Hammel Pascal, Carrier Ewa, Carney Mairead, Eisner Mark, Fleming Thomas
Digestive and Medical Oncology Department, Hospital Paul Brousse, University Paris-Saclay, 94800 Villejuif, France.
Department of Clinical Development, FibroGen, Inc., San Francisco, CA, USA.
Ther Adv Med Oncol. 2021 Nov 29;13:17588359211059586. doi: 10.1177/17588359211059586. eCollection 2021.
The treatment paradigm for locally advanced pancreatic cancer (LAPC) is evolving rapidly. The development of neoadjuvant therapies composed of combination therapies and the evaluation of their impact on conversion to borderline resectable (BR) status, resection, and ultimately overall survival (OS) are presently being pursued. These efforts justify re-visiting study endpoints in order to better predict therapeutic effects on OS, by capturing not only the achievement of R0 resection at the end of induction therapy but also the long-term reductions in the rate of local and distal recurrence. The proposed herein event-free survival (EFS) endpoint, with its novel definition specific to LAPC, is formulated to achieve these objectives. It is an analog to disease-free survival (DFS) endpoint in the adjuvant setting applied to the neoadjuvant setting and may be a valuable surrogate endpoint for this patient population.
局部晚期胰腺癌（LAPC）的治疗模式正在迅速演变。目前正在探索由联合疗法组成的新辅助疗法的发展及其对转化为可切除边缘（BR）状态、切除以及最终总生存期（OS）的影响评估。这些努力证明有必要重新审视研究终点，以便通过不仅捕捉诱导治疗结束时R0切除的实现情况，还捕捉局部和远处复发率的长期降低情况，来更好地预测对总生存期的治疗效果。本文提出的无事件生存期（EFS）终点，具有针对LAPC的新颖定义，旨在实现这些目标。它类似于辅助治疗环境中应用于新辅助治疗环境的无病生存期（DFS）终点，可能是该患者群体的一个有价值的替代终点。
