NAXIVA findings published in British Journal of Cancer
Findings from NAXIVA, the first clinical trial to evaluate neo-adjuvant downstaging of patients with the unique biological phenomenon of venous tumour thrombus in kidney cancer, have been published in British Journal of Cancer. NAXIVA provides the first Level II evidence that axitinib downstages VTT in a significant proportion of patients leading to a reduction in the extent of surgery.
UM Lead Professor Grant Stewart summarised NAXIVA's findings as follows in a blog post (read it in full here): 'neoadjuvant treatment is where non-surgical treatment is used prior to curative treatment such as surgery to substantially reduce the morbidity of treatment and increase the chances of treatment with curative intent, e.g. radiotherapy to downstage rectal carcinoma prior to surgery. Currently, there are no licenced neoadjuvant treatments for kidney cancer. NAXIVA is the first clinical trial to evaluate neoadjuvant downstaging of patients with the unique biological phenomenon of venous tumour thrombus (VTT) in kidney cancer. A VTT downstaging trial has repeatedly been raised as a need over many years because this subset of patients with tumour growing along the renal vein often into the vena cava and occasionally into the right atrium have a substantially increased risk of perioperative morbidity and mortality (5-15% risk of perisurgical death). As such we undertook this feasibility study of eight weeks of pre-surgical tyrosine kinase inhibitor therapy, with axitinib, in patient with a VTT and biopsy proven clear cell renal cell carcinoma to evaluate whether the tumour thrombus could be substantially down staged to allow safer surgery with less risk of death and complications. The results of NAXIVA, which included 21 patients, indicated that the approach is feasible with acceptable toxicity which did not prevent suitable patients from getting to surgery at the planned date. The primary endpoint, of a reduction in the extent of the tumour thrombus assessed by the Mayo level, a well-established anatomical based classification of the height of the VTT assessed on MRI, showed that 35% of patients had a reduction in the Mayo level equating to a meaningful downstaging. Furthermore, a secondary endpoint of reduction in the extent of surgery showed that 41% of patient required less extensive surgery. Thus, NAXIVA was a positive trial and the first to demonstrate that neoadjuvant systemic therapy can safely be administered in patients with VTT to downstage the disease and reduce the extent of surgery.'