Photo Credit: Graphic BKK1979
The GASTRIPEC-I Trial studied gastric cancer patients with peritoneal metastasis undergoing surgery alone (CRS-A) or with hyperthermic intraperitoneal chemotherapy (CRS + H). Although overall survival showed no significant difference, CRS + H improved progression-free and distant metastasis-free survival.
The following is a summary of “Effect of Hyperthermic Intraperitoneal Chemotherapy on Cytoreductive Surgery in Gastric Cancer With Synchronous Peritoneal Metastases: The Phase III GASTRIPEC-I Trial,” published in the October 2023 issue of Oncology by Rau et al.
For a randomized, controlled, open-label, multicenter phase III trial, researchers investigated the influence of hyperthermic intraperitoneal chemotherapy (HIPEC) following cytoreductive surgery (CRS) on OS in patients with peritoneal metastasis (PM) from gastric cancer (GC).
The study involved adult patients diagnosed with GC and histologically confirmed PM. These patients were randomly allocated in a 1:1 ratio to receive either perioperative chemotherapy and CRS alone (CRS-A) or a combination of CRS and HIPEC (CRS + H). HIPEC treatment involved a specific regimen including mitomycin C at 15 mg/m 2 and cisplatin at 75 mg/m2, diluted in 5 liters of saline solution, administered over 60 minutes at a temperature of 42 ° C. The primary endpoint was the OS rate. Secondary endpoints encompass progression-free survival (PFS), other distant metastasis-free survival (MFS), and evaluating the safety profiles of the treatments. The analysis adhered strictly to the intention-to-treat principle.
The results showed 105 patients( March 2014 to June 2018), with 53 individuals allocated to the CRS-A group and 52 to the CRS + H group. Due to a slow recruitment rate, the trial was prematurely terminated. In 55 patients, the treatment was discontinued before reaching CRS, predominantly due to disease progression or mortality. The median OS for both groups was comparable to 14.9 months for CRS + H (97.2% CI, 8.7 to 17.7) and 14.9 months for CRS-A (97.2% CI, 7.0 to 19.4), with a P-value of .1647. However, the PFS was notably different between the groups, with CRS + H at 7.1 months (95% CI, 3.7 to 10.5) versus CRS-A at 3.5 months (95% CI, 3.0 to 7.0), exhibiting a significant P-value of .047. The MFS also favored the CRS + H group, recording 10.2 months (95% CI, 7.7 to 14.7) than 9.2 months (95% CI, 6.8 to 11.5) for CRS-A, with a P-value of .0286. The grade ≥3 AE incidence was similar between the two groups,38.1% for CRS-A and 43.6% for CRS + H, with a P-value of .79.
They concluded that significant differences in OS were not discernible between the CRS + H and CRS-A groups. Notable improvements in PFS and distant MFS were observed in the CRS + H cohort. It suggested that the potential benefits of HIPEC warranted further investigation, especially given that it did not exacerbate AEs compared to CRS-A.
Source: ascopubs.org/doi/10.1200/JCO.22.02867
