Hirabayashi K, Okada E, Nakazuma Y, Akamatsu Y, Sezaki H, Ohta M, Nakanishi Y
Department of Obstetrics and Gynecology, Fukuyama National Hospital, Hiroshima.
Nihon Sanka Fujinka Gakkai Zasshi. 1992 Mar;44(3):341-8.
From favorable results with 254-S, a new cisplatin analogue, single administration, we have conducted a clinical study to investigate the efficacy of combination of 254-S, ifosfamide and peplomycin, each of which has a different dose limiting factor. A total of 45 patients, including 22 patients with stage III and IV cervical cancer and 23 cases with recurrent cervical cancer, were treated with at least two courses of 254-S (100mg/m2, iv. Day 1), ifosfamide (1,500mg/body, iv. Day 1-5) and peplomycin (5mg/body, im. Day 1-6), and tumor response was evaluated clinically and by CT scanning. The response rate obtained in patients with advanced disease was 81.8% (PR = 17, CR = 1) and that in cases with recurrence was 60.9% (PR = 12, CR = 2). Myelosuppression was the dose limiting factor. In the 121 courses, grade 3 and 4 of leucopenia and thrombocytopenia were observed with an incidence of 44% and 32%, respectively and DIC occurred in 3 cases with poor PS though they recovered after reducing the 254-S dose to 80 mg/m2. The other toxicities were mild except for alopecia. Anaphylaxia was observed in a case at the second administration though the patient recovered in 15 minutes. There was no death. As to prognosis, a significant prolongation of survival period was observed in recurrent cases and 4 cases are alive (NED) after one and a half year. In the advanced cases, until now 3 cases of stage IV have died from the disease. We have concluded that this regimen is effective as a neoadjuvant chemotherapy for advanced cervical cancer and useful for the treatment of recurrent cervical cancer.
从新型顺铂类似物254-S单次给药取得的良好效果出发，我们开展了一项临床研究，以探究254-S、异环磷酰胺和培普利欧霉素联合使用的疗效，这三种药物各自具有不同的剂量限制因素。共有45例患者接受治疗，其中包括22例III期和IV期宫颈癌患者以及23例复发性宫颈癌患者，接受了至少两个疗程的254-S（100mg/m²，静脉注射，第1天）、异环磷酰胺（1500mg/体，静脉注射，第1 - 5天）和培普利欧霉素（5mg/体，肌肉注射，第1 - 6天）治疗，并通过临床检查和CT扫描评估肿瘤反应。晚期疾病患者的缓解率为81.8%（部分缓解 = 17例，完全缓解 = 1例），复发病例的缓解率为60.9%（部分缓解 = 12例，完全缓解 = 2例）。骨髓抑制是剂量限制因素。在121个疗程中，观察到3级和4级白细胞减少和血小板减少的发生率分别为44%和32%，3例PS较差的患者发生了弥散性血管内凝血，不过在将254-S剂量降至80mg/m²后恢复。除脱发外，其他毒性反应较轻。1例患者在第二次给药时出现过敏反应，但15分钟后恢复。无死亡病例。关于预后，复发病例的生存期显著延长，4例患者在一年半后仍存活（无疾病证据）。在晚期病例中，到目前为止，有3例IV期患者死于该疾病。我们得出结论，该方案作为晚期宫颈癌的新辅助化疗有效，对复发性宫颈癌的治疗也有用。
