Li Zhijie, Yang Shuyan, Liu Lei, Han Shiyu
Department of Gynaecology and Obstetrics, Fourth Affiliated Hospital of Harbin Medical University, No,37 Yiyuan Street, Nangang District, Harbin, Heilongjiang Province 150001, China.
Radiat Oncol. 2014 Sep 22;9:212. doi: 10.1186/1748-717X-9-212.
We investigated the efficacy of concurrent chemoradiotherapy (CCRT) over radiotherapy (RT) in Chinese patients with locally advanced cervical carcinoma.
Between January 2005 and January 2008, 192 patients with squamous cell carcinoma of the cervix were included in the study: 96 in arm A (CCRT with 20 mg/m2 cisplatin for 5 days) and 96 in arm B (RT). The overall response rate was the primary endpoint. The secondary endpoints included overall survival, progression-free survival, and toxicity.
The 5-year overall response rate was 67% and 53% for the CCRT and RT arms, respectively, and the difference was statistically significant, while the median overall survival was 68 months (range 3-85 months) and 61 months (range 4-83 months), respectively (P = 0.009). In addition, the median progression-free survival for CCRT was 62 months (range 3-83 months), whereas it was 51 months (range 4-81 months) for the RT arm (P = 0.025). The toxicity profile, both acute and late, was comparable in both arms.
In summary, we demonstrate that CCRT was effective and better tolerated than RT alone in Chinese patients with locally advanced cervical carcinoma.
Chinese Clinical Trials Register: ChiCTR-TRC-13003979.
我们研究了同步放化疗（CCRT）与单纯放疗（RT）对中国局部晚期宫颈癌患者的疗效。
2005年1月至2008年1月期间，192例宫颈鳞状细胞癌患者纳入本研究：A组96例（CCRT，顺铂20mg/m²，连用5天），B组96例（RT）。总缓解率为主要终点。次要终点包括总生存期、无进展生存期和毒性。
CCRT组和RT组的5年总缓解率分别为67%和53%，差异有统计学意义，而中位总生存期分别为68个月（范围3 - 85个月）和61个月（范围4 - 83个月）（P = 0.009）。此外，CCRT组的中位无进展生存期为62个月（范围3 - 83个月），而RT组为51个月（范围4 - 81个月）（P = 0.025）。两组急慢性毒性反应情况相当。
总之，我们证明在中国局部晚期宫颈癌患者中，CCRT比单纯RT更有效且耐受性更好。
中国临床试验注册中心：ChiCTR - TRC - 13003979。
