Retrospective, Multicenter, Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 51
- 试验地点
- 16
- 主要终点
- Height at Start of Alectinib Treatment
研究概览
简要总结
To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC).
详细描述
This study is a post-approval, company-sponsored, observational study. This study is a multicenter, non-interventional, retrospective, chart review of patients with ALK+ NSCLC patients treated using lorlatinib as the second/later line therapy in Japan after failure of alectinib treatment as the first line therapy from 20 November 2018.
All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site. Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December, 2020 in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed NSCLC, with any tumor, node and metastasis (TNM) stage.
- •Confirmed ALK gene rearrangement by any validated test.
- •Confirmed the treatment with alectinib in the first line setting as systemic therapy in the medical record.
- •Confirmed the start treatment with lorlatinib as the second/later-line therapy from 1st May 2019 to 31st December 2020.
排除标准
- •Participating on any clinical trials of which final results has not yet been reported during the study period.
研究组 & 干预措施
Japanese patients with ALK+ NSCLC who received lorlatinib
lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy
干预措施: Lortlatinib (Drug)
结局指标
主要结局
Height at Start of Alectinib Treatment
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Age at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Age at start of lorlatinib treatment was entered based on the data in medical chart. If there were no details about the applicable age, the age was calculated from the date of birth to the start date of lorlatinib treatment.
Height at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Weight at Start of Alectinib Treatment
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Weight at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Body Mass Index (BMI) at Start of Alectinib Treatment
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
BMI at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
ECOG PS is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled and Grade 5: dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG PS were presented. Participants whose ECOG PS was not known were reported under category "Unknown".
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
ECOG PS is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled and Grade 5: dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG PS were presented. Participants whose ECOG PS was not known were reported under category "Unknown".
Number of Participants According to NSCLC Histopathological Subtype
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants according to NSCLC histopathological subtype (adenocarcinoma, squamous cell carcinoma and adenosquamous epithelial carcinoma) were reported in this outcome measure.
Number of Participants According to Presence of Metastases at Start of Alectinib Treatment
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants according to sites of metastasis at start of alectinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
时间窗: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants according to sites of metastases at start of lorlatinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.
Number of Participants According to Presence of Previous Medical History
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants with previous medical history related to history of treatment for ALK+ NSCLC were reported in this outcome measure.
Number of Participants According to Details of Previous Medical History
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants with previous medical history of high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure.
Number of Participants According to Presence of Complications
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Complication was defined as a disease or disorder arising as a consequence of another disease. Number of participants according to presence of complications were reported in this outcome measure.
Number of Participants According to Details of Complications
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants who developed complications such as high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure. One participant may have more than one complication.
Number of Participants According to Smoking History
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Brinkman Index Score
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
The Brinkman index (BI) is a measure of cigarette smoke exposure and is used as a predictor of chronic obstructive pulmonary disease (COPD) in smokers. It is calculated as the number of cigarettes smoked per day multiplied by the number of years of smoking. The scores ranged from 20 to 1050, where higher scores indicated higher cigarette smoke exposure.
Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
ALK test was used to detect specific rearrangements in the ALK gene in cancer cells and tissue. Number of participants with ALK test result were reported in this outcome measure.
Number of Participants According to Type of ALK Testing Method
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants according to the type of ALK testing methods including immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), reverse transcription polymerase chain reaction (RT-PCR) and other methods were presented in this outcome measure. One participant may have more than one type of ALK testing method.
Number of Participants for Whom Dates of ALK Test Was Available
时间窗: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants for whom dates of performing ALK test was available was presented in this outcome measure.
Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment
时间窗: Prior to initiation of lorlatinib treatment (up to approximately 23.7 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of participants according to treatment administered (Anaplastic Lymphoma Kinase- Tyrosine Kinase Inhibitor \[ALK-TKI\] including brigatinib, ceritinib and crizotinib or Other chemotherapy\]) for NSCLC prior to start of lorlatinib treatment were presented in this outcome measure.
Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy
时间窗: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study
Time to treatment failure (TTF) was the time from the first date of lorlatinib treatment to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. Disease progression (PD) was defined in a method that complied with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.
次要结局
- Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib(From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study)
- Objective Response Rate for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy(From the date of initiation of lorlatinib treatment to the date of treatment discontinuation, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this observational study)
- Time to Treatment Failure for Alectinib as the First-Line Therapy: Overall Participants(From the date of initiation of alectinib treatment to the date of any-cause treatment discontinuation or study end (maximum of 61.8 months of alectinib treatment); retrospective data was retrieved and analyzed during 4 months of this observational study)
- Time to Treatment Failure for Subsequent Other Treatment(From the date of initiation of subsequent other treatment to the date of any-cause treatment discontinuation or study end (maximum of 22.9 months of subsequent other treatment); retrospective data was retrieved and analyzed during 4 months of this study)
- Objective Response Rate for Alectinib(From the date of initiation of alectinib treatment to the date of any-cause treatment discontinuation (maximum of 61.8 months of alectinib treatment); retrospective data was retrieved and analyzed during 4 months of this observational study)
- Combined Time to Treatment Failure of the Sum of Alectinib and Subsequent Therapy Including TTF of Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy(From date of initiation of alectinib treatment until date of treatment discontinuation or study end, from Sep-2014 until 15-Oct-2021 (up to approximately 85 months); retrospective data was retrieved and analyzed during 4 months of this study)
- Time to Last Treatment Failure for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy(From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study)