背景:这项研究旨在评估在诊断为IIB-IVA期宫颈癌的患者中,同时设置高风险临床目标体积(CTV-hr)并同时进行综合增强调强放疗(IMRT-SIB)的临床疗效和副作用。
方法:本研究回顾性分析了2014年11月至2019年9月在青岛大学附属医院接受根治性放疗的IIB-IVA期宫颈癌患者。根据是否设置了CTV-hr,将患者分为实验组和对照组。所有患者均接受放化疗联合治疗。紫杉醇的剂量为135mg/m2,顺铂的剂量为75mg/m2,卡铂的剂量为AUC4-6,周期为21天。放射治疗(RT)包括外束放射治疗(EBRT)和腔内近距离放射治疗(ICBT)。在对照组中,阳性淋巴结(GTV-n)以58-62Gy/26-28分的剂量治疗(f),而临床目标体积(CTV)治疗剂量为46-48Gy/26-28f。实验组以54-56Gy/26-28f的剂量同时接受对CTV-hr的综合增强(SIB),与对照组相同的CTV和GTV-n。两组均联合近距离放射治疗,总剂量(EQD2,2Gy/f的等效剂量)为80-90Gy。该研究测量了客观缓解率(ORR),3年无进展生存率(PFS),3年总生存率(OS),复发率,和副作用作为终点。
结果:该研究招募了217名患者,实验组为119,对照组为98。结果显示,实验组的3年OS率较高(87.4%vs.71.4%,p=0.001)和3年PFS率(72.3%与51.0%,p=0.000)与对照组相比。此外,实验组总复发率明显较低(26.1%vs.50.0%,p=0.003),场内复发(15.1%vs.36.7%,p=0.000),和场外复发(13.4%vs.35.7%,p=0.000)与对照组相比。发现所有观察到的差异具有统计学意义。然而,实验组和对照组在ORR和放射学副作用方面无统计学差异,如放射性膀胱炎和肠炎(p>0.05)。
结论:对IIB-IVA期宫颈癌患者设置CTV-hr并进行IMRT-SIB可有效提高3年OS率,3年PFS率和降低复发率,副作用无显著差异。
BACKGROUND: This study aims to evaluate the clinical efficacy and side effects of setting up a high-risk clinical target volume (CTV-hr) alongside simultaneous integrated boost intensity-modulated radiotherapy (IMRT-SIB) in patients diagnosed with stage IIB-IVA cervical cancer.
METHODS: This study retrospectively analysed patients with stage IIB-IVA cervical cancer who received radical radiotherapy at the Affiliated Hospital of Qingdao University between November 2014 and September 2019. The patients were divided into experimental and control groups based on whether CTV-hr was set. All patients received a combined treatment of radiotherapy and chemotherapy. The dosage for paclitaxel was 135 mg/m2, while for cisplatin it was 75 mg/m2 or for carboplatin it was AUC 4-6, given in a cycle of 21 days. Radiotherapy (RT) included external beam radiation therapy (EBRT) and intracavitary brachytherapy (ICBT). In the control group, positive lymph nodes (GTV-n) were treated at a dose of 58-62 Gy/26-28 fractions(f), while clinical target volumes (CTV) were treated with a dose of 46-48 Gy/26-28f. The experimental group received a simultaneous integrated boost (SIB) to CTV-hr at a dose of 54-56 Gy/26-28f, with the same CTV and GTV-n as the control group. Both groups were combined with brachytherapy with a total dose (EQD2, the equivalent dose in 2 Gy/f) of 80-90 Gy. The study measured objective remission rate (ORR), 3-year progression-free survival (PFS) rate, 3-year overall survival (OS) rate, recurrence rate, and side effects as endpoints.
RESULTS: The study enrolled 217 patients, with 119 in the experimental group and 98 in the control group. Results showed that the experimental group had a higher 3-year OS rate (87.4% vs. 71.4%, p = 0.001) and 3-year PFS rate (72.3% vs. 51.0%, p = 0.000) compared to the control group. Additionally, the experimental group had significantly lower rates of overall recurrence (26.1% vs. 50.0%, p = 0.003), in-field recurrence (15.1% vs. 36.7%, p = 0.000), and out-field recurrence(13.4% vs. 35.7%, p = 0.000) compared to the control group. All observed differences were found to be statistically significant. However, the experimental and control groups had no statistically significant difference in ORR and radiological side effects, such as radiation cystitis and enteritis (p > 0.05).
CONCLUSIONS: Setting CTV-hr and performing IMRT-SIB on patients with stage IIB-IVA cervical cancer effectively increased the 3-year OS rate, 3-year PFS rate and reduced recurrence rate, with no significant differences in side effects.