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Axitinib active in advanced thyroid cancer
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Axitinib demonstrated encouraging activity and a favorable safety profile in patients with advanced thyroid cancer, according to results of a phase 2 study.
The findings suggest axitinib (Inlyta, Pfizer), a highly selective VEGF receptor inhibitor, is a viable treatment option for this patient population, researchers wrote.
The analysis included 52 patients with metastatic or unresectable locally advanced medullary or differentiated thyroid cancer. All patients had refractory disease or were not able to undergo treatment with iodine-131.
All patients received a starting dose of 5 mg axitinib twice daily. Patients who did not experience >2 drug-related adverse events for consecutive 2-week periods had the option to increase dosage to 7 mg twice daily, then 10 mg twice daily, unless they had high blood pressure or were receiving antihypertensive medications.
Treatment continued until progression, unacceptable toxicity or withdraw of consent.
Overall response rate served as the primary endpoint. Secondary endpoints included PFS, OS, safety and pharmacokinetic parameters. Researchers also used the MD Anderson Symptom Inventory questionnaire to assess patient-reported outcomes.
The median treatment duration was 12.9 months (range, 0.07-56.2), and 28 patients continued treatment for at least 1 year. The median total daily dose was 10 mg (range, 4.1-18.8).
Eighteen patients demonstrated partial response, translating to an overall response rate of 35%. Eighteen patients had stable disease for ≥16 weeks.
Researchers reported median PFS of 16.1 months and median OS of 27.2 months. Patients with greater exposure to axitinib demonstrated longer median PFS, according to researchers.
Forty-one patients (79%) experienced grade ≥3 adverse events. The most common were fatigue (12%), dyspnea (12%), diarrhea (10%), decreased weight (10%) and pain in extremities (10%).
“The small sample size and lack of a control group may limit the applicability of results from the current trial, yet the duration of treatment and the minimal change from baseline quality of life observed in this study suggest that the impact of axitinib on quality of life in relatively symptom-free patients with advanced thyroid cancer may be acceptable,” the researchers wrote.
Disclosure: The researchers report financial relationships, advisory board roles and employment relationships with Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Merck, Merck-Serono, Novartis, Pfizer, Roche, Sanofi and other pharmaceutical companies.
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