To evaluate neoadjuvant axitinib to reduce the size of T2 renal cell carcinoma (RCC) for shifting from a Radical Nephrectomy (RN) to a Partial Nephrectomy (PN) indication, offering preservation of renal function.
Patients with cT2aN0NxM0 clear-cell RCC, considered not suitable for PN, were enrolled in a prospective, multicenter, phase II trial (AXIPAN). Axitinib was administered 5mg up to 7 to 10mg twice daily, for 2 to 6 months prior surgery, depending on the radiological response. The primary outcome was the number of patients receiving PN for a tumour size <7cm after neoadjuvant axitinib.
18 patients were enrolled. Median tumour size and RENAL score were 76.5mm (70-98) and 11 (7-11), respectively. After axitinib neoadjuvant treatment, 89% of tumours decreased in diameter, with a median size reduction of 17% (64.0 versus 76.5mm, p<0.001). The primary outcome was considered achieved in 12 (67%) patients who underwent PN for tumours <7cm. Sixteen patients underwent PN. Axitinib was tolerated as in metastatic setting. Five patients had grade 3 AEs. Five patients experienced Clavien III-V post-surgery complications. At 2-years follow-up, six patients had metastatic progression, and two had a recurrence.
Neoadjuvant axitinib in cT2 ccRCC is feasible and even with a modest decrease in size, allowed a tumour shrinkage <7cm in 67% of the cases. However, PN procedures remained complex requiring surgical expertise with possible morbidity.
BJU international. 2018 Oct 05 [Epub ahead of print]
Cedric Lebacle, Karim Bensalah, Jean-Christophe Bernhard, Laurence Albiges, Brigitte Laguerre, Marine Gross-Goupil, Herve Baumert, Herve Lang, Thibault Tricard, Brigitte Duclos, Armelle Arnoux, Celine Piedvache, Jean-Jacques Patard, Bernard Escudier
Bicetre University Hospital, Dept. of Urology, Assistance Publique-Hôpitaux de Paris, APHP, University Paris-Saclay, Le Kremlin-Bicetre, France., Pontchaillou University Hospital, Dept. of Urology, Rennes, France., Bordeaux University Hospital, Pellegrin Hospital, Dept. of Urology, French Research network on Kidney Cancer UroCCRBordeaux, France., Gustave Roussy, University Paris-Saclay, Dept. of Medicine, Villejuif, France., Eugene Marquis Center, Dept. of Oncology, Rennes, France., Bordeaux University Hospital, Saint-Andre Hospital, Dept. of Medical Oncology, Bordeaux, France., Saint-Joseph Hospital, Dept. of Urology, Paris, France., Strasbourg University Hospital, Nouvel Hopital Civil, Dept. of Urology, Strasbourg, France., Strasbourg University Hospital, Hautepierre Hospital, Dept. of Oncology, Strasbourg, France., Assistance Publique-Hôpitaux de Paris, Paris-Sud Clinical Research Unit, Dept of Statistics, Bicetre University Hospital, Le Kremlin-BicêtreFrance., Mont de Marsan Hospital, Dept. of Urology, Mont de Marsan, France.