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. 2025 Feb 1;160(2):172-180.
doi: 10.1001/jamasurg.2024.5191.

Best Practices for Delivering Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma

Jordan M Cloyd  1 , Angela Sarna  1 , Matthew J Arango  2 , Susan E Bates  3 , Manoop S Bhutani  4 , Mark Bloomston  5 , Vincent Chung  6 , Efrat Dotan  7 , Cristina R Ferrone  8 , Patricia F Gambino  9 , Ajit H Goenka  10 , Karyn A Goodman  11 , William A Hall  12 , Jin He  13 , Melissa E Hogg  14 , Shiva Jayaraman  15 , Avinash Kambadakone  16 , Matthew H G Katz  4 , Alok A Khorana  17 , Andrew H Ko  18 , Eugene J Koay  4 , David A Kooby  19 , Somashekar G Krishna  2 , Liliana K Larsson  4 , Richard T Lee  20 , Anirban Maitra  4 , Nader N Massarweh  21 , Sameh Mikhail  22 , Mahvish Muzaffar  23 , Eileen M O'Reilly  24 , Manisha Palta  25 , Maria Q B Petzel  4 , Philip A Philip  26 , Marsha Reyngold  24 , Daniel Santa Mina  15 , Davendra P S Sohal  27 , Tilak K Sundaresan  28 , Susan Tsai  1 , Kea L Turner  29 , Timothy J Vreeland  30 , Steve Walston  31 , M Kay Washington  32 , Terence M Williams  6 , Jennifer Y Wo  16 , Rebecca A Snyder  4
Affiliations

Best Practices for Delivering Neoadjuvant Therapy in Pancreatic Ductal Adenocarcinoma

Jordan M Cloyd et al. JAMA Surg. .

Abstract

Importance: Neoadjuvant therapy (NT) is an increasingly used treatment strategy for patients with localized pancreatic ductal adenocarcinoma (PDAC). Little research has been conducted on cancer care delivery during NT, and the standards for optimal delivery of NT have not been defined.

Objective: To develop consensus best practices for delivering NT to patients with localized PDAC.

Design, setting, and participants: This study used a modified Delphi approach consisting of 2 rounds of voting, and a series of virtual conferences (from October to December 2023) to reach expert consensus on candidate best practice statements generated from a systematic review of the literature and expert opinion. An interdisciplinary panel was formed including 47 North American experts from surgical, medical, and radiation oncology, radiology, pathology, gastroenterology, integrative oncology, anesthesia, pharmacy, nursing, cancer care delivery research, and nutrition as well as patient and caregiver stakeholders.

Main outcome and measures: Statements that reached 75% agreement or greater were included in final consensus statements.

Results: Of the 47 participating panel members, 27 (57.64%) were male, and the mean (SD) age was 47.6 (8.2) years. Physicians reported completing training a mean (SD) 14.6 (8.6) years prior and seeing a mean (SD) 110.6 (38.4) patients with PDAC annually; 35 (77.7%) were in academic practice. Final consensus was reached on 82 best practices for delivering NT. Of these, 38 statements focused on pre-NT practices, including diagnosis and staging (n = 15), evaluation and optimization (n = 20), and decision-making (n = 3); 29 statements defined best practices during NT, including initiation (n = 3), delivery of therapy (n = 8), restaging practices (n = 12), and management of complications during NT (n = 6); and 15 best practices were identified to guide treatment post-NT, focusing on surgery (n = 7), pathology (n = 4), and follow-up (n = 3).

Conclusions: Using a modified Delphi consensus technique, best practice guidelines were developed focusing on the optimal standards for delivering NT to patients with localized PDAC. Given the prognostic importance of completing multimodality therapy, efforts to standardize and optimize the delivery of NT represent an immediate opportunity to decrease care variation and improve outcomes for patients with PDAC. Future research should focus on validating and implementing best practice standards into clinical practice.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Arango reported personal fees from Astellas Pharma outside the submitted work. Dr Bates reported grants from Pancreatic Cancer Action Network and the US Department of Defense, clinical trial support from RenovoRx, and advisory board fees from Elmedix outside the submitted work. Dr Dotan reported grants from Ipsen, Eli Lilly, Relay, Kinate, Leap Therapeutics, Incyte, AstraZeneca, Medimmune, Lutris, Dragonfly, Zymeworks, and NGM Biopharmaceuticals and personal fees from Agenus, TME Pharma, Ipsen, Merus, Olympus, Amgen, Pfizer, Taiho, and Incyte outside the submitted work. Dr Goenka reported personal fees from UWorld, Ferronova, Bayer Healthcare, and Candel Therapeutics and grants from the National Institutes of Health, the Mayo Clinic Comprehensive Cancer Center, the Champions for Hope Pancreatic Cancer Research Program of the Funk Zitiello Foundation, the Centene Charitable Foundation, the Hoveida Family Foundation, Sofie Biosciences, and Novartis outside the submitted work. Dr Goodman reported advisory board fees from RenovoRX outside the submitted work. Dr Hall reported travel and research support (to institution) from Elekta and consulting fees from Sonoptima and Aktis Oncology outside the submitted work. Dr Hogg reported nonfinancial support from Intuitive as well as travel funds for courses and personal fees from Olympus outside the submitted work. Dr Kambadakone reported grants from GE Healthcare (through institution), PanCAN, and Bayer outside the submitted work. Dr Khorana reported personal fees from Sanofi, Anthos, Pfizer, WebMD, and Bristol Myers Squibb outside the submitted work. Dr Ko reported grants (paid to institution) from Verastem, Celgene, Roche/Genentech, and Abgenomics and personal fees from Ipsen (member, independent data monitoring committee), Fibrogen (consulting/advisory board), Merus (consulting/advisory board), Arcus (consulting/advisory board), and Genentech (consulting/advisory board) outside the submitted work. Dr Koay reported personal fees from iO Life Sciences (consulting for medical device), AstraZeneca (consulting for immunotherapy), Taylor and Francis (book royalties), and RenovoRx (consulting for medical device) and grants from Varian (imaging and radiotherapy research), GE Healthcare (imaging research), and Siemens (imaging research) outside the submitted work. Dr Krishna reported grants from Mauna Kea Technologies and Tae Woong Medical outside the submitted work. Dr Larsson reported personal fees from Academy of Oncology Nurse & Patient Navigators (presentation about clinical trials diversity) outside the submitted work. Dr Maitra reported patent royalties from Thrive Earlier Detection and consulting fees from Tezcat Biosciences outside the submitted work. Dr O’Reilly reported research funding (to institution) from Genentech/Roche, BioNTech, AstraZeneca, Arcus, Elicio, Parker Institute, the National Cancer Institute, Digestive Care, Break Through Cancer, and Agenus; consulting or data safety monitoring board fees from Arcus, Ability Pharma, Alligator BioSciences, Agenus, BioNTech, Ipsen, Merck, Moma Therapeutics, Novartis, Syros, Leap Therapeutics, Astellas, BMS, Fibrogen, Revolution Medicines, Regeneron, and Merus; and consulting or data safety monitoring board fees (spouse) from Agios, Genentech-Roche, Eisai Servier. Dr Palta reported research support (to institution) from Galera, Merck, and Varian Medical Systems; research support (to institution) and compensation for a 1-time advertisement board in February 2023 from Voxelmetric; and consultant fees royalties for authorship contribution from UpToDate outside the submitted work. Dr Phillip reported grants from Raphael outside the submitted work. Dr Santa Mina reported personal fees from Merck (honorarium for prehabilitation presentation) outside the submitted work and is cofounder and equity stakeholder of PrehabRx, a digital pre- and rehabilitation company. Dr Sohal reported speakers bureau fees from AstraZeneca (started Jan 2024), Incyte (started Jan 2021), Seagen (ended Dec 2023); consulting fees or honoraria from AstraZeneca (ended Jan 2024), Replimune (ended Jan 2024), Cancer Commons (ended Jun 2023), TransThera (ended Jun 2022), Totus Medicines (ended Jul 2023), Valar Labs (ended Dec 2022), Aadi (ended Jun 2023), Elevar, and Regeneron and research funding (to institution) from Aadi, Ability Pharma, Amgen, Apexigen, Astellas, AstraZeneca, Bexion, Bristol Myers Squibb, FibroGen, Genentech, Hengrui, Merck, Mirati, NextCure, PanCAN, Regeneron, Revolution Medicines, Roche, and Triumvira. Dr Vreeland reported consulting fees from LumaBridge outside the submitted work. Dr Washington reported personal fees from Takeda Pharmaceuticals outside the submitted work. No other disclosures were reported.

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