This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Adverse event reporting can be found at the bottom of the page
Menu
Close
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.
Overall Survival with XALKORI® and Post-Progression* Treatments in Patients with ALK+ NSCLC
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)
This French cohort retrospective study (ICFT-1302-CLINALK) sought to assess overall survival in ALK+ non-small cell lung cancer (NSCLC) patients given XALKORI® and understand whether survival outcomes were affected by post-progression* systemic treatments. All patients received 250mg oral XALKORI® twice daily. Progression was defined according to RECIST v1.1.1
Post-progression treatment options included:1
At the time of analysis (data cutoff: 31 July 2015), 209 (65.7%) of the 318 patients enrolled on the study had died. The median duration of follow up was 44.4 months (95% confidence interval [CI]: 40.6-47.5 months).1
*The mean time from diagnosis of advanced disease to initiation of XALKORI® was 13.9 months (95% CI: 12.4-15.5). 14 patients were lost to follow-up.1
The primary endpoint of the study was overall survival (OS) measured from the date of the first dose of XALKORI®. Secondary endpoints included:1
| Characteristic | All patients (N=318) |
|---|---|
| N | 318 |
| Age, years | |
| Median (range) | 58.3 (19.2-88.4) |
| <65 | 221 (69.5%) |
| ≥65 | 97 (30.5%) |
| Gender, n (%) | |
| Male | 161 (50.6%) |
| Female | 157 (49.4%) |
| Ethnicity, n (%) | |
| Non-Asian | 294 (98.3%) |
| Asian | 5 (1.7%) |
| Missing data | 19 |
| Smoking status, n (%) | |
| Current-smoker | 29 (9.4%) |
| Former-smoker | 108 (34.8%) |
| Never-smoker | 173 (55.8%) |
| Missing data | 8 |
| Histology, n (%) | |
| Adenocarcinoma | 292 (91.8%) |
| Large cell | 19 (6.0%) |
| Other | 7 (2.2%) |
| ECOG PS, n (%) | |
| 0 | 92 (31.6%) |
| 1 | 133 (45.7%) |
| 2 | 43 (14.8%) |
| 3 | 21 (7.2%) |
| 4 | 2 (0.7%) |
| Missing data | 27 |
| Stage at diagnosis, n (%) | |
| Localised | 5 (1.6%) |
| Locally advanced | 45 (14.1%) |
| Metastatic | 268 (84.3%) |
| Brain metastasis, n (%) | |
| Yes | 111 (34.9%) |
| No | 207 (65.1%) |
| Line of therapy before crizotinib, n (%) | |
| 0 | 16 (5.0%) |
| 1 | 172 (54.1%) |
| ≥2 | 130 (40.9%) |
Adapted from: Duruisseaux M, et al. Oncotarget. 2017;8(13):21903-17.1
Study Results (Real World Evidence)
Overall Survival (OS)
The primary endpoint of the study was OS from the first XALKORI® dose. Median OS from the first dose of XALKORI® was 16.6 months (95% CI: 12.2-19.6 months).1
Overall survival from the first XALKORI® dose1
Overall survival from the first XALKORI® dose1
Adapted from Duruisseaux M, et al. Oncotarget. 2017.1
Data cutoff: 31 July 2015
Hazard ratio analysis of overall survival from the first dose of XALKORI®1
| Tested | Reference | Univariable analysis | Multivariable analysis | ||||
| HR (95% CI) | p value | HR (95% CI) |
p value | ||||
| Age | <Median | ≥Median | 0.97 (0.74-1.27) | 0.81 | |||
| Gender | Female | Male | 0.99 (0.75-1.29) |
0.93 | |||
| Smoking status | Never | Former/current | 0.79 (0.60-1.03) |
0.09 | (-) | NS | |
| Current smoker | No | Yes | 0.45 (0.30-0.69) |
<0.001 | 0.44 (0.29-0.67) |
<0.001 | |
| Histology | Adenocarcinoma | Non-Adenocarcinoma | 0.64 (0.40-1.02) |
0.06 | 0.59 (0.36-0.97) |
0.04 | |
| PS | 0-1 | 2-4 | 0.36 (0.27-0.50) |
<0.001 | 0.35 (0.26-0.48) |
<0.001 | |
| Stage | III | IV | 0.84 (0.56-1.26) |
0.40 | |||
| Brain metastasis | No | Yes | 0.95 (0.71-1.25) |
0.70 | |||
| Number of treatment lines before crizotinib | 0-1 | ≥2 | 0.79 (0.60-1.04) |
0.09 | (-) | NS | |
| Setting of administration | EMA approval | EAP | 0.86 (0.63-1.17) |
0.33 | |||
Overall survival from the first XALKORI® dose1
Adapted from: Duruisseaux M, et al. Oncotarget. 2017;8(13):21903-17.1
Date cutoff: 31 July 2015
Effect of Post-Progression Treatment on OS
263 patients were included in the analysis of the effect of systemic treatments following progression on XALKORI®. For patients who progressed on XALKORI® and were given an ALK inhibitor as post-progression therapy, the median OS from diagnosis of metastatic disease was 89.6 months (95% CI: 53.5-not reached).1
This was in comparison to a median OS of:1
OS from diagnosis according to treatment initiated following progression on XALKORI®*1
Overall survival from the first XALKORI® dose1
Adapted from Duruisseaux M, et al. Oncotarget. 2017.1
Data cutoff: 31 July 2015
ALK: anaplastic lymphoma kinase, ALKi: anaplastic lymphoma kinase inhibitor, BSC: best supportive care, CI: confidence interval, EAP: Early Access Program, EMA: European Medicines Agency, HR: hazard ratio, NS: not significant, NSCLC: non-small cell lung cancer, OS: overall survival, PFS: progression-free survival, PS: performance score, RECIST: response evaluation criteria in solid tumours
References
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc
This website is brought to you by Pfizer Limited, a company registered in England
and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ
Copyright © 2024 Pfizer Limited. All rights reserved.
VAT registration number GB201048427
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-UNP-GBR-7812. January 2024