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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

3371 - Final results of RENO study: randomized phase II of oral vinorelbine or etoposide with cisplatin & chemo-radiation in stage III NSCLC. SLCG 10/02

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

Topics

Cytotoxic Therapy;  Radiation Oncology

Tumour Site

Presenters

Mariano Provencio Pulla

Citation

Annals of Oncology (2018) 29 (suppl_8): viii488-viii492. 10.1093/annonc/mdy291

Authors

M. Provencio Pulla1, R. de las Peñas2, N. Martinez Banaclocha3, R. MarsÉ Fabregat4, A. Insa Molla5, T. Moran6, M.A. Sala Gonzalez7, B. Massuti Sureda8, P. Mut Sanchis9, A.L. Ortega Granados10, J.M. Jurado11, J. Gomez Codina12, A. Artal-Cortes13, F. Vazquez14, V. Gutierrez Calderon15, P. Diz Tain16, N. Vinolas Segarra17, I. Maestu Maiques18, C. Camps19, M.D. Isla Casado20

Author affiliations

  • 1 Servicio De Oncología Médica, Hospital Universitario Puerta de Hierro - Majadahonda, 28222 - Majadahonda/ES
  • 2 Medical Oncology, Consorcio Hospitalario Provincial de Castellón, 12002 - Castellón/ES
  • 3 Medical Oncology, Hospital General Universitario de Elche, 3203 - Elche/ES
  • 4 Medical Oncology, Hospital Universitario Son Espases, 7010 - Palma de Mallorca/ES
  • 5 Medical Oncology, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 6 Medical Oncology, ICO Badalona, 08912 - Badalona/ES
  • 7 Medical Oncology, Hospital de Basurto, 48013 - Bilbao/ES
  • 8 Medical Oncology, Hospital General Universitario de Alicante, 3010 - Alicante/ES
  • 9 Medical Oncology, Sona Llàtzer Hospital, Palma de Mal - Palma de Mallorca/ES
  • 10 Oncología Médica, Complejo Hospitalario de Jaen Universidad de Jaen, 23007 - Jaen/ES
  • 11 Medical Oncology, Hospital Clinico San Cecilio, 18150 - Granada/ES
  • 12 Oncologia, Hospital Universitari i Politècnic La Fe, 46026 - Valencia/ES
  • 13 Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 14 Medical Oncology, Complejo Hospitalario Universitario de Santiago de Compostela SERGAS, 15706 - Santiago de Compostela/ES
  • 15 Medical Oncology, Universitary and Regional Hospital of Málaga, Málaga/ES
  • 16 Medical Oncology, Hospital Universitario de León, 7005 - Leon/ES
  • 17 Medical Oncology, Hospital Clinic y Provincial de Barcelona, 8036 - Barcelona/ES
  • 18 Medical Oncology, Hospital Dr. Peset Aleixandre, 46017 - Valencia/ES
  • 19 Medical Oncology, Consorcio Hospital General Universitario de Valencia, 46014 - Valencia/ES
  • 20 Medical Oncology, H. Clínico Zaragoza, Zaragoza/ES
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Resources

Abstract 3371

Background

This study aims to compare efficacy and safety of two widely used combinations of cisplatin (P) in this setting: as etoposide (E) and vinorelbine. This last, in its oral formulation (oV) which has achieved comparable results as the IV formulation and patients (pts) prefer it.

Methods

Pts between 18-75years, with histologically proven untreated and unresectable locally-advanced NSCLC (LA-NSCLC), adequate respiratory function, V20≤35% and ECOG-PS 0-1, were randomized 1:1 to oV-P arm: 2 induction cycles (cy) of oV-P followed by 2 cy more with RT; or to E-P arm: 2 cy of E-P concomitants to RT. Both arms with a total radiation dose of 66Gy administered 2 Gys daily. Primary endpoint was progression free survival (PFS) by RECIST 1.1. Secondary endpoints: overall response rate (ORR), overall survival (OS) and safety. With α-error of 0.05 (one-tailed test) and 0.1 β-error, median PFS unacceptable for the oV-P arm of 10 months (m) (p0) and a very acceptable of 15 m (p1), 122 eligible pts were required.

Results

140 pts from 23 institutions of SLCG were randomized between 08/2011-12/2014. 134 pts were treated (66 in oV-P and 68 in E-P arms). Results based on this 134 pts are presented. Median age 62 years [39-76]; PS 0/1, 45%/55%; current smoker 51%; squamous cell 51%; stage IIIB 54%. 244 and 131 cy were given in the oV-P and E-P arms, respectively. All irradiated pts in oV-P arm received at least 60Gy, 7 pts in the E-P arm received less than 60Gy (4 due to toxicity). 1 pt (1.5%) in oV-P arm and 12 pts (17.6%) in E-P arm presented esophagitis G3/4 (p = 0.002). ORR were 39 (61.9%) and 41 pts (65.1%) in the oV-P and E-P arms, respectively (p = 0.711). After 26.3 m [0.03-61] of follow-up, 77.9% pts progressed and 58.6% pts died. Median PFS was 10.8 m (CI95%; 7.5-14) in oV-P arm and 9.1 m (CI95%; 5.5-12.7) in E-P arm (p = 0.389). Median OS was 38 m (CI95%; 21.3-58.8) in oV-P and 27.1 m (CI95%; 19.3-34.9) in E-P arm (p = 0.547).

Conclusions

Clearly both regimens achieve similar efficacy however oV-P has less toxicity, especially esophagitis G3/4.

Clinical trial identification

EudraCT 2010-022927-31.

Legal entity responsible for the study

Spanish Lung Cancer Group.

Funding

Spanish Lung Cancer Group.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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