NEW YORK (Reuters Health) Nov 07 - Vandetanib showed encouraging action against advanced and metastatic medullary thyroid carcinoma in a recently published phase III trial.
Based on the results, the U.S. Food and Drug Administration has approved vandetanib (Caprelsa, AstraZeneca) for this indication.
"Previously there had been no effective therapy for patients with advanced stages of this tumor, although there were infrequent reports of short term responses to chemotherapy," Dr. Samuel A. Wells Jr. told Reuters Health.
Now, he said in an email, "I think that it's fair to say that vandetanib is the standard of care for patients with advanced medullary thyroid carcinoma."
As reported online October 24 in the Journal of Clinical Oncology, Dr. Wells of the National Cancer Institute, Bethesda, Maryland and colleagues randomly assigned 331 patients in a 2:1 ratio to treatment with vandetanib or placebo.
After a median follow-up of 24 months, 124 patients (37%) had progressed and 48 (15%) had died. The research team will do a final survival analysis when 50% of the patients have died.
Patients taking vandetanib had significant longer progression-free survival (hazard ratio, 0.46); the median was 19.3 months in the placebo group and is predicted to be 30.5 months in the active treatment group.
The progression-free survival rate at six months was 83% in the vandetanib group and 63% in placebo patients.
Significant advantages for vandetanib were also seen for objective response rate, disease control rate and biochemical response.
Rates of adverse events were higher with vandetanib; they included diarrhea (56% vs 26%), rash (45% vs 11%), and hypertension (32% vs 5%).
Dr. Benjamin Solomon, co-author of an editorial published with the study, told Reuters Health in an email that the work "establishes vandetanib as an appropriate standard in patients with locally advanced or metastatic medullary thyroid cancer."
However, he cautioned, the drug is associated with some toxicity and its impact on quality of life is not yet clear.
"Treatment with vandetanib is most appropriate for patients who are symptomatic, have high disease burdens or rapidly progressing disease, while those with asymptomatic or slowly progressing patients and low disease burden may be more appropriately monitored off therapy with careful assessment of the tempo of disease progression," said Dr. Solomon, who's affiliated with the Peter MacCallum Cancer Center in East Melbourne, Australia.
Dr. Wells pointed out that targeted therapeutics such as vandetanib are showing promise "not only in the treatment of the more common types of thyroid cancer, but in certain other solid tumor malignancies, as well as leukemia."
"Molecular targeted therapeutics represent a new and significant advance in cancer therapy," he said.
The trial was supported by AstraZeneca.
SOURCE: http://bit.ly/udwjXk
Based on the results, the U.S. Food and Drug Administration has approved vandetanib (Caprelsa, AstraZeneca) for this indication.
"Previously there had been no effective therapy for patients with advanced stages of this tumor, although there were infrequent reports of short term responses to chemotherapy," Dr. Samuel A. Wells Jr. told Reuters Health.
Now, he said in an email, "I think that it's fair to say that vandetanib is the standard of care for patients with advanced medullary thyroid carcinoma."
As reported online October 24 in the Journal of Clinical Oncology, Dr. Wells of the National Cancer Institute, Bethesda, Maryland and colleagues randomly assigned 331 patients in a 2:1 ratio to treatment with vandetanib or placebo.
After a median follow-up of 24 months, 124 patients (37%) had progressed and 48 (15%) had died. The research team will do a final survival analysis when 50% of the patients have died.
Patients taking vandetanib had significant longer progression-free survival (hazard ratio, 0.46); the median was 19.3 months in the placebo group and is predicted to be 30.5 months in the active treatment group.
The progression-free survival rate at six months was 83% in the vandetanib group and 63% in placebo patients.
Significant advantages for vandetanib were also seen for objective response rate, disease control rate and biochemical response.
Rates of adverse events were higher with vandetanib; they included diarrhea (56% vs 26%), rash (45% vs 11%), and hypertension (32% vs 5%).
Dr. Benjamin Solomon, co-author of an editorial published with the study, told Reuters Health in an email that the work "establishes vandetanib as an appropriate standard in patients with locally advanced or metastatic medullary thyroid cancer."
However, he cautioned, the drug is associated with some toxicity and its impact on quality of life is not yet clear.
"Treatment with vandetanib is most appropriate for patients who are symptomatic, have high disease burdens or rapidly progressing disease, while those with asymptomatic or slowly progressing patients and low disease burden may be more appropriately monitored off therapy with careful assessment of the tempo of disease progression," said Dr. Solomon, who's affiliated with the Peter MacCallum Cancer Center in East Melbourne, Australia.
Dr. Wells pointed out that targeted therapeutics such as vandetanib are showing promise "not only in the treatment of the more common types of thyroid cancer, but in certain other solid tumor malignancies, as well as leukemia."
"Molecular targeted therapeutics represent a new and significant advance in cancer therapy," he said.
The trial was supported by AstraZeneca.
SOURCE: http://bit.ly/udwjXk
1 σχόλιο:
I am very thankful for what bovine thyroid supplements has done for me. It not only helped me manage my thyroid problems. it has also given more energy
Δημοσίευση σχολίου