Lenvatinib

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1]

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1]

The median PFS was 18.3 months in the lenvatinib group and 3.6 months in the placebo group (HRprogression or death, 0.21; 99% CI, 0.14–0.31; P < .001). A PFS difference was observed in patients with all histological types of thyroid cancer enrolled in this trial.

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1]

There was no significant difference in OS between the two groups (HR death, 0.73; 95% CI, 0.50–1.07; P = .10), even with the crossover design of the study.

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1]

The objective response rate was 64.8% in the lenvatinib group versus 1.5% in the placebo group (odds ratio [OR], 28.87; 95% CI, 12.46–66.86; P < .001).

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1]

Treatment-related adverse events (all grades) occurred in 97.3% of patients in the lenvatinib group and 59.5% of patients in the placebo group.

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1] › Treatment-related adverse events (all grades) occurred in 97.3% of patients in the lenvatinib group and 59.5% of patients in the placebo group.

Grade 3 or higher adverse events were observed in 75.9% of patients who received lenvatinib and 9.9% of patients who received placebo.

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1] › Treatment-related adverse events (all grades) occurred in 97.3% of patients in the lenvatinib group and 59.5% of patients in the placebo group.

The most common adverse events in the lenvatinib group were hypertension (67.8%), diarrhea (59.4%), fatigue (59%), decreased appetite (50.2%), decreased weight (46.4%), and nausea (41%).

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1] › Treatment-related adverse events (all grades) occurred in 97.3% of patients in the lenvatinib group and 59.5% of patients in the placebo group.

Adverse events led to discontinuation of the study drug in 14.2% of patients who received lenvatinib and 2.3% of patients who received placebo.

A phase III, randomized, double-blind, placebo-controlled study (SELECT [NCT01321554]) evaluated the activity of lenvatinib in patients with progressive, iodine-refractory, differentiated thyroid cancer.[22] In this trial, 261 patients were randomly assigned to receive lenvatinib (24 mg every day), and 131 patients were randomly assigned to receive placebo. Eligible patients had differentiated thyroid cancer (including papillary, follicular, poorly differentiated, and Hürthle cell carcinomas), RAI-refractory disease, and evidence of radiological progression within the previous 13 months. At disease progression, patients in the placebo group could receive open-label lenvatinib. The primary end point was PFS, while the secondary end points were OS, response rate, and safety.[22][Level of evidence B1] › Treatment-related adverse events (all grades) occurred in 97.3% of patients in the lenvatinib group and 59.5% of patients in the placebo group.

In the lenvatinib group, 6 of 20 deaths occurring during the treatment period were considered drug related.