Department of Radiation Oncology, University of South Florida H. Lee Moffittt Cancer Center, Tampa, Florida.
RTOG Statistical Center, Philadelphia, Pennsylvania.
Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):958-963. doi: 10.1016/j.ijrobp.2014.04.041. Epub 2014 Jul 8.
To compare hyperfractionation versus standard fractionation for T2N0 vocal cord carcinoma in a randomized controlled trial.
Patients with T2 vocal cord cancer were stratified by substage (T2a vs T2b) and randomly assigned to receive either hyperfractionation (HFX) to 79.2 Gy in 66 fractions of 1.2 Gy given twice a day, or standard fractionation (SFX) to 70 Gy in 35 fractions given once a day. The trial was designed to detect a 55% reduction in the local failure hazard rate with 80% statistical power.
Between April 1996 and July 2003, a total of 250 patients were enrolled. Of 239 patients analyzable for outcomes, 94% were male, 83% had a Karnofsky performance status of 90-100, and 62% had T2a tumor. Median follow-up for all surviving patients was 7.9 years (range, 0.6-13.1 years). The 5-year local control (LC) rate was 8 points higher but not statistically significant (P=.14 for HFX [78%] vs SFX [70%]), corresponding to a 30% hazard rate reduction. The 5-year disease-free survival (DFS) was 49% versus 40% (P=.13) and overall survival (OS) was 72% versus 63% (P=.29). HFX was associated with higher rates of acute skin, mucosal, and laryngeal toxicity. Grade 3-4 late effects were similar with a 5-year cumulative incidence of 8.5% (3.4%-13.6%) after SFX and 8.5% (3.4%-13.5%) after HFX.
The 5-year local control was modestly higher with HFX compared to SFX for T2 glottic carcinoma, but the difference was not statistically significant. These results are consistent with prior studies of hyperfractionation showing a benefit in local control. Substaging by T2a versus T2b carries prognostic value for DFS and OS. For cost and convenience reasons other altered fractionation schedules have been adopted in routine practice.
在一项随机对照试验中比较 T2N0 声带癌的超分割与常规分割。
将 T2 声带癌患者按亚期（T2a 与 T2b）分层，随机分配接受超分割（HFX）至 79.2 Gy，66 次分割，1.2 Gy 两次/天，或常规分割（SFX）至 70 Gy，35 次分割，1 次/天。试验设计旨在以 80%的统计效力检测局部失败危险率降低 55%。
1996 年 4 月至 2003 年 7 月，共入组 250 例患者。239 例可评估结局的患者中，94%为男性，83% Karnofsky 表现状态为 90-100，62%为 T2a 肿瘤。所有存活患者的中位随访时间为 7.9 年（范围，0.6-13.1 年）。5 年局部控制（LC）率高 8 个百分点，但无统计学意义（HFX[78%]与 SFX[70%]，P=.14），对应危险率降低 30%。5 年无疾病生存率（DFS）为 49%比 40%（P=.13），总生存率（OS）为 72%比 63%（P=.29）。HFX 与较高的急性皮肤、黏膜和喉毒性相关。5 年累积发生率为 8.5%（3.4%-13.6%），SFX 与 HFX 后 5 年的 3-4 级迟发性效应相似。
与 SFX 相比，T2 声门型癌的 HFX 5 年局部控制率略高，但无统计学意义。这些结果与先前的超分割研究一致，表明局部控制有获益。按 T2a 与 T2b 亚期分层对 DFS 和 OS 有预后价值。出于成本和方便的原因，其他改变的分割方案已在常规实践中采用。
