Wide variation in tissue, systemic, and drain fluid exposure after oxaliplatin-based HIPEC: results of the GUTOX study.
| Title: | Wide variation in tissue, systemic, and drain fluid exposure after oxaliplatin-based HIPEC: results of the GUTOX study. |
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| Authors: | de Jong LAW; Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. Loek.dejong@radboudumc.nl.; Elekonawo FMK; Department of Radiology and Nuclear Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; Lambert M; Institut Claudius‑Regaud, IUCT‑Oncopole, and CRCT, Université de Toulouse, Inserm, 1, avenue Irène Joliot‑Curie, Toulouse, France.; de Gooyer JM; Department of Radiology and Nuclear Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; Verheul HMW; Department of Medical Oncology, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; Burger DM; Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; de Wilt JHW; Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; Chatelut E; Institut Claudius‑Regaud, IUCT‑Oncopole, and CRCT, Université de Toulouse, Inserm, 1, avenue Irène Joliot‑Curie, Toulouse, France.; Ter Heine R; Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; de Reuver PR; Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; Bremers AJA; Department of Surgery, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands.; van Erp NP; Department of Pharmacy, Radboud Institute for Health Sciences, Radboud University Medical Center (RUMC), P.O. Box 9101, 6500 HB, Nijmegen, The Netherlands. |
| Source: | Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2020 Jul; Vol. 86 (1), pp. 141-150. Date of Electronic Publication: 2020 Jun 27. |
| Publication Type: | Clinical Trial; Journal Article |
| Language: | English |
| Journal Info: | Publisher: Springer Verlag Country of Publication: Germany NLM ID: 7806519 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-0843 (Electronic) Linking ISSN: 03445704 NLM ISO Abbreviation: Cancer Chemother Pharmacol Subsets: MEDLINE |
| Imprint Name(s): | Publication: Berlin : Springer Verlag; Original Publication: Berlin, New York, Springer International. |
| MeSH Terms: | Ascitic Fluid/*drug effects ; Hyperthermic Intraperitoneal Chemotherapy/*methods ; Oxaliplatin/*pharmacokinetics ; Peritoneal Neoplasms/*therapy; Ascitic Fluid/chemistry ; Hyperthermic Intraperitoneal Chemotherapy/adverse effects ; Oxaliplatin/adverse effects ; Oxaliplatin/blood ; Sodium Chloride/therapeutic use ; Aged ; Aged, 80 and over ; Drainage ; Female ; Humans ; Male ; Middle Aged ; Tissue Distribution |
| Abstract: | Purpose: In this exploratory study, the effect of postprocedural flushing with crystalloids after oxaliplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) on platinum concentrations in peritoneal tissue, blood, and drain fluid was studied. Interpatient variability in oxaliplatin pharmacokinetics and the relation between platinum concentration in peritoneal fluid and platinum exposure in tissue and blood was explored.; Methods: Ten patients with peritoneal carcinomatosis of colorectal origin were treated with HIPEC including postprocedural flushing, followed by ten patients without flushing afterwards. Tissue, peritoneal fluid, blood, and drain fluid samples were collected for measurement of total and ultrafiltered platinum concentrations.; Results: Peritoneal tissue concentration and systemic ultrafiltered platinum exposure showed large inter individual variability, ranging from 65 to 1640 µg/g dry weight and 10.5 to 28.0 µg*h/ml, respectively. No effect of flushing was found on geometric mean platinum concentration in peritoneal tissue (348 vs. 356 µg/g dry weight), blood (14.8 vs. 18.1 µg*h/ml), or drain fluid (day 1: 7.6 vs. 7.7 µg/ml; day 2: 1.7 vs. 1.9 µg/ml). The platinum concentration in peritoneal fluid at the start of HIPEC differed twofold between patients and was positively correlated with systemic exposure (p = .04) and peak plasma concentration (p = .04).; Conclusion: In this exploratory study, no effect was found for postprocedural flushing on platinum concentrations in peritoneal tissue, blood, or drain fluid. BSA-based HIPEC procedure leads to large interpatient variability in platinum exposure in all compartments. The study was registered at ClinicalTrials.gov on 7 December 2017 under registration number NCT03364907. |
| Comments: | Erratum in: Cancer Chemother Pharmacol. 2022 Aug;90(2):189-190. doi: 10.1007/s00280-022-04450-2.. (PMID: 35731259) |
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| Contributed Indexing: | Keywords: Colorectal peritoneal metastasis; HIPEC; Hyperthermic intraperitoneal chemotherapy; Oxaliplatin; Peritoneal carcinomatosis; Pharmacokinetics |
| Molecular Sequence: | ClinicalTrials.gov NCT03364907 |
| Substance Nomenclature: | 04ZR38536J (Oxaliplatin); 451W47IQ8X (Sodium Chloride) |
| Entry Date(s): | Date Created: 20200629 Date Completed: 20210219 Latest Revision: 20220622 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC7338818 |
| DOI: | 10.1007/s00280-020-04107-y |
| PMID: | 32594200 |
| Database: | MEDLINE |
Clinical Trial; Journal Article