Meeting
2016 ASCO Annual Meeting
Randomized phase II trial (RENO): Efficacy results of oral vinorelbine or etoposide combined with cisplatin in chemo-radiotherapy treatment of locally advanced NSCLC (LA-NSCLC)—SLCG 10/02.
Authors
Mariano Provencio
University Hospital Puerta De Hierro, Madrid, Spain
Mariano Provencio , Ramon de las Penas , Amelia Insa , Natividad Martinez-Banaclocha , Raquel Marse Fabregat , Pilar Mut Sanchis , Teresa Moran , Angeles Sala , Bartomeu Massuti , Ana Laura Ortega , Jose Miguel Jurado , Jose Gómez-Codina , Pilar Diz , Angel Artal-Cortes , Vanesa Gutierrez Calderon , Maria Francisca Vazquez , Nuria Vinolas , Miguel Angel Muñoz Quintana , Ramon Garcia-Gomez , Dolores Isla
Organizations
University Hospital Puerta De Hierro, Madrid, Spain, Hospital Provincial de Castellón, Castellón, Spain, Hospital Clinico Universitario de Valencia, Valencia, Spain, General University Hospital de Elche, Elche, Spain, University Hospital Son Espases, Palma De Mallorca, Spain, University Hospital Son Llatzer, Palma De Mallorca, Spain, Catalan Institute of Oncology, Badalona, Spain, Hospital de Basurto, Basurto, Spain, Alicante University Hospital, Alicante, Spain, Complejo Hospitalario de Jaén, Jaén, Spain, Hospital Clinico Universitario, Malaga, Spain, Hospital La Fe, Valencia, Spain, University Health Care Complex of Leon, Leon, Spain, H. Universitario Miguel Servet, Zaragoza, Spain, Regional University Hospital Carlos Haya, Málaga, Spain, University Hospital de Santiago, Santiago De Compostela, Spain, Medical Oncology, Hospital Clínic Barcelona, Barcelona, Spain, Valencian Institute of Oncology, Valencia, Spain, Hospital General Universitario Gregorio Marañón, Madrid, Spain, Department of Medical Oncology, Hospital Clínico Lozano Blesa, Zaragoza, Spain
Research Funding
Other
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 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). 121 confirmed eligibility for efficacy analysis. ORR were 39 (64%) and 40 pts (67%) in the oV-P and E-P arms, respectively (p = 0.889). After 16 m [1-43] of follow-up, 66% pts progressed and 43% pts died. Median PFS is 11.4 m (IC95%; 6-17) in oV-P arm and 11.8 m (IC95%; 7-16) in E-P arm (p = 0.374). Conclusions: Both regimens achieve similar efficacy however oV-P has less toxicity, especially esophagitis G3/4. Further follow-up is needed for the survival analysis. Clinical trial information: EudraCT number 2010-022927-31.
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Abstract Details
Session Type
Poster Session
Session Title
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Track
Lung Cancer
Sub Track
Local-Regional Non–Small Cell Lung Cancer
Clinical Trial Registration Number
EudraCT number 2010-022927-31
Citation
J Clin Oncol 34, 2016 (suppl; abstr 8538)
DOI
10.1200/JCO.2016.34.15_suppl.8538
Abstract #
8538
Poster Bd #
166
Abstract Disclosures
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