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How long do you take Cabometyx for?

Medically reviewed by N. France, BPharm. Last updated on Sep 24, 2021.

Official Answer

by Drugs.com

Cabometyx (cabozantinib) is a chemotherapy drug used to treat patients with:

  • Advanced renal cell carcinoma (kidney cancer), including as a first-line treatment when used in combination with Opdivo (nivolumab)
  • Hepatocellular carcinoma (liver cancer) who have previously been treated with Nexavar (sorafenib)
  • Locally advanced or metastatic differentiated thyroid cancer that has progressed following VGEFR-targeted treatment who do not response to radioactive iodine treatment or who are ineligible for it

Cabometyx comes in the form of a tablet that you take once a day.

Cabometyx is a tyrosine kinase inhibitor that is taken until disease progression - the cancer starts to get worse - or you can no longer tolerate therapy because of side effects or adverse reactions.

Will I stay on the same dose of Cabometyx?

To help manage side effects your doctor might lower or pause your treatment with Cabometyx.

Some adverse reactions that commonly result in dose reductions include diarrhea, palmar-plantar erythrodysesthesia, fatigue, proteinuria, hypertension, increased aspartate aminotransferase (AST), decreased appetite and nausea.

During clinical trials of Cabometyx, some patients needed:

  • Their dose of Cabometyx to be reduced
  • Cabometyx treatment to be paused
  • Cabometyx treatment to be discontinued

Cabometyx in clinical trials - dose reductions, dosing interruptions and treatment discontinuation

Trial name Paused or discontinued treatment Dose reduction
METEOR - 331 patients with advanced renal cell carcinoma treated with Cabometyx 60 mg once daily Treatment was interrupted in 70% of patients

Treatment was discontinued in 10% of patients

Dose was reduced in 60% of patients

20% of patients had their dose reduced from Cabometyx 60 mg once daily to 20 mg once daily

CABOSUN - 78 patients with advanced renal cell carcinoma treated with Cabometyx 60 mg once daily Treatment was held in 73% of patients

Treatment was discontinued in 21% of patients

Dose was reduced in 46% of patients.

The median average daily dose was Cabometyx 50.3 mg

CELESTIAL - 467 patients with advanced hepatocellular carcinoma treated with Cabometyx 60 mg once daily Treatment was interrupted in 84% of patients

Treatment was discontinued in 16% of patients

Dose was reduced in 62% of patients

The dose was reduced to 20 mg daily in 33% of patients

The median average daily dose was 35.8 mg
CHECKMATE-9ER - 320 patients with previously untreated advanced renal cell carcinoma treated with Cabometyx 40 mg once daily and Opdivo 240mg over 30 minutes every 2 weeks Treatment was interrupted or the dose reduced in 83% of patients (46% Cabometyx, 3% Opdivo, 21% both drugs at same time, 6% drugs sequentially)

Treatment was discontinued in 20% of patients (8% Cabometyx only, 7% Opdivo only, 6% both drugs)

Dose of Cabometyx was reduced to 20mg daily or 20 mg every other day in patients who required it
COSMIC-311 187 patients with advanced differentiated thyroid cancer treated with Cabometyx 60 mg once daily (n=125) or placebo (n=62)

Treatment was interrupted in 72% of patients

Treatment was discontinued in 5% of patients

Dose was reduced in 56% of patients. A second dose reduction was also required in 22% of patients

The median average daily dose was 42 mg

How long did patients take Cabometyx for in clinical trials?

Treatment with Cabometyx is typically continued until the cancer starts to progress. To determine how long a patient is likely to take Cabometyx for before their cancer starts to progress researchers measure ‘progression-free survival’ in clinical trials.

The length of time a patient takes Cabometyx for is also affected by the side effects they experience. When a patient can no longer tolerate the side effects, then treatment will need to be stopped. Because some patients stop treatment even though their cancer has not progressed, researchers also measure the 'duration of treatment' - the amount of time a patient takes Cabometyx for - to get a better indication of how long patients take Cabometyx for.

Cabometyx in clinical trials - progression-free survival and duration of treatment

Trial name Median progression-free survival Median duration of treatment
METEOR - 331 patients with renal cell carcinoma treated with Cabometyx 60 mg once daily 7.4 months (95% CI 5.6, 9.1) 7.6 months (range 0.3 - 20.5)
CABOSUN - 78 patients with advanced renal cell carcinoma treated with Cabometyx 60 mg once daily 8.6 months (95% CI 6.8, 14.0) 6.5 months (range 0.2 - 28.7)
CELESTIAL - 467 patients with advanced hepatocellular carcinoma treated with Cabometyx 60 mg once daily 5.2 months (95% CI 4.0, 5.5) 3.8 months (range 0.1 - 37.3)
CHECKMATE-9ER - 320 patients with previously untreated advanced renal cell carcinoma treated with Cabometyx 40 mg once daily and Opdivo 240mg over 30 minutes every 2 weeks 16.6 months (95% CI 12.5, 24.9) 20.2 months (range 17.3 - not reached)
COSMIC-311 - 258 (updated analysis) patients with advanced differentiated thyroid cancer treated with Cabometyx 60 mg once daily (n=170) or placebo (n=88) 11 months (95% CI 7.4, 13.8)
References
  • Cabometyx. How should I take Cabometyx? Available from: https://www.cabometyx.com/how-to-take. [Accessed December 2, 2020].
  • Food and Drug Administration (FDA). Cabometyx. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s012lbl.pdf. [Accessed September 24, 2021].
  • Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016;17(7):917-927. doi:10.1016/S1470-2045(16)30107-3
  • Choueiri TK, Halabi S, Sanford BL, et al. Cabozantinib Versus Sunitinib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial [published correction appears in J Clin Oncol. 2017 Nov 10;35(32):3736] [published correction appears in J Clin Oncol. 2018 Feb 10;36(5):521]. J Clin Oncol. 2017;35(6):591-597. doi:10.1200/JCO.2016.70.7398
  • Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018;379(1):54-63. doi:10.1056/NEJMoa1717002.

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