Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.
Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study.
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DOI：
10.1016/j.ajog.2021.08.029
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发表时间：
2022-01
影响因子：
9.8
通讯作者：
中科院分区：
文献类型：
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微创根治性宫颈切除术已成为希望生育的早期宫颈癌患者开放性根治性子宫切除术的替代方案。最近的数据表明，在I期宫颈癌中，微创根治性子宫切除术后的肿瘤学结局比开放根治性子宫切除术后更差。我们的目的是比较开放与微创根治性宫颈切除术后4.5年无病生存率。这是一项合作性国际回顾性研究（国际根治性气管切开术评估研究），研究对象为2005-2017年间在12个国家的18家中心接受治疗的患者。符合条件的患者患有鳞状细胞癌、腺癌或腺鳞癌;术前肿瘤大小≤2 cm;并接受了开放或微创（机器人或腹腔镜）根治性宫颈切除术和淋巴结评估（盆腔淋巴结切除术和/或前哨淋巴结活检）。排除标准包括新辅助化疗或术前盆腔放疗、既往淋巴结切除术或盆腔腹膜后手术、妊娠、IA 1期疾病伴淋巴血管间隙侵犯、流产的宫颈切除术（转为根治性子宫切除术）或阴道入路。手术入路、适应症和辅助治疗方案由治疗机构决定。共有715例患者进入研究数据库。然而，69名患者被排除在外，剩下646名患者在分析中。终点为4.5年无病生存率（主要）、4.5年总生存率（次要）和复发率（次要）。Kaplan-Meier法用于估计无病生存期和总生存期。进行了事后加权分析，比较了手术入路之间的复发率，开放手术被认为是标准手术，微创手术被认为是实验性的。在646例患者中，358例接受了开放手术，288例接受了微创手术。开放手术患者的中位年龄（范围）为32岁（20-42），微创手术患者的中位年龄为31岁（18-45）（P= 0.11）。开放手术的中位（范围）病理肿瘤大小为15（0-31）mm，微创手术为12（0.8-40）mm（P= 0.33）。开放手术组盆腔淋巴结受累率为5.3%（19/358例患者），微创手术组为4.9%（14/288例患者）（P= 0.81）。开放手术的中位（范围）随访时间为5.5（0.20-16.70）年，微创手术为3.1（0.02-11.10）年（P<0.001）。4.5年时，358例开放手术患者中有17例（4.8%）复发，288例微创手术患者中有18例（6.3%）复发（P= 0.40）。开放手术的4.5年无病生存率为94.3%（95%置信区间，91.6-97.0），微创手术为91.5%（95%置信区间，87.6-95.6）（对数秩P= 0.37）。复发风险的事后倾向评分分析显示，手术入路之间无差异（P=.42）。4.5年时，有6例疾病相关死亡（开放手术，3例;微创手术，3例）（对数秩P=.49）。开放手术的4.5年总生存率为99.2%（95%置信区间，97.6-99.7），微创手术为99.0%（95%置信区间，79.0-99.8）。开放根治性宫颈切除术和微创根治性宫颈切除术的4.5年无病生存率无差异。然而，各组的复发率均较低。正在进行的早期宫颈癌保守治疗的前瞻性研究可能有助于指导未来的治疗。
Minimally invasive radical trachelectomy has emerged as an alternative to open radical hysterectomy for patients with early-stage cervical cancer desiring future fertility. Recent data suggest worse oncologic outcomes after minimally invasive radical hysterectomy than after open radical hysterectomy in stage I cervical cancer. We aimed to compare 4.5-year disease-free survival after open vs minimally invasive radical trachelectomy. This was a collaborative, international retrospective study (International Radical Trachelectomy Assessment Study) of patients treated during 2005–2017 at 18 centers in 12 countries. Eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma; had a preoperative tumor size of ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). The exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, previous lymphadenectomy or pelvic retroperitoneal surgery, pregnancy, stage IA1 disease with lymphovascular space invasion, aborted trachelectomy (conversion to radical hysterectomy), or vaginal approach. Surgical approach, indication, and adjuvant therapy regimen were at the discretion of the treating institution. A total of 715 patients were entered into the study database. However, 69 patients were excluded, leaving 646 in the analysis. Endpoints were the 4.5-year disease-free survival rate (primary), 4.5-year overall survival rate (secondary), and recurrence rate (secondary). Kaplan-Meier methods were used to estimate disease-free survival and overall survival. A post hoc weighted analysis was performed, comparing the recurrence rates between surgical approaches, with open surgery being considered as standard and minimally invasive surgery as experimental. Of 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 (20–42) years for open surgery vs 31 (18–45) years for minimally invasive surgery (P=.11). Median (range) pathologic tumor size was 15 (0–31) mm for open surgery and 12 (0.8–40) mm for minimally invasive surgery (P=.33). The rates of pelvic nodal involvement were 5.3% (19 of 358 patients) for open surgery and 4.9% (14 of 288 patients) for minimally invasive surgery (P=.81). Median (range) follow-up time was 5.5 (0.20–16.70) years for open surgery and 3.1 years (0.02–11.10) years for minimally invasive surgery (P<.001). At 4.5 years, 17 of 358 patients (4.8%) with open surgery and 18 of 288 patients (6.3%) with minimally invasive surgery had recurrence (P=.40). The 4.5-year disease-free survival rates were 94.3% (95% confidence interval, 91.6–97.0) for open surgery and 91.5% (95% confidence interval, 87.6–95.6) for minimally invasive surgery (log-rank P=.37). Post hoc propensity score analysis of recurrence risk showed no difference between surgical approaches (P=.42). At 4.5 years, there were 6 disease-related deaths (open surgery, 3; minimally invasive surgery, 3) (log-rank P=.49). The 4.5-year overall survival rates were 99.2% (95% confidence interval, 97.6–99.7) for open surgery and 99.0% (95% confidence interval, 79.0–99.8) for minimally invasive surgery. The 4.5-year disease-free survival rates did not differ between open radical trachelectomy and minimally invasive radical trachelectomy. However, recurrence rates in each group were low. Ongoing prospective studies of conservative management of early-stage cervical cancer may help guide future management.
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影响因子：
4.8
作者：
Schmeler, Kathleen M.;Pareja, Rene;Ramirez, Pedro T.
通讯作者：
Ramirez, Pedro T.
影响因子：
158.5
作者：
Ramirez, Pedro T.;Frumovitz, Michael;Obermair, Andreas
通讯作者：
Obermair, Andreas
影响因子：
9.8
作者：
Matsuo, Koji;Chen, Ling;Wright, Jason D.
通讯作者：
Wright, Jason D.
影响因子：
2
作者：
Gooley, TA;Leisenring, W;Storer, BE
通讯作者：
Storer, BE
DOI：
10.1136/ijgc-2019-000273
发表时间：
2019-03
期刊：
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
影响因子：
--
作者：
Salvo G;Ramirez PT;Leitao M;Cibula D;Fotopoulou C;Kucukmetin A;Rendon G;Perrotta M;Ribeiro R;Vieira M;Baiocchi G;Falconer H;Persson J;Wu X;Căpilna ME;Ioanid N;Mosgaard BJ;Berlev I;Kaidarova D;Olawaiye AB;Liu K;Nobre SP;Kocian R;Saso S;Rundle S;Noll F;Tsunoda AT;Palsdottir K;Li X;Ulrikh E;Hu Z;Pareja R
通讯作者：
Pareja R