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根治性子宫切除术后高危宫颈癌化疗与放疗及观察的比较:一项随机、前瞻性、多中心试验

Chemotherapy versus radiotherapy versus observation for high-risk cervical carcinoma after radical hysterectomy: A randomized, prospective, multicenter trial.

作者信息

Lahousen M, Haas J, Pickel H, Hackl A, Kurz C, Ogris H, Stummvoll W, Winter R

机构信息

Department of Gynecology and Obstetrics, University of Graz, Graz, A-8036, Austria.

出版信息

Gynecol Oncol. 1999 May;73(2):196-201. doi: 10.1006/gyno.1999.5343.

DOI:10.1006/gyno.1999.5343
PMID:10329034
Abstract

BACKGROUND

Adjuvant treatment modalities after radical hysterectomy have long been used in an attempt to eradicate microscopic tumor residuals in patients at high risk for recurrence. However, it has not been clearly demonstrated that adjuvant radiation, adjuvant chemotherapy, or both improve the outcome. To evaluate the effect of adjuvant treatment in patients with high-risk cervical cancer after radical hysterectomy, the Austrian Gynecologic Oncology Group conducted a prospective, randomized, multicenter clinical trial between 1989 and 1995.

MATERIAL AND METHODS

Seventy-six patients with stage IB-IIB cervical cancer treated with radical hysterectomy with pelvic lymph node metastases and/or vascular invasion randomly received adjuvant chemotherapy (400 mg/m2 carboplatin, and 30 mg bleomycin), standardized external pelvic radiation therapy, or no further treatment.

RESULTS

After a median follow-up of 4.1 years (range, 2-7) there were no statistically significant differences (P = 0.9530) in disease-free survival among the three treatment arms.

CONCLUSION

The data suggest that adjuvant chemotherapy or radiation do not improve survival or recurrence rates in high-risk cervical cancer patients after radical hysterectomy. The most important treatment for these patients seems to be radical abdominal hysterectomy with systematic pelvic lymphadenectomy.

摘要

背景

根治性子宫切除术后的辅助治疗方式长期以来一直被用于试图根除复发高危患者体内的微小肿瘤残留。然而,目前尚未明确证实辅助放疗、辅助化疗或两者联合能改善治疗效果。为评估根治性子宫切除术后辅助治疗对高危宫颈癌患者的疗效,奥地利妇科肿瘤学组在1989年至1995年间开展了一项前瞻性、随机、多中心临床试验。

材料与方法

76例IB-IIB期宫颈癌患者,接受了根治性子宫切除术且伴有盆腔淋巴结转移和/或血管浸润,被随机分配接受辅助化疗(卡铂400mg/m²及博来霉素30mg)、标准化盆腔外照射放疗或不再接受进一步治疗。

结果

中位随访4.1年(范围2 - 7年)后,三个治疗组的无病生存率无统计学显著差异(P = 0.9530)。

结论

数据表明,辅助化疗或放疗并不能提高根治性子宫切除术后高危宫颈癌患者的生存率或降低复发率。对于这些患者,最重要的治疗似乎是根治性腹式子宫切除术及系统性盆腔淋巴结清扫术。

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