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Multicenter Study
. 2024 Jun;13(12):e7345.
doi: 10.1002/cam4.7345.

Prognostic analysis and outcomes of metastatic pancreatic cancer patients receiving nab-paclitaxel plus gemcitabine as second or later-line treatment

Guido Giordano  1 , Michele Milella  2 , Matteo Landriscina  1 , Francesca Bergamo  3 , Giuseppe Tirino  4 , Antonio Santaniello  5 , Alberto Zaniboni  6 , Enrico Vasile  7 , Ferdinando De Vita  8 , Giovanni Lo Re  9 , Vanja Vaccaro  10 , Elisa Giommoni  11 , Donato Natale  12 , Raffaele Conca  13 , Daniele Santini  14 , Luigi Maiorino  15 , Gianni Sanna  16 , Vincenzo Ricci  17 , Aldo Iop  18 , Vincenzo Montesarchio  19 , Letizia Procaccio  3 , Silvia Noventa  6 , Roberto Bianco  5 , Antonio Febbraro  4 , Sara Lonardi  3 , Giampaolo Tortora  20   21 , Isabella Sperduti  22 , Davide Melisi  2   23   24
Affiliations
Multicenter Study

Prognostic analysis and outcomes of metastatic pancreatic cancer patients receiving nab-paclitaxel plus gemcitabine as second or later-line treatment

Guido Giordano et al. Cancer Med. 2024 Jun.

Abstract

Background: Pancreatic cancer (PC) first-line therapy often consists of polychemotherapy regimens, but choosing a second-line therapy after disease progression, especially following first-line FOLFIRINOX, remains a clinical challenge. This study presents results from a large, multicenter, retrospective analysis of Italian patients with metastatic PC (mPC) treated with Nab-paclitaxel/Gemcitabine (AG) as second or later line of treatment. Main objective of the study is to identify prognostic factors that could inform treatment decisions.

Methods: The study included 160 mPC patients treated with AG in 17 Italian institutions. AG was administered according to labelling dose, until disease progression, unacceptable toxicity or patient refusal. Variations in schedules, dose modifications, supportive measures, and response evaluation were determined by individual clinicians' practice.

Results: AG was well-tolerated and exhibited promising clinical activity. The overall response rate (ORR) and the disease control rate (DCR) were 22.5% and 45.6%, respectively. Median progression-free survival (PFS) and overall survival (OS) were 3.9 and 6.8 months, respectively. Among the patients who received AG as a second-line therapy (n = 111, 66.9%), median PFS and OS were 4.2 and 7.4 months, respectively. Notably, in the 76 patients (68%) receiving AG after first-line FOLFIRINOX, an ORR of 19.7% and a DCR of 46.0% were observed, resulting in a median PFS of 3.5 and median OS of 5.7 months. The study identified specific clinical or laboratory parameters (LDH, NLR, fasting serum glucose, liver metastases, ECOG PS, and first-line PFS) as independent prognostic factors at multivariate level. These factors were used to create a prognostic nomogram that divided patients into three risk classes, helping to predict second-line OS and PFS.

Conclusions: This study represents the largest real-world population of mPC patients treated with AG as a second or later line of therapy. It supports the feasibility of this regimen following first-line FOLFIRINOX, particularly in patients with specific clinical and laboratory characteristics who derived prolonged benefit from first-line therapy.

Keywords: FOLFIRINOX; gemcitabine; nab‐paclitaxel; pancreatic cancer; prognostic model; second‐line chemotherapy.

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Conflict of interest statement

Guido Giordano reports: travel and accommodation expenses by Celgene and Astra Zeneca, Honoraria for participation to Advisory Boards from Celgene, Servier, Astra Zeneca and MSD. Michele Milella reports: research funding (to institution) from Roche; travel and accommodation expenses by Astra Zeneca; consulting fees from Astra Zeneca and MSD; Honoraria for participation to Advisory Boards from Astra Zeneca, MDS, Ipsen, Sevier and Viatris. Letizia Procaccio reports: personal fee for scientific consultancy from Astra Zeneca. Sara Lonardi reports: research funding (to Institution) from Amgen, Astellas, Astra Zeneca, Bayer, Bristol‐Myers Squibb, Daichii Sankyo, Hutchinson, Incyte, Merck Serono, Mirati, MSD, Pfizer, Roche, Servier; personal honoraria as invited speaker from Amgen, Bristol‐Myers Squibb, Incyte, GSK, Lilly, Merck Serono, MSD, Pierre‐Fabre, Roche, Servier; participation in advisory board for Amgen, Astellas, Astra Zeneca, Bayer, Bristol‐Myers Squibb, Daiichi‐Sankyo, GSK, Incyte, Lilly, Merck Serono, MSD, Servier, Takeda. Davide Melisi reports: Research Grants from: Celgene, Evotec, Incyte, iOnctura, Roche, Servier, Shire; Consulting fees from: Eli Lilly, Evotec, Incyte, iOnctura, IQVIA, Servier, Shire, Taiho; Honoraria for participation to Advisory Boards from: Incyte, Roche, Servier, Taiho, Terumo; Payment for lectures or presentations from: Baxter, Incyte, MSD Italia, Roche.

Figures

FIGURE 1
FIGURE 1
Kaplan–Meier curve for overall survival and progression free survival in the entire population (N = 160). OS, overall survival; PFS, progression free survival.
FIGURE 2
FIGURE 2
(A) Overall survival and (B) progression free survival according to the prognostic model. AUC, area under curve.
See this image and copyright information in PMC

References

    1. I numeri del cancro in Italia 2021
    1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7‐33. doi:10.3322/caac.21708 - DOI - PubMed
    1. De Dosso S, Siebenhüner AR, Winder T, et al. Treatment landscape of metastatic pancreatic cancer. Cancer Treat Rev. 2021;96:102180. doi:10.1016/j.ctrv.2021.102180 - DOI - PubMed
    1. Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817‐1825. doi:10.1056/NEJMoa1011923 - DOI - PubMed
    1. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab‐paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691‐1703. doi:10.1056/NEJMoa1304369 - DOI - PMC - PubMed

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