Noda K, Takeuchi S, Kurihara S, Sugawa T, Kato T, Ikeda M, Kanazawa K, Tsutsui F, Yamamoto K, Umezu J
Gan To Kagaku Ryoho. 1987 Apr;14(4):1129-35.
A phase II group study of cisplatin for cervical and endometrial carcinomas was carried out in 19 institutes throughout Japan. The patients entered consisted of 62 women with cervical and 7 with endometrial carcinoma of whom 39 and 4 were evaluable, respectively. Cisplatin was administered in either of two regimens; 10-20 mg/m2 i.v., on days 1-5, or 50-100 mg/m2 i.v., on day 1, every 3 to 4 weeks. The responders comprised 4 CRs and 10 PRs for cervical carcinoma and 1 CR and 2 PRs for endometrial carcinoma, and the response rates were 35.9% and 75.0%, respectively. The response rates by histological classification were 39.4% (13/33) for squamous cell carcinoma and 16.7% (1/6) for non-squamous cell carcinoma. Response rates analysed by lesion site were 33.3% for primary tumors, 36.8% for local lesions and 33.3% for metastases. Furthermore, the response rate among patients without any prior chemotherapy was 44.4% vs. 16.7% for those with prior chemotherapy. Adverse effects included nausea and vomiting (95.3%), anorexia (93%), anemia (72.1%), leucopenia (60.5%) and elevation of BUN (16.3%). Adverse effects were tolerable. We concluded from these results that cisplatin is among the most efficacious and useful drugs against cervical (and endometrial) carcinoma(s).
一项关于顺铂治疗宫颈癌和子宫内膜癌的II期组研究在日本全国19家机构开展。入组患者包括62例宫颈癌女性和7例子宫内膜癌女性，其中分别有39例和4例可进行评估。顺铂采用两种方案之一给药：第1 - 5天静脉注射10 - 20mg/m²，或第1天静脉注射50 - 100mg/m²，每3至4周一次。宫颈癌的缓解者包括4例完全缓解（CR）和10例部分缓解（PR），子宫内膜癌为1例CR和2例PR，缓解率分别为35.9%和75.0%。按组织学分类，鳞状细胞癌的缓解率为39.4%（13/33），非鳞状细胞癌为16.7%（1/6）。按病变部位分析，原发肿瘤的缓解率为33.3%，局部病变为36.8%，转移灶为33.3%。此外，未接受过任何化疗的患者缓解率为44.4%，而接受过化疗的患者为16.7%。不良反应包括恶心和呕吐（95.3%）、厌食（93%）、贫血（72.1%）、白细胞减少（60.5%）和血尿素氮升高（16.3%）。不良反应可耐受。从这些结果我们得出结论，顺铂是治疗宫颈癌（和子宫内膜癌）最有效且有用的药物之一。
