Multidrug Treatment of Advanced and Recurrent Endometrial Carcinoma: A Gynecologic Oncology Group Study
Multidrug Treatment of Advanced and Recurrent Endometrial Carcinoma: A Gynecologic Oncology Group Study
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晚期和复发性子宫内膜癌的多药治疗：一项妇科肿瘤学小组研究
作者：
C. Cohen;H. Bruckner;M. Deppe;J. Blessing;H. Homesley;J. Lee;W. Watring
晚期（FIGO III期和IV期）或复发性子宫内膜癌患者（358例）接受以下两种方案之一治疗：1）美法仑和5-氟尿嘧啶，每日一次，持续4天，每4周重复一次，每日一次，持续8周; 2）阿霉素、5-氟尿嘧啶和环磷酰胺，每21天静脉推注一次，每日一次，持续8周。除63名患有已知心脏病的患者被分配到方案1（以避免阿霉素）并单独研究外，所有患者均被随机化。根据体力状态、既往孕激素治疗史、是否存在可测量疾病和疾病分期进行分层。两组中可测量疾病的客观缓解率均为36.8%;每组均为36.8%的疾病稳定，仅26.4%的患者在治疗期间进展。缓解不受复发部位、首次复发时间、是否接受过孕激素或放射治疗或年龄的影响。肿瘤分级和体能状态确实影响缓解，尽管57例客观缓解者中有44例患有未分化肿瘤。这两种组合迅速达到反应，需要仔细的监督，并在治疗通常预后不良的患者特别有用。
Patients (358) with advanced (FIGO stages III and IV) or recurrent endometrial cancer were treated with one of two regimens: 1) melphalan and 5-fluorouracil daily for four days, repeated every four weeks with megace daily for eight weeks and 2) adriamycin, 5-fluorouracil, and cyclophosphamide, intravenous bolus every 21 days with megace daily for eight weeks. All patients were randomized except for 63 with known cardiac disease who were assigned to regimen 1 (to avoid adriamycin) and studied separately. Stratification was effected for performance status, history of previous progestational therapy, presence or absence of measurable disease, and stage of disease. The objective response rate in those with measurable disease was 36.8% in both groups; 36.8% of each group had stable disease, and only 26.4% progressed on treatment. Response was unaffected by site of recurrence, time to first recurrence, presence or absence of previous treatment by progestational or radiation therapy, or age. Grade of tumor and performance status did affect response, although 44 of 57 objective responders had undifferentiated tumors. The two combinations achieved response rapidly, required careful supervision, and were especially useful in treating patients with usually poor prognostic features.