TY  - BOOK
AU  - Sugarbaker, Paul H
TI  - Body surface area-based vs concentration-based perioperative intraperitoneal chemotherapy after optimal cytoreductive surgery in colorectal peritoneal surface malignancy treatment: COBOX trial
SN  - 0022-4790
PY  - 2019///
KW  - *Colorectal Neoplasms/th [Therapy]
KW  - *Hyperthermia, Induced/mt [Methods]
KW  - *Oxaliplatin/ad [Administration & Dosage]
KW  - Aged
KW  - Ascitic Fluid/me [Metabolism]
KW  - Colorectal Neoplasms/dt [Drug Therapy]
KW  - Colorectal Neoplasms/me [Metabolism]
KW  - Colorectal Neoplasms/su [Surgery]
KW  - Cytoreduction Surgical Procedures/mt [Methods]
KW  - Female
KW  - Fluorouracil/ad [Administration & Dosage]
KW  - Humans
KW  - Leucovorin/ad [Administration & Dosage]
KW  - Male
KW  - Middle Aged
KW  - Oxaliplatin/bl [Blood]
KW  - Oxaliplatin/pk [Pharmacokinetics]
KW  - Oxaliplatin/ur [Urine]
KW  - Perioperative Care/mt [Methods]
KW  - Pilot Projects
KW  - Quality of Life
KW  - Washington Cancer Institute
KW  - Clinical Trial, Phase III
KW  - Journal Article
KW  - Randomized Controlled Trial
N2  - BACKGROUND AND OBJECTIVES: Cytoreductive surgery (CRS) and hyperthermic intraperitoneal perioperative chemotherapy (HIPEC) are the standard of care for patients diagnosed with colorectal peritoneal surface malignancy (PSM). Despite a clearly defined standardization of CRS, a large variety of HIPEC modalities are still used in clinical practice; CONCLUSION: Concentration-based chemotherapy delivers the drug in the most standardized way to the tumor nodule, resulting in increasing drug concentrations in the tumor nodule without increasing major morbidity; Copyright (c) 2019 Wiley Periodicals, Inc; METHODS: Body surface area (BSA)- and concentration-based HIPEC protocols were clinically and pharmacologically evaluated in a randomized phase III clinical pilot trial. Oxaliplatin dose was 460 mg/m <sup>2</sup> (BSA-based) in 2 L/m <sup>2</sup> carrier solution (concentration-based). Platinum quantification was performed using a validated inductively coupled plasma mass spectrometry method. Three-month morbidity, mortality, and health-related quality of life (HRQOL) were assessed; RESULTS: Thirty-one patients were randomized to either BSA- or concentration-based HIPEC. Toxicity and efficacy were higher (P < 0.001) in patients receiving concentration-based HIPEC. There was no difference in pharmacologic advantage between the two groups. A higher drug concentration in the tumor nodule at the end of HIPEC was found in the HIPEC-concentration group. There was no difference in major morbidity and mortality between the treatment groups. HRQOL was decreased 3 months postoperatively in the HIPEC-concentration group
UR  - https://dx.doi.org/10.1002/jso.25437
ER  -