Dr. Monica Niger, from Fondazione IRCCS Istituto Nazionale Tumori, provided a summary of the NALIRIFOX vs FOLFIRINOX vs gemcitabine plus nab-paclitaxel study. Pancreatic cancer is known for its aggressive nature and limited effective treatment options.
The standard first-line chemo therapies have been FOLFIRINOX and nab-paclitaxel. The NAPOLI-3 trial, the first positive Phase 3 trial since 2013, demonstrated that NALIRIFOX, a triple regimen, outperformed gemcitabine plus nab-paclitaxel in improving overall survival (OS) and progression-free survival (PFS) for pancreatic cancer patients.
However, since NALIRIFOX is similar to FOLFIRINOX in terms of regimen and potential effects, the researchers wanted to understand the comparative effectiveness of NALIRIFOX and FOLFIRINOX. In their pooled analysis, they examined how the two regimens compared in terms of PFS as first-line treatments for advanced pancreatic cancer.
The analysis should be interpreted cautiously, as it was not a direct comparison, but rather an amalgamation of trial data. Nonetheless, they found that NALIRIFOX significantly improved PFS compared to FOLFIRINOX. Although the absolute difference was only one month, there was no improvement in OS, which remained around 11 months in both trials.
In terms of overall response rates (ORR), GemNabP had a 40% response rate, while FOLFIRINOX and nab-paclitaxel had rates of 13%, 52%, and 29%, respectively. This indirect comparison indicated that NALIRIFOX improved the ORR.
The finding that NALIRIFOX provided a longer median PFS compared to both FOLFIRINOX and GemNabP is clinically significant. However, it does not necessarily imply that NALIRIFOX is superior to the other regimens, particularly considering the lack of improvement in OS. Moreover, the higher cost and increased gastrointestinal toxicity associated with NALIRIFOX must be taken into account when choosing between the regimens.
The analysis also revealed that GemNabP was associated with poorer OS compared to the other two regimens. This finding reinforces the belief that FOLFIRINOX may be more active, although a direct comparison between the two regimens has not yet been conducted. Patients who are not suitable for the triple regimen may still benefit from GemNabP due to its effectiveness and tolerability.
Regarding toxicities, NALIRIFOX had slightly more gastrointestinal toxicity, while FOLFIRINOX was associated with more neutropenia. Modified FOLFIRINOX or supportive care are sometimes used to mitigate the side effects of the full FOLFIRINOX regimen.
In terms of patient selection, NALIRIFOX is not yet approved in some regions, making it unavailable as a treatment option. Considering the comparable efficacy and lower toxicity of FOLFIRINOX, it remains a preferred choice. However, ongoing research should focus on exploring alternative combinations and striving for improved outcomes.
While a direct comparison between FOLFIRINOX and NALIRIFOX may not be feasible, it is crucial to identify key aspects for comparison to inform treatment decisions. However, the current trial suggests that the focus should shift towards discovering new standard-of-care treatments, as the outcomes for first-line pancreatic cancer treatments remain unsatisfactory.
Overall, the key takeaway from the NAPOLI-3 trial is the need for improved treatment options for pancreatic cancer. The study underscores the lack of progress in the field and emphasizes the necessity of finding novel approaches to enhance patient outcomes and survival.