Skip to main content

Thank you for visiting You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

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



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.


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.


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%).


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.

Your institute does not have access to this article

Access options

Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.

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

Change history


  1. Quante AS, Ming C, Rottmann M, Engel J, Boeck S, Heinemann V, et al. Projections of cancer incidence and cancer-related deaths in Germany by 2020 and 2030. Cancer Med. 2016;5:2649–56.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud, Yves B, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N. Engl J Med. 2011;2011:1817–25.

    Article  Google Scholar 

  3. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine (MPACT Trial). N. Engl J Med. 2013;369:1691–703.

    CAS  Article  Google Scholar 

  4. Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, et al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. JCO. 2014;32:2423–9.

    CAS  Article  Google Scholar 

  5. Wang-Gillam A, Hubner RA, Siveke JT, Von Hoff DD, Belanger B, de Jong FA, et al. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: final overall survival analysis and characteristics of long-term survivors. Eur J Cancer. 2019;108:78–87.

    CAS  Article  PubMed  Google Scholar 

  6. Gill S, Ko Y-J, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, et al. PANCREOX: a randomized phase III study of fluorouracil/leucovorin with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. JCO. 2016;34:3914–20.

    CAS  Article  Google Scholar 

  7. Mercadé TM, Chen L-T, Li C-P, Siveke JT, Cunningham D, Bodoky G, et al. Liposomal Irinotecan + 5-FU/LV in metastatic pancreatic cancer. Pancreas. 2020;49:14

    Article  Google Scholar 

  8. Sarabi M, Mais L, Oussaid N, Desseigne F. Use of gemcitabine as a second-line treatment following chemotherapy with folfirinox for metastatic pancreatic adenocarcinoma. Oncol Lett. 2017;13:4917–24.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  9. Gilabert M, Chanez B, Rho YS, Giovanini M, Turrini O, Batist G, et al. Evaluation of gemcitabine efficacy after the FOLFIRINOX regimen in patients with advanced pancreatic adenocarcinoma. Medicine. 2017;96:e6544

    Article  PubMed  PubMed Central  Google Scholar 

  10. Girardi DM, Faria LDBB, Teixeira MC, Costa FP, Hoff PMG, Fernandes GS. Second-line treatment for advanced pancreatic adenocarcinoma: is there a role for gemcitabine. J Gastrointest Canc. 2019;50:860–6.

    CAS  Article  Google Scholar 

  11. Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardière C, et al. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015;113:989–95.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  12. Burris HA, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. JCO. 1997;15:2403–13.

    CAS  Article  Google Scholar 

  13. Petrillo A, Pappalardo A, Pompella L, Tirino G, Calabrese F, Laterza MM, et al. Nab-paclitaxel plus gemcitabine as first line therapy in metastatic pancreatic cancer patients relapsed after gemcitabine adjuvant treatment. Med Oncol. 2019;36:83

    CAS  Article  PubMed  Google Scholar 

  14. Hasegawa R, Okuwaki K, Kida M, Yamauchi H, Kawaguchi Y, Matsumoto T, et al. A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer. Int J Clin Oncol. 2019;24:1574–81.

    CAS  Article  PubMed  Google Scholar 

  15. Soares HP, Bayraktar S, Blaya M, Lopes G, Merchan J, Macintyre J, et al. A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere. Cancer Chemother Pharm. 2014;73:839–45.

    CAS  Article  Google Scholar 

  16. Yoo C, Hwang JY, Kim J-E, Kim TW, Lee JS, Park DH, et al. A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer. Br J Cancer. 2009;101:1658–63.

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  17. Zaanan A, Trouilloud I, Markoutsaki T, Gauthier M, Dupont-Gossart A-C, Lecomte T, et al. FOLFOX as second-line chemotherapy in patients with pretreated metastatic pancreatic cancer from the FIRGEM study. BMC Cancer. 2014;14:441

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  18. Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, et al. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011;47:1676–81.

    CAS  Article  PubMed  Google Scholar 

  19. Scripture C, Figg W, Sparreboom A. Peripheral neuropathy induced by paclitaxel: recent insights and future perspectives. CN. 2006;4:165–72.

    CAS  Article  Google Scholar 

  20. Yalcin S, Dane F, Oksuzoglu B, Ozdemir NY, Isikdogan A, Ozkan M, et al. Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study. BMC Cancer. 2020;20:259

    CAS  Article  PubMed  PubMed Central  Google Scholar 

  21. Tsang ES, Spratlin J, Cheung WY, Kim CA, Kong S, Xu Y, et al. Real-world outcomes among patients treated with gemcitabine-based therapy post-FOLFIRINOX failure in advanced pancreatic cancer. Am J Clin Oncol. 2019;42:903–8.

    CAS  Article  PubMed  Google Scholar 

Download references


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).



Author information

Authors and Affiliations



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.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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.

Supplementary information

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

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).

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI:


Quick links