Abstract
Background
A group of experts from the Peritoneal Surface Oncology Group International (PSOGI) and the BIG-RENAPE group carried out a consensus among surgeons experienced in treating peritoneal malignancies from around the world to derive recommendations on indications of hyperthermic intraperitoneal chemotherapy (HIPEC), choice and details of HIPEC regimens, and areas for future research. This manuscript describes the methodology of achieving this consensus and the degree of participation of experts.
Methods
The Delphi technique was used and the questionnaire comprised three categories: evidence-based recommendations using the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system with the PICO (patient, intervention, comparison, and outcome) method, an opinion survey, and research recommendations. A consensus was achieved if any one option had >50% of votes, or positive or negative recommendations combined had > 70% of votes.
Results
Of the 145 experts solicited, 71.1% in round I and 72.2% in round II took the survey. Participation was highest among surgeons treating both gastrointestinal and gynecological malignancies. Of 113 questions, after round I, a consensus was achieved for 72 (63.7%) questions, and after the second round, consensus was achieved for another 22 (19.4%) questions, making a total of 94 (83.1%) questions for which a consensus was achieved.
Conclusion
This consensus was carried out using a thorough review of literature and robust rating of evidence, and included key experts and opinion leaders from across the world. The results could guide clinicians on the use of HIPEC, both in their day-to-day clinical practice and in designing clinical trials.
Similar content being viewed by others
References
Witmer H, Turaga K. Current indications for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for gastrointestinal malignancies. Adv Oncol. 2021;1:49–61. https://doi.org/10.1016/j.yao.2021.02.005.
Valle M, Van der Speeten K, Garofalo A. Laparoscopic hyperthermic intraperitoneal peroperative chemotherapy (HIPEC) in the management of refractory malignant ascites: a multi-institutional retrospective analysis in 52 patients. J Surg Oncol. 2009;100:331–4. https://doi.org/10.1002/jso.21321.
White MG, Badgwell BD. Laparoscopic heated intraperitoneal chemotherapy in the treatment of carcinomatosis of gastric adenocarcinoma origin. J Clin Med. 2021;10(20):4757. https://doi.org/10.3390/jcm10204757.
Zhang C, Patel A, Hegeholz D, et al. Cytoreductive surgery with HIPEC is a safe and effective palliative option in chemo refractory symptomatic peritoneal metastasis. Ann Surg Oncol. 2022;29:3337–46. https://doi.org/10.1245/s10434-022-11323-8.
Bhatt A, Glehen O. Extent of peritoneal resection for peritoneal metastases: looking beyond a complete cytoreduction. Ann Surg Oncol. 2020;27(5):1458–70. https://doi.org/10.1245/s10434-020-08208-z.
van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, et al. Hyperthermic intraperitoneal chemotherapy in ovarian cancer. N Engl J Med. 2018;378(3):230–40. https://doi.org/10.1056/NEJMoa1708618.
Quénet F, Elias D, Roca L, Goéré D, Ghouti L, Pocard M, Facy O, et al. UNICANCER-GI Group and BIG Renape Group. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(2):256-266. https://doi.org/10.1016/S1470-2045(20)30599-4.
Zivanovic O, Chi DS, Zhou Q, Iasonos A, Konner JA, Makker V, Grisham RN, et al. Secondary cytoreduction and carboplatin hyperthermic intraperitoneal chemotherapy for platinum-sensitive recurrent ovarian cancer: an MSK Team Ovary Phase II Study. J Clin Oncol. 2021;39(23):2594–604. https://doi.org/10.1200/JCO.21.00605.
Yurttas C, Hoffmann G, Tolios A, Haen SP, Schwab M, Königsrainer I, et al. Systematic review of variations in hyper- thermic intraperitoneal chemotherapy (HIPEC) for peritoneal metastasis from colorectal cancer. J Clin Med. 2018;7:567. https://doi.org/10.3390/jcm7120567.
Bhatt A, de Hingh I, Van Der Speeten K, Hubner M, Deraco M, Bakrin N, et al. HIPEC methodology and regimens: the need for an expert consensus. Ann Surg Oncol. 2021;28(13):9098–113. https://doi.org/10.1245/s10434-021-10193-w.
Bhatt A, Van Der Speeten K, Hubner M, Kusamura S, Glehen O. ASO Author Reflections: Standardizing HIPEC methodology and regimens: a prelude to the PSOGI Expert Consensus. Ann Surg Oncol. 2021;28(13):9114–5. https://doi.org/10.1245/s10434-021-10205-9.
Rowe G, Wright G, Bolger F. Delphi: a re-evaluation of research and theory. Technol Forecast Soc Change. 1991;39:235–51. https://doi.org/10.1016/0040-1625(91)90039-I.
Lurvink RJ, Villeneuve L, Govaerts K, de Hingh IHJT, Moran BJ, Deraco M, et al.; List of PSOGI collaborators. The Delphi and GRADE methodology used in the PSOGI 2018 consensus statement on Pseudomyxoma Peritonei and Peritoneal Mesothelioma. Eur J Surg Oncol. 2021;47(1):4-10. doi: https://doi.org/10.1016/j.ejso.2019.03.012.
Guyatt GH, Oxman AD, Akl EA. GRADE guidelines: 1. Introduction e GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64:383–94. https://doi.org/10.1016/j.jclinepi.2010.04.026.
Grades of Recommendation. Assessment, development, and evaluation (GRADE) working group. Education and debate e grading quality of evidence and strength of recommendations. BMJ. 2004;328:1490–4. https://doi.org/10.1136/bmj.328.7454.1490.
Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898. https://doi.org/10.1136/bmj.l4898.
Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index for non-randomized studies (MINORS): development and validation of a new instrument. ANZ J Surg. 2003;73:712–6. https://doi.org/10.1046/j.1445-2197.2003.02748.x.
Higgins JPT, Green S. Cochrane Handbook for systematic reviews of Interventions. Wiley Online Library; 2008. ISBN 978-0-470-69951-5.
Huang X, Lin J, Demner-Fushman D. Evaluation of PICO as a knowledge representation for clinical questions. AMIA Annu Symp Proc. 2006;2006:359–63.
Gouy S, Ferron G, Glehen O, Bayar A, Marchal F, Pomel C, et al. Results of a multicenter phase I dose-finding trial of hyperthermic intraperitoneal cisplatin after neoadjuvant chemotherapy and complete cytoreductive surgery and followed by maintenance bevacizumab in initially unresectable ovarian cancer. Gynecol Oncol. 2016;142:237–42. https://doi.org/10.1016/j.ygyno.2016.05.032.
Bijelic L, Sugarbaker PH, Stuart OA. Hyperthermic intraperi- toneal chemotherapy with melphalan: a summary of clinical and pharmacological data in 34 patients. Gastroenterol Res Pract. 2012;2012:827534. https://doi.org/10.1155/2012/827534.
Sugarbaker PH, Stuart OA, Bijelic L. Intraperitoneal gemc- itabine chemotherapy treatment for patients with resected pancreatic cancer: rationale and report of early data. Int J Surg Oncol. 2011;2011:161862. https://doi.org/10.1155/2011/161862.
Guyatt GH, Oxman AD, Kunz R. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336:924–6. https://doi.org/10.1136/bmj.39489.470347.AD.
Guyatt GH, Oxman AD, Kunz R. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64:395–400. https://doi.org/10.1016/j.jclinepi.2010.09.012.
Balshem H, Helfand M, Schünemann HJ. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011;64(4):401–6. https://doi.org/10.1016/j.jclinepi.2010.07.015.
Guyatt GH, Oxman AD, Vist G. GRADE guidelines: 4. Rating the quality of evidence e study limitations (risk of bias). J Clin Epidemiol. 2011;64:407–15.
Andrews JC, Guyatt GH, Oxman AD. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol. 2013;66:719–25. https://doi.org/10.1016/j.jclinepi.2012.03.013.
Andrews JC, Schünemann HJ, Oxman AD. GRADE guidelines: 15. Going from evidence to recommendation e determinants of a recommendation’s direction and strength. J Clin Epidemiol. 2013;66:726–35. https://doi.org/10.1016/j.jclinepi.2013.02.003.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700. https://doi.org/10.1136/bmj.b2700.
Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials. 2007;8:16. https://doi.org/10.1186/1745-6215-8-16.
Powell C. Methodological issues in nursing research, the Delphi technique: myths and realities. J Adv Nurs. 2003;41:376–82. https://doi.org/10.1046/j.1365-2648,2003.02537.x.
Keeney S, Hasson F, McKenna H. Consulting the oracle: ten lessons from using the Delphi technique in nursing research. J Adv Nurs. 2006;53:205–12. https://doi.org/10.1111/j.1365-2648.2006.03716.x.
Thangaratinam S, Redman CWE. The Delphi technique. TOG. 2005;7:120–5. https://doi.org/10.1576/toag.7.2.120.27071.
Badgwell B, Ikoma N, Murphy MB, Wang X, Estrella J, Roy-Chowdhuri S, et al. A Phase II trial of cytoreduction, gastrectomy, and hyperthermic intraperitoneal perfusion with chemotherapy for patients with gastric cancer and carcinomatosis or positive cytology. Ann Surg Oncol. 2021;28(1):258–64. https://doi.org/10.1245/s10434-020-08739-5.
Farrell R, Burling M, Lee YC, Pather S, Robledo K, Mercieca-Bebber R, et al.; HyNOVA Protocol Steering Committee. Clinical Trial Protocol for HyNOVA. Hyperthermic and Normothermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III epithelial OVArian, fallopian tube and primary peritoneal cancer (ANZGOG1901/2020). J Gynecol Oncol. 2022;33(1):e1. https://doi.org/10.3802/jgo.2022.33.e1.
Turaga K, Levine E, Barone R, Sticca R, Petrelli N, Lambert L, et al. Consensus guidelines from the American Society of Peritoneal Surface Malignancies on standardizing the delivery of hyperthermic intraperitoneal chemotherapy (HIPEC) in colorectal cancer patients in the United States. Ann Surg Oncol. 2014;21:1501–5.
Kusamura S, Baratti D, Younan R, Deraco M. The Delphi approach to Attain consensus in methodology of local regional therapy for peritoneal surface malignancy. J Surg Oncol. 2008;98(4):217–9. https://doi.org/10.1002/jso.21059.
Glehen O, Cotte E, Kusamura S, Deraco M, Baratti D, Passot G, et al. Hyperthermic intraperitoneal chemotherapy: nomenclature and modalities of perfusion. J Surg Oncol. 2008;98(4):242–6. https://doi.org/10.1002/jso.21061.
Baratti D, Kusamura S, Deraco M. The Fifth International Workshop on Peritoneal Surface Malignancy (Milan, Italy, December 4–6, 2006): methodology of disease-specific consensus. J Surg Oncol. 2008;98(4):258–62. https://doi.org/10.1002/jso.21056.
Moran B, Baratti D, Yan TD, Kusamura S, Deraco M. Consensus statement on the loco-regional treatment of appendiceal mucinous neoplasms with peritoneal dissemination (pseudomyxoma peritonei). J Surg Oncol. 2008;98:277–82. https://doi.org/10.1002/jso.21054.
Govaerts K, Lurvink RJ, De Hingh IHJT, Van der Speeten K, Villeneuve L, Kusamura S, et al; PSOGI. Appendiceal tumours and pseudomyxoma peritonei: Literature review with PSOGI/EURACAN clinical practice guidelines for diagnosis and treatment. Eur J Surg Oncol. 2021;47(1):11–35. https://doi.org/10.1016/j.ejso.2020.02.012.
Kusamura S, Kepenekian V, Villeneuve L, Lurvink RJ, Govaerts K, De Hingh IHJT, et al.; PSOGI. Peritoneal mesothelioma: PSOGI/EURACAN clinical practice guidelines for diagnosis, treatment and follow-up. Eur J Surg Oncol. 2021;47(1):36–59. https://doi.org/10.1016/j.ejso.2020.02.011.
Neiderberger M, Spranger J. Delphi technique in health sciences: a map. Front Public Health. 2020;8:457. https://doi.org/10.3389/fpubh.2020.00457.
Acknowledgment
The authors thank the members of each Working Group for lending their expertise, time, and effort to this project. Members of the different working groups: Technical considerations: Kurt Van der Speeten (Belgium), Pompiliu Piso (Germany), Victor Verwaal (Sweden), Shigeki Kusamura (Italy) and Olivier Glehen (France). Colorectal cancer: Martin Hubner (Switzerland), Ignace de Hingh (The Netherlands), Kim Govaerts (Belgium), Shigeki Kusamura (Italy) and Kurt Van der Speeten (Belgium). Gastric cancer: Olivier Glehen (France), Clarisse Eveno (France), Mohammad Alyami (Saudi Arabia), Beate Rau (Germany) and Santiago Gonzalez-Moreno (Spain). Epithelial ovarian cancer: Naoual Bakrin (France), Willemien van Driel (The Netherlands), Oliver Zivanovic (USA), Cedric Nadeau (France) and Aditi Bhatt (India). Pseudomyxoma peritonei: Shigeki Kusamura (Italy), Brendan Moran (UK), Jean-Baptiste Delhorme (France), Abdelkader Taibi (France) and Marcello Deraco (Italy). Peritoneal mesothelioma: Marcello Deraco (Italy), Vahan Kepenekian (France), Olivia Sgarbura (France), Shigeki Kusamura (Italy) and Frederic Marchal (France).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Disclosure
Olivier Glehen is a consultant for Gamida. Shigeki Kusamura, Aditi Bhatt, Martin Hubner, Laurent Villeneuve, Marcelo Deraco, Naoual Bakrin, and Kurt Van Der Speeten report no conflict of interests.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
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.
About this article
Cite this article
Kusamura, S., Bhatt, A., Hubner, M. et al. The 2022 PSOGI International Consensus on HIPEC Regimens for Peritoneal Malignancies: Methodology. Ann Surg Oncol 30, 2508–2519 (2023). https://doi.org/10.1245/s10434-022-12990-3
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1245/s10434-022-12990-3