U.O.C. Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy
U.O.C. Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
Int J Gynecol Cancer. 2024 Feb 5;34(2):197-202. doi: 10.1136/ijgc-2023-004956.
Vaginal carcinoma is a rare malignancy accounting for 1-2% of all gynecological cancers. Surgery has a limited role, while definitive radiotherapy-chemotherapy followed by interventional radiotherapy is considered a valid alternative. The aim of the TRIDENT (TRImodal DEfinitive invasive vagiNal carcinoma Treatment) pilot study was to report the results of a modern standardized trimodal protocol treatment consisting of image guided definitive radiotherapy-chemotherapy followed by image guided interventional radiotherapy in terms of safety and efficacy.
Between January 2019 and December 2021, we analyzed 21 consecutive patients with primary vaginal cancer who had received radiotherapy-chemotherapy followed by interventional radiotherapy. The primary study endpoint was local control, and secondary endpoints were metastasis free survival, overall survival, and rate and severity of acute and late toxicities.
14 patients had FIGO (International Federation of Gynecology and Obstetrics) stage II, five patients had stage III, and two had stage IVB disease. Median total external beam radiotherapy dose for the tumor was 45 Gy. Median total dose on positive nodes was 60 Gy. Median total dose for interventional radiotherapy was 28 Gy over four high dose rate fractions to achieve between 85 and 95 Gy equivalent dose, in 2 Gy fractions (EQD2)α/β10, to the high risk clinical target volume, and 60 Gy EQD2α/β10 to the intermediate risk clinical target volume. All patients received weekly platinum based chemotherapy. Median follow-up was 20 months (range 10-56 months). Two year actuarial local control, metastasis free survival, and overall survival rate were 79.4%, 90.5%, and 79.4%, respectively. In terms of acute toxicity, there were no grade 4 events and only one acute grade (G) 3 toxicity (skin). Only vaginal stenosis (G3) was documented 12 months after therapy due to late toxicity.
In this study, definitive radiotherapy-chemotherapy followed by interventional radiotherapy was a safe and effective treatment modality for primary vaginal cancer.
阴道癌是一种罕见的恶性肿瘤，占妇科癌症的 1-2%。手术的作用有限，而明确的放化疗后联合介入放疗被认为是一种有效的替代方法。TRIDENT（TRImodal DEfinitive invasive vagiNal carcinoma Treatment）试验的目的是报告由图像引导的明确放化疗后联合图像引导介入放疗的现代标准化三联疗法治疗方案的结果，该方案在安全性和疗效方面。
2019 年 1 月至 2021 年 12 月，我们分析了 21 例接受放化疗后联合介入放疗的原发性阴道癌患者。主要研究终点为局部控制，次要终点为无转移生存、总生存以及急性和晚期毒性的发生率和严重程度。
14 例患者为国际妇产科联合会（FIGO）分期 II 期，5 例为 III 期，2 例为 IVB 期。肿瘤总外照射放疗剂量中位数为 45 Gy。阳性淋巴结总剂量中位数为 60 Gy。介入放疗总剂量中位数为 28 Gy，共 4 次高剂量率分次，实现 85-95 Gy 等效剂量，2 Gy 分次（EQD2）α/β10，用于高危临床靶区，和 60 Gy EQD2α/β10 用于中危临床靶区。所有患者均接受每周铂类化疗。中位随访时间为 20 个月（10-56 个月）。两年局部无进展生存率、无转移生存率和总生存率分别为 79.4%、90.5%和 79.4%。急性毒性方面，无 4 级事件，仅有 1 例 3 级毒性（皮肤）。仅在治疗后 12 个月因晚期毒性发生阴道狭窄（G3）。
在这项研究中，明确的放化疗后联合介入放疗是原发性阴道癌的一种安全有效的治疗方法。
