Kusamura Shigeki, Younan Rami, Baratti Dario, Costanzo Pasqualina, Favaro Myriam, Gavazzi Cecilia, Deraco Marcello
Department of Surgery, National Cancer Institute of Milan, Milan, Italy.
Cancer. 2006 Mar 1;106(5):1144-53. doi: 10.1002/cncr.21708.
The purpose of this prospective Phase II study was to analyze morbidity and mortality of cytoreductive surgery (CRS) and intraperitoneal hyperthermic perfusion (IPHP) in the treatment of peritoneal surface malignancies.
A total of 205 patients (50 with peritoneal mesothelioma, 49 with pseudomyxoma peritonei, 41 with ovarian cancer, 32 with abdominal sarcomatosis, 13 with colon cancer, 12 with gastric cancer, and 8 with carcinomatosis from other origins) underwent 209 consecutive procedures. Four patients underwent the intervention twice because of disease relapse. There were 70 men and 135 women. Mean age was 52 years (range, 22-76 yrs). CRS was performed by using peritonectomy procedures. IPHP through the closed abdomen technique was conducted with a preheated (42.5 degrees C) perfusate containing cisplatin + mitomycin C or cisplatin + doxorubicin.
Major morbidity rate was 12%. The most significant complications were 23 anastomotic leaks or bowel perforations, 4 abdominal bleeds, and 4 sepses. Operative mortality rate was 0.9%. On logistic regression model multivariate analysis, extent of cytoreduction (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.29-6.40) and dose of cisplatin for IPHP > or = 240 mg (OR, 3.13; 95% CI, 1.24-7.90) were independent risk factors for major morbidity. Ten patients presented with Grade 3 to 4 toxicity.
CRS + IPHP presented acceptable morbidity, toxicity, and mortality rates, all of which support prospective Phase III clinical trials.
这项前瞻性II期研究的目的是分析细胞减灭术(CRS)和腹腔热灌注化疗(IPHP)治疗腹膜表面恶性肿瘤的发病率和死亡率。
共有205例患者(50例腹膜间皮瘤、49例腹膜假黏液瘤、41例卵巢癌、32例腹部肉瘤病、13例结肠癌、12例胃癌和8例其他来源的癌性腹膜炎)接受了209次连续手术。4例患者因疾病复发接受了两次干预。其中男性70例,女性135例。平均年龄52岁(范围22 - 76岁)。采用腹膜切除术进行CRS。通过封闭腹部技术进行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。
主要发病率为12%。最显著的并发症为23例吻合口漏或肠穿孔、4例腹腔出血和4例脓毒症。手术死亡率为0.9%。在逻辑回归模型多因素分析中,肿瘤细胞减灭程度(优势比[OR],2.88;95%置信区间[CI],1.29 - 6.40)和顺铂用于IPHP的剂量≥240mg(OR,3.13;95%CI,1.24 - 7.90)是主要发病的独立危险因素。10例患者出现3至4级毒性反应。
CRS + IPHP的发病率、毒性和死亡率均可接受,所有这些均支持进行前瞻性III期临床试验。