Topuz E, Aydiner A, Saip P, Bengisu E, Berkman S, Disci R
Department of Medical Oncology, University of Istanbul, Turkey.
Eur J Gynaecol Oncol. 1997;18(1):71-5.
A phase II trial was conducted to further explore the potential of salvage intraperitoneal (IP) cisplatin-based therapy in patients with residual ovarian cancer. Twenty-five patients were treated with a regimen of cisplatin (75 mg/m2) and mitoxantrone (15 mg/m2) delivered IP every three weeks for a maximum of six cycles. Ten patients achieved a pathologically complete response (pCR) and six were clinically stable without evidence of disease. After a median follow-up of 18 months, the median progression-free survival (PFS) was 16 months (95% confidence interval-CI-3-29%). The actuarial PFS at 24 months was 36% (95% CI 13-59). Overall eight out of 25 patients (32%) had an IP relapse and thus were considered as local treatment failures. The major toxic side effects were nausea, vomiting, abdominal pain and renal toxicity. Future trials exploring IP delivery of these drugs should attempt to optimize drug dose and schedule and subset analysis of clinical studies should help in identifying patients who are particularly sensitive to this therapeutic approach.
开展了一项II期试验，以进一步探索挽救性腹腔内（IP）铂类化疗对残留卵巢癌患者的治疗潜力。25例患者接受了顺铂（75mg/m²）和米托蒽醌（15mg/m²）方案治疗，每三周腹腔内给药一次，最多六个周期。10例患者达到病理完全缓解（pCR），6例临床稳定，无疾病证据。中位随访18个月后，中位无进展生存期（PFS）为16个月（95%置信区间-CI-3-29%）。24个月时的精算PFS为36%（95%CI 13-59）。25例患者中有8例（32%）出现腹腔内复发，因此被视为局部治疗失败。主要毒副作用为恶心、呕吐、腹痛和肾毒性。未来探索这些药物腹腔内给药的试验应尝试优化药物剂量和给药方案，临床研究的亚组分析应有助于识别对这种治疗方法特别敏感的患者。
