Body surface area-based vs concentration-based perioperative intraperitoneal chemotherapy after optimal cytoreductive surgery in colorectal peritoneal surface malignancy treatment: COBOX trial.
Body surface area-based vs concentration-based perioperative intraperitoneal chemotherapy after optimal cytoreductive surgery in colorectal peritoneal surface malignancy treatment: COBOX trial.
- 2019
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 2 (BSA-based) in 2 L/m 2 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.
English
0022-4790
10.1002/jso.25437 [doi]
*Colorectal Neoplasms/th [Therapy]
*Hyperthermia, Induced/mt [Methods]
*Oxaliplatin/ad [Administration & Dosage]
Aged
Ascitic Fluid/me [Metabolism]
Colorectal Neoplasms/dt [Drug Therapy]
Colorectal Neoplasms/me [Metabolism]
Colorectal Neoplasms/su [Surgery]
Cytoreduction Surgical Procedures/mt [Methods]
Female
Fluorouracil/ad [Administration & Dosage]
Humans
Leucovorin/ad [Administration & Dosage]
Male
Middle Aged
Oxaliplatin/bl [Blood]
Oxaliplatin/pk [Pharmacokinetics]
Oxaliplatin/ur [Urine]
Perioperative Care/mt [Methods]
Pilot Projects
Quality of Life
Washington Cancer Institute
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
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 2 (BSA-based) in 2 L/m 2 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.
English
0022-4790
10.1002/jso.25437 [doi]
*Colorectal Neoplasms/th [Therapy]
*Hyperthermia, Induced/mt [Methods]
*Oxaliplatin/ad [Administration & Dosage]
Aged
Ascitic Fluid/me [Metabolism]
Colorectal Neoplasms/dt [Drug Therapy]
Colorectal Neoplasms/me [Metabolism]
Colorectal Neoplasms/su [Surgery]
Cytoreduction Surgical Procedures/mt [Methods]
Female
Fluorouracil/ad [Administration & Dosage]
Humans
Leucovorin/ad [Administration & Dosage]
Male
Middle Aged
Oxaliplatin/bl [Blood]
Oxaliplatin/pk [Pharmacokinetics]
Oxaliplatin/ur [Urine]
Perioperative Care/mt [Methods]
Pilot Projects
Quality of Life
Washington Cancer Institute
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial