联合贝伐珠单抗新辅助化疗+同步放化疗治疗局部晚期巨块型宫颈癌的初步临床研究

Preliminary study of neoadjuvant plus chemotherapy combined with concurrent chemoradiotherapy for locally advanced giant cervical cancer

目的初步观察联合贝伐珠单抗的新辅助化疗+同步放化疗在局部晚期巨块型宫颈癌中的临床疗效及不良反应。方法联合贝伐珠单抗新辅助化疗的24例局部晚期巨块型宫颈癌患者作为研究组,前瞻性随机对照的Ⅱ期临床研究(ChiCTR-TRC-11001832)的30例新辅助化疗患者作为对照组。Kaplan-Meier法计算生存率并log-rank检验差异。结果新辅助化疗后研究组与对照组肿瘤体积分别为(1.64±23.15)cm^(3)与(12.83±15.08)cm^(3)(P=0.037),完全缓解(CR)率分别为45.8%与13.3%(P=0.004);后装治疗前研究组与对照组肿瘤体积分别为(0±1.5)cm^(3)与(1.00±10.63)cm^(3)(P=0.022),CR率分别为70%与50%(P=0.009)。中位随访24.6(9.3~101.7)个月。研究组与对照组1、2年总生存率分别为96%、96%与90%、71%(P=0.110),无局部复发生存率分别为96%、96%与97%、89%(P=0.512),无远处转移生存率分别为96%、88%与83%、80%(P=0.297)。两组患者不良反应可接受。结论联合贝伐珠单抗的新辅助化疗可明显缩小肿瘤体积、提高肿瘤CR率,不良反应可耐受。

Objective To preliminarily investigate the efficacy and safety of bevacizumab plus neoadjuvant chemotherapy combined with concurrent chemoradiotherapy in the treatment of locally advanced giant cervical cancer(LACC).Methods Twenty-four patients with LACC who were treated with bevacizumab combined with neoadjuvant chemotherapy were assigned into the study group,and 30 patients receiving neoadjuvant chemotherapy in phaseⅡclinical trial(ChiCTR-TRC-11001832)were allocated in the control group.The survival rate was calculated by the Kaplan-Meier method,and the significance of differences between the variables was determined by the log-rank test.Results The tumor volumes were(1.64±23.15)cm^(3) and(12.83±15.08)(P=0.037),and the complete remission(CR)rates were calculated as 45.8%and 13.3%(P=0.004)in the study and control groups after neoadjuvant chemotherapy.The tumor volumes were(0±1.5)cm^(3) and(1.00±10.63)cm^(3)(P=0.022)and the CR rates were 70%and 50%(P=0.009)in the study and control groups before afterloading treatment.The median follow-up was 24.6(9.3-101.7)months.The 1-and 2-year overall survival rates were 96%,96%and 90%,71%(P=0.110),the recurrence-free survival rates was 96%,96%and 97%,89%(P=0.512),and the distant metastasis-free survival rates were 96%,88%and 83%,80%(P=0.297)in the study and control groups,respectively.Adverse reactions were acceptable in both groups.Conclusion Bevacizumab combined with neoadjuvant chemotherapy can significantly reduce the tumor volume,improve the tumor CR rate and yield tolerable adverse reactions.