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Real World Evidence
The information on this website is based on data from adult patients with ALK (anaplastic lymphoma kinase)-positive / ROS 1-positive advanced NSCLC (non small cell lung cancer) treated with XALKORI®(crizotinib), produced in line with the XALKORI®(crizotinib) Summary of Product Characteristics. XALKORI® (crizotinib) Prescribing Information 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
In this multicentre cohort, retrospective study, 73 patients with ALK+ advanced non-small cell lung cancer (NSCLC) were enrolled. Medical records were reviewed to determine progression-free survival (PFS) and overall survival (OS) following sequential treatment with XALKORI® and ceritinib.*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%) |
*All patients received XALKORI® before eventual treatment with ceritinib.1
†Neuroimaging was not available in 1 patient.1
Adapted from Gainor JF, et al. Clin Cancer Res. 2015;21(12):2745-52.1
Data cutoff: June 2014
Study Results
Progression-Free Survival
For patients with ALK+ advanced NSCLC that have become resistant to XALKORI®, ceritinib has shown anti-tumour activity regardless of whether patients receive interim treatments after XALKORI®.1
With a median follow-up of 53.2 months (data cutoff: June 2014):1
Overall survival from the first XALKORI® dose1
*2 patients permanently discontinued XALKORI® due to toxicity. The median duration of post-progression XALKORI® use was 25 days (range: 0–318). When patients transitioned to new systemic therapies, the majority (72.6%) received ceritinib as the next line of therapy.1
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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