A phase II multicenter trial of concurrent chemoradiotherapy with weekly nedaplatin in advanced uterine cervical carcinoma: Tohoku Gynecologic Cancer Unit Study.
A phase II multicenter trial of concurrent chemoradiotherapy with weekly nedaplatin in advanced uterine cervical carcinoma: Tohoku Gynecologic Cancer Unit Study.
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DOI：
10.3892/or.19.6.1551
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发表时间：
2008-06
期刊：
影响因子：
4.2
通讯作者：
Y. Yokoyama;T. Takano;K. Nakahara;T. Shoji;Hirokazu Sato;H. Yamada;N. Yaegashi;K. Okamura;H. Kurachi;T. Sugiyama;Toshinobu Tanaka;A. Sato;T. Tase;H. Mizunuma
中科院分区：
文献类型：
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作者：
Y. Yokoyama;T. Takano;K. Nakahara;T. Shoji;Hirokazu Sato;H. Yamada;N. Yaegashi;K. Okamura;H. Kurachi;T. Sugiyama;Toshinobu Tanaka;A. Sato;T. Tase;H. Mizunuma
本研究的目的是评价奈达铂同步放化疗治疗局部晚期宫颈鳞癌的有效性和安全性。奈达铂30 mg/m(2)，每周6次，同时进行外照射和腔内放疗。外照射剂量2Gy2次/d，每周5天，疗程5周；A点腔内近距离放射治疗，照射剂量6Gy点，每周1次，共4次。在2003年4月至2006年12月期间，有45名患者参加了这项试验。在45例患者中，40例(88.9%)完成了预定的治疗，并接受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。年龄分布从27岁到79岁不等，中位数为58岁。40例患者达到客观缓解，36例(90%)完全缓解，4例(10%)部分缓解。中位随访29个月(8~52个月)，3年无进展生存率和总生存率分别为58.7%(95%可信区间，42~75%)和78.0%(95%可信区间，56~90.0%)。急性毒性是短暂的，而且是非致命性的。在登记参加试验的45名患者中，只有3名(6.7%)分别有4级白细胞减少症和中性粒细胞减少症。3级腹泻2例(4.4%)，恶心呕吐1例(2.2%)。这些结果表明奈达铂每周30 mg/m(2)同时放疗是治疗晚期宫颈鳞癌的一种有效且耐受性良好的方案。
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.