98P - Nanoliposomal irinotecan with fluorouracil and folinic acid, S-1 alone, or FOLFIRINOX as second-line chemotherapy for advanced pancreatic cancer after gemcitabine plus nab-paclitaxel: A pooled analysis of NAPOLEON-1 and NAPOLEON-2

Background

Among nanoliposomal irinotecan plus fluorouracil and folinic acid (nal-IRI/5-FU/LV), S-1 alone (S-1), and FOLFIRINOX (FFX), the appropriate therapies for patients previously treated with gemcitabine plus nab-paclitaxel (GnP) for advanced pancreatic cancer (APC) are unclear.

Methods

We conducted a comparative study to clarify the therapeutic advantages of these regimens as second-line chemotherapy after GnP using pooled data from two multicenter retrospective studies that enrolled patients with APC who received FFX or GnP (NAPOLEON-1, from 2013 to 2017) or nal-IRI/5-FU/LV (NAPOLEON-2, from 2021). All patients treated with GnP as first-line chemotherapy followed by nal-IRI/5-FU/LV, S-1, or FFX as second-line chemotherapy were included.

Results

Of 479 patients enrolled in the two studies, 181 patients were eligible for this analysis. nal-IRI/5-FU/LV, S-1, and FFX were administered to 102, 62, and 17 patients, respectively. The median follow-up duration was 11.9 months. The baseline performance status (PS) tended to be worse in the S-1 group. Although the response rate was comparable among the nal-IRI/5-FU/LV, S-1, and FFX groups (4%, 2%, and 6%, respectively; P = 0.60), the disease-control rate was lowest in the S-1 group (48%, 21%, and 41%, respectively; P < 0.01). The median progression-free survival (PFS) times in the aforementioned groups were 2.9, 2.5, and 3.0 months, respectively, and the median overall survival (OS) times were 7.6, 4.8, and 4.9 months, respectively. In comparison with the nal-IRI/5-FU/LV group, PFS (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.02–2.03; P = 0.04) and OS (HR, 1.85; 95% CI, 1.27–2.70; P < 0.01) were shorter in the S-1 group. These findings did not change after adjustment for baseline PS, and the adjusted HR was 1.43 (95%CI, 1.004–2.04; P = 0.048) for PFS and 1.72 (95%CI, 1.16–2.56; P < 0.01) for OS. Meanwhile, PFS and OS did not differ between the FFX group and the nal-IRI/5-FU/LV or S-1 group.

Conclusions

Among the three regimens, nal-IRI/5-FU/LV might be a reasonable option for second-line treatment after GnP failure.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.