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

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...

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Published inJournal of clinical oncology Vol. 42; no. 2; pp. 146 - 156
Main Authors Rau, Beate, Lang, Hauke, Koenigsrainer, Alfred, Gockel, Ines, Rau, Horst-Guenter, Seeliger, Hendrik, Lerchenmueller, Christian, Reim, Daniel, Wahba, Roger, Angele, Martin, Heeg, Steffen, Keck, Tobias, Weimann, Arved, Topp, Stefan, Piso, Pompiliu, Brandl, Andreas, Schuele, Silke, Jo, Peter, Pratschke, Johann, Wegel, Sandra, Rehders, Alexander, Moosmann, Nicolas, Gaedcke, Jochen, Heinemann, Volker, Trips, Evelyn, Loeffler, Markus, Schlag, Peter Michael, Thuss-Patience, Peter
Format Journal Article
LanguageEnglish
Published United States Wolters Kluwer Health 10.01.2024
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Summary: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. 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 and cisplatin 75 mg/m 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. 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 CRS-A, 14.9 [97.2% CI, 7.0 to 19.4] months; = .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; = .047) in the CRS + H group. The CRS + H group showed better MFS (10.2 months [95% CI, 7.7 to 14.7] CRS-A, 9.2 months [95% CI, 6.8 to 11.5]; = .0286). The incidence of grade ≥3 adverse events (AEs) was similar between groups (CRS-A, 38.1% CRS + H, 43.6%; = .79). 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.
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ISSN:0732-183X
1527-7755
1527-7755
DOI:10.1200/JCO.22.02867