Veerasarn Vutisiri, Lorvidhaya Vicharn, Kamnerdsupaphon Pimkhuan, Suntornpong Nan, Sangruchi Supatra, Lertsanguansinchai Prasert, Khorprasert Chonlakiet, Sookpreedee Lak, Udompunturak Suthipol
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Prannok Rd., Bangkoknoi, Bangkok, 10700, Thailand.
Gynecol Oncol. 2007 Jan;104(1):15-23. doi: 10.1016/j.ygyno.2006.06.045. Epub 2006 Sep 25.
Concurrent chemoradiation is the standard treatment for locally advanced cervical cancer. This study was a preliminary result of a randomized two arms, prospective, open-label phase III trial comparing the activity and safety of the concurrent chemoradiation of Tegafur-Uracil and carboplatin or carboplatin alone in locally advanced cervical cancer.
The stage IIB-IIIB cervical cancer patients were randomized to have Tegafur-Uracil 225 mg/m(2)/day orally, 5 days a week and carboplatin 100 mg/m(2) IV over 30-60 min, weekly on day 1 concurrent with standard radiotherapy (Group A) or carboplatin alone concurrent with standard radiotherapy (Group B).
Four hundred and sixty-nine patients were randomized to Group A (n=234) or Group B (n=235). The tumor response at 3-month follow-up time showed no significant difference. The only prognostic factor to improve the complete response rate was the hemoglobin level. The patients in Group A, who had Hb <10 gm/dL had the relatively better change to complete response of 1.48 compared to that in Group B (P 0.025, 95% CI 1.07, 2.04). No severe toxicity or adverse event had been reported. The median follow-up time for Group A and Group B was 12.6 and 11.8 months, respectively. There was no statistical difference in PFS and OS.
Concurrent chemoradiation by Tegafur-Uracil and carboplatin showed no difference in tumor response rate or treatment toxicity compared to carboplatin alone. The combination drugs might have benefit in poor prognostic patients such as the baseline Hb <10 gm/dL.
同步放化疗是局部晚期宫颈癌的标准治疗方法。本研究是一项随机双臂、前瞻性、开放标签的III期试验的初步结果，该试验比较了替加氟-尿嘧啶与卡铂同步放化疗或单纯卡铂同步放化疗在局部晚期宫颈癌中的活性和安全性。
IIB-IIIB期宫颈癌患者被随机分为两组，A组口服替加氟-尿嘧啶225mg/m²/天，每周5天，卡铂100mg/m²静脉滴注30-60分钟，每周第1天与标准放疗同步进行；B组单纯卡铂与标准放疗同步进行。
469例患者被随机分为A组（n=234）或B组（n=235）。3个月随访时的肿瘤反应无显著差异。提高完全缓解率的唯一预后因素是血红蛋白水平。A组血红蛋白<10g/dL的患者完全缓解的变化相对较好，为1.48，而B组为1.48（P=0.025，95%CI 1.07，2.04）。未报告严重毒性或不良事件。A组和B组的中位随访时间分别为12.6个月和11.8个月。无进展生存期和总生存期无统计学差异。
与单纯卡铂相比，替加氟-尿嘧啶与卡铂同步放化疗在肿瘤反应率或治疗毒性方面无差异。联合用药可能对预后较差的患者有益，如基线血红蛋白<10g/dL的患者。
