局限期小细胞肺癌高剂量与标准剂量每日两次胸部放疗：一项随机、开放标签、II期试验的最终生存数据、长期毒性及复发模式
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.
作者信息
Grønberg Bjørn Henning, Killingberg Kristin Toftaker, Fløtten Øystein, Bjaanæs Maria Moksnes, Brustugun Odd Terje, Madebo Tesfaye, Langer Seppo Wang, Risumlund Signe Lenora, Schytte Tine, Helbekkmo Nina, Neumann Kirill, Yksnøy Øyvind, Engleson Jens, Fluge Sverre, Naustdal Thor, Giske Liv Ellen, Nyman Jan, Tsakonas Georgios, Halvorsen Tarje Onsøien
机构信息
Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
出版信息
J Thorac Oncol. 2025 Apr 19. doi: 10.1016/j.jtho.2025.04.007.
INTRODUCTION
Chemoradiotherapy is standard treatment for limited-stage SCLC. However, most patients relapse and there is a need for better treatment. 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. Here, we report final survival data and long-term toxicity.
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 F-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. Patients were to receive four courses of platinum and etoposide chemotherapy, and responders were offered prophylactic cranial irradiation.
RESULTS
A total of 170 patients were randomized (60 Gy: n = 89, 45 Gy: 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 cm, and 67% were treated with three-dimensional conformal radiotherapy. Median overall survival in the 60 Gy group was significantly longer (43.5 versus 22.5 mo, hazard ratio 0.68, 95% confidence interval 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). 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.
CONCLUSION
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. This trial is registered at ClinicalTrials.gov: NCT02041845.
引言
同步放化疗是局限期小细胞肺癌（SCLC）的标准治疗方法。然而，大多数患者会复发，因此需要更好的治疗方案。我们研究了60 Gy分40次的每日两次胸部放疗（TRT）与既定的45 Gy分30次的放疗方案相比是否能提高生存率。在此，我们报告最终生存数据和长期毒性。
方法
随机、开放标签的II期试验。符合条件的患者体能状态为0至2，年龄在18岁及以上，接受F-氟脱氧葡萄糖正电子发射断层扫描计算机断层扫描和脑磁共振成像进行分期，并按1:1随机分为60或45 Gy的TRT组。患者接受四个疗程的铂类和依托泊苷化疗，缓解者接受预防性颅脑照射。
结果
共170例患者被随机分组（60 Gy组：n = 89，45 Gy组：n = 81）。中位年龄为65岁，31%的患者年龄在70岁及以上，57%为女性，89%的患者体能状态为0至1，83%为III期疾病，中位计划靶体积为305 cm，67%的患者接受三维适形放疗。60 Gy组的中位总生存期显著更长（43.5个月对22.5个月，风险比0.68，95%置信区间0.48 - 0.98，p = 0.037）。60 Gy组3至4级食管炎（60 Gy组：21%，45 Gy组：18%，p = 0.83）或肺炎（60 Gy组：3%，45 Gy组：0%，p = 0.39）的发生率并未更高。60 Gy组有2例患者出现食管狭窄，而11例患者（60 Gy组：n = 5，45 Gy组：n = 6）出现严重的长期进食和吞咽功能障碍。
结论
对于局限期SCLC患者，60 Gy分40次的每日两次TRT耐受性良好，与45 Gy分30次的放疗方案相比可延长生存期。本试验已在ClinicalTrials.gov注册：NCT02041845。
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