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Open Access 01-12-2021 | Cytostatic Therapy | Peritoneal Surface Malignancy

A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma

Authors: Can Yurttas, MD, Philipp Horvath, MD, Imma Fischer, PhD, Christoph Meisner, PhD, Silvio Nadalin, MD, Ingmar Königsrainer, MD, Alfred Königsrainer, MD, Stefan Beckert, MD, Markus W. Löffler, MD

Published in: Annals of Surgical Oncology | Issue 13/2021

Abstract

Background

Pancreatic ductal adenocarcinoma (PDAC) is a common fatal disease with unfavorable prognosis, even after oncological resection. To improve survival, adding hyperthermic intraperitoneal chemotherapy (HIPEC) has been suggested. Whether HIPEC entails disproportional short-term mortality is unknown and a prospectively determined adverse events profile is lacking. Since both pancreatic resection and HIPEC may relevantly influence morbidity and mortality, this uncontrolled single-arm, open-label, phase I/II pilot trial was designed to assess the 30-day mortality rate, treatment feasibility, and adverse events connected with HIPEC after oncological pancreatic surgery.

Methods

This trial recruited patients scheduled for PDAC resection. A sample size of 16 patients receiving study interventions was estimated to establish a predefined margin of treatment-associated short-term mortality with a power of > 80%. Patients achieving complete macroscopic resection received HIPEC with gemcitabine administered at 1000 mg/m² body surface area heated to 42 °C for 1 hour.

Results

Within 30 days after intervention, no patient died or experienced any adverse events higher than grade 3 that were related to HIPEC. Furthermore, treatment-related adverse events were prospectively documented and categorized as expected or unexpected. This trial supports that the actual mortality rate after PDAC resection and HIPEC is below 10%. HIPEC treatment proved feasible in 89% of patients allocated to intervention. Pancreatic fistulas, as key complications after pancreas surgery, occurred in 3/13 patients under risk.

Conclusion

Combined pancreas resection and gemcitabine HIPEC proved feasible and safe, with acceptable morbidity and mortality. Based on these results, further clinical evaluation can be justified.

Registration Number

NCT02863471 (http://www.clinicaltrials.gov).

Available only for authorised users

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Title: A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma
Authors: Can Yurttas, MD
Philipp Horvath, MD
Imma Fischer, PhD
Christoph Meisner, PhD
Silvio Nadalin, MD
Ingmar Königsrainer, MD
Alfred Königsrainer, MD
Stefan Beckert, MD
Markus W. Löffler, MD
Publication date: 01-12-2021
Publisher: Springer International Publishing
Keyword: Cytostatic Therapy
Published in: Annals of Surgical Oncology / Issue 13/2021
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-021-10187-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A Prospective, Phase I/II, Open-Label Pilot Trial to Assess the Safety of Hyperthermic Intraperitoneal Chemotherapy After Oncological Resection of Pancreatic Adenocarcinoma

Abstract

Background

Methods

Results

Conclusion

Registration Number

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Registration Number

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