[Comparison of the clinical efficacy of different treatments based on radical surgery in stage Ⅰ b2 and Ⅱa2 cervical cancer: a prospective randomized control study].

OBJECTIVE: 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.

METHODS: 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.

RESULTS: (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).

CONCLUSIONS: 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.