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Body surface area‐based vs concentration‐based perioperative intraperitoneal chemotherapy after optimal cytoreductive surgery in colorectal peritoneal surface malignancy treatment: COBOX trial
Author(s) -
Lemoine Lieselotte,
Thijssen Elsy,
Carleer Robert,
Geboers Karlien,
Sugarbaker Paul,
Speeten Kurt
Publication year - 2019
Publication title -
journal of surgical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.201
H-Index - 111
eISSN - 1096-9098
pISSN - 0022-4790
DOI - 10.1002/jso.25437
Subject(s) - medicine , oxaliplatin , hyperthermic intraperitoneal chemotherapy , body surface area , perioperative , chemotherapy , cytoreductive surgery , randomized controlled trial , quality of life (healthcare) , colorectal cancer , malignancy , surgery , cancer , nursing , ovarian cancer
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. 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. 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.