Phase III randomized trial comparing LDR and HDR brachytherapy in treatment of cervical carcinoma
Phase III randomized trial comparing LDR and HDR brachytherapy in treatment of cervical carcinoma
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DOI：
10.1016/j.ijrobp.2004.01.034
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发表时间：
2004-08-01
影响因子：
7
通讯作者：
Charoonsantikul, C
中科院分区：
文献类型：
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作者：
Lertsanguansinchai, P;Lertbutsayanukul, C;Charoonsantikul, C
目的：腔内近距离放射治疗在宫颈癌的治疗中发挥着重要作用。以往的研究结果表明，剂量率对肿瘤控制的影响和并发症的发生之间存在争议。我们进行了一项前瞻性随机临床试验，以比较低剂量率（LDR）和高剂量率（HDR）腔内近距离放射治疗浸润性子宫颈cancer.Methods和材料的治疗的临床结局：共237例患者，以前未经治疗的浸润性子宫颈癌在朱拉隆功国王纪念医院进行了随机1995年6月至2001年12月。排除不合格、治疗不完整和数据不完整的患者，LDR组和HDR组分别有109例和112例患者。所有患者均接受外照射放疗和LDR或HDR腔内近距离放射治疗使用朱拉隆功治疗schedule.Results：LDR和HDR组的中位随访时间分别为40.2和37.2个月。所有患者的3年总生存率和无复发生存率分别为69.6%和70%。LDR和HDR组的3年总生存率分别为70.9%和68.4%（p = 0.75），3年盆腔控制率分别为89.1%和86.4%（p = 0.51）。两组的3年无复发生存率均为69.9%（p = 0.35）。大多数复发是远处转移，特别是在IIB和IIIB期患者中。LDR组和HDR组的3级和4级并发症发生率分别为2.8%和7.1%（p = 0.23）。考虑到患者的便利性、所需医务人员的数量减少以及对卫生保健工作者的辐射减少，HDR腔内近距离放射治疗是常规LDR近距离放射治疗的替代方案。大量的远端失败表明，其他方式，如全身同步或辅助化疗可能会降低这种高复发率，特别是在IIB和IIIB期。(C)2004爱思唯尔公司
Purpose: Intracavitary brachytherapy plays an important role in the treatment of cervical carcinoma. Previous results have shown controversy between the effect of dose rate on tumor control and the occurrence of complications. We performed a prospective randomized clinical trial to compare the clinical outcomes between low-dose-rate (LDR) and high-dose-rate (HDR) intracavitary brachytherapy for treatment of invasive uterine cervical carcinoma.Methods and Materials: A total of 237 patients with previously untreated invasive carcinoma of the uterine cervix treated at King Chulalongkorn Memorial Hospital were randomized between June 1995 and December 2001. Excluding ineligible, incomplete treatment, and incomplete data patients, 109 and 112 patients were in the LDR and HDR groups, respectively. All patients were treated with external beam radiotherapy and LDR or HDR intracavitary brachytherapy using the Chulalongkorn treatment schedule.Results: The median follow-up for the LDR and HDR groups was 40.2 and 37.2 months, respectively. The actuarial 3-year overall and relapse-free survival rate for all patients was 69.6% and 70%, respectively. The 3-year overall survival rate in the LDR and HDR groups was 70.9% and 68.4% (p = 0.75) and the 3-year pelvic control rate was 89.1% and 86.4% (p = 0.51), respectively. The 3-year relapse-free survival rate in both groups was 69.9% (p = 0.35). Most recurrences were distant metastases, especially in Stage IIB and IIIB patients. Grade 3 and 4 complications were found in 2.8% and 7.1% of the LDR and HDR groups (p = 0.23).Conclusion: Comparable outcomes were demonstrated between LDR and HDR intracavitary brachytherapy. Concerning patient convenience, the lower number of medical personel needed, and decreased radiation to health care workers, HDR intracavitary brachytherapy is an alternative to conventional LDR brachytherapy. The high number of distant failure suggests that other modalities such as systemic concurrent or adjuvant chemotherapy might lower this high recurrence, especially in Stage IIB and IIIB. (C) 2004 Elsevier Inc.