Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Early Drug Development Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Cancer. 2021 Nov 15;127(22):4161-4170. doi: 10.1002/cncr.33804. Epub 2021 Jul 22.
The use of external-beam radiotherapy for locally advanced nonanaplastic thyroid cancer remains controversial. This prospective study evaluated the efficacy and tolerability of intensity-modulated radiation therapy (IMRT) with or without concurrent chemotherapy in patients with locally advanced thyroid cancer.
The authors conducted a nonrandomized phase 2 trial of IMRT with or without concurrent doxorubicin in patients with gross residual or unresectable nonanaplastic thyroid carcinoma (ClinicalTrials.gov identifier NCT01882816). The primary end point was 2-year locoregional progression-free survival (PFS). Secondary end points included overall survival (OS), safety, patient-reported outcomes, and functional outcomes.
Twenty-seven patients were enrolled: 12 (44.4%) with unresectable disease and 15 (55.6%) with gross residual disease. The median follow-up was 45.6 months (interquartile range, 42.0-51.6 months); the 2-year cumulative incidences of locoregional PFS and OS were 79.7% and 77.3%, respectively. The rate of grade 3 or higher acute and late toxicities was 33.4%. There were no significant functional differences 12 months after treatment (assessed objectively by the modified barium swallow study). Patient-reported quality of life in the experimental group was initially lower but returned to the baseline after 6 months and improved thereafter. In a post hoc analysis, concurrent chemotherapy with intensity-modulated radiation therapy (CC-IMRT) resulted in significantly less locoregional failure at 2 years (no failure vs 50%; P = .001), with higher rates of grade 2 or higher acute dermatitis, mucositis, and dysphagia but no difference in long-term toxicity, functionality, or patient-reported quality of life.
In light of the excellent locoregional control rates achieved with CC-IMRT and its acceptable toxicity profile as confirmed by functional assessments and patient-reported outcomes, CC-IMRT may be preferred over IMRT alone.
对于局部晚期非典型甲状腺癌，外照射放疗的应用仍存在争议。本前瞻性研究评估了调强放疗（IMRT）联合或不联合同期化疗在局部晚期甲状腺癌患者中的疗效和耐受性。
作者开展了一项非随机 2 期临床试验，评估 IMRT 联合或不联合多柔比星同期化疗在大体残留或不可切除的非典型甲状腺癌患者中的疗效（ClinicalTrials.gov 标识符：NCT01882816）。主要终点为 2 年局部区域无进展生存率（PFS）。次要终点包括总生存率（OS）、安全性、患者报告结局和功能结局。
共入组 27 例患者：12 例（44.4%）为不可切除疾病，15 例（55.6%）为大体残留疾病。中位随访时间为 45.6 个月（四分位距，42.0-51.6 个月）；2 年局部区域 PFS 和 OS 的累积发生率分别为 79.7%和 77.3%。3 级或以上急性和晚期毒性的发生率为 33.4%。治疗后 12 个月时，客观评估的改良钡剂吞咽研究显示，功能无显著差异。实验组患者报告的生活质量最初较低，但 6 个月后恢复基线水平，此后逐渐改善。在一项事后分析中，调强放疗联合同期化疗（CC-IMRT）在 2 年内显著降低局部区域失败率（无失败率 vs 50%；P=0.001），但 2 级或以上急性皮炎、黏膜炎和吞咽困难的发生率较高，但长期毒性、功能或患者报告的生活质量无差异。
鉴于 CC-IMRT 达到的优异局部区域控制率以及其在功能评估和患者报告结局方面证实的可接受毒性特征，CC-IMRT 可能优于单独的 IMRT。
