Abstract 55P
Background
Liquid next-generation sequencing (NGS) of plasma cell-free DNA (cfDNA) has become a promising tool for the identification of driver mutations in non-small cell lung cancer (NSCLC). Whether liquid NGS performed immediately at the start of tumor workup could further enhance NSCLC patient survival is unclear.
Methods
The prospective randomized observational study enrolled patients with suspicious advanced NSCLC. All the eligible patients received liquid NGS (Guardant360) immediately at the first visit and were randomized into two groups: Group A patients obtained the NGS results after the pathological diagnosis and the molecular testing (EGFR, ALK, ROS1, and BRAF) turned out; group B patients were informed of the NGS results once the test had been completed. The primary endpoint was the time-to-treatment of NSCLC. Other cancer-related outcomes were analyzed.
Results
A total of 180 patients were enrolled in our study, with 87 in group A and 93 in group B. Subjects with benign disease, other cancer types, small cell lung cancer, early-stage NSCLC were excluded, and there were 63 group A patients and 59 group B advanced NSCLC patients entering the final analysis. Most of the patients were adenocarcinoma (group A: 49 of 63, 77.8%; group B: 47 of 59, 79.7%). The prevalence of EGFR in the two groups was also similar, with 57.1% (36 of 63) in group A and 56.6% (34 of 59) in group B. Other driver mutations were rare in the two groups (group A: 2 ALK, 1 ROS1; group B: 2 BRAF and 1 MET exon 14 skipping). The median time to treatment of group A vs B was 33 vs 20 days (p-value <0.0001). The result was similar in patients receiving targeted therapy or chemo/immunotherapies. Among EGFR mutant patients who were treated with EGFR TKI, the ORR and PFS did not differ in group A and B (A vs B: ORR 53.6% vs 72%, p=0.384; PFS NE vs 11.9 months, p=0.280). However, in patients treated with immunotherapy with or without chemotherapy, group B patients seemed to have a longer PFS (A vs B, 4.5 vs NE months, p=0.041).
Conclusions
Performing liquid NGS as an initial approach of advanced NSCLC tumor workup can shorten the interval between diagnosis to anti-cancer treatment and perhaps may improve survival in selected patients. Long term follow-up of our study is ongoing.
Legal entity responsible for the study
The authors.
Funding
YongLin Healthcare Foundation.
Disclosure
S. Wu: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb. Y. Lin: Financial Interests, Personal, Invited Speaker: ACT genomics; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Manudipharma; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: TTY Biopharm; Financial Interests, Personal, Other, Travel expense: Pfizer. All other authors have declared no conflicts of interest.