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局限期小细胞肺癌同期每日一次或两次放化疗的长期结果:CONVERT 试验的简短报告。

Long-Term Outcomes After Concurrent Once- or Twice-Daily Chemoradiation in Limited-Stage Small Cell Lung Cancer: A Brief Report From the CONVERT Trial.

机构信息

Department of Radiotherapy Related Research, The Christie NHS Foundation Trust, Manchester, United Kingdom; Patrick G. Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, United Kingdom.

Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.

出版信息

Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1386-1390. doi: 10.1016/j.ijrobp.2024.02.063. Epub 2024 Mar 21.

Abstract

PURPOSE

CONVERT was a phase 3 international randomized clinical trial comparing once-daily (OD) and twice-daily (BD) radiation therapy (RT). This updated analysis describes the 6.5-year outcomes of these regimens delivered with conformal techniques.

METHODS AND MATERIALS

CONVERT (NCT00433563) randomized patients 1:1 between OD RT (66 Gy/33 fractions/6.5 weeks) and BD RT (45 Gy/30 fractions/3 weeks), both delivered with concurrent cisplatin/etoposide. Three-dimensional conformal RT was mandatory, intensity-modulated RT was permitted, and elective nodal irradiation was not allowed. Prophylactic cranial irradiation was delivered at the discretion of treating clinicians. RT treatment planning was subject to central quality assurance.

RESULTS

Five hundred forty-seven patients were recruited at 73 centers. The median follow-up for the surviving cohort (n = 164) was 81.2 months. The median survival for the OD and BD arms were 25.4 months (95% CI, 21.1-30.9) and 30.0 months (95% CI, 25.3-36.5; hazard ratio, 1.13; 95% CI, 0.92-1.38; P = .247). Performance status and tumor volume were associated with survival on multivariate analysis. No treatment-related deaths occurred subsequent to the initial analysis performed in 2017. Regarding late toxicity, 7 patients in the OD arm developed grade 3 esophagitis, 4 of which went on to develop stricture or fistulation, compared with no patients in the BD arm. Grade 3 pulmonary fibrosis occurred in 2 and 3 patients in the OD and BD arms, respectively.

CONCLUSIONS

As the CONVERT trial did not demonstrate the superiority of OD RT and this regimen had a slightly worse toxicity profile after 80 months of follow-up, 45 Gy BD should remain the standard of care in limited stage small cell lung cancer.

摘要

目的

CONVERT 是一项比较每日一次(OD)和每日两次(BD)放疗(RT)的 3 期国际随机临床试验。本更新分析描述了使用适形技术提供的这些方案的 6.5 年结果。

方法和材料

CONVERT(NCT00433563)以 1:1 的比例随机分配患者接受 OD RT(66 Gy/33 个分次/6.5 周)和 BD RT(45 Gy/30 个分次/3 周),两者均同时给予顺铂/依托泊苷。强制性使用三维适形 RT,允许使用调强 RT,不允许选择性淋巴结照射。预防性颅照射由治疗临床医生决定。RT 治疗计划需接受中央质量保证。

结果

73 个中心共招募了 547 名患者。存活队列(n = 164)的中位随访时间为 81.2 个月。OD 和 BD 臂的中位生存期分别为 25.4 个月(95%CI,21.1-30.9)和 30.0 个月(95%CI,25.3-36.5;风险比,1.13;95%CI,0.92-1.38;P =.247)。多变量分析显示,表现状态和肿瘤体积与生存相关。自 2017 年首次分析以来,没有发生与治疗相关的死亡。关于晚期毒性,OD 臂的 7 名患者发生 3 级食管炎,其中 4 名发展为狭窄或瘘管,而 BD 臂无患者发生。OD 和 BD 臂分别有 2 名和 3 名患者发生 3 级肺纤维化。

结论

由于 CONVERT 试验并未显示 OD RT 的优越性,并且在 80 个月的随访后该方案的毒性谱略差,45 Gy BD 应继续成为局限期小细胞肺癌的标准治疗方法。

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