patients. With a multidisciplinary, multifaceted approach, we demonstrate significant improvements to guideline-congruent CINV prophylaxis.

Efficacy of Granisetron in the Prevention of Nausea and Vomiting among Paediatric Oncology Patients Receiving Moderate to Highly Emetogenic Chemotherapy: A Single-Blinded, Non-Inferiority Trial

This single-blinded, non-inferiority trial was conducted over an 8-month period to examine the efficacy of intravenous granisetron at two differing doses in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV)among paediatric patients receiving moderate to highly emetogenic chemotherapy. Seventeen patients (9 males and 8 females) were recruited and randomly assigned to receive alternating granisetron dosages of 0.01 mg/kg and 0.04 mg/kg during each chemotherapy cycle. The severity of CINV during and three days post-completion of chemotherapy, as well as common side effects of granisetron were recorded. A total of 78 cycles of chemotherapy (38 cycles of 0.01 mg/kg and 40 cycles of 0.04 mg/kg) were evaluated. The median age of the study population was 5.2 years (interquartile range 25th, 3.8; 75th, 8.7). Patients’ diagnoses comprised of haematological malignancy, bone tumour and cerebral neoplasm. From this study, we demonstrated that intravenous (IV) granisetron 0.01 mg/kg was non-inferior to 0.04 mg/kg in terms of achieving a complete response for acute CINV. However, a similar observation was not seen in the post-treatment period analysis (delayed CINV). In conclusion, IV granisetron at 0.04 mg/kg/dose provides effective protection and prophylaxis of both acute and delayed CINV. Further study with a larger sample size may be required before a definite conclusion can be made with regards to efficacy of 0.01 mg/kg dose.

Chemotherapy-Induced Nausea and Vomiting Breast Cancer Patients from a Chinese Multicenter Prospective Longitudinal Observational Study

Aims: To assess the occurrence of Chemotherapy-induced nausea and vomiting (CINV) after standard antiemetic therapy in the acute (24 h post-chemotherapy) and delayed (2&ndash;5 days post-chemotherapy) phases, as well as to identify risk factors for CINV in the acute and delayed phases. Methods: This prospective longitudinal and observational study analyzed the data of 400 breast cancer patients scheduled for chemotherapy over two cycles in two hospitals. The self-report survey was developed to assess the occurrence of CINV and their associated factors. CINV was evaluated with a Multinational Association of Supportive Care in Cancer Antiemetic Tool (MAT) on days 2 and 6 of chemotherapy. The incidence of acute and delayed CINV were presented by frequency and percentage. Generalized equation estimates (GEE) was used to identify risk factors of acute and delayed CINV. Results: There were 400 evaluable patients with complete Round 1 data, 334 for Round 2 data. Among 400 patients, 29.8% and 23.5% experienced acute and delayed CINV, respectively. Risk factors associated with for acute CINV were pain/insomnia, history of CINV, history of motion sickness (MS), and highly emetogenic chemotherapy regimen, while history of MS, CINV history, number of completed chemotherapy cycle number &lt; 3, and the incidence of acute CINV were risk factors of delayed CINV (all p &lt; 0.05). Conclusions: The findings may help nurses working for Chinese population in identifying patients at risk for CINV and in planning effective program to reduce the occurrence of CINV.

Applicability of the National Comprehensive Cancer Network/Multinational Association of Supportive Care in Cancer Guidelines for Prevention and Management of Chemotherapy-Induced Nausea and Vomiting in Southeast Asia: A Consensus Statement

A meeting of regional experts was convened in Manila, Philippines, to develop a resource-stratified chemotherapy-induced nausea and vomiting (CINV) management guideline. In patients treated with highly emetogenic chemotherapy in general clinical settings, triple therapy with a serotonin (5-hydroxytryptamine-3 [5-HT3]) antagonist (preferably palonosetron), dexamethasone, and aprepitant is recommended for acute CINV prevention. In resource-restricted settings, triple therapy is still recommended, although a 5-HT3 antagonist other than palonosetron may be used. In both general and resource-restricted settings, dual therapy with dexamethasone (days 2 to 4) and aprepitant (days 2 to 3) is recommended to prevent delayed CINV. In patients treated with moderately emetogenic chemotherapy, dual therapy with a 5-HT3 antagonist, preferably palonosetron, and dexamethasone is recommended for acute CINV prevention in general settings; any 5-HT3 antagonist can be combined with dexamethasone in resource-restricted environments. In general settings, for the prevention of delayed CINV associated with moderately emetogenic chemotherapy, corticosteroid monotherapy on days 2 and 3 is recommended. If aprepitant is used on day 1, it should be continued on days 2 and 3. Prevention of delayed CINV with corticosteroids is preferred in resource-restricted settings. The expert panel also developed CINV management guidelines for anthracycline plus cyclophosphamide combination schedules, multiday cisplatin, and chemotherapy with low or minimal emetogenic potential, and its recommendations are detailed in this review. Overall, these regional guidelines provide definitive guidance for CINV management in general and resource-restricted settings. These consensus recommendations are anticipated to contribute to collaborative efforts to improve CINV management in Southeast Asia.

Phase III study of palonosetron (PALO) given as 30-min IV infusion (IV inf) versus 30-sec IV bolus (IV bol) for prevention of chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy (HEC).

227 Background: PALO (0.50 mg), a distinctive second-generation 5-HT3 receptor antagonist (RA), is a component of the oral fixed combination agent NEPA, the second component being the NK1 RA netupitant. Oral NEPA is approved for acute and delayed CINV prophylaxis after moderately (MEC) and HEC. This study was conducted in support of the NEPA IV formulation (0.25 mg PALO + 235 mg fosnetupitant) administered as a 30-min IV inf, currently under FDA review. Methods: Chemotherapy-naive patients (pts) with solid tumors were randomized (1:1) to receive a single 0.25-mg PALO as a 30-min IV inf or a 30-sec IV bol, 30 min before reference HEC (cisplatin; dacarbazine), with oral dexamethasone (20 mg [D1]; 8 mg BID [D2–4]) (NCT02557035). Primary objective: noninferiority (NI; lower limit of the 99% CI to be > –15% [prespecified NI margin]) in complete response (CR; no emesis/no rescue) in the acute (0–24 h) phase. Secondary objective: safety. Results: 440 pts (median age 59.4 y [25–79]; cisplatin: 97.3%; dacarbazine: 2.7%) were randomized to IV inf (n=225) or IV bol (n=215). Baseline characteristics were similar. Acute CR rate was 82.7% (IV inf) and 86.5% (IV bol), with risk difference of –3.8% (99% CI: –12.2; 4.7) meeting the primary objective of NI. Treatment-emergent AE and study drug-related AE frequency was similar in both arms (Table). One PALO IV inf patient with pre-existing cardiac symptoms, experienced 1 serious AE that eventually lead to death and was considered possibly study drug-related by the investigator. No G≥3 infusion site reactions occurred. No patient in IV inf arm had infusion interruptions. Conclusions: PALO IV inf was noninferior to IV bol in acute CINV prevention after receiving non-AC HEC. Safety profiles were similar. No specific infusion toxicities were observed. The results show that PALO 0.25 mg IV inf is appropriate for the NEPA IV formulation. Clinical trial information: NCT02557035. [Table: see text]

Chemotherapy induced nausea and vomiting in breast cancer treated with antiemetic prophylaxis as recommended by the ASCO antiemesis guidelines.

10109 Background: Current ASCO Antiemesis Guidelines recommend triple antiemetic therapy (a 5HT3RA, an NK1, and dexamethasone) to prevent chemotherapy (CT) induced nausea and vomiting (CINV) in patients undergoing highly emetogenic chemotherapy (HEC). This study evaluated whether this regimen resulted in reduced rates of CINV in patients diagnosed with breast cancer (BC) and initiated on HEC. The primary outcomes of interest were rates of acute and delayed CINV in patients whose antiemesis prophylaxis was or was not in accordance with the ASCO guideline (i.e., Per-guideline vs. Non-Guideline). Costs of treating CINV were also calculated. Methods: Patients were identified in the Premier Healthcare database, a complete geographically diverse census of inpatients and hospital-based outpatients. Adults treated for BC with HEC during the years 2012-14 were identified and stratified based on their antiemesis prophylaxis. Rates of acute (day of CT) and delayed CINV (days 2-7 post CT) were calculated following initiation of HEC. CINV was defined by ICD9 codes for nausea and vomiting or volume depletion/dehydration or use of a rescue antiemetic. Rates of CINV and health care costs were then compared between the two cohorts. Results: A total of 8,388 patients were included in the analysis. Of these, 5,447 (65%) had treatment Per-Guideline and 2,941 (35%) were Non-Guideline. For acute CINV, Per-Guideline patients had a significantly lower rate of CINV when compared to Non-Guideline patients (1.7% vs. 3.2%, respectively, p < .001). Similarly, in delayed CINV Per-Guideline patients had significantly lower rates of CINV when compared to Non-Guideline patients (15.4% vs. 19.1%, p < .001). Patients who experienced CINV also had significantly greater total health care costs versus those without CINV ($32,199 vs. $20,163, respectively, p < .001). Conclusions: The results showed adherence to the ASCO Antiemesis Guidelines led to lower rates of CINV and lower costs. Although defining CINV by claims may tell an incomplete story, this study suggests that following the ASCO Antiemesis Guidelines may help both patients and payers of health care costs.

A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting

Purpose. This study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR).Methods. Patients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy). The pharmacokinetics and pharmacodynamics using RINVR were evaluated.Results. Seventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively.Tmax(h),Cmax(ng/mL), andAUClast(ng·h/mL) were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%), two patients (14.3%), and one (5.6%) patient and a delayed CINV on day 7 was found in eight (47%), three (21.4%), and five (27.8%) patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group) and also showed the tendency for decreasing moderate-to-severe CINV.Conclusions. This study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.

Prospective observational study on chemotherapy-induced nausea and vomiting (CINV) for colorectal cancer patients by the CINV study group of Japan.

652 Background: The aim of this study is to investigate the incidence of Chemotherapy Induced Nausea and Vomiting (CINV) among moderately emetogenic chemotherapy-naive patients with colorectal cancer. We also assessed whether the medical staff accurately recognized the incidence of CINV in their own practices. Methods: A prospective observational study of patients receiving the first cycle of oxaliplatin or irinotecan-based chemotherapy was performed. A 7-day diary for CINV was provided to the patients prior to chemotherapy to record daily incidence of CINV. Observed incidence rates of acute (day1) and delayed (days 2-7) CINV were compared with medical staff's predictions. Results: A total of 191 patients (110 males and 81 females) were registered during the period from April 2011 to December 2012. All patients were treated with oxaliplatin-based (n = 175) or irinotecan-based chemotherapy (n = 16). Acute vomiting was observed in 4 patients (2.1%), while delayed vomiting was observed in 19 patients (10.0%). Acute nausea occurred in 14 patients (7.3%), while 63 patients (33%) were affected by delayed nausea. Irinotecan significantly induced acute nausea more frequently than oxaliplatin did (p = 0.019). The presence of motion sickness was significantly associated with the incidence of acute nausea (p < 0.001) and vomiting (p = 0.003). Antiemetics were given along the guideline to all patients. 58 patients were administered a neurokinin-1 (NK1) receptor antagonist. Patients with NK-1 receptor antagonist showed significantly less incidence of delayed vomiting than patients without one (3% vs 13%, p = 0.048). 30 patients (15.7%) required rescue antiemetics. The staff had estimated the incidence of acute CINV in 91 patients (47.6%). However, only 14 patients (7.3%) really experienced acute CINV. Conclusions: CINV seems to be controllable with appropriate management, but delayed CINV still remains an important problem to be targeted. The presence of motion sickness should be affected by efficient antiemetic management. The extent of CINV in this patient group seems to be overestimated.

Terapi Akupresur Dapat Menurunkan Keluhan Mual Muntah Akut Akibat Kemoterapi Pada Pasien Kanker: Randomized Clinical Trial

AbstrakAkupresur merupakan salah satu terapi komplementer pada pasien yang mengalami mual muntah akut akibat kemoterapi.Tujuan riset ini untuk membuktikan pengaruh akupresur terhadap mual muntah akut pada pasien kanker di dua RS di Jakarta.Penelitian ini merupakan randomized clinical trial dengan metode single blind. Pengambilan sampel dengan cara consecutivesampling dan penentuan kelompok intervensi dan kontrol dengan randomisasi alokasi subjek sederhana. Sampel penelitianberjumlah 44 responden, terdiri dari 22 responden sebagai kelompok intervensi yang dilakukan terapi akupresur sebanyak tigakali sehari, dan 22 responden sebagai kelompok kontrol. Pengujian perbedaan penurunan rerata skor mual, muntah, dan mualmuntah pada kelompok intervensi dan kelompok kontrol menggunakan uji T test. Hasil penelitian menunjukkan penurunanrerata mual muntah akut setelah akupresur pada kelompok intervensi signifikan lebih besar dibanding dengan kelompok kontrol(p= 0,000; α= 0,05). Akupresur secara signifikan dapat menurunkan mual muntah akut akibat kemoterapi pada pasien kankeryang dilakukan akupresur dibandingkan dengan kelompok kontrol. Akupresur direkomendasikan dapat diterapkan sebagaibagian dari intervensi keperawatan dalam pemberian asuhan keperawatan pada pasien yang mengalami mual muntah akutakibat kemoterapi.Kata kunci: akupresur, kemoterapi, mual muntah akutAbstractAcupressure is one of the complementary theraphies for patients with acute chemotherapy-induced nausea and vomiting(CINV). The objective of the study was to prove the effect of acupressure to acute CINV on patients with cancer at two hospitalsin Jakarta. The research used randomized clinical trial with single blind method. A consecutive sampling was used as thesample collection method and simple randomization allocation subject was used to identify samples in the intervention orcontrol group. The number of samples was 44 respondents, consisted of 22 subjects who were given an acupressure theraphy,three times a day; and the remaining was the control group. A t-test was used to examine the differences of the mean nauseaand vomiting scores between the intervention and control groups. The result indicated that there is a signifant decrease of themean acute nausea and vomiting scores after acupressure between the two groups (p= 0.000; α= 0.05). It was concluded thatthe acupressure can significantly decrease acute CINV on patients with cancer in the intervention group if compared withcontrol group. Based on the findings, recommendation is directed to hospital management especially nursing management toapply acupressure as a nursing intervention to patients with acute CINV.Keywords: acupressure, chemotherapy, acute nausea and vomiting