被忽视的老年综合评估与老年胰腺癌患者的过度治疗——一项前瞻性 IV 期临床试验结果。

Neglected geriatric assessment and overtreatment of older patients with pancreatic cancer - Results from a prospective phase IV clinical trial.

机构信息

Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Junior Clinical Cooperation Unit Translational Gastrointestinal Oncology and Preclinical Models (B440), German Cancer Research Center (DKFZ), Heidelberg, Germany; DKFZ-Hector Cancer Institute, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany; Mannheim Cancer Center (MCC), University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

出版信息

J Geriatr Oncol. 2022 Jun;13(5):662-666. doi: 10.1016/j.jgo.2021.12.018. Epub 2022 Jan 3.

DOI:10.1016/j.jgo.2021.12.018

PMID:34991998

Abstract

BACKGROUND

Older patients with metastatic pancreatic cancer may suffer increased toxicity from intensive chemotherapy. Treatment individualization by geriatric assessment (GA) might improve functional outcome.

METHODS

We performed a multicenter, phase IV, open label trial in patients ≥70 years with metastatic pancreatic adenocarcinoma. Patients underwent GA and were assigned to one of three categories based on their scores: Go-Go, Slow-Go, or Frail. These categories were intended to guide physician's treatment decisions when choosing to treat patients with nab-paclitaxel/gemcitabine (arm A), gemcitabine (arm B), or best supportive care (arm C). Primary objective was a stable (loss of five points or less) Barthel's Activities of Daily Living (ADL) score during chemotherapy; secondary endpoints included GA scores during therapy, safety, quality of life, response and survival rates.

RESULTS

Thirty-two patients were enrolled in the trial in six centers in Germany (out of 135 planned), resulting in termination due to low recruitment. Fifteen patients were allocated to nab-paclitaxel/gemcitabine, fifteen to gemcitabine, and two to best supportive care by their physicians, although according to their GA scores 29 patients (91%) were categorized as Slow-Go and three (9%) as Go-Go. Thus, fifteen of 32 (47%) patients were misclassified and given a course of treatment inconsistent with their GA scores. Median progression-free survival (PFS) were 3.3 months and 9.1 months and median time to quality-of-life deterioration 13 days and 29 days in the nab-paclitaxel/gemcitabine and gemcitabine monotherapy arms, respectively. Serious adverse events were reported in 11 (78.6%) patients in the nab-paclitaxel/gemcitabine and 8 (53.3%) patients in the gemcitabine arm.

CONCLUSIONS

Clinical evaluations by investigators differed markedly from geriatric assessments, leading to potential overtreatment. In our modest sample size study, those patients undergoing more intensive therapy had a less favorable course.

摘要

背景

患有转移性胰腺癌的老年患者可能会因强化化疗而增加毒性。通过老年评估（GA）进行个体化治疗可能会改善功能结局。

方法

我们在年龄≥70 岁的转移性胰腺腺癌患者中进行了一项多中心、四期、开放标签试验。患者接受 GA 并根据其评分分为以下三个类别之一：Go-Go、Slow-Go 或脆弱。这些类别旨在指导医生在选择用 nab-paclitaxel/gemcitabine（A 组）、gemcitabine（B 组）或最佳支持治疗（C 组）治疗患者时做出治疗决策。主要目标是在化疗期间保持稳定（下降 5 分或以下）的巴氏日常生活活动（ADL）评分；次要终点包括治疗期间的 GA 评分、安全性、生活质量、反应率和生存率。

结果

该试验在德国的六个中心共招募了 32 名患者（计划招募 135 名），由于招募人数不足而终止。根据医生的治疗方案，15 名患者被分配到 nab-paclitaxel/gemcitabine 组，15 名患者被分配到 gemcitabine 组，2 名患者被分配到最佳支持治疗组，但根据他们的 GA 评分，29 名患者（91%）被归类为 Slow-Go，3 名患者（9%）被归类为 Go-Go。因此，32 名患者中有 15 名（47%）被错误分类，给予与他们的 GA 评分不一致的治疗方案。nab-paclitaxel/gemcitabine 和 gemcitabine 单药治疗组的中位无进展生存期（PFS）分别为 3.3 个月和 9.1 个月，中位生活质量恶化时间分别为 13 天和 29 天。nab-paclitaxel/gemcitabine 组有 11 名（78.6%）患者和 gemcitabine 组有 8 名（53.3%）患者报告有严重不良事件。