scholarly journals Unscheduled hydrations: redefining complete response in chemotherapy-induced nausea and vomiting studies

2020 ◽  
Author(s):  
Rudolph M Navari ◽  
Eric J Roeland

Breakthrough chemotherapy-induced nausea and vomiting (CINV) is nausea and/or vomiting occurring within 5 days of chemotherapy administration despite using guideline-directed prophylactic antiemetic agents. It is highly prevalent (30–40%), usually requiring immediate treatment or “rescue” medication. If breakthrough CINV occurs, antiemetic guidelines recommend using an antiemetic agent from a different class not used in prophylaxis, along with intravenous hydration and/or dexamethasone. Data supporting these guideline recommendations are limited. Importantly, costs associated with breakthrough CINV can be substantial (i.e., unscheduled hydrations). Two retrospective analyses evaluating guideline-adherent CINV prophylaxis suggest that the initial antiemetic selection may decrease breakthrough CINV. Here we review optimal CINV prophylactic strategies and introduce unscheduled hydration as a potential important surrogate for breakthrough CINV aligning with cost-effective cancer care.

2001 ◽  
Vol 36 (3) ◽  
pp. 280-308 ◽  
Author(s):  
Shantel Mullin ◽  
M. Christina Beckwith

Credit This lesson is good for 0.3 CE units, with a passing grade of 70%. Goal The goal of this program is to inform the participant about cost-effective ways to prevent, identify, and manage nausea and vomiting induced by antineoplastic agents. Objectives At the completion of this program the participant will be able to: 1. List antineoplastic agents associated with a high incidence of nausea and vomiting. 2. Identify patient-specific risk factors for developing chemotherapy-induced nausea and vomiting (CINV) and how these factors may influence treatment of this syndrome. 3. Compare the three major types of CINV, including the pathophysiologic mechanism, time of onset, and symptom duration of each type. 4. Explain the mechanism of action and appropriate place in therapy for each type of antiemetic agent. 5. Differentiate between pharmacologic regimens for the prevention and treatment of CINV in adults. 6. Identify drug-specific factors that must be considered when developing a formulary management strategy for the antiemetic agents. 7. Describe specific information that the pharmacist can share with patients to help them understand and manage CINV.


2001 ◽  
Vol 36 (3) ◽  
pp. 280-305 ◽  
Author(s):  
Shantel Mullin ◽  
M. Christina Beckwith

Credit This lesson is good for 0.3 CE units, with a passing grade of 70%. Goal The goal of this program is to inform the participant about cost-effective ways to prevent, identify, and manage nausea and vomiting induced by antineoplastic agents. Objectives At the completion of this program the participant will be able to: 1. List antineoplastic agents associated with a high incidence of nausea and vomiting. 2. Identify patient-specific risk factors for developing chemotherapy-induced nausea and vomiting (CINV) and how these factors may influence treatment of this syndrome. 3. Compare the three major types of CINV, including the pathophysiologic mechanism, time of onset, and symptom duration of each type. 4. Explain the mechanism of action and appropriate place in therapy for each type of antiemetic agent. 5. Differentiate between pharmacologic regimens for the prevention and treatment of CINV in adults. 6. Identify drug-specific factors that must be considered when developing a formulary management strategy for the antiemetic agents. 7. Describe specific information that the pharmacist can share with patients to help them understand and manage CINV.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 44-45
Author(s):  
Meinolf Karthaus ◽  
M O Zahn ◽  
B Tschechne ◽  
B. Gerber ◽  
S Haas ◽  
...  

Introduction: Chemotherapy-induced nausea and vomiting (CINV) is a common and distressing side effect that has a detrimental impact on QoL. For pts receiving highly emetogenic chemotherapy (HEC), which includes those on anthracycline-cyclophosphamide (AC)-based regimens, a triple combination of a neurokinin-1 receptor antagonist (NK1 RA), a 5-hydroxytryptamine-3 (5-HT3) RA and dexamethasone is recommended by the NCCN and MASCC/ESMO. The complexity of the NK1 RA-based schedules may be a reason for the low adherence to antiemetic guidelines and a not sufficient control of CINV in pts receiving HEC and MEC. NEPA is the only available fixed-combination antiemetic. It is composed of an NK1 RA, netupitant (300 mg) and a 5-HT3 RA, palonosetron (0.50 mg); thus, it acts by blocking two main emetic pathways in a single dose and eases compliance to guidelines. Methods: Prospective, non-interventional study at 162 sites in Germany from 09/2015 to 03/2018. The aim was to determine QoL of adult cancer pts receiving NEPA for the prevention of nausea and vomiting associated with 1 or 2 day HEC or MEC in daily clinical practice. The primary outcome was measured via the Functional Living Index-Emesis (FLIE) questionnaire. FLIE questionnaires were analyzed according to the FLIE scoring and administration manual v12; higher scores correlated to better performance on daily life activities due to the lower occurrence of nausea and vomiting. 'No impact on daily life (NIDL) activities' for individual nausea and vomiting domains was defined as a FLIE score higher than 53.8; NIDL for the combined domains of nausea and vomiting was defined as a FLIE score higher than 108. Secondary objectives included evaluating effectiveness, as determined by measuring the rate of complete response (CR) and rescue medication, as well as safety outcomes. Efficacy was documented by the treating physicians and via patient diaries for 3 Ctx cycles within 24 hrs and on 4 additional d after Ctx. Safety, additional medication and physicians' overall satisfaction was reported via eCRF. Results: A total of 2429 pts were enrolled, 2405 of whom were assessed for eligibility; of these, 2173 were included in the final analysis and constitute the full analysis set population (FAS). Evaluable FLIE questionnaires were collected from 1886 (88%) pts in cycle 1, 1795 (88%) pts in cycle 2 and 1698 (86%) pts in cycle 3. A total of 1389 pts received HEC and 764 MEC in cycle 1. The majority of pts (91%) were scheduled to receive 1-day ctx at study entry. More than half of the pts (1230, 56%) received anthracycline/cyclophosphamide-(AC), 19% carboplatin-, 8% cisplatin-, 7% oxaliplatin- and 9% other CTs. NIDL due to vomiting during cycle 1 was reported by 84% of pts in the HEC group and 82% in the MEC group. These frequencies were maintained in cycles 2 and 3. NIDL due to nausea increased from 54% in cycle 1 to 58% in cycle 3 for pts receiving HEC, and from 59% in cycle 1 to 66% in cycle 3 for pts in the MEC group. The rates for the combined domain of NIDL due to nausea and vomiting were consistent across cycle 1 (64%) and in cycles 2 and 3 (66% in each cycle) for pts in the HEC group, while the rates increased from 67% in cycle 1 to 73 and 74% in cycles 2 and 3, respectively, for pts receiving MEC. The CR rate (no emesis and no use of rescue medication) was 89% in the acute phase (0-24 h), 87% in the delayed phase (25-120 h) and 83% in the overall period (0-120 h) in cycle 1. The no significant nausea (NSN) rate was 79 % in the acute, 75 % in the delayed and 67 % in the overall phase in cycle. The majority of physicians (≥89%) and pts (≥86%) rated the effectiveness of NEPA prophylaxis as 'very good' or 'good' during all three ctx cycles. The most common NEPA-related AEs, which occurred in >1% of pts in the overall study period, were fatigue (3%), constipation (3%), nausea (2%) and insomnia (2%). There were no reports of NEPA-related deaths. Conclusions: Real-life data show that NEPA was effective in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. NEPA had beneficial effects on the quality of life and was highly effective in the acute and delayed phase of HEC and MEC. NEPA antiemetic effectiveness was rated highly both by patients and physicians. Disclosures Karthaus: RIEMSER: Consultancy, Honoraria. Schilling:Riemser: Honoraria.


2016 ◽  
Vol 4 (1) ◽  
pp. 46-51 ◽  
Author(s):  
Florence Van Ryckeghem

AbstractChemotherapy-induced nausea and vomiting (CINV) remains one of the most disturbing side effects of cancer treatment. Research in antiemetic therapy has progressed gradually since the early eighties, and the development of antiemetic agents continues. This review focuses on the current management of CINV based on the most recent guidelines, and adherence to the latter is examined more carefully. Setrons (5HT3 receptor antagonists), corticosteroids, and NK-1 receptor antagonists are the cornerstones of antiemetic therapy. Corticosteroids are one of the oldest agents in the prevention of CINV. They are highly effective, increase the effect of other antiemetic agents, and are cost-effective. The latest developed 5HT3 receptor antagonist palonosetron led to an update of the guidelines of CINV. Other types include benzodiazepines, cannabinoids, and olanzapine. Various factors contribute to the overall risk of developing CINV, such as patient characteristics, emetogenic potency of the chemotherapeutic agents, and correct prevention of CINV. Current guidelines determine which is the right preventive regimen for each cancer patient at risk for experiencing CINV. Adherence to these guidelines and implementation in daily practice seem to be below the optimal level. In Belgium, authorities use the guidelines as a base for reimbursement and this has increased the level of implementation.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20573-e20573 ◽  
Author(s):  
G. Bernardo ◽  
R. Palumbo ◽  
M. Frascaroli ◽  
A. Bernardo ◽  
A. Losurdo ◽  
...  

e20573 Background: Chemotherapy(CT)-induced nausea and vomiting (CINV) are common adverse effects in cancer patients. The control of CINV is a relevant objective for the patient's quality of life and also aims to optimize cancer treatment. 5-HT3- receptor antagonists (RAs) are commonly used to prevent CINV. Palonosetron, the only second generation 5-HT3-RA, has a significantly longer half-life and a higher binding activity than the first generation of 5-HT3RAs. Methods: To evaluate the activity, safety and farmacoeconomic profile of palonosetron compared to ondansetron as antiemetic prophylaxis for highly (HEC) or moderately (MEC) emetogenic chemotherapy, 235 consecutive chemo-naïve patients (pts) were assigned (1:1) to receive palonosetron 250 mcg i.v. plus dexamethasone 8 mg i.v. 30 min before CT on day 1 (Group A) or ondansetron 8 mg i.v. plus dexamethasone 8 mg i.v. on day 1, followed by 8 mg os twice daily over 3 days (Group B). Results: The 2 treatment groups were comparable with respect to tumour type (breast 52%, lung 20%, colorectal cancer 11%, ovarian 8%, head & neck 5%, other 4%) and emetogenic potential of CT (HEC in 78 pts, AC-based chemotherapy in 123, MEC in 35). FLIE questionnaires were completed on days 2–5. Complete response (CR) rate for the acute period was 82% in pts given HEC in group A versus 63.2% in group B, 93.4 % versus 80.6% in pts given AC and 100% versus 94.4% in pts given MEC. For the delayed period: 74.4% in group A versus 63.2% in group B for pts receiving HEC, 90.2% versus 71% in pts given AC and 94% versus 88.9% in pts given MEC. FLIE analysis showed a reduced impact of CINV on daily life in group A (p<0.05). The pharmacoeconomic evaluation showed favourable cost effectiveness profiles for palonosetron, with a saving of about 50% per cycle/per patient over ondansetron. A not significant reduced incidence of headache and constipation was observed in group A. Conclusions: Palonosetron was effective in preventing CINV following HEC, AC and MEC in both acute and delayed phases, as well as being cost effective. The CR rates were maintained throughout subsequent cycles of CT, with a significant positive impact on daily functioning and quality of life. No significant financial relationships to disclose.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9626-9626
Author(s):  
J. A. Boice ◽  
H. Schmoll ◽  
C. Brown ◽  
A. Taylor

9626 Background: Aprepitant (A) has been shown in a previous trial to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC) in breast cancer patients receiving cyclophosphamide and anthracycline. This study assessed A in patients with a variety of tumors receiving a broad range of MEC regimens. Methods: This Phase III, randomized, gender-stratified, double-blind, trial enrolled female and male patients ≥18 years old with confirmed malignancies naïve to MEC or highly emetogenic chemotherapy and scheduled to receive a single dose of 1 or more MEC agent. Patients received A triple-therapy regimen (A 125 mg, ondansetron [O] 8 mg b.i.d., and dexamethasone [D] 12 mg on Day 1 of chemotherapy, A 80 mg q.d. on Days 2–3) or a control regimen (O 8 mg b.i.d. and D 20 mg on Day 1, and O 8 mg q12h on Days 2–3) all administered orally. Episodes of vomiting, nausea, and rescue medication use were recorded in a patient diary. Tolerability was assessed by physical and lab examinations, and adverse event (AE) reporting. Primary and key secondary efficacy endpoints were proportions of patients with No Vomiting and Complete Response (no vomiting and no rescue medication use), respectively, during the 120 hours postchemotherapy. Results: Among 848 randomized patients, 77% were female while 52, 20, 13, and 5% of patients had breast, colorectal, lung, or ovarian cancer, respectively. Significantly more patients in the A group achieved No Vomiting and Complete Response (a difference of 14.1 &12.4 percentage points vs. control, respectively). The incidences of AEs were generally similar in the aprepitant (61.9%) and control groups (66.5%). Conclusions: The aprepitant regimen provided superior efficacy over the control regimen in the treatment of CINV in a broad range of patients receiving MEC in both No Vomiting and Complete Response endpoints. Aprepitant was generally well tolerated. [Table: see text] [Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24100-e24100
Author(s):  
Luo Cong ◽  
Mingge Shang ◽  
Lei Chen ◽  
Xu Qi ◽  
Li Jingjing ◽  
...  

e24100 Background: Chemotherapy-induced nausea and vomiting (CINV) is a common symptom in patients who undergoing chemotherapy, it is very important to control CINV to maintain dose intensity and patients' quality of life. To analyse the current situation of CINV for the tumor patients who undergoing chemotherapy, we used a cross-sectional survey to assess CINV status in those patients, and whether the drugs used by doctors in each department met the guidelines, and compared the efficacy of different antiemetic regimens on acute and delayed CINV overall post-chemotherapy periods. Methods: 1,000 patients were randomly selected from 5,468 patients with chemotherapy discharged from different departments of Zhejiang cancer hospital in China between April 1 and April 30, 2019, and there were 87 responses totally. Medical records were collected on patient’s department (internal medicine, surgery, radiotherapy, interventional), chemotherapy regimens, anti-vomiting program, etc. Patients' feedbacks were recorded by CTCAE4.03 standard using MASCC antiemetic tool (Mat). Participants reported the frequency, severity, and impact on daily life of CINV from the day of chemotherapy administration up to 5 days thereafter and nausea and vomiting, as well as pharmacologic and chemotherapy used. Results: A total of 66 antineoplastic drugs were investigated, of which 52 were given intravenously and 14 orally.There were 9, 7, 50 drugs with high, moderate and low emetic risk respectively.The most prescribed prophylactic regimens for the management of CINV were aprepitant, 5-HT3R, H1-RA and dexamethasone and metoclopramide. The overall incidence of CINV were 44.34%, 24.57% and 39.66% patients reported nausea or vomiting in the acute and delayed phases. 19.89% patients had both acute and delayed CINV. The consistency rate of antiemetic with guideline was 63.19% in internal medicine department, 61.41% in surgery department and 52.91% in radiotherapy department, which showed a significant gap between the actual use of drugs and the recommended guidelines(P = 0.001). In 875 patients, 518 patients received guideline recommended antiemetic regimen, the CINV rates of complete response (CR), defined as no vomiting with no rescue medication, were 61.58%. While the CR rates in other 357 patients were 47.06%(P < 0.001). Nausea was more frequent across the overall observation period (43.77% VS 18.86%). However, vomiting was more sever and had a greater impact on life than nausea. Conclusions: Overall, adherence to the guideline recommendations in different departments were poor with varying degrees. Future studies should set hard outcomes, such as the absence of any symptoms, as a primary end point. The standardized management of CINV in patients need to be further strengthened and doctors need to use drugs more regularly to reduce the occurrence of CINV in patients.


2017 ◽  
Vol 1 ◽  
pp. 5 ◽  
Author(s):  
Moawia M.A. Elhassan ◽  
Arwa A.S.A. Ali ◽  
Mohamed O.M. Elmustafa

<strong>Objective</strong>: To evaluate the adherence to American Society of Clinical Oncology (ASCO) guidelines for antiemetic prophylaxis of chemotherapy-induced nausea and vomiting and assess the outcomes of the prescribed antiemetic drugs.<br /> <strong>Methods</strong>: This prospective, observational study enrolled chemotherapy-naive cancer patients who were admitted to the National Cancer Institute between May and July 2015 for intravenous chemotherapy. Patient’s demographic data, chemotherapy protocols and types of antiemetic drugs were collected by reviewing patients’ files, chemotherapy prescription forms and interviewing the patients.<br /> <strong>Results</strong>: The data revealed that 90% of pre-chemotherapy antiemetic prescriptions did not adhere to antiemetic guidelines. The trends of non-adherence included an overuse of ondansetron (14%), under-prescribing of dexamethasone (16%) and corticosteroid duplication (14%). Regarding antiemetic use for the prevention of delayed emesis, the data showed that 90% of antiemetic prescriptions were non-adherent with ASCO guidelines, with overuse of ondansetron (20%) and metoclopramide (37%) and lack of dexamethasone prescriptions (80%) on days 2 and 3 being the most frequently reported trends. The percentage of patients with complete response (no emesis or rescue therapy) over 5 days post chemotherapy was 36%.<br /> <strong>Conclusion</strong>: The study indicated an extremely low adherence rate to ASCO guidelines for antiemetic prophylaxis of chemotherapy-induced nausea and vomiting. Non-adherence included a trend of both underuse and overuse of indicated antiemetic medications.


Author(s):  
Yoshinori Wakasugi ◽  
Satoshi Noda ◽  
Yoshihiro Ikuno ◽  
Miya Horie ◽  
Katsuyuki Kito ◽  
...  

Abstract Background Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) regimen includes a high dose of prednisolone (100 mg/body), which exhibits an anticancer and antiemetic effect. However, its optimal use for antiemetic therapy has not been established yet. We assessed the efficacy of granisetron plus aprepitant versus granisetron for CHOP or rituximab-CHOP (R-CHOP) regimen-induced nausea and vomiting in malignant lymphoma. Methods This retrospective and observational clinical study included patients who received CHOP or R-CHOP regimen as initiating chemotherapy between July 2010 and March 2016 (N = 39). Patients were assigned to an aprepitant [aprepitant (125 mg on day 1, 80 mg on days 2–3) plus granisetron (3 mg); n = 15] or control regimen group [granisetron (3 mg); n = 24]. Complete response (CR), defined as no vomiting and no use of rescue therapy during overall phase (0–120 h), was the primary endpoint. Secondary endpoints included the time to first vomiting and using rescue medication and complete protection (CP) defined as no vomiting and no retching and/or no nausea and no rescue therapy. The patient records were investigated, and data were retrospectively analyzed. Results CR rate CP rates did not significantly differ between the groups during the observation period (80.0% versus 83.3%, p = 1.000; and 80.0% versus 79.2%, p = 1.000, respectively). Additionally, the time to first vomiting and using rescue medication in did not significantly differ between the groups (p = 0.909). Conclusions This study suggests that granisetron alone could be one treatment option in the management of CINV in patients with non-Hodgkin lymphoma receiving CHOP or R-CHOP regimen.


BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Semjon Willier ◽  
Karin Melanie Cabanillas Stanchi ◽  
Martina von Have ◽  
Vera Binder ◽  
Franziska Blaeschke ◽  
...  

Abstract Background Chemotherapy-induced nausea and vomiting (CINV) belong among the most burdensome side effects in hemato-oncology. Mostly, a combination of ondansetron and dexamethasone is used as antiemetic prophylaxis in pediatric patients undergoing emetogenic chemotherapy. However, dexamethasone is prohibited in different pediatric chemotherapy protocols. Currently, data on the use of ondansetron with the new antiemetic agent fosaprepitant without dexamethasone is not available for pediatric patients. Methods In this non-interventional observation study, 79 pediatric patients with a median age of 8.0 years (range 0.5–17.9 years) who received a CINV prophylaxis regimen with either fosaprepitant (4 mg/kg; maximum 150 mg) and ondansetron (as 24-h continuous infusion) (n = 40; fosaprepitant group/FG) or ondansetron only (n = 39; control group/CG) during moderately or highly emetogenic chemotherapy were analyzed. The groups were analyzed and compared for frequency of vomiting, administered doses of on-demand antiemetic dimenhydrinate and adverse events during the acute (0-24 h after chemotherapy administration) and delayed (> 24 h–120 h) CINV phases. Results A total of 112 and 116 chemotherapy blocks were analyzed in the fosaprepitant and the control group, respectively. The emetogenic potential of the administered chemotherapy did not significantly differ (p = 0.8812) between the two cohorts. In the acute CINV phase, the percentage of patients experiencing vomiting (n = 26 patients) and the vomiting events were significantly higher (p = 0.0005 and p < 0.0001, respectively) in the CG (n = 26 patients (66.7%); 88 events) compared with the FG (n = 10 patients (25.0%); 37 events). In the delayed CINV phase, the percentage of patients experiencing vomiting and the vomiting events were also significantly higher (p = 0.0017 and p < 0.0001, respectively) in the CG (n = 31 patients (79.5%); 164 events) compared with the FG (n = 17 patients (42.5%); 103 events). Additionally, significantly more dimenhydrinate doses were administered in the CG compared with the FG patients (n = 322/n = 198; p < 0.0001). The occurrence of adverse events did not significantly differ between the two groups (p > 0.05). Conclusion Fosaprepitant (4.0 mg/kg) in addition to ondansetron, without application of dexamethasone, was well tolerated, safe, effective and superior to ondansetron only as CINV prophylaxis in pediatric patients during moderately and highly emetogenic chemotherapy.


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