(Renal) Report on Axitinib in Treatment-Naive Renal Cell Carcinoma Patients
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- November 10, 2016
- 1 min read
Published at ESMO 2016 by Dr. Brian I. Rini of the Cleveland Clinic in the United States, this retrospective analysis of Phase 2 and Phase 3 clinical trials of Axitinib (Inlyta) in treatment-naive renal cell carcinoma patients demonstrated high response rates, significant tumor reduction, and impressive overall survival (OS) outcomes.
In this trial, 402 patients were enrolled. The starting dose was 5 mg twice daily. At week 4, doses were escalated based on patient ECOG PS scores and tolerability—stepped up to 7 mg, and if well tolerated, further increased to 10 mg. The Phase 3 arm was stratified by ECOG PS, with an Axitinib group (5 mg twice daily) and a Sorafenib group (400 mg), randomized at a 2:1 ratio.
Of the 402 patients, 152 (37.8%) remained on treatment beyond 18 months, while 259 (62.2%) did not. Among the long-term cohort, 119 patients (29.6%) exceeded 2 years, 71 (17.7%) exceeded 3 years, and 28 (7.0%) exceeded 4 years. The median treatment duration was 34.7 months for those treated >18 months and 15 months for those treated ≤18 months.
Patients with longer treatment duration (>18 months) had favorable baseline characteristics: ECOG PS 0, normal ULN, good hemoglobin values, and no bone or liver metastases. Grade 3 or higher adverse events were more common in the >18-month group, including hypertension (25.7%), diarrhea (15.4%), and weight loss (11.2%).
Based on these data, long-term use of Axitinib did not reveal any new or unexpected safety signals.
Note: Image sourced from the Pfizer website, where additional information on this drug can be found.
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