Kusamura S, Deraco M, Baratti D, Inglese M G, Costanzo P, Favaro M, Manzi R, Gavazzi C
Department of Surgery, Melanoma and Sarcoma Unit, National Cancer Institute of Milan.
J Exp Clin Cancer Res. 2003 Dec;22(4 Suppl):207-12.
The purpose of this phase II study was to analyze the morbidity and mortality of cytoreductive surgery (CRS) + intraperitoneal hyperthermic perfusion (IPHP) in the treatment of peritoneal surface malignancies.
One hundred and sixty four patients (36 ovarian cancer, 32 abdominal sarcomatosis, 34 peritoneal mesothelioma, 36 pseudomyxoma peritonei, 12 gastric cancer, 8 colon adenocarcinoma and 8 from other origins) underwent 166 procedures. Two patients underwent the intervention twice due to disease relapse. The mean follow-up was 20.6 months (range: 0.4 - 91.3). The mean age was 52 years (range: 24-76). CRS was performed with peritonectomy procedures. IPHP through Closed abdominal technique was conducted with preheated (42.5 degrees) perfusate containing cisplatin+mitomycin C or cisplatin+doxorubicin for 60/90 minutes.
grade 3/4 morbidity rate was 12.0%. Some frequent post-operatory complications were intestinal fistulas (17), respiratory (5) and abdominal bleeding (4). Multivariate analysis with logistic regression model with the backward elimination method identified carcinomatosis extension (OR: 5.3, CI95%: 1.2-24.5) as the best predictor of morbidity grade 3/4. Four patients presented grade 3/4 toxicity. Operative mortality rate was 0.6%.
CRS+ IPHP presented acceptable morbidity 3/4 toxicity and mortality rates what support the need to be tested in prospective phase III clinical trial.
本II期研究旨在分析细胞减灭术(CRS)+腹腔热灌注化疗(IPHP)治疗腹膜表面恶性肿瘤的发病率和死亡率。
164例患者(36例卵巢癌、32例腹部肉瘤病、34例腹膜间皮瘤、36例腹膜假黏液瘤、12例胃癌、8例结肠腺癌以及8例其他来源肿瘤患者)接受了166次手术。2例患者因疾病复发接受了两次干预。平均随访时间为20.6个月(范围:0.4 - 91.3个月)。平均年龄为52岁(范围:24 - 76岁)。采用腹膜切除术进行CRS。通过闭合腹部技术进行IPHP,使用预热至42.5摄氏度的灌注液,其中含有顺铂+丝裂霉素C或顺铂+阿霉素,持续灌注60/90分钟。
3/4级发病率为12.0%。一些常见的术后并发症包括肠瘘(17例)、呼吸系统并发症(5例)和腹腔出血(4例)。采用向后逐步回归法的逻辑回归模型进行多因素分析,结果显示癌性播散(比值比:5.3,95%置信区间:1.2 - 24.5)是3/4级发病率的最佳预测指标。4例患者出现3/4级毒性反应。手术死亡率为0.6%。
CRS + IPHP的3/4级毒性反应发病率和死亡率均可接受,这支持了有必要在前瞻性III期临床试验中进行验证。