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Objective@#To evaluate the effect of levonorgestrel-releasing intrauterine system (LNG-IUS) plus oral megestrol acetate (MA) as fertility-preserving treatment in patients with early-stage endometrial cancer (EEC). @*Methods@#In this single-center, phase II study with open-label, randomized and controlled design, young patients (18–45 years) diagnosed with primary EEC were screened, who strongly required fertility-preserving treatment. Patients were randomly assigned (1:1) into MA group (160 mg oral daily) or MA (160 mg oral daily) plus LNG-IUS group. Pathologic evaluation on endometrium retrieved by hysteroscopy was performed every 3 months. The primary endpoint was complete response (CR) rate within 16 weeks of treatment. The secondary endpoints were CR rate within 32 weeks of treatment, adverse events, recurrent and pregnancy rate. @*Results@#Between July 2017 and June 2020, 63 patients were enrolled and randomly assigned. Totally 56 patients (26 in MA group; 28 in MA + LNG-IUS group) were included into primary-endpoint analyses. The median follow-up was 31.6 months (range, 3.1–94.0). No significant difference in 16-week CR rate were found between MA and MA + LNG-IUS groups (19.2% vs. 25.0%, p=0.610; odds ratio=1.40; 95% confidence interval=0.38–5.12), while the 32-week CR rates were also similar (57.1% and 61.5%, p=0.743), accordingly. More women in MA + LNG-IUS group experienced vaginal hemorrhage (46.4% vs. 16.1%; p=0.012) compared with MA group. No intergroup difference was found regarding recurrence or pregnancy rate. @*Conclusion@#Compared with MA alone, the addition of LNG-IUS may not improve the early CR rate for EEC, and may produce more adverse events instead.
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Background and purpose:A variety of measures are taken preoperatively to reduce the tumor size of stageⅠb2 bulky cervical cancer before surgery. Which one is safer and more effective, currently, there is no consensus. This article compared the effect in 3 different treatment methods (neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and operation) on patients with stageⅠb2 bulky cervical cancer, and provided evidence for clinical decision. Methods:Retrospective analysis the clinical date of 133Ⅰb2 bulky cervical cancer patients, who received preoperative neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and direct operation from Apr. 2006 to Oct. 2010 in our hospital. Results: The effective rates of neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy group were 91.8% and 92.5%, respectively, there was no statistical difference(P>0.05). The tumor size got smaller after treatment compared with the size before treatment (P0.05). The bleeding volume of neoadjuvant chemo radio therapy group was significantly higher than those in the other 2 groups (158.9±50.7 vs 116.8±45.5, 123.1±30.2;P0.05);Pathological examination showed that vascular invasion in surgery group had statistical differences than other 2 groups (P0.05);Besides, there were no statistical difference on vascular invasion between the 3 groups (P>0.05);And on 3-year overall survival, disease-free survival there was no statistical difference between the 3 groups (P>0.05). Conclusion:Neoadjuvant chemotherapy can effectively reduce tumor size for patients with stage Ⅰb2 bulky cervical cancer before operation, it is better than direct surgery or preoperative chemoradiotherapy in improving the resection rate, and reducing postoperative pathological positive rate, and infection. Neoadjuvant chemotherapy can improve the pathological complete remission rate. The combination of radiation and chemotherapy might produce synergistic effect on huge cervical tumor, but it can’t improve the survival rate. Therefore, neoadjuvant chemotherapy is the best choice for the stageⅠb2 cervical cancer patients. Therefore, a long-term follow-up or large sample randomized controlled trials is necessary to assess the prognosis of preoperative neoadjuvant chemotherapy and neoadjuvant chemoradiotherapy.