德国 EGFR 突变型 III/IV 期 NSCLC 患者的治疗决策、临床结局和药物经济学：一项观察性研究。
Treatment decisions, clinical outcomes, and pharmacoeconomics in the treatment of patients with EGFR mutated stage III/IV NSCLC in Germany: an observational study.
机构信息
Krankenhaus Martha-Maria Halle-Doelau gGmbH, Klinik für Innere Medizin II, Roentgenstr, 106120, Halle, Germany.
Pathologisches Institut, Universitätklinik Heidelberg, Heidelberg, Germany.
出版信息
BMC Cancer. 2018 Feb 5;18(1):135. doi: 10.1186/s12885-018-4032-3.
BACKGROUND
We evaluated treatment decisions and outcomes in a cohort of predominately Caucasian patients with EGFR mutation-positive (EGFR Mut+) non-small-cell lung cancer (NSCLC).
METHODS
REASON (NCT00997230) was a non-interventional study in German patients with stage IIIB/IV NSCLC. Secondary endpoints for EGFR Mut + NSCLC included progression-free survival (PFS), overall survival (OS), adverse event (AE) management, and pharmacoeconomic outcomes.
RESULTS
Among 334 patients with EGFR Mut + NSCLC, tyrosine kinase inhibitors (TKIs) were the most common first-line therapy (56.6%, 53.0% gefitinib). Among patients who received TKIs/gefitinib before first disease progression, PFS was longer compared with those who did not receive a TKI (median 10.1/10.0 vs. 7.0 months; HR 0.67/0.69; log-rank p = 0.012/p = 0.022). OS was longer for those patients who ever received a TKI/gefitinib during their complete therapy course compared with those who never received a TKI (median 18.4/18.1 vs. 13.6 months; HR 0.53/0.55; p = 0.003/p = 0.005). Total mean first-line treatment healthcare costs per person were higher for those receiving TKIs (€46,443) compared with those who received chemotherapy (€27,182). Mean outpatient and inpatient costs were highest with chemotherapy. Rash, diarrhea, and dry skin were the most commonly reported AEs for patients receiving gefitinib.
CONCLUSIONS
In REASON, TKI therapy was the most common first- and second-line treatment for EGFR Mut + NSCLC, associated with increased drug costs compared with chemotherapy. Patients who received gefitinib or a TKI ever during their complete therapy course had prolonged PFS and OS compared with patients who did not receive a TKI.
TRIAL REGISTRATION
The trial was registered on October, 2009 with ClinicalTrials.gov : https://clinicaltrials.gov/ct2/show/NCT00997230?term=NCT00997230&rank=1.
背景
我们评估了主要为高加索人种的表皮生长因子受体突变阳性（EGFR Mut+）非小细胞肺癌（NSCLC）患者队列中的治疗决策和结局。
方法
REASON（NCT00997230）是一项在德国 IIIB/IV 期 NSCLC 患者中进行的非干预性研究。EGFR Mut+ NSCLC 的次要终点包括无进展生存期（PFS）、总生存期（OS）、不良事件（AE）管理和药物经济学结局。
结果
在 334 例 EGFR Mut+ NSCLC 患者中，酪氨酸激酶抑制剂（TKI）是最常见的一线治疗药物（56.6%，53.0%为吉非替尼）。在首次疾病进展前接受 TKI/吉非替尼治疗的患者中，PFS 长于未接受 TKI 治疗的患者（中位 10.1/10.0 与 7.0 个月；HR 0.67/0.69；对数秩检验 p=0.012/p=0.022）。在整个治疗过程中接受过 TKI/吉非替尼治疗的患者，OS 长于未接受 TKI 治疗的患者（中位 18.4/18.1 与 13.6 个月；HR 0.53/0.55；p=0.003/p=0.005）。接受 TKI 治疗的患者的人均一线治疗总医疗保健费用（€46,443）高于接受化疗的患者（€27,182）。化疗的门诊和住院费用最高。接受吉非替尼治疗的患者最常见的不良反应为皮疹、腹泻和皮肤干燥。
结论
在 REASON 中，TKI 治疗是 EGFR Mut+ NSCLC 的最常见的一线和二线治疗方法，与化疗相比，药物成本增加。在整个治疗过程中接受过吉非替尼或 TKI 治疗的患者，其 PFS 和 OS 均长于未接受 TKI 治疗的患者。
试验注册
该试验于 2009 年 10 月在 ClinicalTrials.gov 注册：https://clinicaltrials.gov/ct2/show/NCT00997230?term=NCT00997230&rank=1。
Zotero 插件