Meeting
2024 ASCO Annual Meeting
An Indian real-world experience of intravenous fosnetupitant-palonosetron (IV NEPA) in preventing delayed and extended delayed CINV.
Authors
Hanmant V. Barkate
Glenmark Pharmaceuticals Ltd, Mumbai, India
Hanmant V. Barkate , Dr. Amullya Pednekar , Pragya Shukla , Shaunak Valame , Siddhartha Nanda , Abhinandan Hanji , Naval Kishore Shakya , Arun Kumar Verma , Sagar B Bhagat , Saiprasad Patil , Sumit Bhushan
Organizations
Glenmark Pharmaceuticals Ltd, Mumbai, India, Delhi State Cancer Institute, Delhi, India, Jawaharlal Nehru Cancer Hospital and Research Centre, Bhopal, India, All India Institute of Medical Sciences (AIIMS), Raipur, India, Hanji Cancer Hospital, Belgavi, India, Lakshya Cancer Hospital and Research Centre, Lucknow, India, Subharti Medical College and Hospital, Meerat, India, Glenmark Pharmaceuticals Ltd., Mumbai, India
Research Funding
Glenmark Pharmaceuticals Limited
Background: Although the reports suggest 15-25% cancer patients receiving highly- and moderately emetogenic chemotherapy (HEC and MEC) experience nausea and vomiting beyond day 5, majority of clinical trials focus on delayed chemotherapy induced nausea and vomiting (CINV) only during the first 5 days of treatment. Here we present a real world observational data with fixed combination of IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) in preventing nausea/vomiting in delayed and extended delayed phase among patients receiving HEC/MEC. Methods: An open label, single arm, multicentre, phase IV prospective trial was conducted at six centres following individual Institutional Ethics Committee approval (CTRI/2023/04/051951). Patients in acute (0-24hrs), delayed (>24-120hrs), extended delayed (>120-240hrs) phases and extended overall phase (0-240hrs) were assessed for complete response (CR) (no vomiting and no need of rescue medication), complete protection (CP) [CR + no significant nausea (5mm to <25mm) on visual analogue scale], complete control (CC) [CR + no nausea (<5mm)] and safety. Results: Among 178 patients (Males-114, Females-64), 90 (50.56%) received HEC and 88 (49.44%) received MEC regimen. Cisplatin-Paclitaxel (19.10%) and Carboplatin-Paclitaxel (35.39%) were the most common HEC and MEC regimens respectively. Overall, CR in delayed and extended delayed phases were 93.26% and 96.07% respectively. Furthermore, CP and CC in delayed and extended delayed phases were 92.13% and 96.07% and 81.46% and 90.45% respectively (Table). In general, IV NEPA was well tolerated, as only 9.55% of patients experienced adverse events with 95.83% of them being mild in nature. Headache (2.25%) and injection site reactions (1.68%) were the most common adverse effect reported. Conclusions: IV NEPA demonstrated high efficacy and good tolerability in a real world Indian setting, exhibiting response rates of >92% in both delayed and extended delayed phases in patients receiving HEC/MEC regimens.Clinical trial information: CTRI/2023/04/051951.
| PARAMETER | Acute Phase (0-24 hrs) | Delayed Phase (>24-120 hrs) | Extended Delayed Phase (>120-240 hrs) | Extended Overall Phase (0-240 hrs) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HEC (N=90) | MEC (N=88) | Overall (N=178) | HEC (N=90) | MEC (N=88) | Overall (N=178) | HEC (N=90) | MEC (N=88) | Overall (N=178) | HEC (N=90) | MEC (N=88) | Overall (N=178) | |
| Complete Response | 67 (74.44%) | 83 (94.32%) | 150 (84.27%) | 81 (90%) | 85 (96.59%) | 166 (93.26%) | 85 (94.44%) | 86 (97.73%) | 171 (96.07%) | 62 (68.89%) | 81 (92.04%) | 143 (80.34%) |
| Complete Protection | 66 (73.33%) | 83 (94.32%) | 149 (83.71) | 79 (87.78%) | 85 (96.59%) | 164 (92.13%) | 85 (94.44%) | 86 (97.73%) | 171 (96.07%) | 60 (66.67%) | 81 (92.04%) | 141 (79.21%) |
| Complete control | 43 (47.78%) | 75 (85.23%) | 118 (66.29%) | 64 (71.11%) | 81 (92.04%) | 145 (81.46%) | 76 (84.44%) | 85 (96.59%) | 161 (90.45%) | 36 (40%) | 73 (82.95% | 109 (61.24%) |
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Abstract Details
Session Type
Poster Session
Session Title
Symptom Science and Palliative Care
Track
Symptom Science and Palliative Care
Sub Track
Palliative Care and Symptom Management
Clinical Trial Registration Number
CTRI/2023/04/051951
Citation
J Clin Oncol 42, 2024 (suppl 16; abstr 12070)
DOI
10.1200/JCO.2024.42.16_suppl.12070
Abstract #
12070
Poster Bd #
199
Abstract Disclosures
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