Netupitant-palonosetron (NEPA) for Preventing Chemotherapy-induced
Nausea and Vomiting: From Clinical Trials to Daily Practice

Aapro, Matti; Jordan, Karin; Scotté, Florian; Celio, Luigi; Karthaus, Meinolf; Roeland, Eric

doi:10.2174/1568009622666220513094352

Cited by 6 publications

(7 citation statements)

References 65 publications

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“…Severity of nausea assessment also reported, NSN (≤25 mm) in 92.38% (n = 327) patients, with 77.97% (n = 276) patients reporting no nausea. The NSN was 60-78% in other real-world studies with NEPA [ 15 , 16 ]. The conventional oral anti-emetic regimen containing aprepitant resulted in no significant nausea in 70-73% of patients, as reported in three randomized controlled trials with cisplatin-based regimens [ 17 - 19 ] and 61% in an anthracycline and cyclophosphamide-based regimen study [ 20 ].…”

Section: Discussionmentioning

confidence: 78%

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India

Gupta,

MV,

Thomas

et al. 2024

Cureus

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Background Chemotherapy-induced nausea and vomiting is a common and unpleasant treatment-related side effect reported by cancer patients receiving chemotherapy. Akynzeo® or NEPA (NEtupitant + PAlonosetron) is the first fixed combination of netupitant and palonosetron that targets both critical pathways involved in emesis while providing a convenient, single oral dose therapy. The current study aimed to assess the effectiveness and safety of NEPA in a real-world setting in India. Methodology This was an open-label, multicenter, prospective, single-arm study conducted at six different locations across India. The study included patients of either gender, aged ≥18 years, naive to chemotherapy, scheduled to receive highly or moderately emetogenic chemotherapy (HEC/MEC), and scheduled to receive oral NEPA, as determined by the investigator. Results A total of 360 people were screened and enrolled in the study. HEC was prescribed to 289 (81.64%) patients, while MEC was prescribed to 65 (18.36%) patients. Complete response was achieved in 94.92% of patients during the acute phase, 95.20% during the delayed phase, and 93.22% during the overall phase. During the overall phase, 92.73% and 95.38% of patients on the HEC and MEC regimens, respectively, achieved complete response. Adverse events were reported in 3.88% of patients. Conclusions Oral NEPA was found to be effective in the Indian real-world setting, eliciting a >90% complete response with HEC and MEC regimens across the acute, delayed, and overall phases.

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Section: Discussionmentioning

confidence: 78%

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India

Gupta,

MV,

Thomas

et al. 2024

Cureus

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“…A posthoc pooled analysis of phase 3 study conducted by Aapro et al demonstrated that NEPA when received orally had significant superiority in nausea control during the delayed and overall periods compared with palonosetron in the cisplatin and Doxorubicin and Cyclophosphamide (AC) based settings and a considerable advantage compared with aprepitant-based regimens in non-AC-based HEC [ 15 ]. Three pivotal, multicentre, randomized, double-blind and registration studies focusing on cisplatin-based highly HEC, who either received a single oral dose of NEPA plus dexamethasone before chemotherapy or aprepitant-based regimen (APR), showed delayed phase had notable differences in response rates between patients treated with NEPA plus dexamethasone and those receiving APR, 5-HT3RA, and dexamethasone.…”

Section: Discussionmentioning

confidence: 99%

Retrospective Evaluation of a Dexamethasone Sparing Antiemetic Regimen: An Antiemetic Prophylaxis Study on NEPA (Netupitant Plus Palonosetron) for Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in Cancer Patients

Agre,

Pol

et al. 2023

Cureus

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Background Corticosteroids, specifically dexamethasone (DEX), have been extensively utilized for the prevention of chemotherapy-induced nausea and vomiting (CINV). However, their usage is associated with a range of adverse events. In contrast, the combination of Netupitant Plus Palonosetron (NEPA) with a single dose of DEX provides comparable efficacy in preventing CINV over a five-day period following chemotherapy administration. This regimen offers the advantage of reducing the need for additional doses of DEX, particularly in the high-risk setting of HEC (Highly emetic chemotherapy). Objective To evaluate dexamethasone sparing anti-emetic regimen (single dose dexamethasone with NEPA) for prophylaxis of CINV in patients receiving HEC. Methodology This is a retrospective, observational, real-world, single-center study including data of 69 patients who received high‐dose emetogenic chemotherapy and were administered DEX (8 or 12 mg) on day 1, with no dose of DEX on days 2, 3, and 4, combined with an oral combination of tablet netupitant 300 mg and palonosetron 0.5 mg. NEPA was taken orally an hour prior to the start of the HEC cycle. The primary efficacy endpoint was complete response (CR) which is defined as no nausea, emesis, or no rescue medication during the Acute (< 24 hours) and Delayed Phase (25-120 hours) of chemotherapy. Results The overall CR achieved in the acute and delayed phase for vomiting is 100% at all four follow-ups. The CR achieved in the acute phase is 95.7% whereas 98.6% of patients showed CR in the delayed phase respectively. No patient required any rescue medication. No acute and delayed phase of vomiting was reported. Conclusion A simplified regimen of NEPA plus single‐dose DEX offers effective CINV prevention throughout five days post‐chemotherapy with the advantage of sparing patients additional doses of DEX in the high-emetic‐risk setting chemotherapy.

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“…This activation signals the abdominal muscles, diaphragm, and stomach to trigger emesis via stimulating the dorsal vagal complex comprising the vomiting center. 2,3 Therefore, inhibiting both 5HT-3 and NK 1 receptors simultaneously can effectively reduce both acute and delayed CINV. International guideline committees also recommend the use of a combination of antiemetic drugs that target various molecular pathways linked to emesis as the established standard of care for preventing CINV.…”

Section: Introductionmentioning

confidence: 99%

“…Chemotherapy-induced nausea and vomiting (CINV) is a complex condition that can have a detrimental effect on a patient's health, causing electrolyte imbalance, dehydration, and malnutrition that can result in challenges with adherence to therapy, ultimately leading to suboptimal cancer treatment. 1 2 Based on the occurrence of the emesis, CINV is categorized into acute and delayed phases. Acute CINV triggers within 24 hours of the commencement of chemotherapy predominantly by serotonin release from enterochromaffin cells within the gastrointestinal tract.…”

Section: Introductionmentioning

confidence: 99%

“…Though the safety and efficacy of commercially available NEPA capsules have been evaluated across the globe in various clinical trials, adherence to the guidelines regarding the use of NEPA in clinical practice is suboptimal. 2 It has also been reported that results from these clinical trials of antiemetic drugs may not represent actual real-world data. Therefore, a retrospective study is required to evaluate the practical effectiveness of the recommended anti-emetic regimen for CINV.…”

Section: Introductionmentioning

confidence: 99%

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Generic Netupitant Plus Palonosetron and Dexamethasone for Prophylaxis of Chemotherapy-Induced Nausea and Vomiting (CINV) in Cancer Patients Receiving Highly or Moderately Emetogenic Chemotherapy: A Retrospective Study

Simhadri,

Dayyala,

Musinipally

et al. 2024

South Asian J Cancer

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Chemotherapy-induced nausea and vomiting (CINV) is a challenging adverse effect that is associated with deteriorating quality of life. Inhibiting neurokinin 1 and 5-hydroxytryptamine type 3 receptors involved in the major emesis pathways has significantly prevented CINV and is recommended as standard treatment in international antiemetic guidelines. This retrospective study was conducted to explore the efficacy of formulated netupitant (NE; 300 mg) and palonosetron (PA; 0.50mg) tablets with dexamethasone in patients receiving high and moderate emetogenic chemotherapy. A single dose of NE, PA, and dexamethasone was given 1 hour prior to the chemotherapy for 4 days. The key end-points were to assess complete response (CR), complete protection (CP), and complete control (CC) with no emesis, no nausea, and no use of rescue medication during acute (0–24 hours) and delayed phase (24–120 hours) of CINV. This study conducted on 212 patients showed overall rates of CR, CP, and CC as 97.5, 91.1, and 92.19%, respectively, in the acute phase and 95.09, 88.06, and 87.74% in a delayed phase. These patients underwent 1,387 cycles of chemotherapy involving both high emetogenic chemotherapy and moderate emetogenic chemotherapy regimens. A decrease in the rate of CR, CP, and CC from 93.47, 76.20, and 73.90% (acute phase) to 86.95, 69.67, and 67.37% (delayed phase) with highly emetogenic chemotherapy was observed, while the combination treatment achieved 100 CR, CP, and CC in both the acute and delayed phase with the moderately emetogenic chemotherapy regimen. Our study demonstrated the promising efficacy of the triple treatment with formulated NE and PA tablets in combination with dexamethasone in preventing and managing CINV in real-world settings.

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Netupitant-palonosetron (NEPA) for Preventing Chemotherapy-induced Nausea and Vomiting: From Clinical Trials to Daily Practice

Cited by 6 publications

References 65 publications

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India

An Open-Label, Single-Arm, Multicenter, Observational Study Evaluating the Safety and Effectiveness of Akynzeo® in the Management of Chemotherapy-Induced Nausea and Vomiting in India

Retrospective Evaluation of a Dexamethasone Sparing Antiemetic Regimen: An Antiemetic Prophylaxis Study on NEPA (Netupitant Plus Palonosetron) for Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in Cancer Patients

Generic Netupitant Plus Palonosetron and Dexamethasone for Prophylaxis of Chemotherapy-Induced Nausea and Vomiting (CINV) in Cancer Patients Receiving Highly or Moderately Emetogenic Chemotherapy: A Retrospective Study

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