1057 - Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine (nab-P/G) vs FOLFIRINOX (FFX) in patients (pts) with advanced pancreatic cancer (aPC)

Background

Current guidelines recommend chemotherapy with nab-P/G or FFX as the preferred first-line (1L) treatment for metastatic (m)PC pts with good performance status. However, no clinical trial has directly compared 1L nab-P/G vs FFX in mPC or aPC. We conducted a systematic review of the real-world comparative effectiveness of nab-P/G vs FFX in this setting.

Methods

Embase, Medline, and ASCO GI 2018 were searched through January 2018 for real world, retrospective studies directly comparing 1L nab-P/G vs FFX in mPC/aPC. Radiotherapy studies were excluded.

Results

550/580 records did not meet eligibility criteria, mainly as they were not comparative (264) nor 1L (188). After removing 5 duplicates, the remaining 25 studies (16 mPC; 9 aPC) assessed > 5464 pts who received nab-P/G or FFX. Generally, a lower proportion of pts in the nab-P/G group (range, 59% - 100%) had an ECOG PS score of 0 or 1 vs FFX (82% - 100%) (12 studies). Median overall survival (OS; 19 studies) ranged from 5.5 mo to “not reached” for nab-P/G, and 8.6 to 15.9 mo for FFX (Table); median progression-free survival (12 studies) ranged from 4 to 8.5 mo and 3.7 to 11.7 mo, respectively. In 2 studies that reported OS based on ECOG PS, the median OS for pts with ECOG PS 0/1 was 12.1 and 14.1 mo for nab-P/G vs 11.4 and 13.7 mo for FFX. Overall response rates ranged from 10% to 41% for nab-P/G and 6% to 34% for FFX (4 studies), and disease control rates ranged from 50% to 92% and 56% to 89%, respectively (5 studies). Safety outcomes were heterogeneously reported in 1667 pts (10 studies) receiving nab-P/G or FFX (Table).Table: 724P

Reported as database persistence, a proxy for OS.

For pts with ECOG PS 0/1, OS was 12.1 mo for nab-P/G and 11.4 mo for FFX.

aPC includes mPC. The numbers in parentheses are for pts with mPC.

Biomarker study observing homologous recombination deficiency low vs high in each treatment regimen with data presented here as a range.

Modified FFX (no bolus 5-FU and reduced dose irinotecan).

For pts with ECOG PS 0/1, OS was 14.1 mo for nab-P/G and 13.7 mo for FFX.

Represents minimum as some studies did not report the number of pts. The numbers in parentheses are for pts with mPC. 1L, first line; AE, adverse event; aPC, advanced pancreatic cancer; FFX, FOLFIRINOX; mPC, metastatic pancreatic cancer; nab-P/G, nab-paclitaxel/gemcitabine; NR, not reported; OS, overall survival; PFS, progression-free survival.

Conclusions

Several real-world studies have compared the effectiveness of nab-P/G vs FFX, highlighting the clinical significance. A systematic review of these studies shows that nab-P/G and FFX have comparable effectiveness in mPC/aPC. Differences were observed in the toxicity profiles for the 2 regimens, which may drive treatment decisions. Table. Studies reporting OS, PFS, and safety.

Clinical trial identification

Legal entity responsible for the study

Celgene Corporation.

Funding

Celgene Corporation.

Editorial Acknowledgement

Editorial assistance was provided by Narender Dhingra, MediTech Media.

Disclosure

E.G. Chiorean: Advisor: Celgene, Genentech, Novocure, Pfizer; Research funding: Boehringer Ingelheim, Celgene, Ignyta, Incyte, Lilly, Stemlive. G. Giordano: Honoraria: Celgene, Sanofi; Consultancy: Celgene; Travel accomodation expenses, Celgene. G. Kim: Consultant, Speaker: Celgene, Ipsen. S-E. Al-Batran: Consultancy: Bristo-Myers Squibb, Celgene, Lilly, Merck, Roche, Servier; Speaker: Celgene, Lilly, Nordic Bioscience, Roche; research funding, Celgene, Hospira, Lilly, Medac, Novartis, Roche, Vibor. All other authors have declared no conflicts of interest.