Ⅰ期和Ⅱ期乳腺癌短程放疗同步加量治疗，一项随机临床试验的早期毒性反应。
Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial.
机构信息
Department of Radiotherapy, UZ Brussel, Brussels, Belgium.
出版信息
Radiat Oncol. 2012 Jun 1;7:80. doi: 10.1186/1748-717X-7-80.
BACKGROUND
TomoBreast is a unicenter, non-blinded randomized trial comparing conventional radiotherapy (CR) vs. hypofractionated Tomotherapy (TT) for post-operative treatment of breast cancer. The purpose of the trial is to compare whether TT can reduce heart and pulmonary toxicity. We evaluate early toxicities.
METHODS
The trial started inclusion in May 2007 and reached its recruitment in August 2011. Women with stage T1-3N0M0 or T1-2N1M0 breast cancer completely resected by tumorectomy (BCS) or by mastectomy (MA) who consented to participate were randomized, according to a prescribed computer-generated randomization schedule, between control arm of CR 25x2 Gy/5 weeks by tangential fields on breast/chest wall, plus supraclavicular-axillary field if node-positive, and sequential boost 8x2 Gy/2 weeks if BCS (cumulative dose 66 Gy/7 weeks), versus experimental TT arm of 15x2.8 Gy/3 weeks, including nodal areas if node-positive and simultaneous integrated boost of 0.6 Gy if BCS (cumulative dose 51 Gy/3 weeks). Outcomes evaluated were the pulmonary and heart function. Comparison of proportions used one-sided Fisher's exact test.
RESULTS
By May 2010, 70 patients were randomized and had more than 1 year of follow-up. Out of 69 evaluable cases, 32 were assigned to CR (21 BCS, 11 MA), 37 to TT (20 BCS, 17 MA). Skin toxicity of grade ≥1 at 2 years was 60% in CR, vs. 30% in TT arm. Heart function showed no significant difference for left ventricular ejection fraction at 2 years, CR 4.8% vs. TT 4.6%. Pulmonary function tests at 2 years showed grade ≥1 decline of FEV1 in 21% of CR, vs. 15% of TT and decline of DLco in 29% of CR, vs. 7% of TT (P = 0.05).
CONCLUSIONS
There were no unexpected severe toxicities. Short course radiotherapy of the breast with simultaneous integrated boost over 3 weeks proved feasible without excess toxicities. Pulmonary tests showed a slight trend in favor of Tomotherapy, which will need confirmation with longer follow-up of patients.
TRIAL REGISTRATION
[corrected] ClinicalTrials.gov NCT00459628.
背景
TomoBreast 是一项单中心、非盲的随机试验，比较了常规放疗（CR）与适形调强放疗（TT）在乳腺癌术后治疗中的疗效。该试验的目的是比较 TT 是否能降低心脏和肺部毒性。我们评估早期毒性。
方法
该试验于 2007 年 5 月开始纳入患者，并于 2011 年 8 月完成招募。接受肿瘤切除术（BCS）或乳房切除术（MA）完全切除 T1-3N0M0 或 T1-2N1M0 期乳腺癌的女性，如果同意参加，根据规定的计算机生成的随机分组方案，随机分配至对照组（CR），采用切线野照射乳房/胸壁，25x2 Gy/5 周，淋巴结阳性者加锁骨下-腋窝野，如果 BCS 则序贯加量 8x2 Gy/2 周（累积剂量 66 Gy/7 周），或实验组（TT），采用 15x2.8 Gy/3 周，包括淋巴结阳性者和同时加量 0.6 Gy，如果 BCS（累积剂量 51 Gy/3 周）。评估的结局是肺和心脏功能。采用单侧 Fisher 精确检验比较比例。
结果
截至 2010 年 5 月，70 例患者被随机分组并随访超过 1 年。在 69 例可评估病例中，32 例分配至 CR（21 例 BCS，11 例 MA），37 例分配至 TT（20 例 BCS，17 例 MA）。2 年时皮肤毒性≥1 级的发生率为 CR 组 60%，TT 组 30%。2 年时左心室射血分数无显著差异，CR 组 4.8%，TT 组 4.6%。2 年时肺功能检查显示，CR 组有 21%的患者出现 FEV1 分级≥1 下降，TT 组为 15%，CR 组有 29%的患者出现 DLco 下降，TT 组为 7%（P=0.05）。
结论
无意外严重毒性。3 周内采用同步整合加量的短程乳腺癌放疗是可行的，没有过度毒性。肺功能检查显示 Tomotherapy 有轻微优势，需要更长时间的随访来证实。
试验注册
[修正]ClinicalTrials.gov NCT00459628。
Zotero 插件