Oral vinorelbine versus etoposide with cisplatin and chemo-radiation as treatment in patients with stage III non-small cell lung cancer: A randomized phase II (RENO study)
Por:
Isla D, De Las Peñas R, Insa A, Marsé R, Martínez-Banaclocha N, Mut P, Morán T, Sala MÁ, Massuti B, Ortega AL, Jurado JM, Gómez-Codina J, Diz P, Artal Á, Gutiérrez V, Vázquez MF, Viñolas N, Maestu I, Camps C, Álvarez R, de Mon Soto MÁ, Ponce S and Provencio M
Publicada:
1 sep 2019
Ahead of Print:
1 dic 2018
Resumen:
Objectives: Concomitant chemo-radiation is the standard treatment for
unresectable stage III non-small cell lung cancer (LA-NSCLC), The aim of
this study was to assess the safety and efficacy of oral vinorelbine and
cisplatin (OVP) compared with etoposide and cisplatin (EP), both in
combination with radiotherapy, in this setting.
Material and methods: An open-label, randomized phase II trial was
undertaken including 23 hospitals in Spain. Adults with untreated
unresectable stage III NSCLC were randomizedl:1 to receive: oral
vinorelbine (days 1 and 8 with cisplatin on day 1 in 3-week cycles; 2
cycles of induction, 2 cycles in concomitance) or etoposide (days 1-5
and 29-32 with cisplatin on days 1 and 8 in 4-week cycles; 2 cycles in
concomitance). Both groups received concomitant radiotherapy 2 Gy/day
(66 Gy). The primary endpoint was progression free survival (PFS).
Results: One hundred and forty patients were enrolled. Sixty-nine
patients received OVP and 71 received EP. Globally adverse events grade
3/4 per cycle were fewer in the vinorelbine arm (19.4%) than in the
etoposide arm (62.6%) (p < 0.001). One patient (1.5%) in the OVP arm and
12 pts (17.6%) in the EP arm presented esophagitis grade 3/4 (p =
0.002). Median PFS was similar in both groups (10.8 [95% CI 7.7-13.8]
and 9.6 months [95% CI 4.4-14.8]; p = 0.457, respectively). Preliminary
median overall survival was 30 months in the OVP arm and 31.9 months in
the EP arm (p = 0.688).
Conclusions: Our findings show that OVP could be considered a standard
combination with similar efficacy and better safety profile for the
treatment of LA-NSCLC patients.
Filiaciones:
Isla D:
Medical Oncology, University Hospital Clínico Lozano Blesa, Zaragoza, Spain
De Las Peñas R:
Medical Oncology, Provincial Hospital de Castellón, Castellón, Spain
Insa A:
Medical Oncology, University Hospital Clínic, Valencia, Spain
Marsé R:
Medical Oncology, University Hospital Son Espases, Palma De Mallorca, Spain
:
Medical Oncology, General University Hospital de Elche, Elche, Spain
Mut P:
Medical Oncology, Hospital Son Llàtzer, Palma De Mallorca, Spain
Morán T:
Medical Oncology, Catalan Institute of Oncology, Hospital Universitari Germans Triasi Pujol, Universitat Autònoma de Barcelona, Badalona, Spain
Sala MÁ:
Medical Oncology, University Hospital Basurto, Bilbao, Spain
:
Medical Oncology, General University Hospital de Alicante, Alicante, Spain
Ortega AL:
Medical Oncology, Hospitality complex of Jaén, Jaén, Spain
Jurado JM:
Medical Oncology, University Hospital San Cecilio, Granada, Spain
Gómez-Codina J:
Medical Oncology, University and Polytechnic Hospital La Fe, Valencia, Spain
Diz P:
Medical Oncology, Assistent Complex of León, Léon, Spain
Artal Á:
Medical Oncology, University Hospital Miguel Servet, Zaragoza, Spain
Gutiérrez V:
Medical Oncology, Regional University Hospital of Málaga, Málaga, Spain
Vázquez MF:
Medical Oncology, University Hospitality Complex of Santiago, Santiago de Compostela, Spain
Viñolas N:
Medical Oncology, University Hospital Clínic de Barcelona, Barcelona, Spain
Maestu I:
Medical Oncology, University Hospital Doctor Peset, Valencia, Spain
Camps C:
Medical Oncology, General University Hospital of Valencia, Centro de Investigación Biomédica en Red de Cáncer. Department of Medicine, Universitat de València, Valencia, Spain
Álvarez R:
Medical Oncology, General University Hospital of Gregorio Marañón, Madrid, Spain
de Mon Soto MÁ:
Medical Oncology, University Hospital of Príncipe de Asturias, Spain
Ponce S:
Medical Oncology, University Hospital 12 de Ocutbre, Spain
Provencio M:
Medical Oncology, University Hospital Puerta de Hierro, Majadahonda Medical Oncology. Spanish Lung Cancer Group (SLCG), Spain
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