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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)
- Source :
- LUNG CANCER, r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, instname, Lung Cancer, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, r-FISABIO. Repositorio Institucional de Producción Científica, r-FHPC. Repositorio Institucional de Producción Científica de la Fundación del Hospital Provincial de Castellón
- Publication Year :
- 2019
- Publisher :
- Elsevier BV, 2019.
-
Abstract
- 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.
- Subjects :
- 0301 basic medicine
Pulmonary and Respiratory Medicine
Oncology
Adult
Male
Cancer Research
medicine.medical_specialty
Lung Neoplasms
Disease-free survival
medicine.medical_treatment
Neoplasm metastasis
Administration, Oral
Vinorelbine
03 medical and health sciences
0302 clinical medicine
Non-small cell lung cancer
Internal medicine
Carcinoma, Non-Small-Cell Lung
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Humans
Progression-free survival
neoplasms
Etoposide
Aged
Neoplasm Staging
Cisplatin
business.industry
Standard treatment
Chemoradiotherapy
Middle Aged
Phase II
respiratory tract diseases
Radiation therapy
Survival Rate
Clinical trial
030104 developmental biology
030220 oncology & carcinogenesis
Concomitant
Female
Patient Safety
business
Clinical trial, Disease-free survival, Etoposide, Neoplasm metastasis, Non-small cell lung cancer, Phase II, Vinorelbine
medicine.drug
Subjects
Details
- ISSN :
- 01695002
- Database :
- OpenAIRE
- Journal :
- LUNG CANCER, r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante, instname, Lung Cancer, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA, r-FISABIO. Repositorio Institucional de Producción Científica, r-FHPC. Repositorio Institucional de Producción Científica de la Fundación del Hospital Provincial de Castellón
- Accession number :
- edsair.doi.dedup.....411fe6d05d5f2a5eb759bf673c22162a