Eaton Bree R, Pugh Stephanie L, Bradley Jeffrey D, Masters Greg, Kavadi Vivek S, Narayan Samir, Nedzi Lucien, Robinson Cliff, Wynn Raymond B, Koprowski Christopher, Johnson Douglas W, Meng Joanne, Curran Walter J
Winship Cancer Institute of Emory University, Atlanta, GA (BRE, WJCJr); NRG Oncology Statistics and Data Management Center, Philadelphia, PA (SLP); Washington University School of Medicine, St. Louis, MO (JDB, CR); Christiana Care/Helen Graham Medical Center, Newark, DE (GM); USON-Texas Oncology, Sugarland, TX (VSK); Michigan Cancer Research Consortium, Ann Arbor, MI (SN); University of Texas Southwestern Medical School, Dallas, TX (LN); University of Pittsburgh Medical Center, Pittsburgh, PA (RBW); Christiana Care Health System, Wilmington, DE (CK); Florida Radiation Oncology Group, Jacksonville, FL (DWJ); The Ottawa Hospital, Ottawa, ON, Canada (JM)
Winship Cancer Institute of Emory University, Atlanta, GA (BRE, WJCJr); NRG Oncology Statistics and Data Management Center, Philadelphia, PA (SLP); Washington University School of Medicine, St. Louis, MO (JDB, CR); Christiana Care/Helen Graham Medical Center, Newark, DE (GM); USON-Texas Oncology, Sugarland, TX (VSK); Michigan Cancer Research Consortium, Ann Arbor, MI (SN); University of Texas Southwestern Medical School, Dallas, TX (LN); University of Pittsburgh Medical Center, Pittsburgh, PA (RBW); Christiana Care Health System, Wilmington, DE (CK); Florida Radiation Oncology Group, Jacksonville, FL (DWJ); The Ottawa Hospital, Ottawa, ON, Canada (JM).
J Natl Cancer Inst. 2016 May 19;108(9). doi: 10.1093/jnci/djw034. Print 2016 Sep.
The purpose of this analysis is to evaluate the effect of institutional accrual volume on clinical outcomes among patients receiving chemoradiation for locally advanced non-small cell lung cancer (LA-NSCLC) on a phase III trial.
Patients with LA-NSCLC were randomly assigned to 60 Gy or 74 Gy radiotherapy (RT) with concurrent carboplatin/paclitaxel +/- cetuximab on NRG Oncology RTOG 0617. Participating institutions were categorized as low-volume centers (LVCs) or high-volume centers (HVCs) according to the number of patients accrued (≤3 vs > 3). All statistical tests were two-sided.
Range of accrual for LVCs (n = 195) vs HVCs (n = 300) was 1 to 3 vs 4 to 18 patients. Baseline characteristics were similar between the two cohorts. Treatment at a HVC was associated with statistically significantly longer overall survival (OS) and progression-free survival (PFS) compared with treatment at a LVC (median OS = 26.2 vs 19.8 months; HR = 0.70, 95% CI = 0.56 to 0.88, P = .002; median PFS: 11.4 vs 9.7 months, HR = 0.80, 95% CI = 0.65-0.99, P = .04). Patients treated at HVCs were more often treated with intensity-modulated RT (54.0% vs 39.5%, P = .002), had a lower esophageal dose (mean = 26.1 vs 28.0 Gy, P = .03), and had a lower heart dose (median = V5 Gy 38.2% vs 54.1%, P = .006; V50 Gy 3.6% vs 7.3%, P < .001). Grade 5 adverse events (AEs) (5.3% vs 9.2%, P = .09) and RT termination because of AEs (1.3% vs 4.1%, P = .07) were less common among patients treated at HVCs. HVC remained independently associated with longer OS (P = .03) when accounting for other factors.
Treatment at institutions with higher clinical trial accrual volume is associated with longer OS among patients with LA-NSCLC participating in a phase III trial.
本分析旨在评估在一项III期试验中,机构入组患者数量对局部晚期非小细胞肺癌(LA-NSCLC)接受放化疗患者临床结局的影响。
在NRG肿瘤学RTOG 0617试验中,LA-NSCLC患者被随机分配接受60 Gy或74 Gy放疗(RT),同时联合卡铂/紫杉醇+/-西妥昔单抗。参与的机构根据入组患者数量(≤3例与>3例)分为低入组量中心(LVCs)或高入组量中心(HVCs)。所有统计检验均为双侧检验。
LVCs(n = 195)与HVCs(n = 300)的入组范围分别为1至3例患者与4至18例患者。两个队列的基线特征相似。与在LVC接受治疗相比,在HVC接受治疗与总体生存期(OS)和无进展生存期(PFS)在统计学上显著更长相关(中位OS = 26.2个月对19.8个月;风险比[HR]=0.70,95%置信区间[CI]=0.56至0.88,P = 0.002;中位PFS:11.4个月对9.7个月,HR = 0.80,95%CI = 0.65 - 0.99,P = 0.04)。在HVC接受治疗的患者更常接受调强放疗(54.0%对39.5%,P = 0.002),食管剂量更低(平均值 = 26.1 Gy对28.0 Gy,P = 0.03),心脏剂量更低(中位值 = V5 Gy为38.2%对54.1%,P = 0.006;V50 Gy为3.6%对7.3%,P < 0.001)。5级不良事件(AEs)(5.3%对9.2%,P = 0.09)和因AEs导致的放疗终止(1.3%对4.1%,P = 0.07)在HVC接受治疗的患者中较少见。在考虑其他因素时,HVC仍然与更长的OS独立相关(P = 0.03)。
在III期试验中,对于参与试验的LA-NSCLC患者,在临床试验入组量较高的机构接受治疗与更长的OS相关。