Department of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
Diagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
J Gynecol Oncol. 2023 May;34(3):e24. doi: 10.3802/jgo.2023.34.e24. Epub 2022 Dec 21.
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.
本试验旨在通过腔内和间质近距离治疗（HBT）的混合疗法，为局部晚期宫颈癌患者进行 I/II 期前瞻性临床试验，以证明其可行性和有效性。
符合本临床试验条件的患者为经磁共振成像（MRI）测量预处理宽度≥5cm 的 FIGO 分期 IB2-IVA 子宫颈癌患者。方案治疗包括 30-30.6Gy/15-17 分次全盆腔放疗，同期每周给予顺铂（CDDP）治疗，随后进行 24Gy/4 分次 HBT 治疗，以及中央屏蔽的盆腔放疗，总剂量为 50-50.4Gy/25-28 分次。II 期部分的主要终点是 2 年盆腔无进展生存率（PPFS）高于历史对照的 64%。
2015 年 10 月至 2019 年 10 月，73 例患者进行了初始登记，52 例患者进行了二次登记。中位随访时间为 37.3 个月（范围为 13.9-52.9 个月），2 年 PPFS 为 80.7%（90%置信区间[CI]为 69.7%-88%）。由于 2 年 PPFS 的 90%CI 下限为 69.7%，高于历史对照的 ICBT 数据 64%，因此，本研究的主要终点达到。
前瞻性临床研究证明了 HBT 的有效性。由于方案中确定的剂量目标低于 85Gy，局部控制仍有改进的空间。对于反应较差的肿瘤，可能需要更高的剂量。
