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Published on: April 11, 2016
Impact of Comprehensive Genome Profiling on the Management of Advanced Non-Small Cell Lung Cancer: Preliminary
Antonio Vitale1,2, Luca Mastrantoni1,2, Jacopo Russo1,2
1Comprehensive Cancer Center, Medical Oncology Department, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Purpose:
The clinical and research FPG500 program (ClinicalTrials.gov identifier: NCT06020625) is currently ongoing at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS to tailor matched targeted therapies (MTTs) according to biomarkers predictive of response identified by comprehensive genome profiling (CGP).
Materials And Methods:
The non-small cell lung cancer (NSCLC) cohort results from the FPG500 program are outlined. CGP was performed by TruSight Oncology 500 High Throughput (TSO500HT) assay or Oncomine Focus Assay plus Archer's FusionPlex Lung Panel according to tumor cell content and DNA/RNA quantity. Relevant issues for Molecular Tumor Board (MTB) evaluation included uncommon genomic findings, evaluation for off-label therapies, uncertain result confirmation, and variants of suspect germline origin requiring genetic counseling. Progression-free survival (PFS) and overall survival (OS) for the enrolled patients were assessed using Kaplan-Meier analysis.
Results:
In 2022, 283 patients with NSCLC were considered for sequencing, with 93% meeting eligibility criteria. TSO500HT sequencing was conducted in 76% of patients. Follow-up data were obtained for 187 patients, among whom 81% received treatment. Potential driver alterations were identified in 59% of patients, with 41% receiving MTT: 25% were prescribed approved MTTs, whereas 16% gained access to experimental drugs post-MTB evaluation; of note, 18% did not receive any MTT because the regimen was not yet reimbursed in our country. Median PFS and OS varied among treatment groups, with standard chemotherapy/immunotherapy at 7.7 and 10.7 months, approved tyrosine kinase inhibitors at 18.8 and 23.9 months, and MTT post-MTB discussion at 14 and 23.4 months, respectively.
Conclusion:
The early data of the FPG program (NSCLC cohort) support the implementation of CGP and MTB in clinical practice to grant access to patients harboring actionable molecular alterations to the most effective and individualized available treatment options, thus improving their survival outcomes.
Insights
Comprehensive genome profiling (CGP) and molecular tumor board (MTB) evaluations in non-small cell lung cancer (NSCLC) patients identified actionable biomarkers. This enabled tailored targeted therapies, significantly improving progression-free and overall survival outcomes.
Area of Science:
- Oncology
- Genomics
- Precision Medicine
Background:
- Non-small cell lung cancer (NSCLC) treatment is evolving towards personalized approaches.
- Comprehensive genome profiling (CGP) aids in identifying actionable molecular alterations.
- The FPG500 program investigates tailored matched targeted therapies (MTTs) based on CGP biomarkers.
Purpose of the Study:
- To evaluate the clinical utility of CGP and molecular tumor board (MTB) in tailoring MTTs for NSCLC patients.
- To assess the impact of MTTs on progression-free survival (PFS) and overall survival (OS).
Main Methods:
- CGP was performed using TSO500HT or Oncomine Focus Assay.
- MTBs evaluated genomic findings, off-label therapies, and uncertain results.
- PFS and OS were analyzed using Kaplan-Meier methods for different treatment groups.
Main Results:
- 59% of NSCLC patients had potential driver alterations identified.
- 41% received MTTs, with 25% on approved therapies and 16% on experimental drugs post-MTB.
- MTTs post-MTB discussion showed improved median PFS (14 months) and OS (23.4 months) compared to standard treatments.
Conclusions:
- Early data support integrating CGP and MTB into clinical practice for NSCLC.
- This approach facilitates patient access to effective, individualized treatments.
- Implementation of CGP and MTB improves survival outcomes for NSCLC patients with actionable alterations.
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