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Aylen Vanessa Ospina Serrano
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P09 - Health Services Research/Health Economics - Real World Outcomes (ID 121)
- Event: WCLC 2020
- Type: Posters
- Track: Health Services Research/Health Economics
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P09.49 - Experience with Immunotherapy Treatment in Fundación Santa Fe Bogotá: Real World Data in Metastatic Non-Small Cell Lung Cancer Patients. (ID 3341)
00:00 - 00:00 | Presenting Author(s): Aylen Vanessa Ospina Serrano
- Abstract
Introduction
Immunotherapy for treatment of NSCLC has been commercially available in Colombia since 2017. It has been an interesting process to learn about the management of immune-related adverse events (IRAEs) and evaluation of clinical and radiologic response.
The objective of this study is to show real-world evidence of experience with this kind of treatment in our institution.
Methods
An observational study was conducted with a cohort of patients with non-small stage IV cell lung cancer who received immunotherapy treatment.
Across the follow up to determine tumoral response , we did images after the 3rd, 6th and 12th cycle of treatment, these were measured using IRECIST criteria. The results of this evaluation were then verified with the clinical decision of the oncologists, and in case of considering pseudoprogression, it was confirmed with a new control image.
Toxicities related with immunotherapy were reported using measures of central tendency, and for survival analysis the Kaplan-Meier model was used.
Results
A total of 21 patients under immunotherapy treatment, with or without chemotherapy, met the inclusion criteria of the study. Forty-five images were evaluated after cycle 3,6,12. For all images, IRECIST criteria was used and verified with clinical decision.
The available images included PET-CT (35%) and CT (65% ). Pseudoprogression was found in 13.3% of patients, one case (16.6%) was reported in PET-CT, and 83.3% in CT.
66% of the pseudoprogression cases were observed at the first image (PET-CT or CT), 16.6% at the second image and 16.6% at the last image.
In patients who received chemo-immunotherapy (57.9%) pseudoprogression was 9%, while in patients who received immunotherapy alone (42.1%) pseudoprogression was 39%.
In relation to IRAEs, hypothyroidism was the most frequent adverse event (36.8%) in all the population . Severe IRAEs were reported only in the group of patients with immunotherapy as monoagent : autoimmune colitis (5.2%) and myofascial pain syndrome (5.2%) , which required temporary suspension of treatment.
Clinical outcomes were classified according to PDL-1. For PDL-1 >50% all patients received immunotherapy alone and the OSm was 12.5m and PFS 9.5m. For PDL-1 between 1-49%, all patients received chemo-immunotherapy and PFS was 36m and OSm 36.8m. Patients with PDL1 <1% received treatment with chemotherapy and immunotherapy and the OSm 21.6m and PFS 9.6m.
Conclusion
In our institution, during the follow up of the patients under inmunotherapy treatment, the presence of pseudoprogression in images was similar to reports in worldwide literature. The higher prevalence was reported in the first control with CT scan as well as in patients with immunotherapy treatment as monoagent.
About IRAEs, hypothyroidism was the most frequent adverse event in all the population. Only the patients under inmunotherapy as monoagent had severe IRAEs (10.4%) and required temporary suspension of treatment.
In relation to clinical outcomes, the higher OSm and PFS was for patientes with PDL-1 between 1-49%.
It must be highlighted that this is a small cohort of patients and thus, population conclusions cannot be made.
