scholarly journals Chemotherapy-Induced Nausea and Vomiting in Gastrointestinal Cancer Patients: Do We Need to Revisit Guidelines?

2020 ◽  
Vol 09 (04) ◽  
pp. 245-249
Author(s):  
Akhil Kapoor ◽  
Ashutosh Jain ◽  
Abhishek Sharma ◽  
Minit Shah ◽  
Shravan Chinthala ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Failure Rates ◽  
Moderately Emetogenic Chemotherapy ◽  
Eligibility Criteria ◽  
Antiemetic Prophylaxis ◽  
Gi Cancers ◽  
Low Emetogenic Chemotherapy

Abstract Purpose The objective of this study was to assess the proportion of patients developing chemotherapy-induced nausea and vomiting (CINV) after receiving chemotherapy for gastrointestinal (GI) cancers, despite receiving antiemetic prophylaxis (AEP) as per the standard guidelines. Patients and Methods Between April 2019 and March 2020, all patients planned for chemotherapy were eligible for enrolment in the study. The primary endpoint of the study was the assessment of complete response (CR) rates. Results Overall, 1,276 consecutive patients were screened for this study, while 738 patients fulfilling the eligibility criteria were included. A total of 23.2% of the whole cohort failed to achieve CR. Also, 28.2, 16.9, and 16.6% of patients receiving moderately emetogenic chemotherapy (MEC), low emetogenic chemotherapy (LEC), and high emetogenic chemotherapy (HEC), respectively, failed to achieve CR. The differences in failure to achieve CR was statistically significant between MEC and HEC (p < 0.001) groups. Among MEC group, there was no difference between those who received oxaliplatin (27.8%) versus nonoxaliplatin regimens (25.8%) in terms of failure rates (p = 0.613). Conclusion Approximately one-fourth of patients failed to achieve a complete response from CINV in GI cancers despite using guideline-based AEP. Patients receiving MEC had the highest failure rates suggesting a need to improve AEP in these patients.

A prospective analysis of chemotherapy-induced nausea and vomiting in gastrointestinal cancers: Results from a tertiary cancer center.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12111-12111
Author(s):  
Akhil Kapoor ◽  
Vikas S. Ostwal ◽  
Anant Ramaswamy ◽  
Prabhat Ghanshyam Bhargava ◽  
Sudeep Gupta ◽  
...  
Keyword(s):  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Cancer Center ◽  
Gastrointestinal Cancers ◽  
Eligibility Criteria ◽  
Tract Cancer ◽  
Antiemetic Prophylaxis ◽  
Common Diagnosis ◽  
Delayed Cinv

12111 Background: Chemotherapy-induced nausea and vomiting (CINV) is a bothersome side-effect associated with cancer chemotherapy which adversely impacts both quality of life and the ability to carry out the activities of daily living. This study was conducted to assess the proportion of patients developing CINV after receiving chemotherapy for gastrointestinal (GI) cancers, in spite of receiving antiemetic prophylaxis as per the standard guidelines. Methods: Consecutive patients with GI malignancy who had not received previous chemotherapy were eligible for enrollment in the study if they were scheduled to receive at least one cycle of chemotherapy. SPSS version 20 was used for all statistical calculations. Results: 701 patients fulfilling the eligibility criteria were included in this study, out of which 55.4% were males, median age was 51 years (range 22-77). Biliary tract cancer (34%) was the most common diagnosis followed by colorectal (30.2%) and gastric cancer (19.6%). As per MASCC guidelines, 22.1% patients received highly emetogenic chemotherapy, 56.0% moderately emetogenic chemotherapy (MEC) while 19.9% received regimen with low emetogenicity. Failure to achieve complete response (CR, absence of acute and delayed CINV) was found in 27.4% patients. On separately analysing MEC group, overall CR was not achieved in 33.8% with failure in acute settings in 17.8% and delayed in 16.0% patients. Only significant factor for not achieving CR was use of oxaliplatin based chemotherapy (p = 0.018 for acute and p = 0.014 for delayed CINV). Conclusions: More than one fourth patients failed to achieve complete response for CINV in gastrointestinal cancers despite using prophylaxis as per standard guidelines. Use of oxaliplatin based therapy is an important factor for MEC causing CINV. There is urgent need to update the guidelines for prophylaxis in this setting. [Table: see text]

Efficacy and Safety of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin's Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 5196-5196
Author(s):  
Brian Choi ◽  
Gabriela Borsaru ◽  
Daniel Voisin ◽  
Gianluca Ballinari ◽  
Nicola Di Renzo
Keyword(s):  
Adverse Events ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Negative Consequences ◽  
Efficacy And Safety ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Prophylaxis ◽  
Secondary Endpoints ◽  
Hodgkin's Lymphomas

Abstract Abstract 5196 Background: Patients undergoing chemotherapy (CT) commonly receive repeated cycles of treatment. While chemotherapy-induced nausea and vomiting (CINV) can be a disruptive, unwanted side effect with negative consequences on patient quality of life, possible discontinuation of therapy, and associated increased health care resources, prevention of CINV in cycle 1 diminishes its potential in subsequent cycles. Therefore, optimizing antiemetic prophylaxis at initiation of CT is critical. Palonosetron (PALO), a potent 5-HT3 receptor antagonist (RA) with a distinctly different pharmacokinetic and receptor binding profile, has demonstrated improved CINV protection compared to older 5-HT3 RAs in multiple phase 3 and 4 single-CT-cycle clinical trials; however, few studies have evaluated PALO over multiple cycles of CT. Methods: This was a prospective, multicenter, single-arm study designed to assess the efficacy and safety of single IV doses of PALO 0.25 mg in preventing CINV in chemotherapy-naïve patients with Non-Hodgkin's Lymphomas (NHL) scheduled to receive at least 2 repeated, consecutive cycles of moderately emetogenic chemotherapy (CHOP, R-CHOP or ProMACE-CytaBOM). Corticosteroids were part of the CT regimen but not administered as an antiemetic. The primary efficacy endpoint was complete response (CR: defined as no emesis and no use of rescue medication) during the overall phase (0–120 h) following CT during each cycle. Secondary endpoints included CR during the acute (0–24 h) and delayed (24–120 h) time periods, as well as evaluation of proportion of emesis-free patients and nausea severity (according to a 100 mm VAS) during all 3 time intervals. The safety profile and adverse events were also assessed. Results: A total of 88 patients with either B-cell (91%) or T-cell (9%) NHL received PALO for a total of 317 CT cycles (mean 3.6; median 4). The majority of patients were white (99%) males (60%) with a mean age of 59.7 yrs who received either CHOP (47%) or R-CHOP (52%). CR rates during the acute, delayed and overall phases were sustained across the 4 CT cycles (Table). High proportions of patients remained emesis-free and experienced less than significant nausea (0 to <25 mm VAS) during the 5 days post-CT throughout repeated CT cycles (Table). PALO was well tolerated over repeated cycles, with few adverse events considered possibly/probably/definitely related (TRAEs: treatment related adverse events) (8% of patients; none serious). The incidence of the typically frequent TRAEs of headache and constipation was low (1% and 2%) and there were no unexpected or relevant differences in TRAEs between cycles or in later cycles (6%, 3%, 0%, 4% cycles 1–4, respectively). Conclusion: A single, fixed IV dose of palonosetron was shown to be safe and effective in preventing CINV over repeated chemotherapy cycles in patients with NHL. Disclosures: Voisin: Helsinn Healthcare: Employment. Ballinari:Helsinn Healthcare: Employment.

scholarly journals Management of chemotherapy induced emesis

2004 ◽  
Vol 12 (3) ◽  
pp. 173-176
Author(s):  
Fausto Roila
Keyword(s):  
Rescue Therapy ◽  
Emetogenic Chemotherapy ◽  
Delayed Emesis ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Drug ◽  
Acute Emesis ◽  
Antiemetic Prophylaxis ◽  
Minimal Emetogenic Chemotherapy ◽  
Low Emetogenic Chemotherapy ◽  
Important Progress

Important progress has been achieved in the last few years in the prevention of chemotherapy-induced nausea and vomiting thanks to the introduction in clinical practice first of the 5-HT3 antagonists and of the NK1 antagonists more recently. To prevent acute emesis induced by cisplatin, moderately emetogenic chemotherapy, a combination of aprepitant plus a 5-HT3 antagonist and dexamethasone is now the most efficacious regimen. For the prevention of delayed emesis induced by cisplatin, moderately emetogenic chemotherapy, a combination of dexamethasone plus aprepitant or metoclopramide or a 5- HT3 antagonist / dexamethasone or a 5-HT3 antagonist are the preferred antiemetic regimens. For the prevention of acute emesis induced by low emetogenic chemotherapy a prophylaxis with a single antiemetic drug such as dexamethasone is suggested while no antiemetic prophylaxis should be administered to prevent acute emesis induced by minimal emetogenic chemotherapy or to prevent delayed emesis induced by low or minimal emetogenic chemotherapy. In this last case a rescue therapy should be administered in patients presenting acute or delayed emesis.

scholarly journals Real-world evidence of NEPA, netupitant-palonosetron, in chemotherapy-induced nausea and vomiting prevention: effects on quality of life

2020 ◽  
Vol 16 (14) ◽  
pp. 939-953 ◽  
Author(s):  
Meinolf Karthaus ◽  
Gülten Oskay-Özcelik ◽  
Pia Wülfing ◽  
Carsten Hielscher ◽  
Dagmar Guth ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real World ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Moderately Emetogenic Chemotherapy ◽  
The Real ◽  
Beneficial Effects ◽  
Antiemetic Prophylaxis ◽  
Real World Setting

Aim: To determine quality of life, effectiveness and safety of oral netupitant-palonosetron (NEPA)–based antiemetic prophylaxis in the real-world setting. Materials & methods: Prospective, noninterventional study in adults receiving highly or moderately emetogenic chemotherapy and NEPA for three cycles. NEPA was administered per summary of product characteristics. Results: A total of 2429 patients enrolled, 2173 were evaluable. ‘No impact on daily life’ due to vomiting was reported by 85%/82% of patients in the highly emetogenic chemotherapy/moderately emetogenic chemotherapy groups in cycle 1, with rates of 54%/59% for nausea. Overall, complete response rate was 89%/87%/75% in the acute/delayed/overall phases. NEPA was well tolerated. Conclusion: NEPA had beneficial effects on the quality of life of a heterogeneous group of cancer patients and was safe and effective in the real-world setting.

scholarly journals Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens

2015 ◽  
Vol 04 (01) ◽  
pp. 007-010 ◽  
Author(s):  
Sachin Hingmire ◽  
Nirmal Raut
Keyword(s):  
Rescue Medication ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Efficacy And Safety ◽  
Moderately Emetogenic Chemotherapy ◽  
Open Label ◽  
Highly Emetogenic Chemotherapy ◽  
Serious Adverse Events ◽  
Complete Control

Abstract Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian population with aprepitant containing regimens. Aims: The aim was to assess the Efficacy and Safety of Aprepitant for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy/moderately emetogenic chemotherapy (HEC/MEC) regimens. Settings and Design: Investigator initiated, multicentric, open-label, prospective, noncomparative, observational trial. Subjects and Methods: Triple drug regimen with aprepitant, palonosetron, and dexamethasaone administration was assessed for the prevention of CINV during acute, delayed, and the overall phase (OP) for HEC/MEC Regimens. The primary endpoint was complete response (CR; no emesis and no use of rescue medication) and the key secondary endpoint was the complete control (CC; no emesis, no rescue medication and no more than mild nausea) during the OP. Statistical Analysis Used: Perprotocol efficacy was analyzed for the first cycle with results represented in terms of CR/CC rates using descriptive statistics. Results: Seventy-five patients were included in the study with median age of 49.7 years and 89.7% being females. The CR rate (OP) for patients administered HEC or MEC regimens during the first cycle were 92% and 90.9%, respectively. Similarly, the CC rates (OP) were 75% and 90% for these regimens, respectively. 7 (9.2%) patients reported adverse drug reactions that were mild and transient with no reports of any serious adverse events. Conclusions: Use of aprepitant containing regimen for patients receiving HEC/MEC regimen resulted in significantly high CR and CC response rates, which further consolidate its potential role to improve patient quality of life and compliance to disease management.

scholarly journals Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer After Moderately Emetogenic Chemotherapy

2005 ◽  
Vol 23 (12) ◽  
pp. 2822-2830 ◽  
Author(s):  
David G. Warr ◽  
Paul J. Hesketh ◽  
Richard J. Gralla ◽  
Hyman B. Muss ◽  
Jørn Herrstedt ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Rescue Therapy ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Self Report ◽  
Moderately Emetogenic Chemotherapy ◽  
Breast Cancer Patients ◽  
End Point ◽  
Control Regimen

Purpose This is the first study in which the NK1-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. Patients and Methods Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide ± doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index–Emesis questionnaire. Results Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. Conclusion The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.

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