Division of Gynecologic Oncology, European Institute of Oncology, Viale Ripamonti 435, 20085 Milan, Italy.
Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy; University of Milan-Bicocca, Milan, Italy.
Gynecol Oncol. 2014 Jun;133(3):531-6. doi: 10.1016/j.ygyno.2014.03.001. Epub 2014 Mar 11.
About 50-60% of patients with stage I-II uterine leiomyosarcoma (ULMS), primarily treated with surgery, relapse and die from progressive disease. In this retrospective study we describe the impact of adjuvant chemotherapy in this subset of patients.
140 women treated from 1976 to 2011 were included in the study. Univariate and multivariate analysis were used to test the association of clinical features and adjuvant treatments with overall survival (OS) and disease-free survival (DFS).
62 women did not receive any further treatment after hysterectomy, 14 had radiotherapy (RT), 52 chemotherapy and 12 chemo-radiotherapy. Chemotherapy based on doxorubicin and ifosfamide combination was used in 54 cases. After a median follow-up of 63months, 87 women (62%) have relapsed, and 62 (44%) have died. The vast majority of patients who relapsed had distant recurrences (72%). The 5year median DFS and OS were 43% and 64% respectively. After 5years of follow up 68.7% of women treated with chemotherapy (±RT) vs 65.6% of patients only observed were alive (p=0.521). In the univariate analysis no factors had a statistical impact on DFS, while number of mitosis (>20×10HPF), age (>60years) and adjuvant radiotherapy were found as negative prognostic factors for OS. In the multivariate analysis only mitosis and age remained significant for OS.
Adjuvant chemotherapy was not associated with a significant survival benefit and should not be considered as standard of care for patients with stage I-II ULMS until randomized clinical studies will give further information.
约 50-60%的 I-II 期子宫平滑肌肉瘤(ULMS)患者主要通过手术治疗,因疾病进展而复发并死亡。在这项回顾性研究中,我们描述了辅助化疗对这部分患者的影响。
本研究纳入了 1976 年至 2011 年期间接受治疗的 140 名女性患者。使用单因素和多因素分析来检验临床特征和辅助治疗与总生存期(OS)和无病生存期(DFS)的相关性。
62 名患者在子宫切除术后未接受任何进一步治疗,14 名患者接受了放疗(RT),52 名患者接受了化疗,12 名患者接受了化疗联合放疗。54 例患者接受了多柔比星和异环磷酰胺联合化疗。中位随访 63 个月后,87 名患者(62%)复发,62 名患者(44%)死亡。绝大多数复发患者发生远处转移(72%)。5 年中位 DFS 和 OS 分别为 43%和 64%。随访 5 年后,接受化疗(±RT)治疗的患者中 68.7%存活,而仅观察的患者中 65.6%存活(p=0.521)。单因素分析显示,DFS 无统计学意义,而有丝分裂数(>20×10HPF)、年龄(>60 岁)和辅助放疗是 OS 的负预后因素。多因素分析显示,只有有丝分裂数和年龄对 OS 有显著影响。
辅助化疗与生存获益无显著相关性,在随机临床试验提供更多信息之前,不应将其视为 I-II 期 ULMS 患者的标准治疗方法。