细胞减灭术联合洛铂和多西他赛腹腔热灌注化疗可改善腹盆腔恶性肿瘤腹膜转移患者的生存情况。
Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies.
作者信息
Wu Hai-Tao, Yang Xiao-Jun, Huang Chao-Qun, Sun Jian-Hua, Ji Zhong-He, Peng Kai-Wen, Zhang Qian, Li Yan
机构信息
Department of Peritoneal Cancer Surgery, Beijing Shijitan Hospital Affiliated to the Capital Medical University, No 10 Tieyi Road, Yangfangdian, Haidian District, Beijing, 100038, China.
Department of Oncology, Zhongnan Hospital Wuhan University, Hubei Key Laboratory of Tumor Biological Behaviors and Hubei Cancer Clinical Study Center, Wuhan, 430071, China.
出版信息
World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4.
BACKGROUND
This work was to evaluate the perioperative safety and efficacy of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) with lobaplatin and docetaxel in patients with peritoneal carcinomatosis (PC) from gastrointestinal and gynecological cancers.
METHODS
Patients were treated by CRS + HIPEC with lobaplatin 50 mg/m(2) and docetaxel 60 mg/m(2) in 6000 mL of normal saline at 43 ± 0.5 °C for 60 min. Vital signs were recorded for 6 days after CRS + HIPEC procedures. Perioperative serious adverse events (SAE), hematological, hepatic, renal, and electrolytes parameters, the changes in serum tumor markers (TM) before and after operation, patient recovery, and overall survival (OS) were analyzed.
RESULTS
One hundred consecutive PC patients underwent 105 CRS + HIPEC procedures and postoperative chemotherapy. The median CRS + HIPEC duration was 463 (range, 245-820) min, and the highest temperature and heart rate during six postoperative days were 38.6 °C (median 37.5 °C) and 124 bpm (median 100 bpm), respectively. The 30-day perioperative SAE occurred in 16 (15.2 %) and mortality occurred in 2 (1.9 %) patients. Most routine blood laboratory tests at 1 week after surgery turned normal. Among 82 cases with increased preoperative TM CEA, CA125, and CA199, 71 cases had TM levels reduced or turned normal. Median time to nasogastric tube removal was 5 (range, 3-23) days, to liquid food intake 6 (range, 4-24) days, and to abdominal suture removal 15 (range, 10-30) days. At the median follow-up of 19.7 (range, 7.5-89.2) months, the median OS was 24.2 (95 % CI, 15.0-33.4) months, and the 1-, 3-, and 5-year OS rates were 77.5, 32.5, and 19.8 %, respectively. Univariate analysis identified five independent prognostic factors on OS: the origin of PC, peritoneal cancer index, completeness of CRS, cycles of adjuvant chemotherapy, and SAE.
CONCLUSIONS
CRS + HIPEC with lobaplatin and docetaxel to treat PC is a feasible procedure with acceptable safety and can prolong the survival in selected patients with PC.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT00454519.
背景
本研究旨在评估细胞减灭术（CRS）联合洛铂和多西他赛的热腹腔内化疗（HIPEC）对胃肠道和妇科癌症腹膜转移癌（PC）患者围手术期的安全性和疗效。
方法
患者接受CRS+HIPEC治疗，将50mg/m²洛铂和60mg/m²多西他赛加入6000mL生理盐水中，在43±0.5°C下持续60分钟。CRS+HIPEC术后6天记录生命体征。分析围手术期严重不良事件（SAE）、血液学、肝脏、肾脏和电解质参数、手术前后血清肿瘤标志物（TM）的变化、患者恢复情况及总生存期（OS）。
结果
100例连续的PC患者接受了105次CRS+HIPEC手术及术后化疗。CRS+HIPEC的中位持续时间为463（范围245 - 820）分钟，术后6天内最高体温和心率分别为38.6°C（中位值37.5°C）和124次/分钟（中位值100次/分钟）。30天围手术期SAE发生率为16例（15.2%），2例（1.9%）患者死亡。术后1周多数常规血液检查恢复正常。术前TM CEA、CA125和CA199升高的82例患者中，71例TM水平降低或恢复正常。鼻胃管拔除中位时间为5（范围3 - 23）天，开始进流食时间为6（范围4 - 24）天，腹部缝线拆除时间为15（范围10 - 30）天。中位随访19.7（范围7.5 - 89.2）个月时，中位OS为24.2（95%CI，15.0 - 33.4）个月，1年、3年和5年OS率分别为77.5%、32.5%和19.8%。单因素分析确定了OS的五个独立预后因素：PC的起源、腹膜癌指数、CRS的完整性、辅助化疗周期和SAE。
结论
CRS联合洛铂和多西他赛的HIPEC治疗PC是一种可行的手术，安全性可接受，能延长部分PC患者的生存期。
试验注册
ClinicalTrials.gov，NCT00454519
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