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Real World Evidence
The information on this website is based on data from adult patients with ALK+ NSCLC treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics for Great Britain. For XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
Progression-Free and Overall Survival in ALK+ NSCLC Patients Treated with Sequential XALKORI® and ceritinib
Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.
Study Design (Real World Evidence)
In this multicentre cohort, retrospective study, outcomes of 73 patients with ALK+ advanced non-small cell lung cancer (NSCLC) were analysed. Medical records were reviewed to determine progression-free survival (PFS) and overall survival (OS) following sequential treatment with XALKORI® and ceritinib. The median number of lines of treatment prior to XALKORI® was 1 (range: 0-8).1
The majority of patients (n=56) received a starting dose of 750mg once-daily XALKORI®.1
*Median number of lines of therapy prior to XALKORI® was 1 (range: 0-8). 27.4% of patients were treated with other therapies between XALKORI® and ceritinib.1
Characteristic | All Patients (N=73) |
---|---|
Age at diagnosis, years | |
Median | 50 |
Range | 22-72 |
Sex, n (%) | |
Male | 38 (52%) |
female | 35 (48%) |
Ethnicity, n (%) | |
Caucasian | 54 (74%) |
Asian | 17 (23%) |
Other | 2 (3%) |
Smoking history, n (%) | |
Never | 57 (78%) |
Light (≤10 pack years) | 10 (14%) |
Heavy (≥10 pack years) | 6 (8%) |
Histology, n (%) | |
Adenocarcinoma | 69 (95%) |
Squamous | 3 (4%) |
Adenosquamous | 1 (1%) |
Stage at disgnosis, n (%) | |
Stage I-II | 2 (3%) |
Stage III-IV | 71 (97%) |
Lines of therapy before crizotinib*, n (%) | |
0 | 10 (14%) |
1 | 32 (44%) |
2 | 16 (22%) |
3 | 7 (10%) |
4-8 | 8 (11%) |
Brain metastases before crizotinib, n (%)† | |
Present | 25 (35%) |
Absent | 47 (65%) |
Adapted from Gainor JF, et al. Clin Cancer Res. 2015;21(12):2745-52.1
Data cutoff: June 2014
*All patients received XALKORI® before eventual treatment with ceritinib.1
†Neuroimaging was not available in 1 patient.1
Study Results (Real World Evidence)
Progression-Free Survival
Overall Survival
After a median follow-up of 53.2 months (data cutoff: June 2014), the median OS in the overall study population (n=73) was 49.4 months (95% CI: 35.5-63.1 months).1
OS from the time of metastatic NSCLC diagnosis for the overall study population*1
Overall survival from the first XALKORI® dose1
*10 patients received XALKORI® in first line; the remainder in the second-line or later. The median number of lines of therapy prior to XALKORI® was 1 (range 0–8).1
Adapted from Gainor JF, et al. Clin Cancer Res. 2015;21(12):2745-52.1
Data cutoff: June 2014
ALK: anaplastic lymphoma kinase, CI: confidence interval, mPFS: median progression-free survival NSCLC: non-small cell lung cancer, OS: overall survival, PFS: progression-free survival
References
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