Evaluation of axitinib to downstage cT2a renal tumours and allow partial nephrectomy: a phase II study

Abstract

contributed equally to this work and are equal first authors. J.-J.P. and B.E. contributed equally to this work and are equal senior authors. ObjectiveTo evaluate the ability of 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 and MethodsPatients with cT2aN0NxM0 clear-cell RCC, considered not suitable for PN, were enrolled in a prospective, multicentre, phase II trial (AXIPAN). Axitinib 5 mg, and up to 7-10 mg, was administered twice daily, for 2-6 months before surgery, depending on the radiological response. The primary outcome was the number of patients receiving PN for a tumour <7 cm in size after neoadjuvant axitinib. ConclusionNeoadjuvant axitinib in cT2 ccRCC is feasible and, even with a modest decrease in size, allowed a tumour shrinkage <7 cm in 12 cases; however, PN procedures remained complex, requiring surgical expertise with possible morbidity.

Systemic therapy in the management of localized and locally advanced renal cell carcinoma: Current state and future perspectives

“…Five (27.8%) patients experienced Clavien III–V post‐surgery complications. Similar to Lane et al ., the authors concluded that neoadjuvant axitinib leads to a modest decrease in tumor size that permitted downstage PN in most cases; however, procedures remained complex, requiring surgical expertise with morbidity …”

“…Similar to Lane et al, the authors concluded that neoadjuvant axitinib leads to a modest decrease in tumor size that permitted downstage PN in most cases; however, procedures remained complex, requiring surgical expertise with morbidity. 52 McDonald et al carried out a multicenter retrospective study to compare the renal functional outcomes of patients with complex masses who underwent neoadjuvant sunitinib therapy for imperative indications when PN was thought not to be feasible (n = 47, median tumor size 7.2 cm, median RENAL 11) with a cohort of patients with complex masses who underwent PN without prior neoadjuvant therapy (n = 78, median tumor size 6 cm, median RENAL 10). 41 The neoadjuvant treatment group received 50 mg sunitinib daily for two 6-week cycles, and the authors noted that the median tumor size and RENAL score decreased to 5.8 (P = 0.012) and 9 (P = 0.001), respectively, with 16 (34%) patients achieving PR by RECIST criteria.…”

Expanding the feasibility of nephron‐sparing surgery: time for a paradigm shift?

“…Differences in outcomes between that trial and the present one by Lebacle et al. could be explained by differences in study populations and/or drug regimens. A more recent study by Karam et al.…”

“…In this issue of the BJU Int , Lebacle et al. evaluated the role of neoadjuvant axitinib, an oral tyrosine kinase inhibitor currently recommended as a second‐line option for metastatic clear cell RCC, to downstage cT2 kidney cancer and allow a partial nephrectomy (PN). In this multicentre prospective study, 18 patients with RCC (median tumour size 7.6 cm and R.E.N.A.L.…”

“…Only a limited number of studies have specifically explored the role of neoadjuvant therapy to enable NSS with variable results (Table ) . Overall, these studies suggest that even a modest tumour size reduction can facilitate kidney preservation in a significant number of cases.…”