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Clinical Studies

Gemcitabine + Nab-paclitaxel or Gemcitabine alone after FOLFIRINOX failure in patients with metastatic pancreatic adenocarcinoma: a real-world AGEO study

A Correction to this article was published on 11 February 2022

This article has been updated

Abstract

Background

Gemcitabine (Gem) alone or with Nab-paclitaxel (Gem-Nab) is used as second-line treatment for metastatic pancreatic adenocarcinoma (mPA) after FOLFIRINOX (FFX) failure; however, no comparative data exist. This study evaluates the efficacy and safety of adding Nab-paclitaxel to Gem for mPA after FFX failure.

Methods

In this retrospective real-world multicenter study, from 2011 to 2019, patients with mPA receiving Gem-Nab (Gem 1000 mg/m² + Nab 125 mg/m², 3 out of 4 weeks) or Gem alone were included after progression on FFX.

Results

A total of 427 patients were included. Patients receiving Gem-Nab had more metastatic sites, peritoneal disease and less PS 2 (24% vs. 35%). After median follow-up of 22 months, Gem-Nab was associated with better disease control rate (DCR) (56% vs. 32%; P < 0.001), progression-free survival (PFS) (3.5 vs. 2.3 months; 95% CI: 0.43–0.65) and overall survival (OS) (7.1 vs. 4.7 months; 95% CI: 0.53–0.86). After multivariate analysis, Gem-Nab and PS 0/1 were associated with better OS and PFS. Grade 3/4 toxicity was more frequent with Gem-Nab (44% vs. 29%).

Conclusion

In this study, Gem-Nab was associated with better DCR, PFS and OS compared with Gem alone in patients with mPA after FFX failure, at the cost of higher toxicity.

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Fig. 1: Progression-free and overall survival.
Fig. 2: Subgroup analysis of survival.

Change history

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Acknowledgements

We thank all investigators of the AGEO (Association des Gastro-Entérologues Oncologues) group for their support and participation to this project. Presented in part as a poster discussion at the World Congress on Gastrointestinal Cancer 2020 (Barcelona, Spain).

Funding

None.

Author information

Authors and Affiliations

Authors

Contributions

Conception/design of the work: SZ, JT and SP. Acquisition of the data: SZ, VH, AL, DT, MS, MG, JW, JE, PA, DB, CM, AD, JT and SP. Analysis of the data: SZ, VH, EA, JT and SP. Interpretation of the data: SZ, VH, EA, JT and SP. Drafting the work: SZ, VH, EA, JT and SP. Revising it critically: all. Final approval of the version to be published: all.

Corresponding author

Correspondence to Simon Pernot.

Ethics declarations

Ethics approval and consent to participate

All patients alive at the time of data collection were informed before being enrolled in this study by written information. This study was performed in accordance with the Declaration of Helsinki. The collection and the treatment of the data were conducted according to the MR 004 authorisation, registered at the Commission National Informatique et Liberté (CNIL).

Consent to publish

Not applicable.

Competing interests

SZ, MS, MG, JW, DB, CM and AD declare no competing interests. V. Hautefeuille: lectures: AAA, Novartis, Ipsen, Amgen, Merck, Sanofi. Advisory for AAA, Novartis, Ipsen, Amgen, Merci, Sanofi. Travel support: AAA, Novartis, Ipsen, Amgen, Pfizer, Servier. E Auclin: travel expenses: Mundipharma. Lectures and educational activities: Sanofi Genzymes. A. Lièvre: honoraria for lectures from AAA, Amgen, Bayer, BMS, HalioDx, Incyte, Ipsen, Merck, Novartis, Pierre Fabre, Roche, Sandoz, Sanofi and Servier and for consulting/advisory relationship from AAA, Amgen, Bayer, Incyte, Ipsen, Merck, Novartis Pierre Fabre, Sandoz and Servier. Travel (or subscription to congress) support from AAA, Bayer, Ipsen, Merck, Mylan, Novartis, Pfizer, Roche and Servier. D. Tougeron: honoraria from AstraZeneca, Bayer, BMS, IPSEN, MERCK, MSD, Roche, Sanofi, Servier, Amgen, Pierre Fabre. J Edeline: honoraria from Roche, Bayer, Ipsen, MSD, BMS, Eisai, Boston Scientific, AstraZeneca. P. Artru: honoraria as a speaker and/or in an advisory role from Roche Genentech, Servier, Pierre Fabre, Amgen, Merck and Bayer. J Taieb: honoraria as a speaker and/or in an advisory role from Merck KGaA, Sanofi, Roche Genentech, MSD, Lilly, AstraZeneca, Servier, Novartis, Pierre Fabre, HallioDx and Amgen. S Pernot: SP declares honoraria for the speaker or advisory roles for Amgen, Roche, Merck KGaA, Servier, Sanofi, Pierre Fabre, AstraZeneca.

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The original online version of this article was revised: In this article the author name Sonia Zaibet was incorrectly written as Simon Zaibet. The original article has been corrected.

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Zaibet, S., Hautefeuille, V., Auclin, E. et al. Gemcitabine + Nab-paclitaxel or Gemcitabine alone after FOLFIRINOX failure in patients with metastatic pancreatic adenocarcinoma: a real-world AGEO study. Br J Cancer 126, 1394–1400 (2022). https://doi.org/10.1038/s41416-022-01713-w

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