机构临床试验入组数量与头颈部癌症患者的生存情况。
Institutional clinical trial accrual volume and survival of patients with head and neck cancer.
机构信息
Evan J. Wuthrick and Maura L. Gillison, Ohio State University Medical Center, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Qiang Zhang, Jonathan Harris, and Qian Wu, Radiation Therapy Oncology Group Statistical Center; Eric M. Horwitz, Fox Chase Cancer Center, Philadelphia, PA; David I. Rosenthal, University of Texas MD Anderson Cancer Center, Houston, TX; Phuc Felix Nguyen-Tan, Centre Hospitalier de l'Université de Montréal-Notre Dame, Montreal; André Fortin, Hôtel-Dieu de Quebec, Quebec City, Quebec; Nancy E. Read, Western University, London Regional Cancer Center, London, Ontario, Canada; Craig L. Silverman, James Graham Brown Cancer Center, University of Louisville, Louisville, KY; Adam Raben, Christiana Care Helen F. Graham Cancer Center, Newark, DE; Harold E. Kim, Wayne State University, Detroit, MI; and Quynh-Thu Le, Stanford University, Palo Alto, CA.
出版信息
J Clin Oncol. 2015 Jan 10;33(2):156-64. doi: 10.1200/JCO.2014.56.5218. Epub 2014 Dec 8.
PURPOSE
National Comprehensive Cancer Network guidelines recommend patients with head and neck cancer (HNC) receive treatment at centers with expertise, but whether provider experience affects survival is unknown.
PATIENTS AND METHODS
The effect of institutional experience on overall survival (OS) in patients with stage III or IV HNC was investigated within a randomized trial of the Radiation Therapy Oncology Group (RTOG 0129), which compared cisplatin concurrent with standard versus accelerated fractionation radiotherapy. As a surrogate for experience, institutions were classified as historically low- (HLACs) or high-accruing centers (HHACs) based on accrual to 21 RTOG HNC trials (1997 to 2002). The effect of accrual volume on OS was estimated by Cox proportional hazards models.
RESULTS
Median RTOG accrual (1997 to 2002) at HLACs was four versus 65 patients at HHACs. Analysis included 471 patients in RTOG 0129 (2002 to 2005) with known human papillomavirus and smoking status. Patients at HLACs versus HHACs had better performance status (0: 62% v 52%; P = .04) and lower T stage (T4: 26.5% v 35.3%; P = .002) but were otherwise similar. Radiotherapy protocol deviations were higher at HLACs versus HHACs (18% v 6%; P < .001). When compared with HHACs, patients at HLACs had worse OS (5 years: 51.0% v 69.1%; P = .002). Treatment at HLACs was associated with increased death risk of 91% (hazard ratio [HR], 1.91; 95% CI, 1.37 to 2.65) after adjustment for prognostic factors and 72% (HR, 1.72; 95% CI, 1.23 to 2.40) after radiotherapy compliance adjustment.
CONCLUSION
OS is worse for patients with HNC treated at HLACs versus HHACs to cooperative group trials after accounting for radiotherapy protocol deviations. Institutional experience substantially influences survival in locally advanced HNC.
目的
美国国家综合癌症网络指南建议头颈部癌症（HNC）患者在具有专业知识的中心接受治疗，但提供者的经验是否会影响生存尚不清楚。
方法
在放射治疗肿瘤学组（RTOG）的一项随机试验中，研究了机构经验对 III 或 IV 期 HNC 患者总生存（OS）的影响，该试验比较了顺铂联合标准与加速分割放疗。作为经验的替代指标，根据 21 项 RTOG HNC 试验（1997 年至 2002 年）的入组情况，将机构分为历史上低入组（HLACs）或高入组中心（HHACs）。通过 Cox 比例风险模型估计入组量对 OS 的影响。
结果
HLACs 的中位 RTOG 入组量（1997 年至 2002 年）为 4 例，而 HHACs 为 65 例。分析包括 RTOG 0129 中的 471 例已知人乳头瘤病毒和吸烟状况的患者（2002 年至 2005 年）。与 HHACs 相比，HLACs 患者的表现状态更好（0：62%比 52%；P=0.04），T 分期更低（T4：26.5%比 35.3%；P=0.002），但其他方面相似。HLACs 与 HHACs 相比，放疗方案偏差更高（18%比 6%；P<0.001）。与 HHACs 相比，HLACs 患者的 OS 更差（5 年：51.0%比 69.1%；P=0.002）。在调整预后因素和放疗依从性调整后，HLACs 治疗与死亡风险增加 91%（风险比[HR]，1.91；95%CI，1.37 至 2.65）和 72%（HR，1.72；95%CI，1.23 至 2.40）相关。
结论
在考虑放疗方案偏差后，与 HHACs 相比，HLACs 治疗的 HNC 患者的 OS 较差。机构经验对局部晚期 HNC 的生存有很大影响。
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