Li X, Kong W M, Han C, Yan Z, Zhao H, Zhang W Y, Wang J D
Department of Gynecologic Oncology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100006, China.
Zhonghua Fu Chan Ke Za Zhi. 2016 Jul 25;51(7):524-9. doi: 10.3760/cma.j.issn.0529-567X.2016.07.008.
To compare the clinical efficacy of different treatments based on radical surgery in stage Ⅰ b2 and Ⅱ a2 cervical cancer through prospective randomized controlled study.
A total of 133 patients with stage Ⅰ b2 and Ⅱ a2 cervical cancer treated at Beijing Obstetrics and Gynecology Hospital of Capital Medical University during January 2009 to December 2012 were enrolled and randomly assigned to receive one of the following three treatments: preoperative intracavitary irradiation(PII)group, radical hysterectomy(RH)group, and neoadjuvant chemotherapy(NACT)group. Operation method included uterine extensive resection, pelvic lymph node excision, with or without para-aortic lymph node resection. The recent curative effect and side effect of preoperative treatment were observed. The operation time, intraoperative blood loss, surgical complications, postoperative pathological risk factors and postoperative adjuvant therapy and side effect, the survival situation were evaluated among the 3 groups.
(1)The response rates were 88%(37/42)and 82%(37/45)respectively of the PII group and NACT group. The difference was insignificant(P=0.528). Side effects were less in the PII group. Only 5 patients(12% , 5/42)had slight gastrointestinal reaction. Myelosuppression and gastrointestinal reaction in NACT group were 76%(34/45)and 67%(30/45)respectively, which were more serious than that in group PII group(P<0.05).(2)Intraoperative blood loss and operation time in PII group [(678± 239)ml and(181±39)minutes]and NACT group [(625±137)ml and(168±25)minutes]had a decreasing trend compared with that in RH group [(711 ± 319)ml and(202 ± 64)minutes], but the differences were no significant(P >0.05). NACT group could shorten operation time compared with the RH group(P <0.05). The lymph node metastases rate were 30%(14/46), 29%(12/42)and 29%(13/45)and the deep stromal invasion rate were 22%(10/46), 31%(13/42)and 31%(14/45)in RH group, PII group and NACT group respectively(all P>0.05). The lymph-vascular space involvement(LVSI)in NACT group was significantly lower than that in RH group [31%(14/45)vs 57%(26/46), P=0.015]. The number of patients with histological risk factors in NACT group was higher thanthat in RH group [27%(12/45)vs 9%(4/46), P= 0.024]. All surgery were successfully completed and no treatment-related deaths occurred in three groups. The incidence of 3-4 grade adverse reactions evaluated by the common terminology criteria for adverse event(CTCAE)was 13%(6/46), 14%(6/42), 18%(8/45)in RH group, PII group and NACT group respectively(P=0.855). Three-year disease free survival(PFS)were 74.0%, 78.5% and 80.0%, and 3-year overall survival(OS)were 80.4%, 83.3% and 84.4% in RH group, PII group and NACT group respectively(all P>0.05).
The recent curative effect of PII and NACT were similar. They couldn't improve 3-year of PFS and OS of the patients with Ⅰb2 and Ⅱa2 stage cervical cancer. But NACT can reduce the operation difficulty and can reduce the incidence of postoperative pathological risk factors, which could reduce postoperative adjuvant therapy.
通过前瞻性随机对照研究，比较不同根治性手术方式治疗Ⅰb2期和Ⅱa2期宫颈癌的临床疗效。
选取2009年1月至2012年12月在首都医科大学附属北京妇产医院接受治疗的133例Ⅰb2期和Ⅱa2期宫颈癌患者，随机分为以下三组之一：术前腔内照射（PII）组、根治性子宫切除术（RH）组和新辅助化疗（NACT）组。手术方式包括广泛性子宫切除术、盆腔淋巴结切除术，可选择或不进行腹主动脉旁淋巴结切除术。观察术前治疗的近期疗效和副作用。评估三组患者的手术时间、术中出血量、手术并发症、术后病理危险因素、术后辅助治疗及副作用、生存情况。
（1）PII组和NACT组的有效率分别为88%（37/42）和82%（37/45）。差异无统计学意义（P = 0.528）。PII组副作用较少。仅5例患者（12%，5/42）有轻微胃肠道反应。NACT组的骨髓抑制和胃肠道反应分别为76%（34/45）和67%（30/45），比PII组更严重（P < 0.05）。（2）PII组[（678±239）ml和（181±39）分钟]和NACT组[（625±137）ml和（168±25）分钟]的术中出血量和手术时间与RH组[（711±319）ml和（202±64）分钟]相比有下降趋势，但差异无统计学意义（P > 0.05）。NACT组与RH组相比可缩短手术时间（P < 0.05）。RH组、PII组和NACT组的淋巴结转移率分别为30%（14/46）、29%（12/42）和29%（13/45），深部间质浸润率分别为22%（10/46）、31%（13/42）和31%（14/45）（均P > 0.05）。NACT组的脉管间隙浸润（LVSI）明显低于RH组[31%（14/45）对57%（26/46），P = 0.015]。NACT组有组织学危险因素的患者数量高于RH组[27%（12/45）对9%（4/46），P = 0.024]。三组手术均成功完成且未发生与治疗相关的死亡。根据不良事件通用术语标准（CTCAE）评估的3 - 4级不良反应发生率在RH组、PII组和NACT组分别为13%（6/46）、14%（6/42）和18%（8/45）（P = 0.855）。RH组、PII组和NACT组的三年无病生存率（PFS）分别为74.0%、78.5%和80.0%，三年总生存率（OS）分别为80.4%、83.3%和84.4%（均P > 0.05）。
PII和NACT的近期疗效相似。它们不能提高Ⅰb2期和Ⅱa2期宫颈癌患者的三年PFS和OS。但NACT可降低手术难度并可降低术后病理危险因素的发生率，从而可减少术后辅助治疗。
