Birrer, Dominique L., Golcher, Henriette, Casadei, Riccardo, Haile, Sarah R., Fritsch, Ralph, Hussung, Saskia, Brunner, Thomas B., Fietkau, Rainer, Meyer, Thomas, Gruetzmann, Robert, Merkel, Susanne, Ricci, Claudio ORCID: 0000-0002-6638-4479, Ingaldi, Carlo, Di Marco, Mariacristina, Guido, Alessandra, Serra, Carla, Minni, Francesco, Pestalozzi, Bernhard, Petrowsky, Henrik, DeOliveira, Michelle, Bechstein, Wolf O., Bruns, Christiane J., Oberkofler, Christian E., Puhan, Milo, Lesurtel, Mickaeel, Heinrich, Stefan and Clavien, Pierre-Alain (2021). Neoadjuvant Therapy for Resectable Pancreatic Cancer A New Standard of Care. Pooled Data From 3 Randomized Controlled Trials. Ann. Surg., 274 (5). S. 713 - 721. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. ISSN 1528-1140

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Abstract

Objective: The aim of this study was to pool data from randomized controlled trials (RCT) limited to resectable pancreatic ductal adenocarcinoma (PDAC) to determine whether a neoadjuvant therapy impacts on disease-free survival (DFS) and surgical outcome. Summary Background Data: Few underpowered studies have suggested benefits from neoadjuvant chemo (+/- radiation) for strictly resectable PDAC without offering conclusive recommendations. Methods: Three RCTs were identified comparing neoadjuvant chemo (+/- radio) therapy vs. upfront surgery followed by adjuvant therapy in all cases. Data were pooled targeting DFS as primary endpoint, whereas overall survival (OS), postoperative morbidity, and mortality were investigated as secondary endpoints. Survival endpoints DFS and OS were compared using Cox proportional hazards regression with study-specific baseline hazards. Results: A total of 130 patients were randomized (56 in the neoadjuvant and 74 in the control group). DFS was significantly longer in the neoadjuvant treatment group compared to surgery only [hazard ratio (HR) 0.6, 95% confidence interval (CI) 0.4-0.9] (P = 0.01). Furthermore, DFS for the subgroup of R0 resections was similarly longer in the neoadjuvant treated group (HR 0.6, 95% CI 0.35-0.9, P = 0.045). Although postoperative complications (Comprehensive Complication Index, CCI(R)) occurred less frequently (P = 0.008), patients after neoadjuvant therapy experienced a higher toxicity, but without negative impact on oncological or surgical outcome parameters. Conclusion: Neoadjuvant therapy can be offered as an acceptable standard of care for patients with purely resectable PDAC. Future research with the advances of precision oncology should now focus on the definition of the optimal regimen.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Birrer, Dominique L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Golcher, HenrietteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Casadei, RiccardoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haile, Sarah R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fritsch, RalphUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hussung, SaskiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brunner, Thomas B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fietkau, RainerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meyer, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gruetzmann, RobertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Merkel, SusanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ricci, ClaudioUNSPECIFIEDorcid.org/0000-0002-6638-4479UNSPECIFIED
Ingaldi, CarloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Di Marco, MariacristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Guido, AlessandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Serra, CarlaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Minni, FrancescoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pestalozzi, BernhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Petrowsky, HenrikUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
DeOliveira, MichelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bechstein, Wolf O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bruns, Christiane J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oberkofler, Christian E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Puhan, MiloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lesurtel, MickaeelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinrich, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Clavien, Pierre-AlainUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-601721
DOI: 10.1097/SLA.0000000000005126
Journal or Publication Title: Ann. Surg.
Volume: 274
Number: 5
Page Range: S. 713 - 721
Date: 2021
Publisher: LIPPINCOTT WILLIAMS & WILKINS
Place of Publication: PHILADELPHIA
ISSN: 1528-1140
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ADJUVANT CHEMOTHERAPY; PREOPERATIVE CHEMORADIATION; SURGICAL COMPLICATIONS; OPEN-LABEL; GEMCITABINE; CHEMORADIOTHERAPY; RESECTION; ADENOCARCINOMA; SURGERY; CLASSIFICATIONMultiple languages
SurgeryMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60172

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