有高危因素的早期宫颈癌患者术后紫杉醇联合卡铂同期化放疗的疗效和安全性观察

目的评价紫杉醇联合卡铂同期放疗(CCRT)在治疗有高危因素早期宫颈癌术后的疗效和毒副反应。方法收集本科2008年7月1日至2011年6月30日收治ⅠB1～ⅡB宫颈鳞癌根治术后有高危因素的患者54例,其中行同期化放疗15例,39例行序贯放疗。同期化疗方案为紫杉醇(135 mg/m~2)联合卡铂(AUC=5)于放疗第一周进行一个疗程。辅助化疗方案同同期化疗,于放疗结束后开始,每21天一个疗程。比较同期化放疗和序贯放疗的复发率、无进展生存期(PFS)和总生存期(OS)以及急性期和晚期不良反应。结果 54例患者均按计划完成治疗,同期化放疗的中位放疗剂量50 Gy(46～52 Gy,每次2 Gy)和人均化疗次数4次(3～5次)与序贯放疗相似(P=0.60和P=0.34)。在中位随访20个月(8～43个月)期间发现,同期化放疗较序贯放疗能减少局部复发率(0/15 vs 9/39,P=0.04),而两组无进展生存期(log-rank,P=0.26)和总生存期(log-rank,P=0.51)相似。同期化放疗患者出现3～4级血液学不良反应比例高于序贯放疗(4/15 vs 1/39,P=0.03),而3级胃肠道急性不良反应相似(4/15 vs 5/39,P=0.22),随访期间两组患者未发现3～4级晚期不良反应。结论紫杉醇联和卡铂的同期化放疗能减少有高危因素的早期宫颈癌术后患者局部复发,并有较好耐受性。

Efficacy and safety of paclitaxel combined with carboplatin as a regimen for postoperative concurrent chemoradiotherapy for early stage uterine cervical cancer with high risk factors

Objective To evaluate the efficacy and safety of the outcomes and toxicity of paclitaxel and carboplatin with concurrent radiation therapy （CCRT） for cervical cancer patients after hysterectomy for early stage uterine cervical car- cinoma with high risk factors. Methods We retrospectively analyzed patients with FIGO stage Ⅰ B1 to stage ⅡB cervical cancer with high risk factors who had undergone radical surgery between July 2008 and June 2011. Of these 54 patients who were treated postoperatively with pelvic radiotherapy plus concurrent chemotherapy （CCRT） （ n = 15） or sequential radio- therapy （SRT） （ n = 39） , concurrent chemotherapy with paclitaxel （ 135 mg/m2 ） and earboplatin （ area under the curve,5 ） was administered in the first week of radiotherapy. Adjuvant chemotherapy was administered every 3 weeks alter radio- therapy. The recurrence rate, progression-free survival （PFS）, overall survival （OS） and acute and late toxicity were compared between the treatment groups. Results All patients completed radiotherapy and adjuvant chemotherapy for 3 6 cycles. Median total dose was 50Gy （ range ： 46 - 52Gy at 2 Gy/fraction） and the number of chemotherapy was 4 cycles （3 - 5 cycles） for CCRT, which was similar to SRT （ P = 0. 60, P = 0. 34 respectively）. During a median follow up of 20 months （range, 8- 43 months）, CCRT produces better local control rate than SRT （0/15 vs 9/39, P = 0. 04）. The difference of PFS and OS between these 2 treatments were not statistically significant （ log-rank, P = 0. 26, P = 0. 51, re- spectively）. The hematological acute toxicity in the CCRT group was noted in 4 patients, which was more than SRT （4/15 vs 1/39, P = 0. 03 ）. The difference of grade 3 gastrointestinal toxicity between these 2 treatments was similar （4/15 vs 5/ 39, P = 0. 22）. No grade 3 -4 late toxicity was seen in either CCRT or SRT during follow-up period. Conclusion Con- current chemoradiation with paclitaxel and carboplatin after hysterectomy produces excellent local control rate and is well tolerated for patients with high-risk cervical cancer.