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三维适形放疗与图像引导调强放疗治疗局部晚期宫颈癌的随机对照研究 III 期

Three-Dimensional Conformal Radiotherapy Versus Image-Guided Intensity Modulated External Beam Radiotherapy in Locally Advanced Cervical Cancer: A Phase III Randomized Control Study.

机构信息

Dept of Radiotherapy and Oncology, PGIMER, Chandigarh, India.

Dept of Radiation Oncology, Homi Bhabha Cancer Hospital and Research Centre, Mullanpur, India.

出版信息

Clin Oncol (R Coll Radiol). 2024 Nov;36(11):728-737. doi: 10.1016/j.clon.2024.08.004. Epub 2024 Aug 10.

DOI:10.1016/j.clon.2024.08.004
PMID:39209678
Abstract

AIMS

The standard treatment of locally advanced cervical carcinoma is radical chemoradiation followed by brachytherapy which has improved survival. Hence, a major concern is our attempt to reduce the incidence of acute and late toxicities. IMRT has been shown to reduce toxicities. In this study, we have compared 3DCRT with IG-IMRT using patient-specific margins to evaluate tumor control as well as OAR-related toxicities.

MATERIALS AND METHODS

This was a single institution prospective phase III randomised control study including patients of squamous cell carcinoma of cervix (stage II-IIIB, FIGO 2009) without pelvic lymph node involvement. All patients were simulated using intermediate bladder filling protocol and those in the IG-IMRT arm, underwent additional scans with full and empty bladder to assess the range of internal motion and generate individualised ITV margin. EBRT dose of 46Gy/23#/4.5 weeks was delivered with weekly concurrent cisplatin followed by brachytherapy. All toxicities during EBRT and till 3 months post brachytherapy were considered acute toxicity. Post-treatment, patients were followed up every 2 months for first 2 years and then once every 6 months. Disease-related outcomes were assessed with clinical examination and symptom-directed imaging.

RESULTS

Two hundred patients were screened for inclusion and of them, 89 patients in 3DCRT and 84 patients in IG-IMRT arms were considered for final analysis. The baseline characteristics were comparable in both arms, majority of patients in both arms having stage II disease. For OARs, all dosimetric parameters were significantly better in the IG-IMRT arm. Acute radiation induced toxicities (dermatitis, genito-urinary and gastrointestinal toxicities) were significantly less in the IG-IMRT arm. The local, pelvic, and distant control were comparable in both arms.

CONCLUSION

Based on our experience, the use of IG-IMRT with patient-specific ITV margins results in reduction in acute OAR toxicities in patients without compromising on tumor control.

摘要

目的

局部晚期宫颈癌的标准治疗方法是根治性放化疗后行近距离放疗,这已提高了生存率。因此,我们主要关注的是尝试降低急性和晚期毒性的发生率。调强放疗(IMRT)已被证明可降低毒性。在这项研究中,我们比较了 3DCRT 和 IG-IMRT,使用患者特定的边缘来评估肿瘤控制以及与 OAR 相关的毒性。

材料和方法

这是一项单机构前瞻性 III 期随机对照研究,纳入无盆腔淋巴结受累的宫颈鳞癌患者(FIGO 2009 分期 IIB-IIIB 期)。所有患者均采用中间膀胱充盈方案进行模拟,IG-IMRT 组的患者还进行了全膀胱和排空膀胱扫描,以评估内部运动范围并生成个体化 ITV 边缘。给予 46Gy/23#/4.5 周的 EBRT 剂量,每周给予顺铂同步化疗,随后行近距离放疗。EBRT 期间和近距离放疗后 3 个月内的所有毒性均被认为是急性毒性。治疗后,患者在前 2 年每 2 个月随访一次,然后每 6 个月随访一次。通过临床检查和症状导向的影像学评估疾病相关结局。

结果

对 200 名患者进行了筛选,其中 3DCRT 组 89 例,IG-IMRT 组 84 例患者纳入最终分析。两组患者的基线特征无差异,多数患者为 II 期疾病。对于 OAR,IG-IMRT 组的所有剂量学参数均明显更好。IG-IMRT 组的急性放射性诱导毒性(皮炎、泌尿生殖和胃肠道毒性)明显更少。两组患者的局部、盆腔和远处控制无差异。

结论

根据我们的经验,在不影响肿瘤控制的情况下,使用具有患者特定 ITV 边缘的 IG-IMRT 可降低无盆腔淋巴结受累的宫颈癌患者的急性 OAR 毒性。

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