Non-Small-Cell Lung Carcinoma
Conditions
Brief summary
This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.
Interventions
DRUGAlectinib
Observational treatment based on physician choice
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a documented diagnosis of NSCLC. 2. Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC. 3. Patients who received treatment with alectinib during the study identification period, including those who initiated alectinib prior (index date-1) to the start of the study identification period. 4. During the study observation period, patients observed with at least 2 visits after the index date-1.
Exclusion criteria
1. Receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded. 2. Patients enrolled in clinical trials prior to receiving alectinib during the study ID period (index date-1), will be included and flagged in the analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | During the inclusion period from 01-Jun-2017 to 31-Aug-2020 (maximum up to 39 months); eligible data was studied during approximately 31 months of this retrospective study | Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure. |
| Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | From initiation of index treatment to discontinuation from 01-Jun-2017 to 31-Aug-2021 (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study | Number of participants classified according to reason for Alectinib treatment discontinuation were reported in this outcome measure. One participant could have more than one reason for discontinuation. |
| Duration of Therapy (DOT) | Alectinib or post-alectinib treatment initiation till its discontinuation or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study | DOT was defined as duration of time between alectinib or post-alectinib treatment initiation and discontinuation as documented in the iKM EHR database. Participants who did not have evidence of discontinuation, starting new therapy, or whose last prescription date was less than (\<) 30 days from the end of the study period, were censored at last visit date or end of study period. |
| Overall Survival (OS) | From start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study | OS was defined as the interval between treatment and the date of death (any cause) as documented in the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first. |
| Progression Free Survival (PFS) | From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study | PFS was measured from the initiation of the treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date. |
Countries
United States
Participant flow
Pre-assignment details
Participants with anaplastic lymphoma kinase + non-small cell lung cancer (ALK+ NSCLC) who were on treatment with Alectinib during 01 June 2017 and 31 August 2020 were eligible for this study. Data of eligible participants from 01 June 2017 to 31 August 2021, were extracted from iKnowMed (iKM) electronic health record (EHR). Data was evaluated per objectives of this retrospective observational study from 27 March 2020 to 01 November 2022.
Participants by arm
| Arm | Count |
|---|---|
| All Eligible Participants Participants who were on treatment with Alectinib for ALK+ NSCLC in real world clinical practices during 01-Jun-2017 to 31-Aug-2020. | 161 |
| Total | 161 |
Baseline characteristics
| Characteristic | All Eligible Participants |
|---|---|
| Age, Continuous | 61.4 Years STANDARD_DEVIATION 13.4 |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score 0 | 18 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score 1 | 70 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score 2 | 20 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score Greater than or equal to (>=) 3 | 2 Participants |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Score Not documented | 51 Participants |
| Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status Negative | 114 Participants |
| Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status Not documented | 41 Participants |
| Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status Positive | 2 Participants |
| Number of Participants According to Epidermal Growth Factor Receptor (EGFR) Mutation Status Unknown | 4 Participants |
| Number of Participants According to Practice Region Midwest | 34 Participants |
| Number of Participants According to Practice Region Northeast | 9 Participants |
| Number of Participants According to Practice Region South | 58 Participants |
| Number of Participants According to Practice Region West | 60 Participants |
| Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression 1-49 percent (%) Expression | 38 Participants |
| Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression >= 50% Expression | 38 Participants |
| Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression Negative | 15 Participants |
| Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression Not documented | 42 Participants |
| Number of Participants According to Programmed Death-Ligand 1 (PD-L1) Expression Unknown | 28 Participants |
| Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status Negative | 78 Participants |
| Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status Not documented | 68 Participants |
| Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status Positive | 0 Participants |
| Number of Participants According to ROS Proto-Oncogene 1 (ROS1) Status Unknown | 15 Participants |
| Number of Participants According to Stage at Initial NSCLC Diagnosis Early Stage (IA, IB, II [not specified], IIA) | 13 Participants |
| Number of Participants According to Stage at Initial NSCLC Diagnosis Limited/Regional (IIIA) | 12 Participants |
| Number of Participants According to Stage at Initial NSCLC Diagnosis Locally advanced (IIIB/IIIC) | 6 Participants |
| Number of Participants According to Stage at Initial NSCLC Diagnosis Metastatic (IV) | 129 Participants |
| Number of Participants According to Stage at Initial NSCLC Diagnosis Stage III (Not specified) | 1 Participants |
| Number of Participants According to Tumor Histology Adenocarcinoma | 132 Participants |
| Number of Participants According to Tumor Histology Adenosquamous carcinoma | 2 Participants |
| Number of Participants According to Tumor Histology Large cell carcinoma | 1 Participants |
| Number of Participants According to Tumor Histology Not documented | 22 Participants |
| Number of Participants According to Tumor Histology Other | 2 Participants |
| Number of Participants According to Tumor Histology Squamous cell carcinoma | 2 Participants |
| Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status Not documented | 60 Participants |
| Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status Positive | 0 Participants |
| Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status Unknown | 36 Participants |
| Number of Participants According to v-raf Murine Sarcoma Viral Oncogene Homolog B1 Mutation Status Wild-type | 65 Participants |
| Number of Participants Classified According to Smoking History Current | 5 Participants |
| Number of Participants Classified According to Smoking History Former | 51 Participants |
| Number of Participants Classified According to Smoking History Never | 81 Participants |
| Number of Participants Classified According to Smoking History No information | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants |
| Race (NIH/OMB) White | 111 Participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 56 / 161 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Duration of Therapy (DOT)
DOT was defined as duration of time between alectinib or post-alectinib treatment initiation and discontinuation as documented in the iKM EHR database. Participants who did not have evidence of discontinuation, starting new therapy, or whose last prescription date was less than (\<) 30 days from the end of the study period, were censored at last visit date or end of study period.
Time frame: Alectinib or post-alectinib treatment initiation till its discontinuation or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Eligible Participants | Duration of Therapy (DOT) | 23.9 Months |
Primary
Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
Number of participants classified according to reason for Alectinib treatment discontinuation were reported in this outcome measure. One participant could have more than one reason for discontinuation.
Time frame: From initiation of index treatment to discontinuation from 01-Jun-2017 to 31-Aug-2021 (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Hospice | 7 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Toxicity | 13 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Death | 15 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Progression | 55 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Decline in performance status | 1 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Participant choice | 1 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Physician choice | 1 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Unknown | 3 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | Other | 3 Participants |
| All Eligible Participants | Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation | No evidence of alectinib discontinuation | 68 Participants |
Primary
Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
Number of participants classified according to ALK-TKI treatment patterns or sequencing were reported in this outcome measure.
Time frame: During the inclusion period from 01-Jun-2017 to 31-Aug-2020 (maximum up to 39 months); eligible data was studied during approximately 31 months of this retrospective study
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed other | 3 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib only | 103 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed by chemotherapy | 8 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed by lorlatinib | 23 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed by crizotinib | 1 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed by immunotherapy | 2 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed by brigatinib | 15 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed by chemoimmunotherapy | 4 Participants |
| All Eligible Participants | Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence | Alectinib followed by ceritinib | 2 Participants |
Primary
Overall Survival (OS)
OS was defined as the interval between treatment and the date of death (any cause) as documented in the iKM EHR database. Participants who did not die within the study observation period were censored on the study end date or the last visit date available in the dataset, whichever occurred first.
Time frame: From start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Eligible Participants | Overall Survival (OS) | 46.3 Months |
Primary
Progression Free Survival (PFS)
PFS was measured from the initiation of the treatment to the date of progression (documented by provider as disease has progressed or worsening of disease) or date of death due to any cause, censoring participants who were still alive at the end of the study observation period and did not progress at the last visit date.
Time frame: From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
Population: Analysis population included all eligible participants whose data were included and observed in this study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Eligible Participants | Progression Free Survival (PFS) | 41.4 Months |