PMID- 37906724
OWN - NLM
STAT- MEDLINE
DCOM- 20240108
LR  - 20240131
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 42
IP  - 2
DP  - 2024 Jan 10
TI  - Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in 
      Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I 
      Trial.
PG  - 146-156
LID - 10.1200/JCO.22.02867 [doi]
AB  - PURPOSE: In patients with peritoneal metastasis (PM) from gastric cancer (GC), 
      chemotherapy is the treatment of choice. Cytoreductive surgery (CRS) and 
      hyperthermic intraperitoneal chemotherapy (HIPEC) are still being debated. This 
      randomized, controlled, open-label, multicenter phase III trial (EudraCT 
      2006-006088-22; ClinicalTrials.gov identifier: NCT02158988) explored the impact 
      on overall survival (OS) of HIPEC after CRS. PATIENTS AND METHODS: Adult patients 
      with GC and histologically proven PM were randomly assigned (1:1) to 
      perioperative chemotherapy and CRS alone (CRS-A) or CRS plus HIPEC (CRS + H). 
      HIPEC comprised mitomycin C 15 mg/m(2) and cisplatin 75 mg/m(2) in 5 L of saline 
      perfused for 60 minutes at 42 degrees C. The primary end point was OS; secondary 
      endpoints included progression-free survival (PFS), other distant metastasis-free 
      survival (MFS), and safety. Analyses followed the intention-to-treat principle. 
      RESULTS: Between March 2014 and June 2018, 105 patients were randomly assigned 
      (53 patients to CRS-A and 52 patients to CRS + H). The trial stopped prematurely 
      because of slow recruitment. In 55 patients, treatment stopped before CRS mainly 
      due to disease progression/death. Median OS was the same for both groups (CRS + 
      H, 14.9 [97.2% CI, 8.7 to 17.7] months v CRS-A, 14.9 [97.2% CI, 7.0 to 19.4] 
      months; P = .1647). The PFS was 3.5 months (95% CI, 3.0 to 7.0) in the CRS-A 
      group and 7.1 months (95% CI, 3.7 to 10.5; P = .047) in the CRS + H group. The 
      CRS + H group showed better MFS (10.2 months [95% CI, 7.7 to 14.7] v CRS-A, 9.2 
      months [95% CI, 6.8 to 11.5]; P = .0286). The incidence of grade >/=3 adverse 
      events (AEs) was similar between groups (CRS-A, 38.1% v CRS + H, 43.6%; P = .79). 
      CONCLUSION: This study showed no OS difference between CRS + H and CRS-A. PFS and 
      MFS were significantly better in the CRS + H group, which needs further 
      exploration. HIPEC did not increase AEs.
FAU - Rau, Beate
AU  - Rau B
AUID- ORCID: 0000-0001-5820-6907
AD  - Department of Surgery, Charite-Universitatsmedizin Berlin, Corporate Member of 
      Freie Universitat, Berlin, Germany.
FAU - Lang, Hauke
AU  - Lang H
AD  - Department of Surgery, Johannes Gutenberg Universitat Mainz Klinikum, Mainz, 
      Germany.
FAU - Koenigsrainer, Alfred
AU  - Koenigsrainer A
AD  - Department of Surgery, Universitatsklinikum Tubingen, Tubingen, Germany.
FAU - Gockel, Ines
AU  - Gockel I
AUID- ORCID: 0000-0001-7423-713X
AD  - Department of Surgery, Universitatsklinikum Leipzig, Leipzig, Germany.
FAU - Rau, Horst-Guenter
AU  - Rau HG
AUID- ORCID: 0009-0007-9967-744X
AD  - Emeritus Department of Surgery, Amper Kliniken AG, Dachau, Germany.
FAU - Seeliger, Hendrik
AU  - Seeliger H
AUID- ORCID: 0000-0002-5937-052X
AD  - Department of Surgery, Charite-Universitatsmedizin Berlin, Berlin, Germany.
FAU - Lerchenmueller, Christian
AU  - Lerchenmueller C
AD  - Department of Medical Oncology, Gemeinschaftspraxis fur Hamatologie und 
      Onkologie-Munster, Munster, Germany.
FAU - Reim, Daniel
AU  - Reim D
AD  - Department of Surgery, Klinikum rechts der Isar, Technische Universitat Munchen, 
      Munchen, Germany.
FAU - Wahba, Roger
AU  - Wahba R
AUID- ORCID: 0000-0003-0037-8620
AD  - Department of General, Visceral, Cancer and Transplantation Surgery, Faculty of 
      Medicine and University Hospital of Cologne, University of Cologne, Cologne, 
      Germany.
FAU - Angele, Martin
AU  - Angele M
AD  - Department of Surgery, Klinikum der Universitat Munchen-Grosshadern, Munchen, 
      Germany.
FAU - Heeg, Steffen
AU  - Heeg S
AUID- ORCID: 0000-0003-3368-0703
AD  - Department of Medicine II, Medical Center-University of Freiburg, Faculty of 
      Medicine, University of Freiburg, Germany.
FAU - Keck, Tobias
AU  - Keck T
AD  - Department of Surgery, Campus Lubeck, Universitatsklinikum Schleswig-Holstein, 
      Lubeck, Germany.
FAU - Weimann, Arved
AU  - Weimann A
AUID- ORCID: 0000-0001-5474-2171
AD  - Department of Surgery, St Georg-Krankenhaus Leipzig, Leipzig, Germany.
FAU - Topp, Stefan
AU  - Topp S
AD  - Department of Surgery, Bonifatius Hospital Lingen (fur Dusseldorf), Lingen, 
      Germany.
FAU - Piso, Pompiliu
AU  - Piso P
AD  - Department of Surgery, Krankenhaus Barmherzige Bruder Regensburg, Regensburg, 
      Germany.
FAU - Brandl, Andreas
AU  - Brandl A
AUID- ORCID: 0000-0003-1990-2584
AD  - Department of Surgery, Charite-Universitatsmedizin Berlin, Corporate Member of 
      Freie Universitat, Berlin, Germany.
FAU - Schuele, Silke
AU  - Schuele S
AUID- ORCID: 0000-0002-5640-187X
AD  - Department of Surgery, Universitatsklinikum Jena, Jena, Germany.
FAU - Jo, Peter
AU  - Jo P
AD  - Department of Surgery, Universitatsmedizin Gottingen, Gottingen, Germany.
FAU - Pratschke, Johann
AU  - Pratschke J
AD  - Department of Surgery, Charite-Universitatsmedizin Berlin, Corporate Member of 
      Freie Universitat, Berlin, Germany.
FAU - Wegel, Sandra
AU  - Wegel S
AD  - Department of Surgery, Charite-Universitatsmedizin Berlin, Corporate Member of 
      Freie Universitat, Berlin, Germany.
FAU - Rehders, Alexander
AU  - Rehders A
AD  - Department of Surgery, Universitatsklinikum Dusseldorf, Dusseldorf, Germany.
FAU - Moosmann, Nicolas
AU  - Moosmann N
AD  - Department of Medical Oncology, Krankenhaus Barmherzige Bruder Regensburg, 
      Regensburg, Germany.
FAU - Gaedcke, Jochen
AU  - Gaedcke J
AUID- ORCID: 0000-0002-6130-5874
AD  - Department of Surgery, Universitatsmedizin Gottingen, Gottingen, Germany.
FAU - Heinemann, Volker
AU  - Heinemann V
AUID- ORCID: 0000-0002-1349-3321
AD  - Department of Medical Oncology, Klinikum der Universitat Munchen-Grosshadern, 
      Munchen, Germany.
FAU - Trips, Evelyn
AU  - Trips E
AUID- ORCID: 0000-0002-6530-5855
AD  - Zentrum fur Klinische Studien (ZKS) Leipzig, Medizinische Fakultat, Universitat 
      Leipzig, Leipzig, Germany.
AD  - Coordination Centre for Clinical Trials Dresden, Carl Gustav Carus Medical 
      Faculty, Technische Universitat Dresden, Dresden, Germany.
FAU - Loeffler, Markus
AU  - Loeffler M
AD  - Institut fur Medizinische Informatik, Statistik und Epidemiologie (IMISE), 
      Medizinische Fakultat, Universitat Leipzig, Leipzig, Germany.
FAU - Schlag, Peter Michael
AU  - Schlag PM
AD  - Department of Surgery and Surgical Oncology, Charite-Universitatsmedizin Berlin, 
      Berlin, Germany.
FAU - Thuss-Patience, Peter
AU  - Thuss-Patience P
AUID- ORCID: 0000-0002-8544-9872
AD  - Department of Hematology, Oncology and Cancer Immunology, 
      Charite-Universitatsmedizin Berlin, Berlin, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT02158988
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20231031
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - KJ7654W82V (crisamicin A)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Stomach Neoplasms/drug therapy/surgery
MH  - *Peritoneal Neoplasms/drug therapy/secondary
MH  - Hyperthermic Intraperitoneal Chemotherapy
MH  - Combined Modality Therapy
MH  - Cytoreduction Surgical Procedures/adverse effects
MH  - *Hyperthermia, Induced
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Survival Rate
MH  - Retrospective Studies
PMC - PMC10824373
COIS- The following represents disclosure information provided by authors of this 
      manuscript. All relationships are considered compensated unless otherwise noted. 
      Relationships are self-held unless noted. I = Immediate Family Member, Inst = My 
      Institution. Relationships may not relate to the subject matter of this 
      manuscript. For more information about ASCO's conflict of interest policy, please 
      refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center. Open 
      Payments is a public database containing information reported by companies about 
      payments made to US-licensed physicians (Open Payments).
EDAT- 2023/10/31 18:43
MHDA- 2024/01/08 06:42
PMCR- 2023/10/31
CRDT- 2023/10/31 16:03
PHST- 2024/01/08 06:42 [medline]
PHST- 2023/10/31 18:43 [pubmed]
PHST- 2023/10/31 16:03 [entrez]
PHST- 2023/10/31 00:00 [pmc-release]
AID - JCO.22.02867 [pii]
AID - 10.1200/JCO.22.02867 [doi]
PST - ppublish
SO  - J Clin Oncol. 2024 Jan 10;42(2):146-156. doi: 10.1200/JCO.22.02867. Epub 2023 Oct 
      31.