A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN)

Bellmunt Molins, Joaquim, 1959-; Kerst, Jan Martin; Vázquez, Francisca; Morales-Barrera, Rafael; Grande,  Enrique; Medina, Ana; González Graguera, M.B.; Rubio, Gabriel; Anido, Urbano; Fernández Calvo, Ovidio; González-Billalabeitia, Enrique; Van den Eertwegh, Alfons Johannes M.; Pujol, E.; Perez-Gracia, Jose Luis; González Larriba, José Luis; Collado, R.; Los, Maartje; Maciá, Sonia; De Wit, R.; SOGUG; DUOS

A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN)

Mostra el registre complet Registre parcial de l'ítem

dc.contributor.author Bellmunt Molins, Joaquim, 1959-ca
dc.contributor.author Kerst, Jan Martinca
dc.contributor.author Vázquez, Franciscaca
dc.contributor.author Morales-Barrera, Rafaelca
dc.contributor.author Grande, Enriqueca
dc.contributor.author Medina, Anaca
dc.contributor.author González Graguera, M.B.ca
dc.contributor.author Rubio, Gabrielca
dc.contributor.author Anido, Urbanoca
dc.contributor.author Fernández Calvo, Ovidioca
dc.contributor.author González-Billalabeitia, Enriqueca
dc.contributor.author Van den Eertwegh, Alfons Johannes M.ca
dc.contributor.author Pujol, E.ca
dc.contributor.author Perez-Gracia, Jose Luisca
dc.contributor.author González Larriba, José Luisca
dc.contributor.author Collado, R.ca
dc.contributor.author Los, Maartjeca
dc.contributor.author Maciá, Soniaca
dc.contributor.author De Wit, R.ca
dc.contributor.author SOGUG
dc.contributor.author DUOS
dc.date.accessioned 2017-11-16T08:58:54Z
dc.date.issued 2017
dc.description.abstract BACKGROUND:Despite the advent of immunotherapy in urothelial cancer, there is still a need to find effective cytotoxic agents beyond first and second lines. Vinflunine is the only treatment approved in this setting by the European Medicines Agency and taxanes are also widely used in second line. Cabazitaxel is a taxane with activity in docetaxel-refractory cancers. A randomized study was conducted to compare its efficacy versus vinflunine. PATIENTS AND METHODS: This is a multicenter, randomized, open-label, phase II/III study, following a Simon's optimal method with stopping rules based on an interim futility analysis and a formal efficacy analysis at the end of the phase II. ECOG Performance Status, anaemia and liver metastases were stratification factors. Primary objectives were overall response rate for the phase II and overall survival for the phase III. RESULTS: Seventy patients were included in the phase II across 19 institutions in Europe. Baseline characteristics were well balanced between the two arms. Three patients (13%) obtained a partial response on cabazitaxel (95% CI 2.7-32.4) and six patients (30%) in the vinflunine arm (95% CI 11.9-54.3). Median progression-free survival for cabazitaxel was 1.9 versus 2.9 months for vinflunine (P = 0.039). The study did not proceed to phase III since the futility analysis showed a lack of efficacy of cabazitaxel. A trend for overall survival benefit was found favouring vinflunine (median 7.6 versus 5.5 months). Grade 3- to 4-related adverse events were seen in 41% patients with no difference between the two arms. CONCLUSION: This phase II/III second line bladder study comparing cabazitaxel with vinflunine was closed when the phase II showed a lack of efficacy of the cabazitaxel arm. Vinflunine results were consistent with those known previously.
dc.format.mimetype application/pdfca
dc.identifier.citation Bellmunt J, Kerst JM, Vázquez F, Morales-Barrera R, Grande E, Medina A. et at. A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN). Ann Oncol. 2017 Jul 1;28(7):1517-1522. DOI: 10.1093/annonc/mdx186
dc.identifier.doi http://dx.doi.org/10.1093/annonc/mdx186
dc.identifier.issn 0923-7534
dc.identifier.uri http://hdl.handle.net/10230/33251
dc.language.iso eng
dc.publisher Oxford University Pressca
dc.relation.ispartof Annals of Oncology. 2017 Jul 1;28(7):1517-22
dc.rights © Oxford University Press. This is a pre-copy-editing, author-produced PDF of an article accepted for publication in Annals of Oncology following peer review. The definitive publisher-authenticated version Bellmunt J, Kerst JM, Vázquez F, Morales-Barrera R, Grande E, Medina A. et at. A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN). Ann Oncol. 2017 Jul 1;28(7):1517-1522, is available online at: https://academic.oup.com/annonc/article-lookup/doi/10.1093/annonc/mdx186.
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.subject.keyword Cabazitaxel
dc.subject.keyword Urothelial cancer
dc.subject.keyword Vinflunine
dc.subject.other Aparell urinari -- Càncer
dc.title A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN)ca
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/acceptedVersion

Col·leccions

Articles (Hospital del Mar Research Institute)