Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium.
Centre Hospitalier Universitaire (CHU) de Martinique, Fort-de-France, France.
BMC Cancer. 2021 Nov 4;21(1):1177. doi: 10.1186/s12885-021-08916-z.
Long-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce. TomoBreast compared conventional radiotherapy (CR) with tomotherapy (TT), on the hypothesis that TT might reduce lung-heart toxicity.
Among 123 women consenting to participate, 64 were randomized to CR, 59 to TT. CR delivered 50 Gy in 25 fractions/5 weeks to breast/chest wall and regional nodes if node-positive, with a sequential boost (16 Gy/8 fractions/1.6 weeks) after lumpectomy. TT delivered 42 Gy/15 fractions/3 weeks to breast/chest wall and regional nodes if node-positive, 51 Gy simultaneous-integrated-boost in patients with lumpectomy. PRO were assessed using the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30. PRO scores were converted into a symptom-free scale, 100 indicating a fully symptom-free score, 0 indicating total loss of freedom from symptom. Changes of PRO over time were analyzed using the linear mixed-effect model. Survival analysis computed time to > 10% PRO-deterioration. A post-hoc cardiorespiratory outcome was defined as deterioration in any of dyspnea, fatigue, physical functioning, or pain.
At 10.4 years median follow-up, patients returned on average 9 questionnaires/patient, providing a total of 1139 PRO records. Item completeness was 96.6%. Missingness did not differ between the randomization arms. The PRO at baseline were below the nominal 100% symptom-free score, notably the mean fatigue-free score was 64.8% vs. 69.6%, pain-free was 75.4% vs. 75.3%, and dyspnea-free was 84.8% vs. 88.5%, in the TT vs. CR arm, respectively, although the differences were not significant. By mixed-effect modeling on early ≤2 years assessment, all three scores deteriorated, significantly for fatigue, P ≤ 0.01, without effect of randomization arm. By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035. By survival analysis of the time to PRO deterioration, TT improved 10-year survival free of cardiorespiratory deterioration from 66.9% with CR to 84.5% with TT, P = 0.029.
Modern radiation therapy can significantly improve long-term PRO.
Trial registration number ClinicalTrials.gov NCT00459628 , April 12, 2007 prospectively.
乳腺癌辅助放疗后长期前瞻性患者报告结局（PRO）数据较为缺乏。TomoBreast 研究旨在比较常规放疗（CR）和调强放疗（TT），假设 TT 可能降低肺-心毒性。
123 例患者同意参与，其中 64 例随机分配至 CR 组，59 例随机分配至 TT 组。CR 组采用 50Gy/25 次/5 周方案，用于乳房/胸壁和区域淋巴结，如果淋巴结阳性，则在乳房肿瘤切除术后给予序贯推量（16Gy/8 次/1.6 周）。TT 组采用 42Gy/15 次/3 周方案，用于乳房/胸壁和区域淋巴结，如果淋巴结阳性，则对乳房肿瘤切除术后患者行 51Gy 同步加量。PRO 使用欧洲癌症研究与治疗组织问卷 QLQ-C30 进行评估。PRO 评分转换为无症状量表，100 表示完全无症状，0 表示完全失去症状自由。采用线性混合效应模型分析 PRO 随时间的变化。生存分析计算 PRO 恶化>10%的时间。事后心肺结局定义为呼吸困难、疲劳、身体功能或疼痛恶化任何一项。
中位随访 10.4 年，患者平均每例返回 9 份问卷/患者，共提供 1139 份 PRO 记录。项目完整性为 96.6%。缺失率在随机分组之间无差异。基线 PRO 低于名义上的 100%无症状评分，尤其是平均无疲劳评分分别为 TT 组 64.8%比 CR 组 69.6%，无疼痛评分分别为 TT 组 75.4%比 CR 组 75.3%，无呼吸困难评分分别为 TT 组 84.8%比 CR 组 88.5%，尽管差异无统计学意义。通过早期≤2 年评估的混合效应模型，所有三项评分均恶化，疲劳评分显著恶化，P≤0.01，与随机分组无关。通过 2 年以上晚期评估的模型，TT 与 CR 与疲劳无变化或疼痛无变化评分无显著关联，但与呼吸困难无恶化显著改善 8.9%相关，P=0.035。通过 PRO 恶化时间的生存分析，TT 将 CR 组 10 年无心肺恶化的生存率从 66.9%提高到 TT 组的 84.5%，P=0.029。
现代放疗可显著改善长期 PRO。
ClinicalTrials.gov 注册号 NCT00459628，2007 年 4 月 12 日前瞻性注册。
