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E-Poster Display

1306P - Platin pemetrexed with or without bevacizumab with upfront versus “at progression” brain radiotherapy in advanced non squamous non-small cell lung cancer with asymptomatic brain metastasis: A randomized phase III trial (Metal2 trial)

Date

17 Sep 2020

Session

E-Poster Display

Topics

Immunotherapy

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Isabelle Monnet

Citation

Annals of Oncology (2020) 31 (suppl_4): S754-S840. 10.1016/annonc/annonc283

Authors

I. Monnet1, A. Vergnenegre2, G. Robinet3, H. Berard4, R. Lamy5, L. Falchero6, S. vieillot7, R. Schott8, H. Lena9, S. Chouabe10, P. Thomas11, R. Gervais12, A. Madroszyk Flandin13, S. Abdiche14, A. Chiappa15, L. Greillier16, C. Decroisette17, J.B. Auliac18, C. Chouaid19

Author affiliations

  • 1 Pneumology, CH Intercommunal de Créteil, 94010 - Creteil/FR
  • 2 Uotc Department- Unité Oncologie Thoracique Et Cutanée, CHU Limoges - Hopital Dupuytren, 87042 - Limoges/FR
  • 3 Oncology, C.H.U. Brest - Hôpital Morvan, 29609 - Brest/FR
  • 4 Oncology, Hôpital d'Instruction des armées Sainte-Anne, Toulon/FR
  • 5 Oncology, CH Sud Bretagne, 56322 - Lorient/FR
  • 6 Pneumology, Hospital Center De Villefranche-Sur-Saône, 69400 - Gleizé/FR
  • 7 Radiation Oncology, catalan oncology center, 66000 - PERPIGNAN/FR
  • 8 Medical Oncology, Centre Paul Strauss Centre de Lutte contre le Cancer, 67065 - Strasbourg/FR
  • 9 Pneumology, CHU Rennes - Hôpital Pontchaillou, 35033 - Rennes/FR
  • 10 Pneumology, hopital manchester, 080000 - charleville-mezieres/FR
  • 11 Pneumology, CHU Alpes du Sud - Site de Gap, 5007 - Gap/FR
  • 12 Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 13 Oncology, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 14 Radiation Oncology, Centre Hospitalier de Libourne Hôpital Robert Boulin, 33505 - Libourne/FR
  • 15 Pneumologie, CH Cornouaille, 02900 - Quimper/FR
  • 16 Multidisciplinary Oncology And Therapeutic Innovations, Hopital St. Marguerite Assistance Publique Hopitaux de Marseille, 13009 - Marseille/FR
  • 17 Pneumology, Le Centre Hospitalier Annecy Genevois, 74370 - Metz-Tessy/FR
  • 18 Pneumology, CH François Quesnay, 78201 - Mantes La Jolie/FR
  • 19 Pneumology, CH Intercommunal de Créteil, 94010 - Créteil/FR

Resources

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Abstract 1306P

Background

In patients with advanced non-small cell lung cancer (NSCLC) and brain metastasis (BM), the role and the timing of brain radiotherapy (BR) are not well established. This study investigates whether the upfront BR is superior to “at progression” BR in patients with NSCLC and asymptomatic BM.

Methods

This open-label, multicenter, phase 3 trial, randomized (1:1) patients with non squamous NSCLC and asymptomatic BM, between upfront or “at progression” BR (whole brain or stereotaxic), associated with chemotherapy (platin-pemetrexed and bevacizumab in eligible patients, followed by pemetrexed with or without bevacizumab as maintenance). Primary endpoint was progression free survival (PFS), secondary endpoints were overall survival (OS), global and cerebral objective response rate (ORR), toxicity, quality of life (NCT02162537).

Results

The trial has been stopped early because of a slow recruitment; 95 patients were included and 91 randomized from 01/2014 to 01/2018 in 24 centers, 45 in upfront BR, 46 in “at progression” BR arm (age: 60 ± 8,3, men: 74%, PS 0/1: 51.7%/48.3%; adenocarcinoma: 92.2%, extra cerebral metastases: 57.8%), without differences between arms. Significantly more patients received BR in upfront arm compare to “at progression” arm (87% versus 20%, p<0.001); Duration of chemotherapy was identical (4 months) in both arms. Respectively 42.2% and 43.5% received a second line treatment (mainly docetaxel), in upfront and “at progression” arms; there is no differences in term of median PFS (4.7, 95% CI: 3.4-7.5 versus 4.8, 95% CI 2.4-6.5 months,), cerebral and extra cerebral ORR (ORR 27 % vs 13 %, p =0.064, and 30% vs 41%, p=0.245) and median OS (8.5, months 95%CI 5.6-11.1 versus 8.3 months, 95% CI 4.5-11.5 respectively). There is a trend for more gr 3/4 neutropenia in “at progression” compare to upfront arm (13% vs 6%, p = 0.045), and no difference for the other toxicities.

Conclusions

The significant difference in terms of proportion of BR performed in the two arms suggests that upfront BR is not mandatory in this situation.

Clinical trial identification

NCT02162537.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Lilly, Roche.

Disclosure

All authors have declared no conflicts of interest.

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