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Poster display session

3423 - Preliminar analysis 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). NORA trial (GECP 15/02)

Date

09 Sep 2017

Session

Poster display session

Presenters

Margarita Majem Tarruella

Citation

Annals of Oncology (2017) 28 (suppl_5): v457-v459. 10.1093/annonc/mdx379

Authors

M. Majem Tarruella1, L. Isla Casado2, M. Guirado3, B. Massuti Sureda4, A.L. Ortega Granados5, R. Marse Fabregat6, M. Domine Gomez7, R. de las Peñas8, M.T. Moran Bueno9, S. Vazquez Estevez10, M.A. Sala Gonzalez11, J. Coves Sarto12, J.M. Sánchez-Torres13, D. Vicente Baz14, J. Gonzalez-Larriba15, A. Paredes16, N. Farré17, L. Fernández Fornos18, A. Mena19, M. Provencio Pulla20

Author affiliations

  • 1 Medical Oncology, Hospital de la Santa Creu i Sant Pau, 8026 - Barcelona/ES
  • 2 Medical Oncology, University Hospital Lozano Blesa, Zaragoza/ES
  • 3 Medical Oncology, Hospital General Universitario de Elche, Elche/ES
  • 4 Medical Oncology, Hospital General Universitario de Alicante, 3010 - Alicante/ES
  • 5 Oncología Médica, Complejo Hospitalario de Jaén, 23006 - Jaén/ES
  • 6 Medical Oncology, Hospital Universitario Son Espases, Palma de Mallorca/ES
  • 7 Medical Oncology, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 8 Medical Oncology, Consorcio Hospitalario Provincial de Castellón, Castellón/ES
  • 9 Medical Oncology, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, 8916 - Badalona/ES
  • 10 Medical Oncology, Hospital Universitario Lucus Augusti, 27003 - Lugo/ES
  • 11 Medical Oncology Department, Hospital de Basurto, 48013 - Bilbao/ES
  • 12 Medical Oncology, Hospital Son Llàtzer, 7198 - Palma de Mallorca/ES
  • 13 Medical Oncology, Hospital Universitario de La Princesa, 28006 - Madrid/ES
  • 14 Medical Oncology, Hospital Universitario Virgen Macarena, 41003 - Sevilla/ES
  • 15 Medical Oncology, Hospital Clinico Universitario San Carlos, 28040 - Madrid/ES
  • 16 Medical Oncology, Hospital Universitario Donostia, San Sebastián/ES
  • 17 Radiation Oncology, Hospital de la Santa Creu i Sant Pau, 8026 - Barcelona/ES
  • 18 Radiation Oncology, Hospital General Universitario de Elche, Elche/ES
  • 19 Radiation Oncology, Hospital Universitario Son Espases, Palma de Mallorca/ES
  • 20 Medical Oncology, Hospital Universitario Puerta de Hierro Majadahonda, 28222 - Madrid/ES
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Resources

Abstract 3423

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, 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

Since May 2016, 58 pts have been recruited. Fifty-three pts have been included in the analysis. Pt characteristics: Male 72%; median age 63 (range 33-75); PS 0/1 62/48%; smokers 48%; adenocarcinoma/squamous 43.4/35.9%; stage IIIA/B 35.9/58.5%. Hematological G3-4 toxicities: neutropenia 18.9%; anemia 3.8%; febrile neutropenia 7.5%. Non-hematological G3-4 toxicities: esophagitis 1.9%; infection without neutropenia 1.9%; dyspnea 3.8%; thromboembolism 3.8%. No treatment-related deaths were reported.

Conclusions

mOV-P administered with RT has a manageable safety profile. Based on this, accrual is ongoing.

Clinical trial identification

EudraCT 2015-003312-21.

Legal entity responsible for the study

Spanish Lung Cancer Group (SLCG)

Funding

Spanish Lung Cancer Group (SLCG)

Disclosure

All authors have declared no conflicts of interest.

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