Bossé Dominick, Mercer Jamison, Raissouni Soundouss, Dennis Kristopher, Goodwin Rachel, Jiang Di, Powell Erin, Kumar Aalok, Lee-Ying Richard, Price-Hiller Julie, Heng Daniel Y C, Tang Patricia A, MacLean Anthony, Cheung Winson Y, Vickers Michael M
The Ottawa Hospital Cancer Center, Ottawa, ON, Canada.
Dr H. Bliss Murphy Cancer Centre, St John's, NL, Canada.
Clin Colorectal Cancer. 2016 Sep;15(3):243-9. doi: 10.1016/j.clcc.2016.02.003. Epub 2016 Feb 13.
The PROSPECT trial (N1048) is evaluating the selective use of chemoradiation in patients with cT2N1 and cT3N0-1 rectal cancer undergoing sphincter-sparing low anterior resection. We evaluated outcomes of PROSPECT-eligible and -ineligible patients from a multi-institutional database.
Data from patients with locally advanced rectal cancer who received chemoradiation and low anterior resection from 2005 to 2014 were retrospectively collected from 5 Canadian centers. Overall survival, disease-free survival (DFS), recurrence-free survival (RFS), and time to local recurrence (LR) were estimated using the Kaplan-Meier method, and a multivariate analysis was performed adjusting for prognostic factors.
A total of 566 (37%) of 1531 patients met the PROSPECT eligibility criteria. Eligible patients were more likely to have better PS (P = .0003) and negative circumferential resection margin (P < .0001). PROSPECT eligibility was associated with improved DFS (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.61-0.91), overall survival (HR, 0.73; 95% CI, 0.57-0.95), and RFS (HR, 0.68; 95% CI, 0.54-0.86) in univariate analyses. In multivariate analysis, only RFS remained significantly improved for PROSPECT-eligible patients (HR, 0.75; 95% CI, 0.57-1.00, P = .0499). The 3-year DFS and freedom from LR for PROSPECT-eligible patients were 79.1% and 97.4%, respectively, compared to 71.1% and 96.8% for PROSPECT-ineligible patients.
Real-world data corroborate the eligibility criteria used in the PROSPECT study; the criteria identify a subgroup of patients in whom risk of recurrence is lower and in whom selective use of chemoradiation should be actively examined.
PROSPECT试验（N1048）正在评估在接受保留括约肌的低位前切除术的cT2N1和cT3N0 - 1期直肠癌患者中选择性使用放化疗的效果。我们从一个多机构数据库评估了符合和不符合PROSPECT标准的患者的结局。
回顾性收集了2005年至2014年期间在5个加拿大中心接受放化疗和低位前切除术的局部晚期直肠癌患者的数据。采用Kaplan - Meier方法估计总生存期、无病生存期（DFS）、无复发生存期（RFS）和局部复发时间（LR），并针对预后因素进行多变量分析。
1531例患者中有566例（37%）符合PROSPECT纳入标准。符合标准的患者更可能具有较好的体能状态（P = 0.0003）和阴性环周切缘（P < 0.0001）。在单变量分析中，PROSPECT纳入标准与改善DFS（风险比[HR]，0.75；95%置信区间[CI]，0.61 - 0.91）、总生存期（HR，0.73；95% CI, 0.57 - 0.95）和RFS（HR，0.68；95% CI，0.54 - 0.86）相关。在多变量分析中，仅符合PROSPECT标准的患者的RFS仍有显著改善（HR, 0.75；95% CI, 0.57 - 1.00，P = 0.0499）。符合PROSPECT标准的患者的3年DFS和无LR率分别为79.1%和97.4%，而不符合PROSPECT标准的患者分别为71.1%和96.8%。
真实世界数据证实了PROSPECT研究中使用的纳入标准；这些标准识别出了一组复发风险较低的患者亚组，对于该亚组患者应积极研究选择性使用放化疗的情况。
