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G. Cruz-Rico
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P2.03b - Poster Session with Presenters Present (ID 465)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03b-083 - Soluble Angiogenic Factors as Predictive Biomarkers of Response to Docetaxel plus Nintedanib as Second Line Therapy in NSCLC (ID 5199)
14:30 - 14:30 | Author(s): G. Cruz-Rico
- Abstract
Background:
Angiogenesis is fundamental for progression in non-small cell lung cancer (NSCLC). Nintedanib is a potent, triple angiokinase inhibitor of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-derived growth factor (PDGF). We evaluated the association between plasma levels of VEGF, FGF, and PDGF, both baseline and after treatment with Nintedanib plus Docetaxel, as well as disease control rate (DCR), progression-free survival (PFS) and overall survival (OS), among patients with NSCLC.
Methods:
Thirty-eight patients were enrolled from July 2014 through October 2015. Stage IIIB/IV NSCLC patients who had progression after first-line chemotherapy with adenocarcinoma histology were included. Patients received Docetaxel 75mg/m2 on day 1 plus 200mg of Nintedanib orally twice daily on days 2-21 every three weeks until unacceptable adverse events or disease progression. Peripheral blood samples were taken at baseline and after completion of the second cycle of Docetaxel plus Nintedanib therapy to measure angiogenic factors.
Results:
Mean age at diagnosis was 58.7 years. Eighty-two percent of the patients had metastatic disease, and a good (<2) ECOG performance status (97.4%). Acinar (21.1%) and papillary (15.8%) sub-histological types were the most common adenocarcinoma predominant patterns. Overall response rate and DCR were of 7.9% and 47.3%, respectively. Baseline values of FGF, VEGF and PDGF were 27.6 pg/ml; 122.7 pg/ml and 8,655 pg/ml. Patients with DCR were more likely to have lower median serological values of FGF at follow-up (33.1 vs. 88.1 pg/ml; p=0.0017). Median PFS was 3.7 months. Both in the univariate and multivariate analyses, a higher percentage change reduction in PDGF after treatment was associated with a longer PFS (6.37 vs. 3.58 months, p=0.059; Hazard ratio (HR): 3.15, p=0.024). OS of patients was 8.8 months. Both in the univariate and mutivariate analysis a higher percentage change in FGF was associated with a longer OS (13.8 vs. 7.16 months, p=0.006; HR: 3.63, p=0.033].
Conclusion:
A higher reduction of plasma levels of FGF and PDGF was associated with better clinical outcomes.
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P2.03b-088 - PET-CT with 68Ga-RGD as Biomarker of Response to Nintedanib plus Docetaxel as Second Line Therapy in NSCLC (ID 5196)
14:30 - 14:30 | Author(s): G. Cruz-Rico
- Abstract
Background:
Nintedanib, an approved second-line treatment for NSCLC in combination with docetaxel, is an oral angiokinase inhibitor against pro-angiogenic pathways. Advanced techniques in nuclear medicine have developed new radiotracers, such as Ga68-RGD for assessment of tumor vascularity and therapy response. The αVβ3 integrin is a transmembrane protein of great importance in tumor angiogenesis, due to its massive overexpression. Peptides containing the RGD sequence have high affinity for αVβ3 integrin receptors overexpressed in tumor cells. We evaluate objective-response rate (ORR), disease-control rate (DCR) by RECIST v.1.1, progression-free survival benefit (PFS) and overall survival (OS) obtained by Nintedanib plus Docetaxel therapy, and its response measured by PET-CT with Ga68-RGD biomarker.
Methods:
Study enrollment from July 2014 to October 2015. Inclusion criteria were confirmed adenocarcinoma histology, and disease progression after platinum-based-chemotherapy. Thirty-eight patients were assigned to receive Docetaxel (75mg/m2, IV) on day 1 plus Nintedanib (200mg, orally twice daily) on days 2-21 every three weeks until unacceptable adverse events or disease progression. All patients underwent a PET-CT with IV tracer Ga68-RGD and measurements at three time points (30, 60 and 120 mins) prior treatment start and after completing 2 therapy cycles.
Results:
Mean age at diagnosis was 58.7±11.4 years. Of the 38 patients, 31 had complete data for analysis. After 2 treatment cycles, the PET-CT assessment response, based on baseline Lung/Spleen SUVmax index, showed an ORR of 7.9% and DCR of 47.3%. Median PFS of 3.7 months and median Hypertensive patients were more likely to have a higher PFS (6.3 vs. 3.3 months; p=0.023), as well as patients with a larger baseline tumoral-volume by Ga68-RGD PET-CT (2.1 vs. 6.1 months; p=0.007). Global OS was of 8.8 months. Non-smokers were more likely to have larger OS (9.3 vs 4.2; p=0.008). Also a median OS was longer among patients with higher Lung/Spleen SUVmax index percentage change after treatment (9.4 vs. 4.9 months; p=0.05) was found.
Conclusion:
A larger baseline tumoral-volume can be associated to a higher progression-free survival due to the major cellular component to target with antiangiogenic therapy, as well as a strong association of larger survival assessed by the Lung/Spleen SUVmax index after treatment, marked by the Ga68-RGD radiotracer.
