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Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin With or Without Panitumumab in Patients With Advanced Urothelial Carcinoma: Multicenter, Randomized, French Unicancer GETUG/AFU 19 Study

Stéphane Culine 1 Aude Fléchon 2 Gwenaelle Gravis 3 Guilhem Roubaud 4 Yohann Loriot 5, 6 Florence Joly 7 Philippe Barthélémy 8 Elias Assaf 9 Hakim Mahammedi 10 Philippe Beuzeboc 11 Nadine Houédé 12, 13 Frédéric Rolland 14 Aline Guillot 15 Marine Gross-Goupil 16 Jean-Philippe Spano 17 Sophie Tartas 18 Mathilde Deblock 19 Christine Chevreau 20 Camille Serrate 21 Hélène Manduzio 22 Muriel Habibian 22 Simon Thézénas 23 Yves Allory 24 
Abstract : This study looked at whether epidermal growth factor receptor inhibition by the monoclonal antibody panitumumab could increase the efficacy of standard chemotherapy in advanced urothelial cancer. Results were disappointing, with higher toxicity and no improvement in efficacy in the combination arm. Background: Epidermal growth factor receptor (EGFR) overexpression is frequent and associated with poor outcome in urothelial carcinoma. EGFR inhibition could improve the antitumor activity of chemotherapy. Patients and methods: Patients with advanced, treatment-naïve, histologically confirmed advanced urothelial carcinoma and no HRAS or KRAS mutation in the primary tumor received dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) without or with the anti-EGFR monoclonal antibody panitumumab (Pmab). A randomized (1:2) phase II design was used with progression-free survival (PFS) as the primary endpoint. Results: Ninety-seven eligible patients were randomized; 96 patients were evaluable for toxicity and 87 for efficacy. The median PFS were 6.8 months (95% confidence interval [CI], 6.3-9.2) for dd-MVAC and 5.7 months (95% CI, 4.6-6.4 months) for dd-MVAC+Pmab. For both immunohistochemical and molecular definition of basal/squamous-like (BASQ) tumors, no difference was observed in objective response rates or PFS between the two arms in BASQ and non-BASQ tumors. Conclusion: dd-MVAC+Pmab was associated with more serious adverse events and no improvement in efficacy outcomes.
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https://hal.umontpellier.fr/hal-03631553
Contributeur : Nathalie Salvy-Córdoba Connectez-vous pour contacter le contributeur
Soumis le : mardi 5 avril 2022 - 17:23:35
Dernière modification le : mardi 29 novembre 2022 - 04:00:17

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Stéphane Culine, Aude Fléchon, Gwenaelle Gravis, Guilhem Roubaud, Yohann Loriot, et al.. Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin With or Without Panitumumab in Patients With Advanced Urothelial Carcinoma: Multicenter, Randomized, French Unicancer GETUG/AFU 19 Study. Clinical Genitourinary Cancer, 2021, 19 (4), pp.e216-e222. ⟨10.1016/j.clgc.2021.02.005⟩. ⟨hal-03631553⟩

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