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Poster Display session 1

2204 - NORA trial (GECP 15/02): Updated results of the Spanish Lung Cancer Group (SLCG) phase II trial of concurrent chemo-radiotherapy (CT-RT) with cisplatin (P) plus metronomic oral vinorelbine (mOV) for unresectable locally advanced non-small cell lung cancer (LA-NSCLC)

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

María Guirado

Citation

Annals of Oncology (2019) 30 (suppl_5): v591-v601. 10.1093/annonc/mdz259

Authors

M. Guirado1, M. Majem2, B. Massuti3, R. de las Penas Bataller4, A.L. Ortega Granados5, M.D. Isla Casado6, M. Domine Gomez7, R. Marse Fabregat8, M..A. Sala9, A. Paredes Lario10, M.T. Moran Bueno11, S. Vazquez Estevez12, J. Coves Sarto13, J.L. Gonzalez-Larriba14, J.M. Sanchez Torres15, D. Vicente16, N. Farre Bernado17, L. Fernandez-Fornos18, F. Varcarcel19, M. Provencio20

Author affiliations

  • 1 Department Of Medical Oncology, Hospital General Universitario de Elche, 03203 - Elche/ES
  • 2 Department Of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona/ES
  • 3 Department Of Medical Oncology, Hospital General Universitario de Alicante, 03010 - Alicante/ES
  • 4 Medical Oncology, Hospital Provincial Castellon, 12002 - Castellón/ES
  • 5 Oncología Médica, Complejo Hospitalario de Jaen Universidad de Jaen, 23007 - Jaen/ES
  • 6 Department Of Medical Oncology, Hospital Clinico Universitario Lozano Blesa, 50009 - Zaragoza/ES
  • 7 Department Of Medical Oncology, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 8 Dept. Medical Oncology, Hospital Universitario Son Espases, 07120 - Palma de Mallorca/ES
  • 9 Department Of Medical Oncology, Hospital de Basurto, Bilbao/ES
  • 10 Medical Oncology, Hospital Universitario Donostia, 20014 - San Sebastián/ES
  • 11 Department Of Medical Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, 08916 - Badalona/ES
  • 12 Department Of Medical Oncology, Hospital Xeral Calde of Lugo, 27004 - Lugo/ES
  • 13 Department Of Medical Oncology, Hospital Son Llatzer, 7198 - Palma de Mallorca/ES
  • 14 Department Of Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 15 Department Of Medical Oncology, Hospital Universitario de La Princesa, 28006 - Madrid/ES
  • 16 Department Of Medical Oncology, Hospital Universitario Virgen Macarena, 41007 - Sevilla/ES
  • 17 Department Of Radiotherapic Oncology, Hospital de la Santa Creu i Sant Pau, 08026 - Barcelona/ES
  • 18 Department Radiotherapic Oncology, Hospital General Universitario de Alicante, 03010 - Alicante/ES
  • 19 Department Of Radiotherapic Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, 28222 - Madrid/ES
  • 20 Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, 28222 - Madrid/ES

Resources

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Abstract 2204

Background

CT-RT is the standard treatment for unresectable LA-NSCLC. P plus vinorelbine is widely used. Metronomic CT is a frequent administration of low doses of CT. mOV has shown good efficacy and improved safety, and could improve the RT effect. Our goal is to evaluate the efficacy and safety of P-mOV with radical RT in patients (pts) with LA-NSCLC.

Methods

Pts aged 18-75 years with histologically proven untreated and unresectable LA-NSCLC, adequate bone marrow, hepatic & renal function, ECOG PS0-1, received P 80mg/m2 D1 every 3 weeks combined with mOV 50mg/day on days D1, 3 & 5/weekly, 2 cycles (cy) as induction; patients without progression received 2 more cy of P at the same dose with mOV 30mg/day on D1, 3 & 5/weekly, concurrently with RT (66Gy in 6.5weeks). Primary endpoint was progression-free survival (PFS) by RECIST v1.1; secondary endpoints were: overall response rate (ORR), disease control rate (DCR), overall survival and safety profile. To guarantee an overall type-1 α error no greater than 0.05 and a type II (β) error 0.1 for PFS, a sample size of 67 pts was planned.

Results

Sixty-seven pts were recruited in 17 Spanish sites from 04/2016 to 06/2017. One of them didn’t meet all the inclusion criteria. We analyzed 66 pts included. Pt characteristics: Male 77.3%; median age 62 (range 33-75); PS 0/1 52/49%; smokers 53%; adenocarcinoma/squamous 43.9/42.4%; stage IIIA/B 42.4/57.6%. Only 32.3% of pts presented any grade 3-4 adverse event, including: neutropenia 20.0%; anemia 4.6%; febrile neutropenia 6.2%; esophagitis 3.1%; pneumonitis 1.5%. There were two deaths non-related to the treatment, during this period. Fifty-one pts have completed the treatment. ORR: 67.7%. DCR: 84.6%. With a median follow-up of 22.3 months (range 1.1-34.9), the median PFS is 11.5 months (CI95%; 9.9-15,4).

Conclusions

mOV-P with RT is as effective as the standard administration of vinorelbine, improving its safety profile.

Clinical trial identification

EudraCT 2015-003312-21.

Editorial acknowledgement

Legal entity responsible for the study

Spanish Lung Cancer Group.

Funding

Pierre Fabre.

Disclosure

All authors have declared no conflicts of interest.

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