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).
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.
Study Type
OBSERVATIONAL
Enrollment
51
as provided in real world practice
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Age at Start of Lorlatinib Treatment
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.
Time frame: 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
Height at Start of Alectinib Treatment
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Height at Start of Lorlatinib Treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi, Osaka, Japan
Kinki University Hospital
Sayama, Osaka, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
...and 6 more locations
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
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".
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
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".
Time frame: 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 NSCLC Histopathological Subtype
Number of participants according to NSCLC histopathological subtype (adenocarcinoma, squamous cell carcinoma and adenosquamous epithelial carcinoma) were reported in this outcome measure.
Time frame: 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 Alectinib Treatment
Time frame: 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
Time frame: 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
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.
Time frame: 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 Metastases at Start of Lorlatinib Treatment
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.
Time frame: 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 Presence of Previous Medical History
Number of participants with previous medical history related to history of treatment for ALK+ NSCLC were reported in this outcome measure.
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Details of Previous Medical History
Number of participants with previous medical history of high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure.
Time frame: 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 Complications
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.
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Details of Complications
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.
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Smoking History
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Brinkman Index Score
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.
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result
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.
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Type of ALK Testing Method
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.
Time frame: 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 ALK Test Was Available
Number of participants for whom dates of performing ALK test was available was presented in this outcome measure.
Time frame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment
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 frame: 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
Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy
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.
Time frame: 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
Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib
Time frame: 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
Objective response rate was defined as the percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 from first date lorlatinib treatment until date of treatment discontinuation. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures \<10 mm. PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.
Time frame: 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
Time to treatment failure was the time from the first date of alectinib 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. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.
Time frame: 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
Time to treatment failure was the time from the first date of the other subsequent treatment to the date of other subsequent 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. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.
Time frame: 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
Objective response rate was defined as the percentage of participants with BOR of either CR or PR according to RECIST version 1.1 from the first date of alectinib until the date of treatment discontinuation. CR = disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, both target and non-target must have short axis measures \<10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.
Time frame: 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
Combined TTF is defined as sum of the time from the first date of alectinib to the date of any-cause alectinib discontinuation, the time from the first date of lorlatinib to the date of lorlatinib discontinuation and the time from the first date of the other subsequent treatment to the date of other subsequent treatment discontinuation. If participants continued treatment, combined TTF was censored at the available last date of treatment or the study end period. Combined TTF was analyzed using Kaplan-Meier method.
Time frame: 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
Time to last treatment failure (TLTF) is the time from the first date of lorlatinib to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death in the last treatment. If participants continued treatment, TLTF was censored at the available last date of treatment or the study end period. PD was defined as \>= 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm and appearance of one or more new lesions. TLTF was analyzed using Kaplan-Meier method.
Time frame: 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