dc.creator | Camerini, A. | es |
dc.creator | Morabito, A. | es |
dc.creator | Montanino, A. | es |
dc.creator | Bernabé-Caro, Reyes | es |
dc.creator | Grossi, F. | es |
dc.creator | Kowalski, D. | es |
dc.date.accessioned | 2022-11-02T14:31:00Z | |
dc.date.available | 2022-11-02T14:31:00Z | |
dc.date.issued | 2021-02-19 | |
dc.identifier.citation | Camerini, A., Morabito, A., Montanino, A., Bernabé-Caro, R., Grossi, F. y Kowalski, D. (2021). Metronomic oral vinorelbine in previously untreated advanced non-small-cell lung cancer patients unfit for platinum-based chemotherapy: results of the randomized phase II Tempo Lung trial. ESMO Open, 6 (2), 100051. https://doi.org/10.1016/j.esmoop.2021.100051. | |
dc.identifier.issn | 2059-7029 | es |
dc.identifier.uri | https://hdl.handle.net/11441/138601 | |
dc.description.abstract | Background: To assess the efficacy and safety of a metronomic schedule of oral vinorelbine (mVNR) in advanced non small-cell lung cancer (NSCLC) in patients unfit for platinum-based combination chemotherapy.
Patients and methods: This was a multicenter, prospective, randomized, open-label phase II study in treatment-naive
patients with TNM stage IIIB/IV NSCLC. Patients received mVNR at a fixed dose of 50 mg 3 or standard schedule
60-80 mg/m2 weekly until disease progression or unacceptable toxicity. The primary endpoint was progression-free
survival (PFS) without grade 4 toxicity (G4PFS; NCI-CTC v4). Main secondary objectives were safety, disease control
rate (DCR) without grade 4 toxicity (G4DCR), DCR, PFS, overall survival (OS) and quality of life (QoL).
Results: A total of 167 patients were included, 83 and 84 patients in the mVNR and standard arms, respectively. The
median G4PFS was 4.0 months [95% confidence interval (CI): 2.6-4.3] and 2.2 months (95% CI: 1.5-2.9), hazard ration
(HR) ¼ 0.63 (95% CI: 0.45-0.88), P ¼ 0.0068 in favor of metronomic arm; G4DCR was 45.8% and 26.8% in the mVNR and
standard arms, respectively. Grade 3-4 treatment-related adverse events were less frequent in the mVNR arm (25.3%
versus 54.4%) mainly owing to a reduction in all grades (15.7% versus 51.9%) and grade 3-4 neutropenia (10.8% versus
42%). PFS was 4.3 (95% CI: 3.3-5.1) and 3.9 months (95% CI: 2.8-5.2) in mVNR and standard arms, respectively. No
difference in median OS was observed. QoL was comparable between arms.
Conclusions: Metronomic oral vinorelbine significantly prolonged median G4PFS in advanced NSCLC patients unfit for platinum combinations as first-line treatment. It was associated with a clear reduction in toxicity and may be considered as an important option in this challenging population. | es |
dc.format | application/pdf | es |
dc.format.extent | 9 p. | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier | es |
dc.relation.ispartof | ESMO Open, 6 (2), 100051. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Vinorelbine | es |
dc.subject | Carcinoma non-small-cell lung | es |
dc.subject | Administration and dosage | es |
dc.subject | Randomized controlled trial | es |
dc.subject | Frail | es |
dc.title | Metronomic oral vinorelbine in previously untreated advanced non-small-cell lung cancer patients unfit for platinum-based chemotherapy: results of the randomized phase II Tempo Lung trial | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://www.sciencedirect.com/science/article/pii/S2059702921000053?via%3Dihub | es |
dc.identifier.doi | 10.1016/j.esmoop.2021.100051 | es |
dc.journaltitle | ESMO Open | es |
dc.publication.volumen | 6 | es |
dc.publication.issue | 2 | es |
dc.publication.initialPage | 100051 | es |