Sato Seiya, Shimada Muneaki, Ohta Tsuyoshi, Kojimahara Takanobu, Tokunaga Hideki, Takano Tadao, Yamaguchi Satoshi, Tanabe Hiroshi, Nishio Shin, Kigawa Junzo
*Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago City; †Department of Obstetrics and Gynecology, Yamagata University Faculty of Medicine, Yamagata; ‡Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine, Sendai; §Department of Gynecologic Oncology, Hyogo Cancer Center, Akashi; ∥Department of Obstetrics and Gynecology, Jikei University School of Medicine, Minato; ¶Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume; and #Department of Obstetrics and Gynecology, Matsue City Hospital, Matsue, Japan.
Int J Gynecol Cancer. 2016 Mar;26(3):561-7. doi: 10.1097/IGC.0000000000000650.
We conducted this study to evaluate the efficacy and safety of adjuvant chemotherapy using taxane plus carboplatin (CBDCA) for high-risk stage IB-IIB patients with uterine cervical non-squamous cell carcinoma after radical hysterectomy.
Thirty-seven patients were eligible. Pelvic lymph node involvement and/or parametrial invasion were defined as high-risk factors. The patients were treated with 6 cycles of paclitaxel (PTX, 175 mg/m(2)) or docetaxel (DTX, 60 mg/m(2)) followed by CBDCA (area under the curve, 6) every 3 weeks. The primary end point was 2-year progression-free survival (PFS) rate, and the secondary end point was the assessment of adverse events.
Twenty-two patients received PTX/CBDCA (TC) chemotherapy, and the remaining 15 patients underwent DTX/CBDCA (DC) chemotherapy. The 2-year PFS rate was 62.1% (95% confidence interval, 44.6%-75.5%). Patients receiving DC chemotherapy showed a better 2-year PFS rate compared to those with TC chemotherapy, but the difference was not statistically significant (80.0% vs 50.0%, P = 0.1400). The most common grade 3/4 adverse events were hematologic toxicities, which were generally well tolerable. Nonhematologic toxicity was generally mild.
Taxane and CBDCA combination chemotherapy, especially DC chemotherapy, may be one of the useful adjuvant treatments for high-risk stage IB-IIB patients with uterine cervical non-squamous cell carcinoma after radical hysterectomy.
我们开展本研究以评估在根治性子宫切除术后，使用紫杉烷联合卡铂（CBDCA）对高危IB-IIB期子宫颈非鳞状细胞癌患者进行辅助化疗的疗效和安全性。
37例患者符合条件。盆腔淋巴结受累和/或宫旁浸润被定义为高危因素。患者每3周接受6个周期的紫杉醇（PTX，175mg/m²）或多西他赛（DTX，60mg/m²）治疗，随后给予CBDCA（曲线下面积，6）。主要终点是2年无进展生存率（PFS），次要终点是不良事件评估。
22例患者接受PTX/CBDCA（TC）化疗，其余15例患者接受DTX/CBDCA（DC）化疗。2年PFS率为62.1%（95%置信区间，44.6%-75.5%）。接受DC化疗的患者2年PFS率高于接受TC化疗的患者，但差异无统计学意义（80.0%对50.0%，P = 0.1400）。最常见的3/4级不良事件是血液学毒性，总体耐受性良好。非血液学毒性一般较轻。
紫杉烷和CBDCA联合化疗，尤其是DC化疗，可能是根治性子宫切除术后高危IB-IIB期子宫颈非鳞状细胞癌患者有用的辅助治疗方法之一。
