Optimization of hyperthermic intraperitoneal chemotherapy with oxaliplatin plus irinotecan at 43°C after compete cytoreductive surgery:: Mortality and morbidity in 106 consecutive patients

Optimization of hyperthermic intraperitoneal chemotherapy with oxaliplatin plus irinotecan at 43°C after compete cytoreductive surgery:: Mortality and morbidity in 106 consecutive patients
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DOI:
10.1245/s10434-007-9348-1
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发表时间:
2007-06-01
影响因子:
3.7
通讯作者:
Raynard, Bruno
Raynard, Bruno
中科院分区:
医学2区
文献类型:
--
作者:
Elias, Dominique;Goere, Diane;Raynard, Bruno

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背景:腹膜癌病(PC)被认为是一种致死性疾病,现在可以通过手术(治疗肉眼肿瘤种植)结合热疗(HIPEC)(治疗残留的微观疾病)来治愈。本研究的目的是分析一种结合最佳(R0-R1)细胞减少、最佳HIPEC联合奥沙利铂和伊立替康以及最佳均质腹膜内温度为43℃的特定方法的发病率和死亡率。方法:这项前瞻性第二阶段研究共纳入106例患者。在PC完全切除后,采用Coliseum技术,奥沙利铂(360 mg/m2)联合伊立替康(360 mg/m2)加入2 L/m2的5%葡萄糖溶液中,在43℃的实际腹膜温度下30min以上,患者在HIPEC前1小时静脉注射5-氟尿嘧啶(400 mg/m2)和亚叶酸钙(20 mg/m2),进行三种治疗。最常见的并发症是消化道瘘(24%)、肺部感染(16%)和严重的血液毒性(11%)。发病率与肿瘤评分(P=.0008)、切除器官数(P=.0001)、手术时间(P=.0001)和出血量(P=.0001)有明显的统计学相关性。结论:考虑到预期的生存优势,这种新的方法在三个方面(完全细胞减少、奥沙利铂联合伊立替康和高温)导致了相对较高但可接受的不良事件发生率。
Background: Peritoneal carcinomatosis (PC), which has hitherto been regarded as a lethal entity, can now be cured with surgery (treating macroscopic tumor seeding) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) (treating residual microscopic disease). The purpose of this study was to analyze the morbidity and mortality of a particular approach associating optimal (R0-R1) cytoreduction, optimal HIPEC combining oxaliplatin and irinotecan, and an optimal homogeneous intraperitoneal temperature of 43 degrees C.Methods: A total of 106 consecutive patients were included in this prospective phase 2 study. After complete resection of the PC, HIPEC was performed by the Coliseum technique with oxaliplatin (360 mg/m(2)) combined with irinotecan (360 mg/m2) in 2 L/m(2) of 5% dextrose, over 30 minutes at a real intraperitoneal temperature of 43 degrees C. During the hour preceding HIPEC, patients received 5-fluorouracil (400 mg/m2) and leucovorin (20 mg/m2) intravenously, resulting in tritherapy.Results: Postoperative mortality and morbidity rates were 4% and 66%, respectively. The most frequent complications were digestive fistula (24%), lung infection (16%), and severe hematological toxicity (11%). Statistical correlation was evidenced between morbidity and the carcinomatosis score (P = .0008), the number of resected organs (P = .0001), the duration of surgery (P = .0001), and blood loss (P = .0001).Conclusions: This new approach, optimized in three respects (complete cytoreduction, combination oxaliplatin with irinotecan, and high temperature) has resulted in a relatively high but acceptable incidence of adverse events considering the expected advantage for survival.