Abstract 1169P
Background
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.
Methods
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.
Results
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. Table: 1169P
| 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 |
Conclusions
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.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The author.
Funding
The Norwegian Research Council.
Disclosure
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.