Sugiyama K, Gordon A, Popat S, Okines A, Larkin J, Chau I
Gastrointestinal Unit, Department of Medicine, Royal Marsden Hospital, London and Surrey, UK; Department of Medical Oncology, NHO Nagoya Medical Center, Nagoya, Aichi, Japan.
Gastrointestinal Unit, Department of Medicine, Royal Marsden Hospital, London and Surrey, UK.
ESMO Open. 2025 Feb;10(2):104122. doi: 10.1016/j.esmoop.2024.104122. Epub 2025 Jan 27.
Pathological response (PR) is an oncological outcome measure that indicates the therapeutic response to neoadjuvant therapy. In clinical trials involving neoadjuvant or perioperative interventions, overall survival and disease/event-free survival are typically the primary outcome measures. Although some evidence suggests that pathological complete response (pCR) can serve as a surrogate marker for the primary endpoint in prospective trials, it remains uncertain whether pCR is a true surrogate marker for patients with cancer undergoing curative resection across all solid tumours. Here, we review the role of PR as a surrogate marker and its associated methodological issues in the era of perioperative immune checkpoint inhibitors.
病理反应（PR）是一种肿瘤学结局指标，用于指示对新辅助治疗的治疗反应。在涉及新辅助或围手术期干预的临床试验中，总生存期和无疾病/无事件生存期通常是主要结局指标。尽管一些证据表明病理完全缓解（pCR）可作为前瞻性试验中主要终点的替代标志物，但对于所有实体瘤中接受根治性切除的癌症患者，pCR是否为真正的替代标志物仍不确定。在此，我们综述了在围手术期免疫检查点抑制剂时代，PR作为替代标志物的作用及其相关的方法学问题。
