Hammad Nazik, Heilbrun Lance K, Philip Philip A, Shields Anthony F, Zalupski Mark M, Venkatramanamoorthy Raghu, El-Rayes Bassel F
Division of Hematology and Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.
Asia Pac J Clin Oncol. 2010 Jun;6(2):98-105. doi: 10.1111/j.1743-7563.2010.01290.x.
The aim of this study was to determine the predictive role of pretreatment carbohydrate antigen 19-9 (CA19-9) measurement and its change after one cycle of gemcitabine-based therapy for response, time to progression (TTP) and overall survival (OS).
Analyses were derived from three consecutive gemcitabine-containing phase II clinical trials between 1997 and 2004.
A total of 111 patients with pancreas cancer was studied. Baseline CA19-9 concentrations were dichotomized near the median. Lower baseline CA19-9 levels were positively associated with OS (median 9.1 vs 6.1 months, P = 0.0057) and TTP (median 6.4 vs 4.2 months, P = 0.0044).The covariate adjusted hazard ratio (HR) for progression among patients with baseline CA19-9 >or= 1000 ng/mL was HR = 1.94 (95% CI 1.24-3.02), with P = 0.0035. The covariate adjusted risk of death among patients with baseline CA19-9 >or= 1000 ng/ml was similarly elevated: HR = 1.90 (95% CI 1.23-2.94), with P = 0.0039. Change in CA19-9 levels from baseline to the end of treatment cycle 1 did not predict objective response (P = 0.75). There was somewhat longer OS (median 8.7 vs 7.1 months) and TTP (median 7.1 vs 5.4 months) in patients with >or=50% reduction in serum CA19-9 concentrations, but this was not statistically significant (P = 0.74 and 0.81, respectively).
Baseline CA19-9 levels may predict survival in patients with advanced pancreas cancer. The change in CA19-9 levels determined within 1 month of the initiation of therapy did not predict treatment outcome.
本研究旨在确定治疗前糖类抗原19-9(CA19-9)检测及其在以吉西他滨为基础的一个治疗周期后的变化对疗效、疾病进展时间(TTP)和总生存期(OS)的预测作用。
分析来源于1997年至2004年间连续进行的三项含吉西他滨的II期临床试验。
共研究了111例胰腺癌患者。基线CA19-9浓度在中位数附近进行二分法划分。较低的基线CA19-9水平与OS(中位数9.1个月对6.1个月,P = 0.0057)和TTP(中位数6.4个月对4.2个月,P = 0.0044)呈正相关。基线CA19-9≥1000 ng/mL患者进展的协变量调整风险比(HR)为HR = 1.94(95%CI 1.24 - 3.02),P = 0.0035。基线CA19-9≥1000 ng/ml患者的协变量调整死亡风险同样升高:HR = 1.90(95%CI 1.23 - 2.94),P = 0.0039。从基线到治疗周期1结束时CA19-9水平的变化不能预测客观缓解(P = 0.75)。血清CA19-9浓度降低≥50%的患者OS(中位数8.7个月对7.1个月)和TTP(中位数7.1个月对5.4个月)略长,但无统计学意义(分别为P = 0.74和0.81)。
基线CA19-9水平可预测晚期胰腺癌患者的生存情况。治疗开始1个月内测定的CA19-9水平变化不能预测治疗结果。