Jain Suneil, Poon Ian, Soliman Hany, Keller Brian, Kim Anthony, Lochray Fiona, Yeung Latifa, Cheung Patrick
Centre for Cancer Research and Cell Biology, Queens University Belfast, United Kingdom.
Radiother Oncol. 2013 Aug;108(2):320-5. doi: 10.1016/j.radonc.2013.06.045. Epub 2013 Aug 27.
The optimal duration over which lung SBRT should be delivered is unknown. We conducted a randomized pilot study in patients treated with four fractions of lung SBRT delivered over 4 or over 11 days.
Patients with a peripheral solitary lung tumor (NSCLC or pulmonary metastasis) ≤ 5 cm were eligible. For NSCLC lung tumors ≤ 3 cm, a dose of 48 Gy in 4 fractions was used, otherwise 52 Gy in 4 fractions was delivered. Patients were randomized to receive treatment over 4 consecutive days or over 11 days. The primary end-point was acute grade ≥ 2 toxicity. Secondary end-points included quality of life (QOL) assessed using the EORTC QLQ-C30 and QLQ-LC13 questionnaires.
Fifty four patients were enrolled. More patients in the 11 day group had respiratory symptoms at baseline. 55.6% patients treated over 4 days and 33.3% of patients treated over 11 days experienced acute grade ≥ 2 toxicity (p=0.085). Dyspnea, fatigue and coughing domains were worse in the 11 day group at baseline. At 1 and 4 months, more patients in the 4 day group experienced a clinically meaningful worsening in the dyspnea QOL domain compared to the 11 day group (44.5% vs 15.4%, p=0.02; 38.5% vs 12.0%, p=0.03, respectively). However, raw QOL scores were not different at these time-points between treatment groups.
Grade 2 or higher acute toxicity was more common in the 4 day group, approaching statistical significance. More patients treated on 4 consecutive days reported a clinically meaningful increase in dyspnea, although interpretation of these results is challenging due to baseline imbalance between treatment groups. Larger studies are required to validate these results.
肺部立体定向放疗(SBRT)的最佳疗程尚不清楚。我们对接受4次肺部SBRT治疗且疗程为4天或11天的患者进行了一项随机试验研究。
纳入外周孤立性肺肿瘤(非小细胞肺癌或肺转移瘤)≤5 cm的患者。对于直径≤3 cm的非小细胞肺癌肺肿瘤,采用48 Gy分4次照射,否则采用52 Gy分4次照射。患者被随机分为连续4天或11天接受治疗。主要终点是急性2级及以上毒性反应。次要终点包括使用欧洲癌症研究与治疗组织(EORTC)QLQ-C30和QLQ-LC13问卷评估的生活质量(QOL)。
共纳入54例患者。11天治疗组更多患者在基线时出现呼吸道症状。4天治疗组55.6%的患者和11天治疗组33.3%的患者出现急性2级及以上毒性反应(p = 0.085)。基线时,11天治疗组的呼吸困难、疲劳和咳嗽领域情况更差。在1个月和4个月时,与11天治疗组相比,4天治疗组更多患者在呼吸困难QOL领域出现具有临床意义的恶化(分别为44.5%对15.4%,p = 0.02;38.5%对12.0%,p = 0.03)。然而,治疗组间在这些时间点的原始QOL评分并无差异。
2级及以上急性毒性反应在4天治疗组更常见,接近统计学意义。更多连续4天接受治疗的患者报告呼吸困难有具有临床意义的增加,尽管由于治疗组间基线不平衡,这些结果的解读具有挑战性。需要更大规模的研究来验证这些结果。