MIAMI – Axitinib initiated at 5 mg twice daily and titrated up by increments of 2 mg/day every 2 weeks in the absence of certain grade 2 or higher toxicities resulted in toleration of higher daily doses with sustained efficacy in patients with metastatic renal cell carcinoma (mRCC), a study presented at the 14th International Kidney Cancer Symposium 2015 (IKCS) has shown.1

Because standard dose escalation from 5 mg twice daily to 7 mg twice daily to 10 mg twice daily is not tolerable by all patients, researchers at the Cleveland Clinic Taussig Cancer Institute in Cleveland, OH, sought to evaluate an alternative titration strategy’s impact on tolerability and efficacy.

“Prospective data support the clinical benefit of axitinib dose titration in patients with mRCC,” Kimberly Allman, CNP, nurse practitioner at Cleveland Clinic Taussig Cancer Institute, said during the poster presentation. “An alternative titration schema may be better tolerated and may improve efficacy.”

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For the study, researchers analyzed data from 11 patients with mRCC who received axitinib according to an alternative dose escalation schema at Cleveland Clinic. Of those patients, 9 had clear cell RCC, 1 had papillary RCC, and 1 had an unclassified histology. All had undergone prior nephrectomy and prior systemic therapy with VEGF-targeted therapy, PD-1/PD-L1 directed therapy, and/or cytokines.

Axitinib was initiated at a dose and frequency of 5 mg twice daily and titrated up by 2 mg/day increments every 2 weeks as long as patients did not report grade 2 or greater fatigue, hand-foot syndrome, mucositis, or diarrhea.

Results showed that most patients tolerated a maximum dose greater than 5 mg twice daily, while 1 patient could only tolerate 5 mg twice daily and 1 tolerated less than 5 mg twice daily. Researchers found that major toxicities included grade 2 to 3 diarrhea, fatigue, and mucositis.

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In regard to efficacy, of the 8 evaluable patients, 2 patients achieved a partial response as best response and 6 had stable disease.

“This individualized dose titration schedule of axitinib has resulted in tolerance of higher daily dose with sustained efficacy and an acceptable safety profile,” Ms. Allman concluded. “A prospective study is being designed to validate these findings.”


  1. Allman K, Garcia JA, Grivas P, et al. An individualized dose titration schedule of axitinib in patients with metastatic renal cell carcinoma [abstract]. BJU Int. 2015. doi: 10.1111/bju.13365.