Jones A L, Trott P, Cunningham D, Rosin R D, Coleman D, Sauven P, Glazer G, Cunningham D, Hermon-Taylor J, Coombes R C
CRC section of Medicine, Institute of Cancer Research, Sutton, U.K.
Ann Oncol. 1994 Feb;5(2):123-6. doi: 10.1093/oxfordjournals.annonc.a058762.
This phase II trial was designed to evaluate the feasibility, toxicity, relapse pattern and survival following adjuvant intraperitoneal cisplatin in patients with gastric cancer at high risk of relapse.
Patients who had undergone complete surgical resection of adenocarcinoma of the stomach and who had positive serosa and/or regional lymph nodes and/or peritoneal washings has insertion of either a Tenckhoff catheter or temporary peritoneal dialysis catheter and were treated with cisplatin 60 mg/m2 intraperitoneally every 21 days for 4-6 courses. Peritoneal lavage or cytology was done before each treatment.
Eighteen patients were studied. Seventeen patients had serosal involvement, 11 had regional lymph node involvement and 2 had positive peritoneal washings before treatment. The median number of courses of chemotherapy was 4 (range 2-6). Radioisotope tracer studies (6 patients) showed good distribution throughout the peritoneal cavity. No WHO grade 3/4 toxicity was seen. Twelve patients (67%) have relapsed, 6 (33%) intra-abdominally, 4 (22%) with hepatic metastases and 2 (11%) outside the abdominal cavity. The median survival was 17 months.
Cisplatin can be administered safely as adjuvant therapy to patients with gastric cancer, however, as single agent therapy the pattern of relapse and subsequent death was similar to that expected. The occurrence of distant metastases may argue for systemic rather than local adjuvant treatment.
本II期试验旨在评估辅助性腹腔内顺铂治疗对复发高危胃癌患者的可行性、毒性、复发模式及生存率。
接受胃癌腺癌完整手术切除、浆膜和/或区域淋巴结及/或腹腔冲洗液阳性的患者，插入Tenckhoff导管或临时腹膜透析导管，每21天接受60mg/m²顺铂腹腔内治疗，共4 - 6个疗程。每次治疗前进行腹腔灌洗或细胞学检查。
研究了18例患者。17例患者有浆膜受累，11例有区域淋巴结受累，2例治疗前腹腔冲洗液阳性。化疗疗程中位数为4（范围2 - 6）。放射性同位素示踪研究（6例患者）显示药物在整个腹腔内分布良好。未观察到WHO 3/4级毒性。12例患者（67%）复发，6例（33%）腹腔内复发，4例（22%）肝转移，2例（11%）腹腔外复发。中位生存期为17个月。
顺铂可作为胃癌患者的辅助治疗安全给药，然而，作为单药治疗，复发模式及随后的死亡情况与预期相似。远处转移的发生可能支持全身而非局部辅助治疗。
