Umayahara Kenji, Takekuma Munetaka, Hirashima Yasuyuki, Noda Shin-Ei, Ohno Tatsuya, Miyagi Etsuko, Hirahara Fumiki, Hirata Eiji, Kondo Eiji, Tabata Tsutomu, Nagai Yutaka, Aoki Yoichi, Wakatsuki Masaru, Takeuchi Masahiro, Toita Takafumi, Takeshima Nobuhiro, Takizawa Ken
Department of Gynecology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.
Gynecol Oncol. 2016 Feb;140(2):253-8. doi: 10.1016/j.ygyno.2015.12.008. Epub 2015 Dec 14.
A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer.
Patients with FIGO stage III-IVA uterine cervical cancer without para-aortic lymphadenopathy were enrolled. Patients received definitive radiotherapy (RT) consisting of external beam whole-pelvic RT and high-dose-rate intracavitary brachytherapy. The cumulative linear quadratic equivalent dose was 62-65Gy prescribed at point A. weekly CDDP at 30mg/m(2) and PTX at 50mg/m(2) were administered concurrently with RT for ≥5 courses.
Sixty-eight of the 70 registered patients were eligible. The complete response rate was 76.5% (95% confidence interval [CI], 66.4-86.6%). With a median follow-up of 27months (range, 7.9-33.5), the 2-year cumulative progression-free survival and the 2-year cumulative overall survival rates were 83.8% (95% CI, 75.1-92.6%) and 92.7% (95% CI, 86.4-98.9%), respectively. The pelvic cumulative disease progression-free and the 2-year cumulative distant metastasis rates were 89.6% (95% CI, 82.3-96.9%) and 13.2% (95% CI, 5.2-21.3%), respectively. The 2-year cumulative late complication rates were 25% for all grades, 13.2% for grade 1, 5.9% for grade 2, 2.9% for grade 3, and 2.9% for grade 4.
For locally advanced cervical cancer, CCRT with weekly CDDP 30mg/m(2) and PTX at 50mg/m(2) demonstrated favorable antitumor activity, and was feasible and safe with respect to the protocol-specified serious adverse reactions and events. Evaluation of this regimen in phase III trials is warranted.
开展一项多中心II期试验，以评估每周使用顺铂（CDDP）和紫杉醇（PTX）同步放化疗（CCRT）治疗局部晚期子宫颈癌患者的疗效和毒性。
纳入国际妇产科联盟（FIGO）分期为III-IVA期且无腹主动脉旁淋巴结转移的子宫颈癌患者。患者接受由体外全盆腔放疗和高剂量率腔内近距离放疗组成的根治性放疗（RT）。在A点规定的累积线性二次等效剂量为62-65Gy。每周给予顺铂30mg/m²和紫杉醇50mg/m²，与放疗同步进行≥5个疗程。
70例登记患者中有68例符合条件。完全缓解率为76.5%（95%置信区间[CI]，66.4-86.6%）。中位随访27个月（范围7.9-33.5个月），2年累积无进展生存率和2年累积总生存率分别为83.8%（95%CI，75.1-92.6%）和92.7%（95%CI，86.4-98.9%）。盆腔累积无疾病进展率和2年累积远处转移率分别为89.6%（95%CI，82.3-96.9%）和13.2%（95%CI，5.2-21.3%）。2年累积晚期并发症发生率：所有级别为25%，1级为13.2%，2级为5.9%，3级为2.9%，4级为2.9%。
对于局部晚期宫颈癌，每周使用30mg/m²顺铂和50mg/m²紫杉醇的同步放化疗显示出良好的抗肿瘤活性，就方案规定的严重不良反应和事件而言是可行且安全的。有必要在III期试验中对该方案进行评估。
