Cabozantinib

The METEOR trial (NCT01865747) randomly assigned 658 patients who had previously been treated with a VEGF TKI to receive either cabozantinib (60 mg qd) or everolimus (10 mg qd).[24,56] Doses were reduced in 60% of the patients receiving cabozantinib, compared with 25% of the patients assigned to everolimus.

The METEOR trial (NCT01865747) randomly assigned 658 patients who had previously been treated with a VEGF TKI to receive either cabozantinib (60 mg qd) or everolimus (10 mg qd).[24,56] Doses were reduced in 60% of the patients receiving cabozantinib, compared with 25% of the patients assigned to everolimus.

The incidence of grade 3 or 4 adverse events was 68% with cabozantinib compared with 58% with everolimus.

The METEOR trial (NCT01865747) randomly assigned 658 patients who had previously been treated with a VEGF TKI to receive either cabozantinib (60 mg qd) or everolimus (10 mg qd).[24,56] Doses were reduced in 60% of the patients receiving cabozantinib, compared with 25% of the patients assigned to everolimus.

The most common high-grade adverse events were hypertension (15%), diarrhea (11%), and fatigue (9%) with cabozantinib, compared with anemia (16%), fatigue (7%), and hyperglycemia (5%) with everolimus.

The METEOR trial (NCT01865747) randomly assigned 658 patients who had previously been treated with a VEGF TKI to receive either cabozantinib (60 mg qd) or everolimus (10 mg qd).[24,56] Doses were reduced in 60% of the patients receiving cabozantinib, compared with 25% of the patients assigned to everolimus.

Dose reductions of cabozantinib were mainly the result of diarrhea, palmar-plantar erythrodysesthesia syndrome, and fatigue.

The METEOR trial (NCT01865747) randomly assigned 658 patients who had previously been treated with a VEGF TKI to receive either cabozantinib (60 mg qd) or everolimus (10 mg qd).[24,56] Doses were reduced in 60% of the patients receiving cabozantinib, compared with 25% of the patients assigned to everolimus.

With a median follow-up of about 19 months, median OS was 21.4 months for patients who received cabozantinib and 16.5 months for patients who received everolimus (HR, 0.66; 95% CI, 0.53–0.83; P = .0003).

The METEOR trial (NCT01865747) randomly assigned 658 patients who had previously been treated with a VEGF TKI to receive either cabozantinib (60 mg qd) or everolimus (10 mg qd).[24,56] Doses were reduced in 60% of the patients receiving cabozantinib, compared with 25% of the patients assigned to everolimus.

These results were confirmed when the prespecified final analysis was performed after 430 deaths had been confirmed. Median survival was 21.4 months with cabozantinib and 17.1 months with everolimus (HR, 0.70; 95% CI, 0.58–0.85).[57]

A subsequent trial compared cabozantinib with sunitinib in the first-line setting. The study randomly assigned 157 patients with intermediate- or poor-risk metastatic renal cell carcinoma to receive either cabozantinib or sunitinib.[9,10]

A subsequent trial compared cabozantinib with sunitinib in the first-line setting. The study randomly assigned 157 patients with intermediate- or poor-risk metastatic renal cell carcinoma to receive either cabozantinib or sunitinib.[9,10]

Adverse events were seen in more than 95% of the patients.

A subsequent trial compared cabozantinib with sunitinib in the first-line setting. The study randomly assigned 157 patients with intermediate- or poor-risk metastatic renal cell carcinoma to receive either cabozantinib or sunitinib.[9,10] › Adverse events were seen in more than 95% of the patients.

Grade 3 to 4 adverse events were seen in 68% of the patients on the cabozantinib arm and 65% of the patients on the sunitinib arm.

A subsequent trial compared cabozantinib with sunitinib in the first-line setting. The study randomly assigned 157 patients with intermediate- or poor-risk metastatic renal cell carcinoma to receive either cabozantinib or sunitinib.[9,10] › Adverse events were seen in more than 95% of the patients.

Adverse events included hypertension, diarrhea, fatigue, and thrombocytopenia.

A subsequent trial compared cabozantinib with sunitinib in the first-line setting. The study randomly assigned 157 patients with intermediate- or poor-risk metastatic renal cell carcinoma to receive either cabozantinib or sunitinib.[9,10] › Adverse events were seen in more than 95% of the patients.

Grade 5 adverse events occurred in 4% of the patients on the cabozantinib arm and 10% of the patients on the sunitinib arm.

A subsequent trial compared cabozantinib with sunitinib in the first-line setting. The study randomly assigned 157 patients with intermediate- or poor-risk metastatic renal cell carcinoma to receive either cabozantinib or sunitinib.[9,10]

With a median follow-up of 34.5 months, there was no significant difference in OS between the two arms, and the OS curves crossed multiple times.

A subsequent trial compared cabozantinib with sunitinib in the first-line setting. The study randomly assigned 157 patients with intermediate- or poor-risk metastatic renal cell carcinoma to receive either cabozantinib or sunitinib.[9,10]

PFS, however, was longer with cabozantinib (8.6 months vs. 5.3 months [HR, 0.48; 95% CI, 0.31–0.74]), demonstrating that PFS is an inadequate surrogate for OS.[9,10][Level of evidence B1]