論文No2605
Application of clinical trial inclusion criteria to clinical practice patients to quantify the burden of CNS metastases on health-related quality of life and healthcare resource use in patients with NSCLC
Gracy Crane,Vlatka Smoljanovic,Nasreen Khan,...Nuria Lara,Adam Gondos,Stefan Hammerschmidt
LUNG CANCER, VOLUME 149, P144-153, NOVEMBER 01, 2020
＜目的＞
進行非小細胞肺がん(NSCLC)患者の中枢神経系(CNS)転移が
健康関連QoL(HRQoL)と医療リソース使用(HRU)に及ぼす影響を、
臨床試験登録基準を利用して前向きのヨーロッパ臨床実践試験で検討する。
＜方法＞
18歳以上で転移性NSCLC患者でECOG PS 0-2で12週間以上の予後が見込まれる群が
２つのコホートでベースラインのCNS転移の状態にもとづいて登録された。
背景、臨床的特徴、NSCLC治療データ、HRQoL、HRUを
ベースラインと２回の受診時(２回目の受診時と６週間後の３回目）で収集した。
HRQoLは検証された質問票で評価した。
＜結果＞
162名が登録された（n=80 CNSコホート、n=82 non-CNSコホート）。
ベースラインの背景に差はなかったが、
CNS患者は若年で(mean ± standard deviation age: 62.1 ± 9.6 vs 65.6 ± 9.7 years, p = 0.021)、
BMIが低かった(13.8 % underweight [<18.5kg/m2] vs 3.7 %, p = 0.049)。
HRQoLスコアの平均値は全体の受診では似通っていた。
がん薬物療法、経過、同時治療はコホート間で若干の例外を除いて同様であった。
CNS患者の方が入院がベースライン時点で多く入院しており(10.3 % vs 2.2 %)、
長期間であった (mean 7.2 vs 4.6 days; p < 0.001)。
２回目の受診時までにより多くのCNS患者が入院しており(50.0 % vs 29.3 %; p = 0.009)、
救急受診も多かった(11.8 % vs 2.7 %; p = 0.032)。
ベースラインにおいて、CNS患者の方が頭部MRIを多く撮像しており (80.0 % vs 31.7 %; p < 0.001)、
しかしFDG-PETは少なかった(10.0 % vs 28.0 %; p = 0.004)。
＜感想＞
限られたコホートの報告ですが、進行NSCLC患者において、脳転移のありなしは健康関連QoLに差がなかったようです。入院、救急受診は脳転移のある群の方が多かったようです。
Objectives
Quantify the burden of central nervous system (CNS) metastases on health-related quality of life (HRQoL) and healthcare resource use (HRU) in patients with advanced non-small-cell lung cancer (NSCLC) from a prospective European study in clinical practice, utilising clinical trial inclusion criteria.
Materials and Methods
Patients ≥18 years, with metastatic NSCLC, Eastern Oncology C0operative Group (ECOG) performance status 0–2 and life expectancy ≥12 weeks were enrolled in two cohorts by baseline CNS metastases status. Demographics, clinical characteristics, NSCLC management data, HRQoL and HRU were collected at baseline and two follow-up visits (Visits 2 and 3, 6 weeks apart). HRQoL was assessed using validated questionnaires.
Results
162 patients were enrolled (n = 80 CNS cohort, n = 82 non-CNS cohort). Baseline characteristics were balanced, but CNS patients were younger (mean ± standard deviation age: 62.1 ± 9.6 vs 65.6 ± 9.7 years, p = 0.021) with a lower body mass index (13.8 % underweight [<18.5kg/m2] vs 3.7 %, p = 0.049). Mean HRQoL scores were similar between cohorts at all visits. Cancer pharmacotherapy, procedures and concomitant treatment were comparable across cohorts, with some exceptions. More CNS patients were hospitalised at baseline (10.3 % vs 2.2 %) for longer (mean 7.2 vs 4.6 days; p < 0.001). By Visit 2, more CNS patients were hospitalised (50.0 % vs 29.3 %; p = 0.009) with emergency room visits (11.8 % vs 2.7 %; p = 0.032). At baseline, more CNS versus non-CNS patients had Magnetic Resonance Imaging (MRI) scans (80.0 % vs 31.7 %; p < 0.001), but fewer had fluorodeoxyglucose (FDG)-positron emission tomography (PET)-computed tomography (CT) scans (10.0 % vs 28.0 %; p = 0.004).
Conclusion
These data from clinical practice show minor differences in HRQoL/HRU between patients with advanced NSCLC with/without CNS metastases when applying selected clinical trial criteria. Although follow-up was short, HRQoL scores were similar between cohorts at all visits, supporting the wider inclusion of selected patients with CNS disease into clinical trials.