一项随机II期试验中患者报告的与健康相关的生活质量，该试验比较了标准剂量与高剂量每日两次胸部放疗在局限期小细胞肺癌中的应用。
Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer.
作者信息
Killingberg Kristin Toftaker, Halvorsen Tarje Onsøien, Fløtten Øystein, Brustugun Odd Terje, Langer Seppo W, Nyman Jan, Hornslien Kjersti, Madebo Tesfaye, Schytte Tine, Risum Signe, Tsakonas Georgios, Engleson Jens, Grønberg Bjørn Henning
机构信息
Department of Clinical and Molecular Medicine, NTNU, 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, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
出版信息
Lung Cancer. 2022 Apr;166:49-57. doi: 10.1016/j.lungcan.2022.02.002. Epub 2022 Feb 8.
OBJECTIVES
In a randomized phase II trial, twice daily (BID) thoracic radiotherapy (TRT) of 60 Gy/40 fractions improved survival compared with 45 Gy/30 fractions in limited stage small-cell lung cancer (LS SCLC). Notably, the higher dose did not cause more toxicity. Here we present health related quality of life (HRQoL) reported by the trial participants during the first 2 years.
MATERIALS AND METHODS
170 patients were randomized 1:1 to TRT of 45 Gy or 60 Gy concurrently with cisplatin/etoposide chemotherapy. The 150 patients who commenced TRT and completed a minimum of one HRQoL-questionnaire were included in the present study. Patients reported HRQoL on the European Organization for Research and Treatment of Cancer Core 30 and Lung Cancer 13 Quality of Life Questionnaires. Questionnaires were completed weeks 0, 4 (before TRT), 8 (end of TRT), 12 (response evaluation after chemoradiotherapy) and 16 (end of prophylactic cranial irradiation), then every 10 weeks year one, and every 3 months year two. Primary HRQoL endpoints were dysphagia and dyspnea. A difference in mean score of ≥10 was defined as clinically significant.
RESULTS
Maximum dysphagia was reported on week 8, with no significant difference between treatment arms (mean scores 45 Gy: 44.2, 60 Gy: 51.1). The 60 Gy arm had more dysphagia in the convalescence period, but dysphagia scores returned to baseline levels at week 16 in both arms. For dyspnea there were no significant changes, or differences between treatment arms, at any timepoint. There were no significant differences between treatment arms for any other HRQoL-scales.
CONCLUSION
TRT of 60 Gy did not cause significantly higher maximum dysphagia, though patients on the 60 Gy arm reported more dysphagia the first 8 weeks of convalescence. The higher dose was well tolerated and is an attractive alternative to current TRT schedules in LS SCLC. Trial reg Clinicaltrials.gov NCT0204184.
目的
在一项随机II期试验中，与45Gy/30次分割的放疗方案相比，局限期小细胞肺癌（LS SCLC）患者接受60Gy/40次分割的每日两次胸段放疗（TRT）可提高生存率。值得注意的是，更高剂量并未导致更多毒性反应。在此，我们展示了试验参与者在最初2年报告的健康相关生活质量（HRQoL）。
材料与方法
170例患者按1:1随机分为接受45Gy或60Gy的TRT并同时接受顺铂/依托泊苷化疗。本研究纳入了150例开始TRT并至少完成一份HRQoL问卷的患者。患者通过欧洲癌症研究与治疗组织核心30问卷和肺癌13生活质量问卷报告HRQoL。问卷在第0周、第4周（TRT前）、第8周（TRT结束时）、第12周（放化疗后反应评估）和第16周（预防性脑照射结束时）完成，然后在第一年每10周、第二年每3个月完成一次。HRQoL的主要终点是吞咽困难和呼吸困难。平均得分差异≥10被定义为具有临床意义。
结果
第8周报告的吞咽困难最为严重，各治疗组之间无显著差异（平均得分45Gy组：44.2，60Gy组：51.1）。60Gy组在恢复期吞咽困难情况更多，但两组在第16周时吞咽困难评分均恢复至基线水平。对于呼吸困难，在任何时间点均无显著变化，各治疗组之间也无差异。在任何其他HRQoL量表上，各治疗组之间均无显著差异。
结论
60Gy的TRT并未导致显著更高的最大吞咽困难，尽管60Gy组患者在恢复期的前8周报告有更多吞咽困难。更高剂量耐受性良好，是局限期小细胞肺癌当前TRT方案的一个有吸引力的替代方案。试验注册号Clinicaltrials.gov NCT0204184。
Zotero 插件