Found 1 Presentation For Request "1169P"
- NSCLC, metastatic
- NSCLC, metastatic
1169P - Aggregated cancer registry data from Norway to create an external cohort for patients with metastatic NSCLC squamous cell carcinoma
- Siri Børø (Oslo, Norway)
It is not uncommon that oncology clinical trials are conducted with few patients and/or as single arm studies. This leaves both researchers and regulatory bodies with less opportunity to perform any comparative evaluation of effect between new treatment intervention and a given standard of care (SoC) treatment. We investigated if aggregated data from the CRN could be used to create a RW- registry cohort of patients with metastatic squamous cell NSCLC, treated with chemotherapy in 1L. We also analyzed survival in the group and did a non-validated comparison of survival from a similar patient group from published phase III trials.
Part 1: To create an RW- cohort, we examined the eligibility criteria of relevant, published, phase III trials for patients with met.squamous cell NSCLC. We used that to benchmark which variables it was necessary, as a minimum, to gather information on from the CRN. The RW- registry cohort was finally defined by the eligibility criteria given in the Result section. Part 2: Median, observed and relative survival.
The median survival (MS) for both sexes in the cohort was 8.3 months (6.7,9.5). Females had a longer MS than males, 9.1 months (5.5,18.5) vs 7.9 (5.8,9.4), respectively. The relative survival (RS) for both sexes was 31.2 % (22.6,43.0) and females displayed a larger RS than males, 35.5 % (20.5,61.5) vs 29.6 % (20.1,43.6), respectively. The observed survival after 12 months for sexes combined was 34.3 % (25.2,43.7) while it was 43.3 % (25.6,59.9) for females and 30.4% (20.1,41.4) for males.
Defining the cohort Number Number excluded 1. Adult patients (18 years+) diagnosed from 2014-2016, in Norway 9509 2. Squamous cell carcinoma, NSCLC (ICD10 C33-34) 1847 7662 3. Histologically verified 1837 10 4. Stage 4/metastatic 479 1358 5. Information on systemic cancer treatment available 273 206 6. Patients who had died within 30 days after diagnosis were excluded. 236 37 7. 1L treatment with any regime containing chemotherapy 112 124 8. Patients with any malignancy with regional disease or more advanced, including unknown status before primary lung cancer diagnosis, were excluded. 99 13 Number of patients in the RW-cohort 99
It is possible to create a relevant RW- registry cohort of patients with met.squamous cell carcinoma of the lung, although we lacked some important variables, e.g. ECOG status. The median survival (8.3 months) in the RW-cohort was shorter than that of the control arm in e.g. KN-407(11.3 months). We aim to further investigate whether the CRN can be used to document the effect of treatments on “unselected” RW-populations.
Legal entity responsible for the study
The Norwegian Research Council.
S. Børø: Other, Personal, Full or part-time Employment, Siri Børø is employed by Merck AB Norway and a phd student at the University of Oslo. The phd is supported by a financial grant from the Norwegian Research Council for 3 years since 2021, through their Industrial phd program.