Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
Radiother Oncol. 2020 Aug;149:181-188. doi: 10.1016/j.radonc.2020.05.020. Epub 2020 May 14.
No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.
目前尚无随机对照试验（RCT）确定无法治愈的头颈部鳞状细胞癌（HNSCC）患者的最佳姑息性放疗方案。我们进行了 RCT，比较了两种放射治疗方案在疗效、毒性和生活质量（QoL）方面的差异。
入组患者为不适合根治性治疗的局部晚期 HNSCC 患者和转移性疾病有限的患者，按 1:1 比例随机分配至 1 组（36 Gy 分 6 次，每周 2 次）或 2 组（50 Gy 分 16 次，每周 4 次）。
由于入组缓慢，试验提前终止（入组 34 例）。1 组和 2 组的客观缓解率分别为 38.9%和 57.1%（p=0.476）。局部区域进展时间未达到。1 年时局部区域控制率分别为 57.4%和 69.3%（p=0.450，HR=0.56，95%CI 0.12-2.58）。1 年总生存率分别为 33.3%和 57.1%，中位生存时间分别为 35.4 周和 59.5 周（p=0.215，HR=0.55，95%CI 0.21-1.43）。1 组急性≥3 级毒性发生率较低（16.7%比 57.1%，p=0.027），其中 3 级黏膜炎发生率差异最大（5.6%比 42.9%，p=0.027）。然而，患者报告的任何 QoL 评分均无明显恶化。
这项提前关闭的不完整研究无法得出明确结论。长程放疗并未显示出明显更好的肿瘤学结果，但与更严重的 3 级黏膜炎相关。QoL 评分无明显差异。因此，应谨慎提倡较短的治疗方案。但是，由于统计效能不足，这种建议应谨慎解释。
