Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I Trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Beate Rau - , Charité – Universitätsmedizin Berlin (Author)
  • Hauke Lang - , University Medical Center Mainz (Author)
  • Alfred Koenigsrainer - , University Hospital Tübingen (Author)
  • Ines Gockel - , University Hospital Leipzig (Author)
  • Horst-Guenter Rau - , Helios Amper Hospital Dachau (Author)
  • Hendrik Seeliger - , Charité – Universitätsmedizin Berlin (Author)
  • Christian Lerchenmueller - , Joint Practice for Hematology and Oncology Münster (Author)
  • Daniel Reim - , Klinikum Rechts der Isar (MRI TUM) (Author)
  • Roger Wahba - , Uniklinik Köln (Author)
  • Martin Angele - , Hospital of the Ludwig-Maximilians-University (LMU) Munich (Author)
  • Steffen Heeg - , University Medical Center Freiburg (Author)
  • Tobias Keck - , Universitätsklinikum Schleswig-Holstein - Campus Lübeck (Author)
  • Arved Weimann - , Klinikum St. Georg Leipzig (Author)
  • Stefan Topp - , St. Bonifatius Hospital Lingen (Author)
  • Pompiliu Piso - , Hospital of the Brothers of Mercy Regensburg (Author)
  • Andreas Brandl - , Charité – Universitätsmedizin Berlin (Author)
  • Silke Schuele - , Jena University Hospital (Author)
  • Peter Jo - , University Medical Center Göttingen (Author)
  • Johann Pratschke - , Charité – Universitätsmedizin Berlin (Author)
  • Sandra Wegel - , Charité – Universitätsmedizin Berlin (Author)
  • Alexander Rehders - , University Hospital Duesseldorf (Author)
  • Nicolas Moosmann - , Hospital of the Brothers of Mercy Regensburg (Author)
  • Jochen Gaedcke - , University Medical Center Göttingen (Author)
  • Volker Heinemann - , Hospital of the Ludwig-Maximilians-University (LMU) Munich (Author)
  • Evelyn Trips - , Administrative Units of the Faculty of Medicine, Coordination Centre for Clinical Studies Dresden (KKS-DD), University Hospital Leipzig (Author)
  • Markus Loeffler - , Leipzig University (Author)
  • Peter Michael Schlag - , Charité – Universitätsmedizin Berlin (Author)
  • Peter Thuss-Patience - , Charité – Universitätsmedizin Berlin (Author)

Abstract

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/m2 and cisplatin 75 mg/m2 in 5 L of saline perfused for 60 minutes at 42°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.

Details

Original languageEnglish
Pages (from-to)146-156
Number of pages11
JournalJournal of Clinical Oncology
Volume42
Issue number2
Publication statusE-pub ahead of print - 31 Oct 2023
Peer-reviewedYes

External IDs

unpaywall 10.1200/jco.22.02867
Scopus 85181760743
ORCID /0000-0002-6530-5855/work/151983261

Keywords

Sustainable Development Goals

Keywords

  • Stomach Neoplasms/drug therapy, Humans, Peritoneal Neoplasms/drug therapy, Hyperthermia, Induced, Adult, Cytoreduction Surgical Procedures/adverse effects, Survival Rate, Combined Modality Therapy, Retrospective Studies, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Hyperthermic Intraperitoneal Chemotherapy