Abstract 1330
Background
There is a lack of well-established biomarkers to predict the efficacy of pemetrexed-based therapy. In this prospective phase II study, we investigated the correlation of folate receptor (FR)-positive circulating tumor cell (CTC) level with pemetrexed efficacy in patients with advanced non-squamous non-small cell lung cancer (nsNSCLC).
Methods
A total of 98 nsNSCLC patients were enrolled. Peripheral blood was collected from each patient prior to initiation of treatment. FR-positive CTCs were enriched by immunomagnetic leukocyte depletion and quantified using LT-PCR method.
Results
Patients with relatively low CTC level (11-16 FU/3 mL, n = 32) showed a significantly shorter progression-free survival (PFS) and overall survival (OS) compared to the ‘high CTC level group’ (≥16 FU/3 mL, n = 28; median PFS: 133 versus 320 days, hazard ratio[HR]=4.78, P = 0.0008; median OS: 632 days versus ‘not reached’, HR = 10.89, P = 0.0013). The ‘high CTC level group’ also achieved superior objective response rate (ORR) and disease control rate (DCR) over the ‘low CTC level group’ (ORR: 40.9% versus 9.5%, P = 0.0339; DCR: 100% versus 81.0%, P = 0.0485). The efficacy of pemetrexed in the ‘negative-CTC group’ (<11 FU/3 mL, n = 38) falls between the ‘high CTC level group’ and the ‘low CTC level group’ (median PFS: 290 days; median OS: 1122 days; ORR: 21.2%; DCR: 93.9%). When patients received only 1 cycle of treatment (n = 10) were excluded, the differences in both ORR, DCR, and OS between the CTC subgroups were more significant.
Conclusions
Our results implied that FR-positive CTC is an efficacious biomarker to predict the outcome of first-line pemetrexed-based therapy in nsNSCLC patients.
Clinical trial identification
ChiCTR-ONC-13003475.
Editorial acknowledgement
Legal entity responsible for the study
Shanghai Pulmonary Hospital.
Funding
This study was partially supported by Shanghai Committee of Science and technology (No. 14411970800). The funder had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2023 - Patients with brain metastases treated with afatinib in clinical practice – results from the prospective non-interventional study GIDEON
Presenter: Eckart Laack
Session: Poster Display session 1
Resources:
Abstract
1613 - Lerociclib (G1T38), an oral CDK4/6 inhibitor, dosed continuously in combination with osimertinib for EGFRmut non-small cell lung cancer: initial Phase 1b results
Presenter: David Berz
Session: Poster Display session 1
Resources:
Abstract
2853 - Real-world implementation of sequential targeted therapies for EGFR-mutated NSCLC
Presenter: Petros Christopoulos
Session: Poster Display session 1
Resources:
Abstract
1974 - A Phase II Open-Label, Multicentre Study to Assess the Anti-tumour Activity of Afatinib in Patients with Activating Epidermal Growth Factor Receptor mutation (EGFRm) from Circulating Tumor DNA (CtDNA)
Presenter: Young-Chul Kim
Session: Poster Display session 1
Resources:
Abstract
3370 - Influence of cow’s milk on the absorption and exposure of erlotinib in NSCLC patients
Presenter: Geerten Veerman
Session: Poster Display session 1
Resources:
Abstract
5900 - PTEN loss as Predictor of Tumor Heterogeneity (TH) and Poor Prognosis in EGFR-mutant Advanced Non-Small Cell Lung Cancer (ANSCLC) Patients (pts) Receiving Tyrosine-Kinase Inhibitors (TKIs).
Presenter: Miriam Ferrara
Session: Poster Display session 1
Resources:
Abstract
1302 - Safety of lorlatinib in subgroups of patients from a phase 1/2 trial
Presenter: Enriqueta Felip
Session: Poster Display session 1
Resources:
Abstract
1497 - Brigatinib (BRG) in Asian vs non-Asian patients (pts) with crizotinib (CRZ)-refractory ALK+ NSCLC in the phase 2 ALTA trial
Presenter: Dae Ho Lee
Session: Poster Display session 1
Resources:
Abstract
2349 - The safety assessment of crizotinib and alectinib from real world data of 840 ALK-inhibitor naïve patients with NSCLC harboring ALK-rearrangement (WJOG9516L).
Presenter: Kei Kunimasa
Session: Poster Display session 1
Resources:
Abstract
1120 - Brigatinib in ALK TKI-pretreated ALK+ metastatic non-small cell lung cancer (mNSCLC): the Use Via Expanded Access to Brigatinib (UVEA-Brig) study
Presenter: Silvia Novello
Session: Poster Display session 1
Resources:
Abstract