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[奥地利首个多中心卵巢癌研究结果:III期和IV期患者中序贯化疗(阿霉素/顺铂 - 长春新碱/环磷酰胺 - 甲氨蝶呤)与2种标准方案(阿霉素/环磷酰胺或阿霉素/顺铂)的前瞻性随机比较]

[Results of the first Austrian multicenter ovarian cancer study: prospective randomized comparison of sequential chemotherapy (adriamycin/cisplatin--vincristine/cyclophosphamide--methotrexate) with 2 standard protocols (adriamycin/cyclophosphamide or adriamycin/cisplatin) in stage III and IV patients].

作者信息

Salzer H, Gitsch E, Dittrich C, Sevelda P, Karrer K, Schemper M, Stempel-Smekal G, Langer M, Wagner G, Rainer H

出版信息

Geburtshilfe Frauenheilkd. 1985 Nov;45(11):761-8. doi: 10.1055/s-2008-1036132.

Abstract

From June 1980 to December 1982 164 patients with ovarian cancer stage III and IV were randomized into the three-legged Austrian Ovarian Cancer Study. A new polychemotherapy, known as the "changing-scheme" (adriamycin/cisplatinum--vincristine/cyclophosphamide--high dose methotrexate), developed in Vienna, was compared with adriamycin/cyclophosphamide and adriamycin/cisplatinum. The risk factors were stratified by means of special computer-assisted randomization. The first study evaluation in 1982 showed a significant advantage for the changing-scheme with regard to recurrence-free interval and survival (Mantel test: p less than 0.01, Breslow test: p less than 0.03). No difference was found between the combinations of adriamycin/cyclophosphamide and adriamycin/cisplatinum. At the second study evaluation in June 1984 the differences previously observed were no longe present to the same significant extent. The changing-scheme continued to be superior for the subgroups of patients with highly differentiated tumors, without ascites, with larger postoperative tumor burden and with liver metastases. The use of this therapy is be recommended for women with advanced ovarian cancer, especially in consideration of the much lower toxicity caused by the less frequent cisplatinum administrations as compared to the adriamycin/cisplatinum combination.

摘要

1980年6月至1982年12月,164例III期和IV期卵巢癌患者被随机纳入奥地利卵巢癌三足研究。将维也纳研发的一种新的多药化疗方案,即“交替方案”(阿霉素/顺铂——长春新碱/环磷酰胺——大剂量甲氨蝶呤)与阿霉素/环磷酰胺以及阿霉素/顺铂进行比较。通过特殊的计算机辅助随机化对危险因素进行分层。1982年的首次研究评估显示,交替方案在无复发生存期和总生存期方面具有显著优势(曼特尔检验:p<0.01,布雷斯洛检验:p<0.03)。阿霉素/环磷酰胺与阿霉素/顺铂联合方案之间未发现差异。在1984年6月的第二次研究评估中,之前观察到的差异不再具有相同程度的显著性。对于高分化肿瘤、无腹水、术后肿瘤负荷较大以及有肝转移的患者亚组,交替方案仍然更具优势。鉴于与阿霉素/顺铂联合方案相比,顺铂给药频率较低导致毒性低得多,推荐对晚期卵巢癌女性使用这种治疗方法。

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