细胞减灭术联合腹腔热灌注化疗可改善结直肠癌腹膜转移患者的生存：来自中国一家中心的II期研究。
Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival for patients with peritoneal carcinomatosis from colorectal cancer: a phase II study from a Chinese center.
作者信息
Huang Chao-Qun, Yang Xiao-Jun, Yu Yang, Wu Hai-Tao, Liu Yang, Yonemura Yutaka, Li Yan
机构信息
Department of Oncology, Zhongnan Hospital of Wuhan University, Hubei Cancer Clinical Study Center & Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, P.R. China.
Department of Oncology, Zhongnan Hospital of Wuhan University, Hubei Cancer Clinical Study Center & Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, P.R. China; NPO Organization to Support Peritoneal Dissemination Treatment, Osaka, Japan.
出版信息
PLoS One. 2014 Sep 26;9(9):e108509. doi: 10.1371/journal.pone.0108509. eCollection 2014.
BACKGROUND
Peritoneal carcinomatosis (PC) is a difficult clinical challenge in colorectal cancer (CRC) because conventional treatment modalities could not produce significant survival benefit, which highlights the acute need for new treatment strategies. Our previous case-control study demonstrated the potential survival advantage of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) over CRS alone. This phase II study was to further investigate the efficacy and adverse events of CRS+HIPEC for Chinese patients with CRC PC.
METHODS
A total of 60 consecutive CRC PC patients underwent 63 procedures consisting of CRS+HIPEC and postoperative chemotherapy, all by a designated team focusing on this combined treatment modality. All the clinico-pathological information was systematically integrated into a prospective database. The primary end point was disease-specific overall survival (OS), and the secondary end points were perioperative safety profiles.
RESULTS
By the most recent database update, the median follow-up was 29.9 (range 3.5-108.9) months. The peritoneal cancer index (PCI) ≤20 was in 47.0% of patients, complete cytoreductive surgery (CC0-1) was performed in 53.0% of patients. The median OS was 16.0 (95% confidence interval [CI] 12.2-19.8) months, and the 1-, 2-, 3-, and 5-year survival rates were 70.5%, 34.2%, 22.0% and 22.0%, respectively. Mortality and grades 3 to 5 morbidity rates in postoperative 30 days were 0.0% and 30.2%, respectively. Univariate analysis identified 3 parameters with significant effects on OS: PCI ≤20, CC0-1 and adjuvant chemotherapy over 6 cycles. On multivariate analysis, however, only CC0-1 and adjuvant chemotherapy ≥6 cycles were found to be independent factors for OS benefit.
DISCUSSION
CRS+HIPEC at a specialized treatment center could improve OS for selected CRC PC patients from China, with acceptable perioperative safety.
背景
腹膜癌病（PC）是结直肠癌（CRC）治疗中一项棘手的临床挑战，因为传统治疗方式无法带来显著的生存获益，这凸显了对新治疗策略的迫切需求。我们之前的病例对照研究表明，细胞减灭术（CRS）联合腹腔热灌注化疗（HIPEC）相较于单纯CRS具有潜在的生存优势。本II期研究旨在进一步探究CRS+HIPEC对中国CRC合并PC患者的疗效及不良事件。
方法
共有60例连续的CRC合并PC患者接受了63例包含CRS+HIPEC及术后化疗的手术，所有手术均由专注于这种联合治疗方式的指定团队进行。所有临床病理信息被系统整合到一个前瞻性数据库中。主要终点是疾病特异性总生存期（OS），次要终点是围手术期安全性。
结果
根据最新的数据库更新，中位随访时间为29.9（范围3.5 - 108.9）个月。47.0%的患者腹膜癌指数（PCI）≤20，53.0%的患者接受了完全细胞减灭术（CC0 - 1）。中位OS为16.0（95%置信区间[CI] 12.2 - 19.8）个月，1年、2年、3年和5年生存率分别为70.5%、34.2%、22.0%和22.0%。术后30天的死亡率和3至5级发病率分别为0.0%和30.2%。单因素分析确定了3个对OS有显著影响的参数：PCI≤20、CC0 - 1和超过6个周期的辅助化疗。然而，多因素分析发现只有CC0 - 1和≥6个周期的辅助化疗是OS获益的独立因素。
讨论
在专业治疗中心进行的CRS+HIPEC可改善部分中国CRC合并PC患者的OS，围手术期安全性可接受。
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