NALIRIFOX
What is NALIRIFOX
NALIRIFOX is a chemotherapy regimen that may be used as a first-line treatment for pancreatic cancer that has spread (metastatic pancreatic adenocarcinoma). NALIRIFOX consists of 4 different agents:
- Onivyde (irinotecan liposomal) is a topoisomerase inhibitor that has been encapsulated in a liposomal base which allows for more sustained levels of irinotecan and its active metabolite SN-38
- Oxaliplatin is a platinum-based alkylating agent that forms cross-links in DNA
- Fluorouracil is an antimetabolite that disrupts the formation of DNA
- Leucovorin is similar to the vitamin folic acid and is used to protect healthy cells from the effects of chemotherapy agents.
NALIRIFOX vs FOLFIRINOX?
What is the difference between NALIRIFOX and FOLFIRINOX?
NALIRIFOX contains:
- Irinotecan liposomal (Onivyde)
- Oxaliplatin
- Fluorouracil
- Leucovorin
FOLFIRINOX contains:
- Irinotecan (unencapsulated)
- Oxaliplatin
- Fluorouracil
- Leucovorin
The only difference is the formulation of irinotecan used. In NALIRIFOX, the irinotecan has been encapsulated which allows it to remain in circulation for longer than unencapsulated irinotecan before it is converted to its active metabolite SN-38. Research has shown it demonstrates higher and more sustained levels of irinotecan and SN-38 compared with free irinotecan. In FOLFIRINOX, the irinotecan is unencapsulated.
There have been no head-to-head comparison trials between NALIRIFOX and FOLFIRINOX. An informal cost analysis suggests encapsulated irinotecan is approximately 67 times more expensive than unencapsulated irinotecan in the United States.
What studies have been done using NALIRIFOX?
The NAPOLI 3 trial was a randomized, open-label, phase 3 trial that compared NALIRIFOX to nab-paclitaxel and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma who had not yet received any treatment.
- 383 patients received NALIRIFOX and 387 received nab-paclitaxel plus gemcitabine.
- The median follow-up was 16.1 months.
- The median overall survival (OS) was 11.1 months (95% confidence interval [CI] 10.0–12.1) with NALIRIFOX versus 9.2 months (95% CI 8.3-10.6) with nab-paclitaxel plus gemcitabine (hazard ratio 0.83, 95% CI 0.70-0.99; p = 0.036).
- This was considered a statistically significant finding and represented an overall difference in survival of 1.9 months.
- Treatment-related deaths occurred in 6 (2%) patients in the NALIRIFOX group and 8 (2%) patients in the nab-paclitaxel–gemcitabine group.
- The study was funded by Ipsen.
See also
- Breast Cancer Guide: Causes, Symptoms & Diagnosis
- Breast Cancer: Treatment and Prevention Options
- Cancer
- Mesothelioma
- Prostate Cancer
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Sources
- Onivyde Product Information. https://d2rkmuse97gwnh.cloudfront.net/a88aa6d6-3ca0-4362-a711-d53c45ae33ff/68b50c8f-8577-4904-950d-d82fa1f91417/68b50c8f-8577-4904-950d-d82fa1f91417_source__v.pdf
- Devanabanda B, Kasi A. Oxaliplatin. [Updated 2023 May 16]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557690/
- Fluorouracil Injection. National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/drugs/fluorouracil
- Leucovorin Medline Plus. https://medlineplus.gov/druginfo/meds/a682336.html
- NALIRIFOX Improves Survival Compared with Nab-paclitaxel Plus Gemcitabine in First-Line Treatment for Patients with Metastatic Pancreatic Ductal Adenocarcinoma. 22 Sept 2023. ESMO. https://www.esmo.org/oncology-news/nalirifox-improves-survival-compared-with-nab-paclitaxel-plus-gemcitabine-in-first-line-treatment-for-patients-with-metastatic-pancreatic-ductal-adenocarcinoma
- Wainberg ZA, Melisi D, Macarulla T, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomized, open-label, phase 3 trial. The Lancet; Published online 11 September 2023. DOI: https://doi.org/10.1016/S0140-6736(23)01366-1
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.