Abstract 351P
Background
Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FFX) has been reported to exhibit significant improvements in both overall survival (OS) and progression-free survival (PFS) in patients with pancreatic cancer, compared with gemcitabine (GEM). However, there are no reports on whether PFS is a surrogate marker of OS in pancreatic cancer chemotherapy focusing on FFX or GEM plus nab-paclitaxel. This study aimed to verify whether PFS can be a surrogate marker of OS and aid predict prognosis.
Methods
This study was an integrated analysis of the NAPOLEON study and a retrospective cohort of the NAPOLEON-2 study—a multicenter observational study conducted in Japan. The primary and secondary endpoints were OS and PFS, respectively. The correlation between OS and PFS in 1st- and 2nd-line treatments was assessed using MM estimation. The correlation between the number of key drugs used and OS was calculated using the Pearson correlation coefficient and bootstrapping method with 2000 resamplings of 100 cases each. The seven key drugs included 5-FU, IRI, l-OHP, GEM, nab-paclitaxel, nanoliposomal IRI, and S-1. Analysis was performed in patients with confirmed OS at the end of follow-up, and NAPOLEON-2 cases were only in those who received 5-fluorouracil, leucovorin, and nanoliposomal irinotecan (NFF) as 2nd-line treatment.
Results
Among the 479 patients, the correlation between PFS and OS from 1st- and 2nd-line chemotherapies was calculated for 310 and 225 patients, respectively. The R-squared values for the correlation between PFS and OS from 1st- and 2nd-line chemotherapies were 0.74 and 0.76, respectively. There was no statistically significant difference in 1st-line treatment between the FFX and gemcitabine plus nab-paclitaxel groups (P=0.92). Although this correlation was not affected by regimens in 2nd-line treatment, the FFX group did not have a stronger correlation than the NFF group. The correlation between the number of key drugs used and OS was weak.
Conclusions
PFS can be a surrogate marker of OS in 1st- and 2nd-line therapies. We hope that appropriate prognostic estimation will contribute to appropriate treatment selection, including supportive care.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.