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新辅助治疗与辅助治疗对可切除胰腺腺癌的疗效:一项决策分析

Efficacy of Neoadjuvant Versus Adjuvant Therapy for Resectable Pancreatic Adenocarcinoma: A Decision Analysis.

作者信息

Sharma Gaurav, Whang Edward E, Ruan Daniel T, Ito Hiromichi

机构信息

Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

Department of Surgery, VA Boston Healthcare System, West Roxbury, MA, USA.

出版信息

Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1229-37. doi: 10.1245/s10434-015-4711-0. Epub 2015 Jul 8.

Abstract

BACKGROUND

Neoadjuvant therapy-based protocols for potentially resectable pancreatic adenocarcinoma (PAC) have not been directly compared with adjuvant protocols in large prospective randomized trials. This study aimed to compare the efficacy of neoadjuvant versus adjuvant therapy-based management by using a formal decision analytic model.

METHODS

A decision analytic model was created with a Markov process to compare neoadjuvant and adjuvant chemo- and/or chemoradiation therapy-based strategies for simulated cohorts of patients with potentially resectable PAC. Base-case probabilities were derived from the published data of 21 prospective phases 2 and 3 trials (3708 patients) between 1997 and 2014. The primary outcome measures determined in an intent-to-treat fashion were overall and quality-adjusted survival rates. One- and two-way sensitivity analyses were performed to assess the effects of model uncertainty on outcomes.

RESULTS

The median overall survival and 2-year survival rates for the patients in the standard adjuvant therapy arm of the study were 20 months and 42.2 % versus 22 months and 46.8 % for those in the neoadjuvant strategy arm. Quality-adjusted survival was 18.4 and 19.8 months, respectively. Sensitivity analysis demonstrated that when recurrence-free survival after completion of neoadjuvant therapy and resection is less than 13.9 months or when the rate for progression of disease precluding resection during neoadjuvant therapy is greater than 44 %, the neoadjuvant strategy is no longer the favored option.

CONCLUSIONS

The decision analytic model suggests that neoadjuvant therapy-based management improves the outcomes for patients with potentially resectable pancreatic cancer. However, the benefits in terms of overall and quality-adjusted survival are modest.

摘要

背景

在大型前瞻性随机试验中,基于新辅助治疗的方案与可切除胰腺癌(PAC)的辅助治疗方案尚未进行直接比较。本研究旨在通过使用正式的决策分析模型比较新辅助治疗与辅助治疗的疗效。

方法

采用马尔可夫过程创建决策分析模型,比较基于新辅助和辅助化疗及/或放化疗的策略对模拟的可切除PAC患者队列的疗效。基础概率来自1997年至2014年间21项前瞻性2期和3期试验(3708例患者)的已发表数据。以意向性治疗方式确定的主要结局指标为总生存率和质量调整生存率。进行单因素和双因素敏感性分析,以评估模型不确定性对结局的影响。

结果

该研究标准辅助治疗组患者的中位总生存期和2年生存率分别为20个月和42.2%,而新辅助策略组为22个月和46.8%。质量调整生存期分别为18.4个月和19.8个月。敏感性分析表明,当新辅助治疗和切除术后无复发生存期小于13.9个月或新辅助治疗期间疾病进展导致无法切除的发生率大于44%时,新辅助策略不再是首选方案。

结论

决策分析模型表明,基于新辅助治疗的管理可改善可切除胰腺癌患者的结局。然而,在总生存期和质量调整生存期方面的益处不大。

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