ConCerv：低危早期宫颈癌保守性手术的前瞻性研究。
ConCerv: a prospective trial of conservative surgery for low-risk early-stage cervical cancer.
机构信息
Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Instituto Nacional de Cancerología, Bogotá, and Clínica de Oncología Astorga, Medellin, Colombia.
出版信息
Int J Gynecol Cancer. 2021 Oct;31(10):1317-1325. doi: 10.1136/ijgc-2021-002921. Epub 2021 Sep 7.
OBJECTIVE
The objective of the ConCerv Trial was to prospectively evaluate the feasibility of conservative surgery in women with early-stage, low-risk cervical cancer.
METHODS
From April 2010 to March 2019, a prospective, single-arm, multicenter study evaluated conservative surgery in participants from 16 sites in nine countries. Eligibility criteria included: (1) FIGO 2009 stage IA2-IB1 cervical carcinoma; (2) squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) histology; (3) tumor size 2 cm; (4) no lymphovascular space invasion; (5) depth of invasion 10 mm; (6) negative imaging for metastatic disease; and (7) negative conization margins. Cervical conization was performed to determine eligibility, with one repeat cone permitted. Eligible women desiring fertility preservation underwent a second surgery with pelvic lymph node assessment, consisting of sentinel lymph node biopsy and/or full pelvic lymph node dissection. Those not desiring fertility preservation underwent simple hysterectomy with lymph node assessment. Women who had undergone an 'inadvertent' simple hysterectomy with an unexpected post-operative diagnosis of cancer were also eligible if they met the above inclusion criteria and underwent a second surgery with pelvic lymph node dissection only.
RESULTS
100 evaluable patients were enrolled. Median age at surgery was 38 years (range 23-67). Stage was IA2 (33%) and IB1 (67%). Surgery included conization followed by lymph node assessment in 44 women, conization followed by simple hysterectomy with lymph node assessment in 40 women, and inadvertent simple hysterectomy followed by lymph node dissection in 16 women. Positive lymph nodes were noted in 5 patients (5%). Residual disease in the post-conization hysterectomy specimen was noted in 1/40 patients-that is, an immediate failure rate of 2.5%. Median follow-up was 36.3 months (range 0.0-68.3). Three patients developed recurrent disease within 2 years of surgery-that is, a cumulative incidence of 3.5% (95% CI 0.9% to 9.0%).
DISCUSSION
Our prospective data show that select patients with early-stage, low-risk cervical carcinoma may be offered conservative surgery.
目的
ConCerv 试验的目的是前瞻性评估早期低危宫颈癌患者行保守性手术的可行性。
方法
2010 年 4 月至 2019 年 3 月，一项前瞻性、单臂、多中心研究对来自 9 个国家 16 个中心的参与者进行了保守性手术评估。纳入标准包括：（1）FIGO 2009 分期为 IA2-IB1 期宫颈癌；（2）鳞癌（任何分级）或腺癌（仅 1 级或 2 级）组织学；（3）肿瘤直径<2cm；（4）无淋巴血管间隙浸润；（5）浸润深度<10mm；（6）无转移性疾病的影像学证据；（7）宫颈锥切缘阴性。行宫颈锥切术以确定是否符合入组条件，允许重复锥切。有生育需求的合格女性行第二次手术，包括盆腔淋巴结评估，包括前哨淋巴结活检和/或全盆腔淋巴结清扫术。不希望保留生育能力的患者行单纯子宫切除术，同时评估淋巴结。如果满足上述纳入标准且仅行盆腔淋巴结清扫术，也将行“意外”单纯子宫切除术且术后诊断为癌症的患者纳入。
结果
共纳入 100 例可评估患者。中位手术年龄为 38 岁（范围 23-67 岁）。分期为 IA2（33%）和 IB1（67%）。手术包括锥切术加淋巴结评估 44 例，锥切术加淋巴结评估后行单纯子宫切除术 40 例，意外行单纯子宫切除术加淋巴结清扫术 16 例。5 例（5%）患者有阳性淋巴结。在 40 例行锥切术加淋巴结评估后行单纯子宫切除术的患者中，有 1 例患者的子宫切除术后标本中残留疾病，即即刻失败率为 2.5%。中位随访时间为 36.3 个月（范围 0.0-68.3 个月）。3 例患者在术后 2 年内复发疾病，即累积发病率为 3.5%（95%CI 0.9%至 9.0%）。
讨论
我们的前瞻性数据表明，一些早期低危宫颈癌患者可能适合接受保守性手术。
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