High-Dose Versus Standard-Dose Twice-Daily Thoracic Radiotherapy in Limited-Stage SCLC: Final Survival Data, Long-Term Toxicity, and Relapse Patterns in a Randomized, Open-Label, Phase II Trial.

However, most patients relapse and there is a need for better treatment.

然而，大多数患者会复发，因此需要更有效的治疗方法。

We investigated whether twice-daily thoracic radiotherapy (TRT) of 60 Gy/40 fractions improves survival compared with the established schedule of 45 Gy/30 fractions.

我们调查了每天两次胸部放疗（TRT）60 Gy/40次是否比已建立的45 Gy/30次方案更能改善生存率。

Here, we report final survival data and long-term toxicity.

在这里，我们报告了最终的生存数据和长期毒性。

Methods

Randomized, open-label, phase II trial. Eligible patients had performance status of 0 to 2, were above or equal to 18 years of age, underwent 18F-fluorodeoxyglucose positron emission tomography computed tomography and brain magnetic resonance imaging for staging, and were randomized 1:1 to TRT of 60 or 45 Gy.

随机、开放标签、II期试验。符合条件的患者表现状态为0至2，年龄在18岁或以上，进行了18F-氟脱氧葡萄糖正电子发射断层扫描和脑磁共振成像以进行分期，并按1:1的比例随机接受60或45 Gy的放疗。

Patients were to receive four courses of platinum and etoposide chemotherapy, and responders were offered prophylactic cranial irradiation.

患者将接受四轮铂类和依托泊苷化疗，反应良好的患者将提供预防性颅脑放疗。

Results

A total of 170 patients were randomized (60 Gy: n = 89, 45 Gy: n = 81).

共有170名患者被随机分配（60 Gy组：n = 89，45 Gy组：n = 81）。

Median age was 65 years, 31% above or equal to 70 years, 57% women, 89% had performance status of 0 to 1, 83% stage III disease, median planning target volume was 305 cm3, and 67% were treated with three-dimensional conformal radiotherapy.

中位年龄为65岁，31%的患者年龄在70岁或以上，女性占57%，89%的患者表现状态为0至1，83%的患者为III期疾病，中位计划靶体积为305 cm³，67%的患者接受了三维适形放射治疗。

Median overall survivalin the 60 Gy group was significantly longer (43.5 versus 22.5 mo, hazard ratio0.68, 95% confidence interval0.48-0.98, p = 0.037).

60 Gy组的中位总生存期显著更长（43.5个月对比22.5个月，风险比0.68，95%置信区间0.48-0.98，p = 0.037）。

The 60 Gy group did not experience more acute grades 3 to 4 esophagitis (60 Gy: 21%, 45 Gy: 18%, p = 0.83) or pneumonitis (60 Gy: 3%, 45 Gy: 0%, p = 0.39).

60 Gy组并未出现更多的3至4级急性食管炎（60 Gy: 21%，45 Gy: 18%，p = 0.83）或肺炎（60 Gy: 3%，45 Gy: 0%，p = 0.39）。

Two patients, both in the 60 Gy group, developed esophageal strictures, whereas 11 patients (60 Gy: n = 5, 45 Gy: n = 6) developed severe long-term eating and swallowing dysfunction.

在60 Gy组中有两名患者发展为食管狭窄，而11名患者（60 Gy组：n=5，45 Gy组：n=6）出现了严重的长期进食和吞咽功能障碍。

Conclusions

Twice-daily TRT of 60 Gy/40 fractions was well tolerated and prolonged survival compared with 45 Gy/30 fractions in patients with limited-stage SCLC.

每日两次的60 Gy/40次分割放疗在有限期小细胞肺癌患者中耐受性良好，并且与45 Gy/30次分割放疗相比，延长了生存期。

This trial is registered at ClinicalTrials.gov: NCT02041845.

该试验已在ClinicalTrials.gov注册，注册号为NCT02041845。