Abstract | OBJECTIVES: 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 randomized1:1 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.
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Authors | Dolores Isla, Ramón De Las Peñas, Amelia Insa, Raquel Marsé, Natividad Martínez-Banaclocha, Pilar Mut, Teresa Morán, María Ángeles Sala, Bartomeu Massuti, Ana Laura Ortega, José Miguel Jurado, José Gómez-Codina, Pilar Diz, Ángel Artal, Vanesa Gutiérrez, María Francisca Vázquez, Nuria Viñolas, Inmaculada Maestu, Carlos Camps, Rosa Álvarez, Melchor Álvarez de Mon Soto, Santiago Ponce, Mariano Provencio |
Journal | Lung cancer (Amsterdam, Netherlands)
(Lung Cancer)
Vol. 135
Pg. 161-168
(09 2019)
ISSN: 1872-8332 [Electronic] Ireland |
PMID | 31446990
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2018. Published by Elsevier B.V. |
Chemical References |
- Etoposide
- Cisplatin
- Vinorelbine
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Topics |
- Administration, Oral
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology, radiotherapy)
- Chemoradiotherapy
- Cisplatin
(administration & dosage)
- Etoposide
(administration & dosage)
- Female
- Humans
- Lung Neoplasms
(drug therapy, pathology, radiotherapy)
- Male
- Middle Aged
- Neoplasm Staging
- Patient Safety
- Survival Rate
- Vinorelbine
(administration & dosage)
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