Chinese expert consensus on cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal malignancies.

Locoregional spread of abdominopelvic malignant tumors frequently results in peritoneal carcinomatosis (PC). The prognosis of PC patients treated by conventional systemic chemotherapy is poor, with a median survival of < 6 mo. However, over the past three decades, an integrated treatment strategy of cytoreductive surgery (CRS) + hyperthermic intraperitoneal chemotherapy (HIPEC) has been developed by the pioneering oncologists, with proved efficacy and safety in selected patients. Supported by several lines of clinical evidence from phases I, II and III clinical trials, CRS + HIPEC has been regarded as the standard treatment for selected patients with PC in many established cancer centers worldwide. In China, an expert consensus on CRS + HIPEC has been reached by the leading surgical and medical oncologists, under the framework of the China Anti-Cancer Association. This expert consensus has summarized the progress in PC clinical studies and systematically evaluated the CRS + HIPEC procedures in China as well as across the world, so as to lay the foundation for formulating PC treatment guidelines specific to the national conditions of China.

Oral traditional Chinese medication for adhesive small bowel obstruction.

BACKGROUND: Small bowel obstruction (SBO) is one of the most common emergent complications of general surgery. Intra-abdominal adhesions are the leading cause of SBO. Because surgery can induce new adhesions, non-operative management is preferred in the absence of signs of peritonitis or strangulation. Oral traditional Chinese herbal medicine has long been used as a non-operative therapy to treat adhesive SBO in China. Many controlled trials have been conducted to investigate its therapeutic value in resolving adhesive SBO. OBJECTIVES: The aim of this review was to assess the efficacy and safety of oral traditional Chinese medicine (TCM) for adhesive small bowel obstruction. SEARCH METHODS: We searched the following databases, without regard to language or publishing restrictions: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Chinese Biomedical Database (CBM), China National Knowledge Infrastructure/Chinese Academic Journals full-text Database (CNKI), and VIP (a full-text database of Chinese journals). The searches were conducted in November 2011. SELECTION CRITERIA: Randomised controlled trials and quasi-randomised controlled trials comparing Chinese medicines administered orally, via the gastric canal, or both with a placebo or conventional therapy in participants diagnosed with adhesive SBO were considered. We also considered trials of TCM (oral administration, gastric tube perfusion, or both) plus conventional therapy compared with conventional therapy alone for patients with adhesive SBO. Studies addressing the safety and efficacy of oral traditional Chinese medicinal agents in the treatment of adhesive SBO were also considered. DATA COLLECTION AND ANALYSIS: Two authors collected the data independently. We assessed the risk of bias according to the following methodological criteria: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other sources of bias. Dichotomous data are presented as risk ratios (OR) and 95% confidence intervals (CI); continuous outcomes are presented as mean differences (MD) and 95% CIs. The data analyses were carried out using Review Manager 5.1. For cases in which necessary information was not reported in the paper, we contacted the primary authors for additional information. MAIN RESULTS: Five randomised trials involving 664 participants were analysed. Five different herbal medicines were tested in these trials, including Huo-Xue-Tong-Fu decoction, Xiao-Cheng-Qi-Tang decoction, a combination of Xiao-Cheng-Qi-Tang and Si-Jun-Zi-Tang decoctions, Chang-Nian-Lian-Song-Jie-Tang decoction, and Fufang-Da-Cheng-Qi-Tang decoction. There were variations in the tested herbal compositions and methods of medicine administration. The main outcomes reported in the trials were effects on abdominal pain, abdominal distension, constipation defection, time of first defecation after treatment, and reoperation rate during the course of the disease. Secondary outcomes selected for this review were not available, including complications such as small bowel perfusion (bowel resection, system complications, and other possible complications), length of hospital stay, cost of hospitalisation, and time from admission to surgical intervention. The results of five trials showed that patients receiving TCM combined with conventional therapy seemed to have improved outcomes compared with patients receiving conventional treatment alone (OR 4.24, 95% CI 2.83 to 6.36).However, we cannot conclusively determine the efficacy of TCM in this review due to inadequate reporting, low methodological quality, and the prevalence of various biases in the reviewed studies. Furthermore, because none of the reviewed trials discussed adverse events, we could not evaluate the safety of TCM for adhesive SBO patients. All trials were conducted and published in China. AUTHORS' CONCLUSIONS: Although many studies have assessed the use of TCM products for adhesive SBO, most were excluded from this review due to their methodological limitations. This systematic review did not find sufficient evidence to support the objective efficacy and safety of TCM for patients with adhesive SBO. The positive evidence should be interpreted with caution given the insufficient number of studies with large sample sizes, the absence of well-designed, high-quality trials, and the lack of safety information. Therefore, further studies with larger sample sizes and high-quality, randomised, and controlled trials are necessary to produce more accurate and meaningful data on the efficacy of Chinese herbal medicines for adhesive SBO.

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.

BACKGROUND: This 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. METHODS: Sixty-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. RESULTS: Major 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. CONCLUSIONS: For synchronous gastric PC, CRS + HIPEC with mitomycin C 30 mg and cisplatin 120 mg may improve survival with acceptable morbidity.

Hyperthermic intraperitoneal chemotherapy for gastric and colorectal cancer in Mainland China.

AIM: To investigate the current status of peritoneal carcinomatosis (PC) management, as well as the usage of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in mainland China. METHODS: A potentially curative therapeutic strategy for selecting patients with PC, known as "Techniques", consists of CRS in combination with HIPEC. A systemic search of published works and clinical trials was performed. Additional papers were retrieved by cross-checking references and obtaining information from Chinese oncologists and relevant conferences. One hundred and one papers and one registered clinical trial on HIPEC were included. RESULTS: A literature review identified 86 hospitals in 25 out of all 31 areas of mainland China that perform HIPEC. The earliest report included in our survey was published in 1993. Different approaches to HIPEC have been utilized, i.e. palliative, prophylactic, and possibly curative treatment. Only one center has consistently performed HIPEC according to the "Sugarbaker Protocol", which involves evaluating the extent of PC with peritoneal cancer index and the results of CRS with the completeness of cytoreduction. Positive preliminary results were reported: 7 of 21 patients with PC survived, free of tumors, during an 8-43-mo follow-up period. Hyperthermic strategies that include HIPEC have been practiced for a long time in mainland China, whereas the "Sugarbaker Protocol/Techniques" has been only rarely implemented in China. The Peritoneal Surface Oncology Group International hosts a biannual workshop with the intent to train more specialists in this field and provide support for the construction of quality treatment centers, especially in developing countries like China, whose population is huge and has a dramatically increased incidence of cancer. CONCLUSION: To popularize Sugarbaker Protocol/Techniques in mainland China in PC management arising from gastric cancer or colorectal cancer will be the responsibility of the upcoming Chinese Peritoneal Surface Oncology Group.