A confirmatory trial of hysterectomy with minimal parametrectomy for stage IB1 cervical cancer involving a tumor diameter of 2 cm or less: a Japan Clinical Oncology Group study (JCOG1101).
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引用次数: 0
Abstract
Objective: The standard surgery for stage IB uterine cervical cancer is radical hysterectomy (RH). However, RH is highly invasive, and there is a need to establish less invasive techniques.
Methods: We conducted a prospective, single-arm trial to evaluate the efficacy and safety of modified radical hysterectomy (MRH)in patients with International Federation of Gynecology and Obstetrics 2008 stage IB1 cervical cancer involving a tumor diameter of ≤2 cm measured on magnetic resonance imaging. The protocol treatment consisted of MRH and adjuvant (chemo)radiotherapy if indicated. The primary endpoint was 5-year overall survival (OS). The expected OS was set at 95.8%; i.e., the OS of RH in our previous observational study.
Results: Of 225 eligible patients, 193 (85.8%) had pT1b1 (Union for International Cancer Control 7th) disease, and 184 (81.8%) had a pathological maximum tumor diameter of ≤2 cm. Parametrial involvement, lymph node metastasis, stromal invasion involving ≥2/3 of the stroma, and surgical margins of <1 cm (including carcinoma in situ) were observed in 3 (1.3%), 16 (7.1%), 30 (13.3%), and 11 (4.9%) patients, respectively. The 5-year OS and relapse-free survival rates were 98.2% (90% confidence interval [CI]=96.0%-99.2%) and 94.7% (95% CI=90.8%-96.9%), respectively. The median time to the disappearance of residual urine after urethral catheter removal was 1 day. There were no treatment-related deaths. Grade 3/4 adverse events were observed in 17 patients (7.6%).
Conclusion: MRH may be as effective as and less invasive than RH for stage IB1 uterine cervical cancer involving a tumor diameter of ≤2 cm.
Trial registration: Japan Registry of Clinical Trials Identifier: jRCTs031180167.
期刊介绍：
The Journal of Gynecologic Oncology (JGO) is an official publication of the Asian Society of Gynecologic Oncology. Abbreviated title is ''J Gynecol Oncol''. It was launched in 1990. The JGO''s aim is to publish the highest quality manuscripts dedicated to the advancement of care of the patients with gynecologic cancer. It is an international peer-reviewed periodical journal that is published bimonthly (January, March, May, July, September, and November). Supplement numbers are at times published. The journal publishes editorials, original and review articles, correspondence, book review, etc.
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