PMID- 30838646
OWN - NLM
STAT- MEDLINE
DCOM- 20190514
LR  - 20190514
IS  - 1096-9098 (Electronic)
IS  - 0022-4790 (Linking)
VI  - 119
IP  - 7
DP  - 2019 Jun
TI  - Body surface area-based vs concentration-based perioperative intraperitoneal
      chemotherapy after optimal cytoreductive surgery in colorectal peritoneal surface
      malignancy treatment: COBOX trial.
PG  - 999-1010
LID - 10.1002/jso.25437 [doi]
AB  - 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.
CI  - (c) 2019 Wiley Periodicals, Inc.
FAU - Lemoine, Lieselotte
AU  - Lemoine L
AUID- ORCID: http://orcid.org/0000-0002-3394-8813
AD  - Department of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
AD  - Department of Surgical Oncology, Ziekenhuis Oost-Limburg, Genk, Belgium.
FAU - Thijssen, Elsy
AU  - Thijssen E
AD  - Applied and Analytical Chemistry, Institute for Materials Research, Hasselt
      University, Diepenbeek, Belgium.
FAU - Carleer, Robert
AU  - Carleer R
AD  - Applied and Analytical Chemistry, Institute for Materials Research, Hasselt
      University, Diepenbeek, Belgium.
FAU - Geboers, Karlien
AU  - Geboers K
AD  - Department of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
FAU - Sugarbaker, Paul
AU  - Sugarbaker P
AUID- ORCID: http://orcid.org/0000-0002-2431-7366
AD  - Center for Gastrointestinal Malignancies, MedStar Washington Hospital Center,
      Washington, District of Columbia.
FAU - van der Speeten, Kurt
AU  - van der Speeten K
AD  - Department of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
AD  - Department of Surgical Oncology, Ziekenhuis Oost-Limburg, Genk, Belgium.
LA  - eng
GR  - Limburgs Kankerfonds
GR  - 141631/Agentschap voor Innovatie door Wetenschap en Technologie
GR  - Limburg Sterk Merk
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190305
PL  - United States
TA  - J Surg Oncol
JT  - Journal of surgical oncology
JID - 0222643
RN  - 04ZR38536J (Oxaliplatin)
RN  - Q573I9DVLP (Leucovorin)
RN  - U3P01618RT (Fluorouracil)
SB  - IM
MH  - Aged
MH  - Ascitic Fluid/metabolism
MH  - Colorectal Neoplasms/drug therapy/metabolism/surgery/*therapy
MH  - Cytoreduction Surgical Procedures/methods
MH  - Female
MH  - Fluorouracil/administration & dosage
MH  - Humans
MH  - Hyperthermia, Induced/*methods
MH  - Leucovorin/administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Oxaliplatin/*administration & dosage/blood/pharmacokinetics/urine
MH  - Perioperative Care/methods
MH  - Pilot Projects
MH  - Quality of Life
OTO - NOTNLM
OT  - body surface area-based
OT  - colorectal peritoneal surface malignancy
OT  - concentration-based
OT  - hyperthermic intraperitoneal perioperative chemotherapy
OT  - oxaliplatin
EDAT- 2019/03/07 06:00
MHDA- 2019/05/15 06:00
CRDT- 2019/03/07 06:00
PHST- 2018/11/23 00:00 [received]
PHST- 2019/01/15 00:00 [revised]
PHST- 2019/02/18 00:00 [accepted]
PHST- 2019/03/07 06:00 [pubmed]
PHST- 2019/05/15 06:00 [medline]
PHST- 2019/03/07 06:00 [entrez]
AID - 10.1002/jso.25437 [doi]
PST - ppublish
SO  - J Surg Oncol. 2019 Jun;119(7):999-1010. doi: 10.1002/jso.25437. Epub 2019 Mar 5.