Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial.
Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial.
复制标题
DOI：
10.1245/s10434-011-1631-5
复制
发表时间：
2011-06
影响因子：
3.7
通讯作者：
Li Y
中科院分区：
文献类型：
--
作者：
Yang XJ;Huang CQ;Suo T;Mei LJ;Yang GL;Cheng FL;Zhou YF;Xiong B;Yonemura Y;Li Y
本研究旨在评价肿瘤细胞减灭术（CRS）联合腹腔温热化疗（HIPEC）治疗胃癌腹膜转移（PC）的有效性和安全性。将68例胃PC患者随机分为单纯CRS组（n = 34）或CRS + HIPEC组（n = 34），分别接受顺铂120 mg和丝裂霉素C 30 mg溶于6000 ml生理盐水中，43 ± 0.5°C，60-90 min。主要终点是总生存率，次要终点是安全性。两组间的主要临床病理学特征平衡。CRS + HIPEC组的PC指数为2-36（中位数15），CRS组为3-23（中位数15）（P = 0.489）。CRS组和CRS + HIPEC组CRS评分（CC 0-1）的完整性分别为58.8%（20/34）和58.8%（20/34）（P = 1.000）。在中位随访32个月（7.5-83.5个月）时，CRS组34例病例中有33例（97.1%）死亡，CRS + HIPEC组34例病例中有29例（85.3%）死亡。CRS组的中位生存期为6.5个月（95%置信区间4.8-8.2个月），CRS + HIPEC组为11.0个月（95%置信区间10.0-11.9个月）（P = 0.046）。CRS组4例患者（11.7%）和CRS + HIPEC组5例患者（14.7%）发生严重不良事件（P = 0.839）。多因素分析显示CRS + HIPEC、同步PC、CC 0-1、全身化疗≥ 6周期、无严重不良事件是生存期较好的独立预测因素。对于同步胃PC，CRS + HIPEC+丝裂霉素C 30 mg和顺铂120 mg可改善生存率，且发病率可接受。
This randomized phase III study was to evaluate the efficacy and safety of cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) for the treatment of peritoneal carcinomatosis (PC) from gastric cancer. Sixty-eight gastric PC patients were randomized into CRS alone (n = 34) or CRS + HIPEC (n = 34) receiving cisplatin 120 mg and mitomycin C 30 mg each in 6000 ml of normal saline at 43 ± 0.5°C for 60–90 min. The primary end point was overall survival, and the secondary end points were safety profiles. Major clinicopathological characteristics were balanced between the 2 groups. The PC index was 2–36 (median 15) in the CRS + HIPEC and 3–23 (median 15) in the CRS groups (P = 0.489). The completeness of CRS score (CC 0–1) was 58.8% (20 of 34) in the CRS and 58.8% (20 of 34) in the CRS + HIPEC groups (P = 1.000). At a median follow-up of 32 months (7.5–83.5 months), death occurred in 33 of 34 (97.1%) cases in the CRS group and 29 of 34 (85.3%) cases of the CRS + HIPEC group. The median survival was 6.5 months (95% confidence interval 4.8–8.2 months) in CRS and 11.0 months (95% confidence interval 10.0–11.9 months) in the CRS + HIPEC groups (P = 0.046). Four patients (11.7%) in the CRS group and 5 (14.7%) patients in the CRS + HIPEC group developed serious adverse events (P = 0.839). Multivariate analysis found CRS + HIPEC, synchronous PC, CC 0–1, systemic chemotherapy ≥ 6 cycles, and no serious adverse events were independent predictors for better survival. For synchronous gastric PC, CRS + HIPEC with mitomycin C 30 mg and cisplatin 120 mg may improve survival with acceptable morbidity.
登录
查看更多内容
影响因子：
3.7
作者：
Sugarbaker, PH;Alderman, R;Chang, D
通讯作者：
Chang, D
影响因子：
--
作者：
Shen, P;Levine, EA;Loggie, BW
通讯作者：
Loggie, BW
影响因子：
3.7
作者：
Glehen, Olivier;Gilly, Francois Noel;Elias, Dominique
通讯作者：
Elias, Dominique
影响因子：
3.8
作者：
Scaringi, S.;Kianmanesh, R.;Msika, S.
通讯作者：
Msika, S.
影响因子：
158.5
作者：
Sakuramoto, Shinichi;Sasako, Mitsuru;Arai, Kuniyoshi
通讯作者：
Arai, Kuniyoshi