Yokoyama Yoshihito, Takano Tadao, Nakahara Kenji, Shoji Tadahiro, Sato Hirokazu, Yamada Hidekazu, Yaegashi Nobuo, Okamura Kunihiro, Kurachi Hirohisa, Sugiyama Toru, Tanaka Toshinobu, Sato Akira, Tase Toru, Mizunuma Hideki
Department of Obstetrics and Gynecology, Hirosaki University School of Medicine, Hirosaki, Japan.
Oncol Rep. 2008 Jun;19(6):1551-6.
The purpose of this study was to evaluate the effectiveness and safety of concurrent chemoradiotherapy using weekly nedaplatin for the treatment of locally advanced squamous cell carcinoma of the uterine cervix. Nedaplatin at 30 mg/m(2) was administered weekly 6 times with a concurrent external beam and intracavity radiotherapy. External beam radiation was delivered with a fraction dose of 2 Gy per day for 5 days a week during a 5-week period and intracavitary brachytherapy, of which the fraction size is 6 Gy to point A, was given once a week for a total of 4 times using a remote after-loading system. Forty-five patients were enrolled in this trial between April 2003 and December 2006. Of the 45 patients, 40 (88.9%) completed the scheduled treatment and were evaluated for efficacy and safety. Of these, 4 were stage Ib2, 12 were stage IIb, 18 were stage IIIb and 6 were stage IVa. The age distribution ranged from 27 to 79 years with a median age of 58. The 40 patients achieved an objective response, 36 (90%) a complete response and 4 (10%) a partial response. At a median follow-up of 29 months (range, 8-52), the 3-year progression-free and overall survival were 58.7% (95% confidence interval, 42-75%) and 78.0% (95% confidence interval, 56-90.0%), respectively. Acute toxicities were transient and rendered non-lethal. Of the 45 patients enrolled for the trial, only 3 (6.7%) had grade 4 leukopenia and neutropenia, respectively. Grade 3 diarrhea and nausea/ vomiting were observed in 2 (4.4%) and 1 (2.2%), respectively. These results indicate that weekly nedaplatin of 30 mg/m(2) with concurrent radiotherapy is an effective and well-tolerated regimen for advanced squamous cell carcinoma of the uterine cervix.
本研究的目的是评估每周使用奈达铂同步放化疗治疗局部晚期子宫颈鳞状细胞癌的有效性和安全性。奈达铂剂量为30mg/m²，每周给药1次，共6次，同时进行体外照射和腔内放疗。体外照射在5周内每周5天，每天分次剂量为2Gy，腔内近距离放疗，A点分次剂量为6Gy，使用遥控后装系统每周1次，共4次。2003年4月至2006年12月期间，45例患者入组本试验。45例患者中，40例（88.9%）完成了预定治疗，并进行了疗效和安全性评估。其中，Ib2期4例，IIb期12例，IIIb期18例，IVa期6例。年龄分布为27至79岁，中位年龄为58岁。40例患者获得客观缓解，36例（90%）完全缓解，4例（10%）部分缓解。中位随访29个月（范围8至52个月），3年无进展生存率和总生存率分别为58.7%（95%置信区间，42 - 75%）和78.0%（95%置信区间，56 - 90.0%）。急性毒性是短暂的，无致命性。在入组试验的45例患者中，分别只有3例（6.7%）出现4级白细胞减少和中性粒细胞减少。3级腹泻和恶心/呕吐分别在2例（4.4%）和1例（2.2%）中观察到。这些结果表明，每周30mg/m²奈达铂同步放疗是治疗晚期子宫颈鳞状细胞癌的一种有效且耐受性良好的方案。
