局部晚期子宫颈癌用腔内和间质性放射治疗混合技术的I/II期前瞻性临床试验。
Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer.
发表日期：2022 Dec 21
作者：
Naoya Murakami, Miho Watanabe, Takashi Uno, Shuhei Sekii, Kayoko Tsujino, Takahiro Kasamatsu, Yumiko Machitori, Tomomi Aoshika, Shingo Kato, Hisako Hirowatari, Yuko Kaneyasu, Tomio Nakagawa, Hitoshi Ikushima, Ken Ando, Masumi Murata, Ken Yoshida, Hiroto Yoshioka, Kazutoshi Murata, Tatsuya Ohno, Noriyuki Okonogi, Anneyuko I Saito, Mayumi Ichikawa, Takahito Okuda, Keisuke Tsuchida, Hideyuki Sakurai, Ryoichi Yoshimura, Yasuo Yoshioka, Atsunori Yorozu, Naonobu Kunitake, Hiroyuki Okamoto, Koji Inaba, Tomoyasu Kato, Hiroshi Igaki, Jun Itami
来源：
Journal of Gynecologic Oncology
摘要：
本试验的目的是在I/II期前瞻性临床试验中展示腔内和间隙放疗的混合治疗方法(HBT)在局部晚期宫颈癌患者中的可行性和有效性。符合以下条件的患者可参与本临床试验：磁共振成像测得的FIGO IB2-IVA期宫颈癌患者预处理宽度≥5厘米。治疗方案包括每周同时化疗的全盆放疗30-30.6Gy/15-17次，后接4次HBT放疗24Gy和盆腔放疗50-50.4Gy/25-28次（中央防护屏障）。II期部分的主要终点是2年盆腔进展生存率（PPFS）高于历史对照的64%。在2015年10月至2019年10月期间，73名患者参与了初步登记，52名患者进行了二次登记。在中位随访时间为37.3个月（范围为13.9-52.9个月）的情况下，2年PPFS为80.7％（90％置信区间[CI]= 69.7％-88％）。由于2年PPFS的90％CI下限为69.7％，高于历史ICBT数据64％，因此实现了本研究的主要终点。前瞻性临床研究证明了HBT的有效性。因为协议中确定的剂量目标低于85Gy，所以对于局部控制还有改善的空间。对于反应不佳的肿瘤可能需要更高的剂量。 ©2023. 亚洲妇产科肿瘤学会，韩国妇产科肿瘤学会和日本妇产科肿瘤学会。
The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial.Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50-50.4 Gy in 25-28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%.Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9-52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%-88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met.The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.