Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: A Multi-Site Retrospective Chart Review Study in the U.S.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status
研究概览
简要总结
This study aims to characterize the profile and outcomes for patients with Squamous Cell Carcinoma of the Lung (SqCC) who progress on 1L pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2L) therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of squamous or mixed histology non-small cell lung cancer
- •Treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage IIIB or IV)
- •First cycle of pembrolizumab received after 06/01/2018
- •Permanently discontinued 1L pembrolizumab treatment
- •Initiated second-line treatment at least 3 months prior to the date of data collection, with either :
- •Any chemotherapy
- •Age ≥ 18 years
排除标准
- •Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial
研究组 & 干预措施
Second line (2L) afatinib
Second line (2L) afatinib treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))
干预措施: Second line (2L) afatinib (Drug)
Second line (2L) chemotherapy
Second line (2L) chemotherapy treated following discontinuation of pembrolizumab in combination with platinum-based doublet chemotherapy (first line (1L))
干预措施: Second line chemotherapy (Drug)
结局指标
主要结局
Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Histology Status
时间窗: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients
Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment. Patients treated with afatinib were analysed for their histology status and categorized into a squamous cell - or mixed histology treatment group.
Time on Treatment With Afatinib During Second Line (2L) Treatment Defined by Epidermal Growth Factor Receptor (EGFR) Mutation Status
时间窗: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated patients
Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment.
Time on Treatment With Afatinib or Chemotherapy During Second Line (2L) Treatment
时间窗: From the start of second-line treatment until discontinuation of second-line treatment, up to 12.3 months for afatinib treated and up to 7.5 months for chemotherapy treated patients
Time on treatment was defined as the interval from the start of second-line treatment until discontinuation of second-line treatment for any reason, e.g. toxicity, progression, death, patient choice. The end of 2L treatment was defined as the date of last treatment order for afatinib plus the days of supply on the last known treatment order up to the date of data collection (but not exceeding). The Kaplan-Meier (KM) method was used to estimate the median and 95% confidence interval for time on treatment.
Number of Patients With Severe Immune-related Adverse Events (irAEs) of Specific Interest During Second-line Treatment
时间窗: From the start of second-line treatment to the end of follow-up, up to 15 months
Chart abstractors (i.e. the patients treating physician) were asked to abstract information regarding severe (grade 3 or higher) irAEs of specific interest (including pneumonitis, colitis, hepatitis, interstitial lung disease, higher indeterminate pulmonary events, death, or discontinuation of therapy due to toxicity) during first line (1L) treatment and second line (2L) for both patients treated with afatinib in 2L and those treated with chemotherapy in 2L. Providers/abstractors were asked only if these specific immune related events occurred.
次要结局
未报告次要终点