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RESEARCH PRODUCT
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)
Bartomeu MassutiRamon De Las PenasMariano ProvencioJosé Miguel JuradoMaría Francisca VázquezRaquel MarséDolores IslaNatividad Martínez-banaclochaPilar DizJosé Gómez-codinaPilar MutMaría ÁNgeles SalaA. InsaVanesa GutiérrezNuria ViñolasMelchor ÁLvarez De Mon SotoRosa AlvarezAna Laura OrtegaI. MaestuCarlos CampsSantiago PonceAngel ArtalTeresa Moransubject
0301 basic medicinePulmonary and Respiratory MedicineOncologyAdultMaleCancer Researchmedicine.medical_specialtyLung NeoplasmsDisease-free survivalmedicine.medical_treatmentNeoplasm metastasisAdministration OralVinorelbine03 medical and health sciences0302 clinical medicineNon-small cell lung cancerInternal medicineCarcinoma Non-Small-Cell LungAntineoplastic Combined Chemotherapy ProtocolsmedicineClinical endpointHumansProgression-free survivalneoplasmsEtoposideAgedNeoplasm StagingEtoposideCisplatinbusiness.industryStandard treatmentVinorelbineChemoradiotherapyMiddle AgedPhase IIrespiratory tract diseasesRadiation therapySurvival RateClinical trial030104 developmental biologyOncology030220 oncology & carcinogenesisConcomitantFemalePatient SafetyCisplatinbusinessClinical trial Disease-free survival Etoposide Neoplasm metastasis Non-small cell lung cancer Phase II Vinorelbinemedicine.drugdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2019-01-01 |