AstraZeneca, One Medimmune Way, Gaithersburg, MD, 20878, USA.
Merck & Co, Inc, Kenilworth, NJ, 07033, USA.
BMC Cancer. 2022 May 20;22(1):563. doi: 10.1186/s12885-022-09661-7.
Metastatic pancreatic cancer (mPC) and its treatments significantly impact health-related quality of life (HRQoL). POLO, a randomized, double-blind, placebo-controlled phase 3 trial evaluated the efficacy of olaparib as maintenance therapy in germline BRCA mutated mPC patients who had not progressed during ≥16 weeks of first-line platinum-based chemotherapy. HRQoL was assessed using the EORTC QLQ-C30. To enhance score interpretation, we derived reference values for treatment-naïve mPC patients from the literature.
A targeted literature review identified EORTC QLQ-C30 baseline values in treatment-naïve mPC patients. Reference values were calculated by deriving means from studies meeting inclusion criteria, with scores from 0 to 100 (higher scores indicate better QoL/functioning but worse symptoms). For POLO patients, means were calculated using pooled baseline data across study arms.
Four studies met inclusion criteria. Depending on the specific scale, sample sizes ranged from n = 466 to n = 639. Compared to newly derived reference values, POLO patients reported markedly better HRQoL scores at baseline across most scales, with eight scales showing differences of ≥10 points. POLO patients' HRQoL scores were often close to or better than general population norm data.
This is the first study to systematically derive EORTC QLQ-C30 reference values for mPC. POLO patients had better HRQoL scores than those in the literature and similar to general population data. Comparatively high HRQoL of POLO patients are likely due to effects of prior first-line treatment and resolution of chemotherapy-related symptoms, response shift, or a combination. Newly derived reference values can enhance interpretation of mPC patients' HRQoL.
The POLO trial was registered on 9 July 2014 with ClinicalTrials.gov as NCT02184195.
转移性胰腺导管腺癌（mPC）及其治疗方案对健康相关生活质量（HRQoL）有显著影响。POLO 是一项随机、双盲、安慰剂对照的 3 期临床试验，评估了奥拉帕利作为一线含铂化疗后未进展且胚系 BRCA 突变的 mPC 患者维持治疗的疗效。采用 EORTC QLQ-C30 评估 HRQoL。为了增强评分解释，我们从文献中为未经治疗的 mPC 患者获得了参考值。
通过有针对性的文献复习，确定了未经治疗的 mPC 患者 EORTC QLQ-C30 的基线值。参考值是通过对符合纳入标准的研究进行平均值计算得出的，分数为 0 到 100（分数越高表示 QoL/功能越好，但症状越差）。对于 POLO 患者，使用各研究臂的 pooled 基线数据计算平均值。
四项研究符合纳入标准。根据特定量表，样本量从 n=466 到 n=639 不等。与新得出的参考值相比，POLO 患者在大多数量表上的基线 HRQoL 评分明显更高，其中 8 个量表的差异≥10 分。POLO 患者的 HRQoL 评分通常接近或优于一般人群的正常值。
这是第一项系统地为 mPC 得出 EORTC QLQ-C30 参考值的研究。POLO 患者的 HRQoL 评分优于文献中的数据，与一般人群数据相似。POLO 患者的 HRQoL 评分相对较高，可能是由于一线治疗的效果和化疗相关症状的缓解、反应转移或两者的综合作用。新得出的参考值可以增强对 mPC 患者 HRQoL 的解释。
POLO 试验于 2014 年 7 月 9 日在 ClinicalTrials.gov 上注册，编号为 NCT02184195。
