Treating patients with nonmetastatic clear-cell renal cell carcinoma (ccRCC) with the tyrosine kinase inhibitor axitinib could not only prevent disease progression, but also shrink tumours before surgery, show the results of a phase II trial.
The 24 ccRCC patients in the study who received a 5 mg dose for up to 12 weeks pre-nephrectomy reported no grade 4 or 5 adverse events according to Common Terminology Criteria for Adverse Events v 4.0. Furthermore, the grade 3 and lower adverse events that were experienced were “easily managed with standard care in the urology clinic setting”, say the researchers in European Urology
While the cohort did report worse of quality of life while receiving axitinib, by week 19 quality of life was not statistically different from the level reported at study screening.
“Potential advantages of neoadjuvant therapy include downsizing and/or downstaging of tumors to change surgical approach from radical to partial nephrectomy or from open to minimally invasive surgery, and to allow for resection of unresectable tumors”, remark Christopher Wood (The University of Texas MD Anderson Cancer Center, Houston, USA) and colleagues.
Participants had locally advanced, nonmetastatic, biopsy-proven ccRCC and all bar one underwent partial or radical nephrectomy after completing the axitinib course. Two patients did not finish the course, one stopped at 11 weeks after experiencing a grade 3 transient elevation of liver enzymes and thrombocytopenia, and one stopped at 7 weeks due to acute kidney injury, from which the patient later recovered. The most common grade 1–2 events included fatigue, hoarseness and nausea, report Wood et al.
Of the 23 patients with an evaluable response at 12 weeks, all showed at least some tumour reduction, with a median 28.3% reduction in the diameter of primary tumours. Eleven (45.8%) patients had a partial disease response according to the Response Evaluation Criteria in Solid Tumors definition, the patient with acute kidney injury was counted as a treatment failure, and the remainder had stable disease.
Patients reported worse quality of life according to the Functional Assessment of Cancer Therapy-Kidney Symptom Index by week 7 of therapy, compared with when they were screened for the study. However, by week 19 after beginning axitinib, these measures had improved and were nonsignificantly different from screening levels.
Wood and his team suggest that their approach is “feasible and safe at least in the perioperative period, with manageable [adverse events] while on drug therapy and postoperatively.”
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