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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

5653 - Analysis of circulating biomarkers in A randomized phase II trial of maintenance oral metronomic vinorelbine in advanced NSCLC following platinum-based chemotherapy: A correlative MA.NI.LA. trial study

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Mattia Boeri

Citation

Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269

Authors

M. Boeri1, F. Nichetti2, L. Porcu3, V. Torri4, A. Del Conte5, A. Martinetti2, E. Sottotetti2, E. Vattemi6, F. Verderame7, M.C. Garassino8, L. Cavanna9, A. Tuzi10, L. Irtelli11, F.G.M. de Braud12, M. Platania2

Author affiliations

  • 1 Research Department, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, 20133 - Milan/IT
  • 2 Medical Oncology 1, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 3 Oncology, ASUIUD Azienda Ospedaliero-Universitaria di Udine, 33100 - udine/IT
  • 4 Oncology, IRCCS Istituto Di Ricerche Farmacologiche Mario Negri, Milan/IT
  • 5 Oncology, Azienda Ospedaliera Sta Maria degli Angeli, 33170 - Pordenone/IT
  • 6 Medical Oncology, Ospedale Centrale di Bolzano ASDAA/SABES, 39100 - Bolzano/IT
  • 7 Oncology, PRESIDIO OSPEDALIERO CERVELLO, 90146 - Palermo/IT
  • 8 Thoracic Unit, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 9 Oncology Department, Azienda Ospedaliera Piacenza, 29121 - Piacenza/IT
  • 10 Oncology, Ospedale di Circolo Fondazione Macchi, 21050 - Varese/IT
  • 11 Oncology, P.O. Clinicizzato Ss. Annunziata Universita' Degli Studi, 66100 - Chieti/IT
  • 12 Medical Oncology & Haemathology, Istituto Nazionale dei Tumori di Milano - Fondazione IRCCS, 20133 - Milan/IT
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Resources

Abstract 5653

Background

The efficacy of maintenance chemotherapy (CT) in advanced NSCLC is still under investigation. The multicenter, open label, randomized, phase II MA.NI.LA trial aimed to assess the activity of metronomic oral vinorelbine versus close observation as maintenance treatment following platinum-based CT in patients with advanced NSCLC. Serum angiogenesis biomarkers and the plasma microRNA signature classifier (MSC) associated with tumor aggressiveness in NSCLC patients were here investigated as prognostic and predictive factors.

Methods

119 advanced NSCLC patients with stable disease after platinum-based CT received maintenance metronomic oral vinorelbine (ARM A) or close observation (ARM B). The primary endpoint of the trial was progression free survival (PFS). Plasma samples for biomarkers evaluation were collected at the baseline from all patients. Concentrations of VEGFA and THBS1 were determined using EIA kit (Chemicon International). To determine MSC risk level, custom made microfluidic cards (Thermo Fisher) were adopted to analyze 8 samples simultaneously by RT-qPCR. Cox regression model was used to evaluate the association of biomarkers to PFS and OS.

Results

In the whole cohort, median age was 68.8; M/F: 79/40; stage IIIb/IV:14/105; adeno/other:73/46; PS 0-1/2:113/7. In front of a median follow up of 23.9 months, median PFS was 4.3 and 2.8 months for ARM A and ARM B, respectively (HR = 0.73; 90%CI 0.53-0.999; p = 0.0493). Considering all 119 patients, high VEGFA and THBS1 plasma levels and positive MSC expression were associated with shorter both PFS and OS. HR for 1000 unit, VEGF: 1.56 (90%CI 0.99-2.46; p = 0.054); HR for 10000 unit, THBS1: 1.16 (90%CI 0.97-1.38; p = 0.114); HR for MSC pos vs neg: 1.61 (90%CI 1.05-2.47; p = 0.028). Similar results were obtained considering OS. No interaction between treatment effect and biomarker values were detected.

Conclusions

In advanced NSCLC following platinum-based induction CT, metronomic oral vinorelbine showed a modest, but significant improvement in PFS. In addition, VEGF and MSC could be considered as prognostic but not predictive factors

Clinical trial identification

NCT02176369.

Legal entity responsible for the study

Clips srl.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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