Sintilimab Plus Modified FOLFIRINOX in Metastatic or Recurrent Pancreatic Cancer: The Randomized Phase II CISPD3 Trial

Background Folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or modified FOLFIRINOX (mFFX) is the first-line standard of care for metastatic pancreatic adenocarcinoma; effective and safe treatment strategies are needed as survival remains poor. Sintilimab, a human immunoglobulin G4 monoclonal antibody for programmed cell death-1, has shown efficacy in various cancers. We evaluated the efficacy and safety of sintilimab with mFFX for metastatic/recurrent pancreatic ductal adenocarcinoma in China. Patients and Methods This was a single-center, randomized, controlled, open-label phase II study. Patients were assigned 1:1 to sintilimab + mFFX or mFFX (n = 55, each). Results In the intention-to-treat population, median overall survivals (primary endpoint) were similar in the sintilimab + mFFX and mFFX groups: 10.9 and 10.8 months, respectively [hazard ratio (HR) 1.07, 95% confidence interval (CI) 0.69–1.68]. The objective response rate was higher [50.0% (95% CI 34.6–65.4%) versus 23.9% (95% CI 11.1–36.7%)] in the sintilimab + mFFX group (P < 0.05). Median (HR, 95% CI) progression-free survival and disease control rates (95% CI) were also similar at 5.9 and 5.7 months (0.93, 0.62–1.40), and 84.1% (72.8–95.3%) and 71.7%, (58.2–85.3%), respectively. Incidences of grade ≥ 3 treatment-emergent adverse events were 84.9% (45/53) and 74.1% (40/54), and that of grade ≥ 3 immune-related adverse events were 5.7% (3/53) and 0 in each group, respectively. Conclusions The study did not meet its primary endpoint, no clear survival benefit was observed, and the benefit of sintilimab + mFFX for advanced pancreatic cancer was not supported; however, the findings suggest that using this regimen for pancreatic cancer is feasible, has an acceptable safety profile, and leads to an objective response rate of 50%. Trial registration ClinicalTrials.Gov; NCT03977272.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:30

Enthalten in:

Annals of surgical oncology - 30(2023), 8 vom: 13. Apr., Seite 5071-5080

Sprache:

Englisch

Beteiligte Personen:

Fu, Qihan [VerfasserIn]
Chen, Yiwen [VerfasserIn]
Huang, Dabing [VerfasserIn]
Guo, Chengxiang [VerfasserIn]
Zhang, Xiaochen [VerfasserIn]
Xiao, Wenbo [VerfasserIn]
Xue, Xing [VerfasserIn]
Zhang, Qi [VerfasserIn]
Li, Xiang [VerfasserIn]
Gao, Shunliang [VerfasserIn]
Que, Risheng [VerfasserIn]
Shen, Yan [VerfasserIn]
Wu, Jian [VerfasserIn]
Zhang, Min [VerfasserIn]
Bai, Xueli [VerfasserIn]
Liang, Tingbo [VerfasserIn]

Links:

Volltext [lizenzpflichtig]

Anmerkungen:

© Society of Surgical Oncology 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

doi:

10.1245/s10434-023-13383-w

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

OLC2144289336

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