Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Improves Survival of Patients with Peritoneal Carcinomatosis from Gastric Cancer: Final Results of a Phase III Randomized Clinical Trial

Abstract

BackgroundThis randomized phase III study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of peritoneal carcinomatosis (PC) from gastric cancer.MethodsSixty-eight gastric PC patients were randomized into CRS alone (n = 34) or CRS + HIPEC (n = 34) receiving cisplatin 120 mg and mitomycin C 30 mg each in 6000 ml of normal saline at 43 ± 0.5°C for 60–90 min. The primary end point was overall survival, and the secondary end points were safety profiles.ResultsMajor clinicopathological characteristics were balanced between the 2 groups. The PC index was 2–36 (median 15) in the CRS + HIPEC and 3–23 (median 15) in the CRS groups (P = 0.489). The completeness of CRS score (CC 0–1) was 58.8% (20 of 34) in the CRS and 58.8% (20 of 34) in the CRS + HIPEC groups (P = 1.000). At a median follow-up of 32 months (7.5–83.5 months), death occurred in 33 of 34 (97.1%) cases in the CRS group and 29 of 34 (85.3%) cases of the CRS + HIPEC group. The median survival was 6.5 months (95% confidence interval 4.8–8.2 months) in CRS and 11.0 months (95% confidence interval 10.0–11.9 months) in the CRS + HIPEC groups (P = 0.046). Four patients (11.7%) in the CRS group and 5 (14.7%) patients in the CRS + HIPEC group developed serious adverse events (P = 0.839). Multivariate analysis found CRS + HIPEC, synchronous PC, CC 0–1, systemic chemotherapy ≥ 6 cycles, and no serious adverse events were independent predictors for better survival.ConclusionsFor synchronous gastric PC, CRS + HIPEC with mitomycin C 30 mg and cisplatin 120 mg may improve survival with acceptable morbidity.

Surgical treatment for peritoneal carcinomatosis from gastric cancer

“…Yang et al reported a randomized controlled trial with 68 patients, with 34 in each arm who were randomized to get CRS+HIPEC versus CRS alone [13]. This trial was not stratified on the peritoneal carcinomatosis index (PCI) which is a marker of the burden of disease in the peritoneal cavity and consequentially complete cytoreduction was achieved only in 58.8% in both arms.…”

Platelet Dynamics in Peritoneal Carcinomatosis Patients Treated with Cytoreductive Surgery and Hyperthermic Intraperitoneal Oxaliplatin

“…The combination of cytoreductive surgery (CRS) and hyperthermic intraperitoneal oxaliplatin (HIO) is a promising strategy for PC treatment (2) since retrospective and prospective analyses, including phase II and phase III clinical trials, as well as meta-analysis, have evidenced its survival benefit, relative to standard palliative surgery and/or chemotherapy (SPSC), in patients with resectable PC of colorectal origin (3,4). The efficacy of this innovative treatment has also been reported in phase II studies in ovarian cancer (5,6) and in phase III studies in gastric cancer (7,8). These results encourage the clinical application of this aggressive treatment, particularly in conditions such as PC of nongynecologic origin, where the long-term survival is hardly ever seen after SPSC (9,10).…”

Preoperative Assessment of Cancer Patients with Peritoneal Metastases for Complete Cytoreduction

“…Patients treated for primary gastric cancer with peritoneal metastases had twice the survival when CRS and HIPEC were used as compared to CRS alone. However, those patients who had CRS and HIPEC for recurrent gastric cancer with peritoneal metastases failed to show benefit [13]. If neoadjuvant intraperitoneal and systemic chemotherapy was used, the differences in synchronous versus metachronous patients with peritoneal metastases was absent [14].…”