Hyperthermic intrathoracic/intraperitoneal chemotherapy versus conventional intrapleural/intraperitoneal chemotherapy for the malignant effusion: a multi-center randomized clinical trial.

OBJECTIVE: To compare the efficacy and safety of hyperthermic intrathoracic/intraperitoneal chemotherapy versus conventional intrapleural/intraperitoneal chemotherapy in the treatment of malignant pleural or peritoneal effusion. METHODS: A randomized clinical trial was carried out in 8 cancer centers across China. Patients with malignant pleural or peritoneal effusion were randomly assigned to the study group or control group. Patients in the study group were treated with cisplatin-based hyperthermic intrathoracic chemotherapy (HITHOC) or hyperthermic intraperitoneal chemotherapy (HIPEC), while the control group was treated with conventional intrapleural or intraperitoneal chemotherapy using same chemotherapeutic regime as the study group. The objective response rate (ORR) was analyzed as primary outcome. Quality-of-life (QOL) score was recorded as secondary outcome using the questionnaire 30 (QLQ-C30) of the European Organization for Research and Treatment of Cancer (EORTC). The efficacy and safety of the two treatments were compared. RESULTS: Total 135 patients were recruited and randomized in this study, with 67 patients in the study group and 68 patients in the control group. The ORR in the study group (80.70%) was significantly higher than that in the control group (31.03%, p < 0.001). However, neither changes of QOL scores, nor incidence rates of adverse events were significantly different between the two groups (p = 0.076 and 0.197, respectively). CONCLUSION: Efficacy of HITHOC or HIPEC is superior to that of conventional modality for the treatment of malignant effusion with comparable side effects.

A novel method of bedside hyperthermic intraperitoneal chemotherapy as adjuvant therapy for stage-III gastric cancer.

OBJECTIVE: To investigate the efficacy and safety of a novel method of hyperthermic intraperitoneal chemotherapy (HIPEC) as adjuvant therapy for stage-III gastric cancer. METHODS: Patients with stage-III gastric cancer who underwent D2 radical gastrectomy were randomly assigned to the HIPEC or control group four weeks after surgery. The HIPEC group was treated with cisplatin (60 mg/m2) administered with a HIPEC device on days 1 and 3 (30 mg/m2 each time), along with oral S-1, 40-60 mg, twice daily, for 14 days. The control group was treated with cisplatin (60 mg/m2) administered intravenously plus oral S-1 (40-60 mg, 2/d for 14 days). The primary outcome of the study was disease-free survival (DFS). RESULTS: Total 114 patients were included in the study, with 57 patients in each group. The median DFS was 29.0 months in the HIPEC group, which was significantly longer than that in the control group (15.0 months, p = 0.006). The two-year DFS rate in the HIPEC group was higher than that in the control group (50.4% vs. 25.5%). Median OS was 42.0 month in the HIPEC group and 31.0 month in the control (p = 0.042). Peritoneal metastasis occurred in six patients in the HIPEC group (10.5%) and 12 patients in the control (21.1%, p = 0.198). No significant difference in the incidence of adverse event except for thrombocytopenia. CONCLUSION: HIPEC with cisplatin plus oral S-1 is a safe and effective adjuvant therapy for patients with advanced gastric cancer following D2 radical gastrectomy. Trial registration: This study was registered at ClinicalTrials.gov with the identifier (NCT number): NCT02396498.

Retrospective analysis on the safety of 5,759 times of bedside hyperthermic intra-peritoneal or intra-pleural chemotherapy (HIPEC).

The current study was designed to analyze safety of the bedside hyperthermic intra-pleural or intra-peritoneal chemotherapy (HIPEC) from September 2007 to July 2015. Total of 5,759 times of bedside HIPEC in 985 cases of malignant pleural or peritoneal carcinomatosis were analyzed. Of them, 1,510 times was given to 315 cases of malignant pleural effusion, while 4,249 times was performed in 402 patients with malignant ascites and 268 patients without ascites (total 670 patients for peritoneal carcinomatosis). In average, patients with pleural effusion was given 5 times bedside HIPEC and stayed in the hospital for 6.7 days; while patients with peritoneal carcinomatosis was given 6 times of HIPEC and stayed in the hospital for 6.5 days. Overall HIPEC-associated mortality was zero. Overall HIPEC-associated incidence of side effect in the intra-pleural HIPEC was 2.0%. Specifically, 0.6% was pneumothorax, 0.3% was cytotoxic agent-induced pleural inflammation, 0.5% was pain at puncture location, and 0.3% was failure of HIPEC procedure. Overall HIPEC-associated incidence of side effect in the intra-peritoneal HIPEC was 2.4%, i.e., failure of HIPEC procedure in 1.3%, pain at puncture location was 0.5%, cytotoxic agent-induced peritoneal inflammation was 0.1%, intestinal obstruction was 0.1% and intestinal perforation was 0.07%. These findings indicated that bedside HIPEC applied in the current study is safe to be performed by a Physician or Oncologist under local anesthesia at a patient's bedside. The procedure is easy to perform and well-tolerated by the patients with late stage cancer or post-surgery recurrent cancer.