在一项转移性胰腺癌患者的随机III期试验（MPACT）中，比较每周纳米白蛋白结合型紫杉醇加吉西他滨与单纯吉西他滨治疗，8周时CA19-9水平下降作为总生存期的预测指标。
CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer.
作者信息
Chiorean E G, Von Hoff D D, Reni M, Arena F P, Infante J R, Bathini V G, Wood T E, Mainwaring P N, Muldoon R T, Clingan P R, Kunzmann V, Ramanathan R K, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A
机构信息
Department of Medicine/Oncology, University of Washington, Fred Hutchinson Cancer Research Center, Seattle
HonorHealth and The Translational Genomics Research Institute (TGen), Scottsdale, USA.
出版信息
Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.
BACKGROUND
A phase I/II study and subsequent phase III study (MPACT) reported significant correlations between CA19-9 decreases and prolonged overall survival (OS) with nab-paclitaxel plus gemcitabine (nab-P + Gem) treatment for metastatic pancreatic cancer (MPC). CA19-9 changes at week 8 and potential associations with efficacy were investigated as part of an exploratory analysis in the MPACT trial.
PATIENTS AND METHODS
Untreated patients with MPC (N = 861) received nab-P + Gem or Gem alone. CA19-9 was evaluated at baseline and every 8 weeks.
RESULTS
Patients with baseline and week-8 CA19-9 measurements were analyzed (nab-P + Gem: 252; Gem: 202). In an analysis pooling the treatments, patients with any CA19-9 decline (80%) versus those without (20%) had improved OS (median 11.1 versus 8.0 months; P = 0.005). In the nab-P + Gem arm, patients with (n = 206) versus without (n = 46) any CA19-9 decrease at week 8 had a confirmed overall response rate (ORR) of 40% versus 13%, and a median OS of 13.2 versus 8.3 months (P = 0.001), respectively. In the Gem-alone arm, patients with (n = 159) versus without (n = 43) CA19-9 decrease at week 8 had a confirmed ORR of 15% versus 5%, and a median OS of 9.4 versus 7.1 months (P = 0.404), respectively. In the nab-P + Gem and Gem-alone arms, by week 8, 16% (40/252) and 6% (13/202) of patients, respectively, had an unconfirmed radiologic response (median OS 13.7 and 14.7 months, respectively), and 79% and 84% of patients, respectively, had stable disease (SD) (median OS 11.1 and 9 months, respectively). Patients with SD and any CA19-9 decrease (158/199 and 133/170) had a median OS of 13.2 and 9.4 months, respectively.
CONCLUSION
This analysis demonstrated that, in patients with MPC, any CA19-9 decrease at week 8 can be an early marker for chemotherapy efficacy, including in those patients with SD. CA19-9 decrease identified more patients with survival benefit than radiologic response by week 8.
背景
一项I/II期研究及随后的III期研究（MPACT）报告称，对于转移性胰腺癌（MPC），使用纳米白蛋白结合型紫杉醇联合吉西他滨（nab-P+Gem）治疗时，CA19-9降低与总生存期（OS）延长之间存在显著相关性。作为MPACT试验探索性分析的一部分，研究了第8周时CA19-9的变化及其与疗效的潜在关联。
患者与方法
未经治疗的MPC患者（N=861）接受nab-P+Gem或单纯吉西他滨治疗。在基线期及每8周评估CA19-9。
结果
对有基线期和第8周CA19-9测量值的患者进行分析（nab-P+Gem组：252例；吉西他滨组：202例）。在一项汇总治疗组的分析中，CA19-9有任何下降的患者（80%）与无下降的患者（20%）相比，OS有所改善（中位生存期分别为11.1个月和8.0个月；P=0.005）。在nab-P+Gem组，第8周时CA19-9有下降（n=206）与无下降（n=46）的患者，确认的总缓解率（ORR）分别为40%和13%，中位OS分别为13.2个月和8.3个月（P=0.001）。在单纯吉西他滨组，第8周时CA19-9有下降（n=159）与无下降（n=43）的患者，确认的ORR分别为15%和5%，中位OS分别为9.4个月和7.1个月（P=0.404）。在nab-P+Gem组和单纯吉西他滨组中，到第8周时，分别有16%（40/252）和6%（13/202）的患者有未经确认的影像学缓解（中位OS分别为13.7个月和14.7个月），分别有79%和84%的患者疾病稳定（SD）（中位OS分别为11.1个月和9个月）。疾病稳定且CA19-9有任何下降的患者（158/199和133/170），中位OS分别为13.2个月和9.4个月。
结论
该分析表明，在MPC患者中，第8周时CA19-9的任何下降都可能是化疗疗效的早期标志物，包括疾病稳定的患者。与第8周时的影像学缓解相比，CA19-9下降识别出更多有生存获益的患者。
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