Department of Radiation Oncology, Cancer Institute, Imam-Khomeini Hospital Complex, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
Radiation Oncology Research Center, Cancer Research Institute, Imam-Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Asian Pac J Cancer Prev. 2024 Sep 1;25(9):3119-3124. doi: 10.31557/APJCP.2024.25.9.3119.
Overall treatment time (OTT) is an important index for local control in patients with locally advanced cervical cancer treated with definitive chemoradiation (External Beam Radiation Therapy (EBRT), Brachytherapy (BT) and concomittant chemotherapy). This study aimed to evaluate the efficiency and safety of reducing OTT by shortening the brachytherapy duration to one week in the intervention group copared to three weeks in the control group.
The study was a non-randomized open-label phase II clinical trial, carried out on 49 cervical cancer patients (26 in intervention grouop and 23 in control group) who received EBRT concomitant with Cisplatin, followed by brachytherap in order to deliver 60 Gy equivalent total doses in 2-Gy fractions (EQD2) to Intermediate Risk-Clinical Tumor Volume (IR-CTV) and 85-90 Gy EQD2 to High Risk-Clinical Tumor Volume (HR-CTV). In the intervention group, all brachytherapy sessions were performed in 1 week, while for the control group, it was administrated in 3 consecutive weeks. The participants were followed (Minimum follow up time was 6 month and median follow up time was 10 month) to assess response and toxicity of the treatment.
Overall, more than 95% of study participants had a complete response and more than 4.0% reported partial response, and no treatment failure was observed. The complete response in intervention and control groups was 96.1% and 95.6%, respectively (P value > 0.05). There was no difference in acute toxicity between the two groups.
considering that short course brachytherapy was non inferior to conventional course from point of Response Rate and Side Effects during follow up time; so this strategy can be considered as an option for reducing the OTT which can at least cause decreasing the costs. Studies with larger sample size and phase 3 are recommended.
在接受根治性放化疗（外照射放疗（EBRT）、近距离放疗（BT）和同期化疗）的局部晚期宫颈癌患者中，总治疗时间（OTT）是局部控制的一个重要指标。本研究旨在评估通过将介入组的近距离治疗时间缩短至一周，与对照组的三周相比，减少 OTT 的效率和安全性。
该研究为非随机开放标签 II 期临床试验，共纳入 49 例宫颈癌患者（介入组 26 例，对照组 23 例），接受 EBRT 联合顺铂治疗，然后行近距离放疗，以 2Gy 剂量（EQD2）向中危临床肿瘤体积（IR-CTV）给予 60Gy 等效总剂量，向高危临床肿瘤体积（HR-CTV）给予 85-90Gy EQD2。在介入组中，所有近距离治疗均在 1 周内完成，而对照组则在 3 周内连续进行。对参与者进行随访（最小随访时间为 6 个月，中位随访时间为 10 个月），以评估治疗的反应和毒性。
总体而言，超过 95%的研究参与者完全缓解，超过 4.0%的参与者部分缓解，未观察到治疗失败。干预组和对照组的完全缓解率分别为 96.1%和 95.6%（P 值>0.05）。两组的急性毒性无差异。
考虑到短程近距离放疗在随访期间的反应率和不良反应方面不劣于常规程放疗；因此，这种策略可以被认为是减少 OTT 的一种选择，至少可以降低成本。建议进行更大样本量和 3 期的研究。
