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Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial

Summary Background Patients with radioactive iodine (131 I)-refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis because of the absence of effective treatment options. In this study, we assessed the efficacy and safety of orally administered sorafenib in the... Full description

Journal Title: The Lancet (British edition) 2014, Vol.384 (9940), p.319-328
Main Author: Brose, Marcia S, Dr
Other Authors: Nutting, Christopher M, Prof , Jarzab, Barbara, Prof , Elisei, Rossella, Prof , Siena, Salvatore, MD , Bastholt, Lars, MD , de la Fouchardiere, Christelle, MD , Pacini, Furio, Prof , Paschke, Ralf, Prof , Shong, Young Kee, Prof , Sherman, Steven I, Prof , Smit, Johannes W A, Prof , Chung, John, MD , Kappeler, Christian, PhD , Peña, Carol, PhD , Molnár, István, MD , Schlumberger, Martin J, Prof
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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recordid: cdi_proquest_miscellaneous_1549199925
title: Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial
format: Article
creator:
  • Brose, Marcia S, Dr
  • Nutting, Christopher M, Prof
  • Jarzab, Barbara, Prof
  • Elisei, Rossella, Prof
  • Siena, Salvatore, MD
  • Bastholt, Lars, MD
  • de la Fouchardiere, Christelle, MD
  • Pacini, Furio, Prof
  • Paschke, Ralf, Prof
  • Shong, Young Kee, Prof
  • Sherman, Steven I, Prof
  • Smit, Johannes W A, Prof
  • Chung, John, MD
  • Kappeler, Christian, PhD
  • Peña, Carol, PhD
  • Molnár, István, MD
  • Schlumberger, Martin J, Prof
subjects:
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents
  • Antineoplastic Agents - administration & dosage
  • Antineoplastic Agents - therapeutic use
  • Biological and medical sciences
  • Blind Method
  • Cancer therapies
  • Chemotherapy
  • Diagnosis
  • Double
  • Double-Blind Method
  • Drug dosages
  • Drug therapy
  • Endocrinopathies
  • Female
  • General aspects
  • Humans
  • Internal Medicine
  • Kaplan
  • Kaplan-Meier Estimate
  • Male
  • Malignant tumors
  • Medical prognosis
  • Medical sciences
  • Meier Estimate
  • Metastasis
  • Middle Aged
  • Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
  • Mutation
  • Niacinamide
  • Niacinamide - administration & dosage
  • Niacinamide - analogs & derivatives
  • Niacinamide - therapeutic use
  • over
  • Pain
  • Patient safety
  • Phenylurea Compounds
  • Phenylurea Compounds - administration & dosage
  • Phenylurea Compounds - therapeutic use
  • Survival Analysis
  • Thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Neoplasms - drug therapy
  • Thyroid. Thyroid axis (diseases)
  • Treatment Outcome
  • Tumors
  • Vascular endothelial growth factor
  • Young Adult
ispartof: The Lancet (British edition), 2014, Vol.384 (9940), p.319-328
description: Summary Background Patients with radioactive iodine (131 I)-refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis because of the absence of effective treatment options. In this study, we assessed the efficacy and safety of orally administered sorafenib in the treatment of patients with this type of cancer. Methods In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (DECISION), we investigated sorafenib (400 mg orally twice daily) in patients with radioactive iodine-refractory locally advanced or metastatic differentiated thyroid cancer that had progressed within the past 14 months. Adult patients (≥18 years of age) with this type of cancer were enrolled from 77 centres in 18 countries. To be eligible for inclusion, participants had to have at least one measurable lesion by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST); Eastern Cooperative Oncology Group performance status 0–2; adequate bone marrow, liver, and renal function; and serum thyroid-stimulating hormone concentration lower than 0·5 mIU/L. An interactive voice response system was used to randomly allocate participants in a 1:1 ratio to either sorafenib or matching placebo. Patients, investigators, and the study sponsor were masked to treatment assignment. The primary endpoint was progression-free survival, assessed every 8 weeks by central independent review. Analysis was by intention to treat. Patients in the placebo group could cross over to open-label sorafenib upon disease progression. Archival tumour tissue was examined for BRAF and RAS mutations, and serum thyroglobulin was measured at baseline and at each visit. This study is registered with ClinicalTrials.gov , number NCT00984282 , and with the EU Clinical Trials Register, number EudraCT 2009–012007–25. Findings Patients were randomly allocated on a 1:1 basis to sorafenib or placebo. The intention-to-treat population comprised 417 patients (207 in the sorafenib group and 210 in the placebo group) and the safety population was 416 patients (207 in the sorafenib group and 209 in the placebo group). Median progression-free survival was significantly longer in the sorafenib group (10·8 months) than in the placebo group (5·8 months; hazard ratio [HR] 0·59, 95% CI 0·45–0·76; p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleSorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial
sourceAlma/SFX Local Collection
creatorBrose, Marcia S, Dr ; Nutting, Christopher M, Prof ; Jarzab, Barbara, Prof ; Elisei, Rossella, Prof ; Siena, Salvatore, MD ; Bastholt, Lars, MD ; de la Fouchardiere, Christelle, MD ; Pacini, Furio, Prof ; Paschke, Ralf, Prof ; Shong, Young Kee, Prof ; Sherman, Steven I, Prof ; Smit, Johannes W A, Prof ; Chung, John, MD ; Kappeler, Christian, PhD ; Peña, Carol, PhD ; Molnár, István, MD ; Schlumberger, Martin J, Prof
creatorcontribBrose, Marcia S, Dr ; Nutting, Christopher M, Prof ; Jarzab, Barbara, Prof ; Elisei, Rossella, Prof ; Siena, Salvatore, MD ; Bastholt, Lars, MD ; de la Fouchardiere, Christelle, MD ; Pacini, Furio, Prof ; Paschke, Ralf, Prof ; Shong, Young Kee, Prof ; Sherman, Steven I, Prof ; Smit, Johannes W A, Prof ; Chung, John, MD ; Kappeler, Christian, PhD ; Peña, Carol, PhD ; Molnár, István, MD ; Schlumberger, Martin J, Prof ; on behalf of the DECISION investigators ; DECISION investigators
descriptionSummary Background Patients with radioactive iodine (131 I)-refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis because of the absence of effective treatment options. In this study, we assessed the efficacy and safety of orally administered sorafenib in the treatment of patients with this type of cancer. Methods In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (DECISION), we investigated sorafenib (400 mg orally twice daily) in patients with radioactive iodine-refractory locally advanced or metastatic differentiated thyroid cancer that had progressed within the past 14 months. Adult patients (≥18 years of age) with this type of cancer were enrolled from 77 centres in 18 countries. To be eligible for inclusion, participants had to have at least one measurable lesion by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST); Eastern Cooperative Oncology Group performance status 0–2; adequate bone marrow, liver, and renal function; and serum thyroid-stimulating hormone concentration lower than 0·5 mIU/L. An interactive voice response system was used to randomly allocate participants in a 1:1 ratio to either sorafenib or matching placebo. Patients, investigators, and the study sponsor were masked to treatment assignment. The primary endpoint was progression-free survival, assessed every 8 weeks by central independent review. Analysis was by intention to treat. Patients in the placebo group could cross over to open-label sorafenib upon disease progression. Archival tumour tissue was examined for BRAF and RAS mutations, and serum thyroglobulin was measured at baseline and at each visit. This study is registered with ClinicalTrials.gov , number NCT00984282 , and with the EU Clinical Trials Register, number EudraCT 2009–012007–25. Findings Patients were randomly allocated on a 1:1 basis to sorafenib or placebo. The intention-to-treat population comprised 417 patients (207 in the sorafenib group and 210 in the placebo group) and the safety population was 416 patients (207 in the sorafenib group and 209 in the placebo group). Median progression-free survival was significantly longer in the sorafenib group (10·8 months) than in the placebo group (5·8 months; hazard ratio [HR] 0·59, 95% CI 0·45–0·76; p<0·0001). Progression-free survival improved in all prespecified clinical and genetic biomarker subgroups, irrespective of mutation status. Adverse events occurred in 204 of 207 (98·6%) patients receiving sorafenib during the double-blind period and in 183 of 209 (87·6%) patients receiving placebo. Most adverse events were grade 1 or 2. The most frequent treatment-emergent adverse events in the sorafenib group were hand–foot skin reaction (76·3%), diarrhoea (68·6%), alopecia (67·1%), and rash or desquamation (50·2%). Interpretation Sorafenib significantly improved progression-free survival compared with placebo in patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Adverse events were consistent with the known safety profile of sorafenib. These results suggest that sorafenib is a new treatment option for patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Funding Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (an Amgen subsidiary).
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languageeng
publisherKidlington: Elsevier Ltd
subjectAdult ; Aged ; Aged, 80 and over ; Antineoplastic Agents ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - therapeutic use ; Biological and medical sciences ; Blind Method ; Cancer therapies ; Chemotherapy ; Diagnosis ; Double ; Double-Blind Method ; Drug dosages ; Drug therapy ; Endocrinopathies ; Female ; General aspects ; Humans ; Internal Medicine ; Kaplan ; Kaplan-Meier Estimate ; Male ; Malignant tumors ; Medical prognosis ; Medical sciences ; Meier Estimate ; Metastasis ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Mutation ; Niacinamide ; Niacinamide - administration & dosage ; Niacinamide - analogs & derivatives ; Niacinamide - therapeutic use ; over ; Pain ; Patient safety ; Phenylurea Compounds ; Phenylurea Compounds - administration & dosage ; Phenylurea Compounds - therapeutic use ; Survival Analysis ; Thyroid cancer ; Thyroid Neoplasms ; Thyroid Neoplasms - drug therapy ; Thyroid. Thyroid axis (diseases) ; Treatment Outcome ; Tumors ; Vascular endothelial growth factor ; Young Adult
ispartofThe Lancet (British edition), 2014, Vol.384 (9940), p.319-328
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1Nutting, Christopher M, Prof
2Jarzab, Barbara, Prof
3Elisei, Rossella, Prof
4Siena, Salvatore, MD
5Bastholt, Lars, MD
6de la Fouchardiere, Christelle, MD
7Pacini, Furio, Prof
8Paschke, Ralf, Prof
9Shong, Young Kee, Prof
10Sherman, Steven I, Prof
11Smit, Johannes W A, Prof
12Chung, John, MD
13Kappeler, Christian, PhD
14Peña, Carol, PhD
15Molnár, István, MD
16Schlumberger, Martin J, Prof
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title
0Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial
1The Lancet (British edition)
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descriptionSummary Background Patients with radioactive iodine (131 I)-refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis because of the absence of effective treatment options. In this study, we assessed the efficacy and safety of orally administered sorafenib in the treatment of patients with this type of cancer. Methods In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (DECISION), we investigated sorafenib (400 mg orally twice daily) in patients with radioactive iodine-refractory locally advanced or metastatic differentiated thyroid cancer that had progressed within the past 14 months. Adult patients (≥18 years of age) with this type of cancer were enrolled from 77 centres in 18 countries. To be eligible for inclusion, participants had to have at least one measurable lesion by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST); Eastern Cooperative Oncology Group performance status 0–2; adequate bone marrow, liver, and renal function; and serum thyroid-stimulating hormone concentration lower than 0·5 mIU/L. An interactive voice response system was used to randomly allocate participants in a 1:1 ratio to either sorafenib or matching placebo. Patients, investigators, and the study sponsor were masked to treatment assignment. The primary endpoint was progression-free survival, assessed every 8 weeks by central independent review. Analysis was by intention to treat. Patients in the placebo group could cross over to open-label sorafenib upon disease progression. Archival tumour tissue was examined for BRAF and RAS mutations, and serum thyroglobulin was measured at baseline and at each visit. This study is registered with ClinicalTrials.gov , number NCT00984282 , and with the EU Clinical Trials Register, number EudraCT 2009–012007–25. Findings Patients were randomly allocated on a 1:1 basis to sorafenib or placebo. The intention-to-treat population comprised 417 patients (207 in the sorafenib group and 210 in the placebo group) and the safety population was 416 patients (207 in the sorafenib group and 209 in the placebo group). Median progression-free survival was significantly longer in the sorafenib group (10·8 months) than in the placebo group (5·8 months; hazard ratio [HR] 0·59, 95% CI 0·45–0·76; p<0·0001). Progression-free survival improved in all prespecified clinical and genetic biomarker subgroups, irrespective of mutation status. Adverse events occurred in 204 of 207 (98·6%) patients receiving sorafenib during the double-blind period and in 183 of 209 (87·6%) patients receiving placebo. Most adverse events were grade 1 or 2. The most frequent treatment-emergent adverse events in the sorafenib group were hand–foot skin reaction (76·3%), diarrhoea (68·6%), alopecia (67·1%), and rash or desquamation (50·2%). Interpretation Sorafenib significantly improved progression-free survival compared with placebo in patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Adverse events were consistent with the known safety profile of sorafenib. These results suggest that sorafenib is a new treatment option for patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Funding Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (an Amgen subsidiary).
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7Blind Method
8Cancer therapies
9Chemotherapy
10Diagnosis
11Double
12Double-Blind Method
13Drug dosages
14Drug therapy
15Endocrinopathies
16Female
17General aspects
18Humans
19Internal Medicine
20Kaplan
21Kaplan-Meier Estimate
22Male
23Malignant tumors
24Medical prognosis
25Medical sciences
26Meier Estimate
27Metastasis
28Middle Aged
29Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
30Mutation
31Niacinamide
32Niacinamide - administration & dosage
33Niacinamide - analogs & derivatives
34Niacinamide - therapeutic use
35over
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37Patient safety
38Phenylurea Compounds
39Phenylurea Compounds - administration & dosage
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44Thyroid Neoplasms - drug therapy
45Thyroid. Thyroid axis (diseases)
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48Vascular endothelial growth factor
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titleSorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial
authorBrose, Marcia S, Dr ; Nutting, Christopher M, Prof ; Jarzab, Barbara, Prof ; Elisei, Rossella, Prof ; Siena, Salvatore, MD ; Bastholt, Lars, MD ; de la Fouchardiere, Christelle, MD ; Pacini, Furio, Prof ; Paschke, Ralf, Prof ; Shong, Young Kee, Prof ; Sherman, Steven I, Prof ; Smit, Johannes W A, Prof ; Chung, John, MD ; Kappeler, Christian, PhD ; Peña, Carol, PhD ; Molnár, István, MD ; Schlumberger, Martin J, Prof
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24Medical prognosis
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29Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
30Mutation
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32Niacinamide - administration & dosage
33Niacinamide - analogs & derivatives
34Niacinamide - therapeutic use
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37Patient safety
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40Phenylurea Compounds - therapeutic use
41Survival Analysis
42Thyroid cancer
43Thyroid Neoplasms
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47Tumors
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jtitleThe Lancet (British edition)
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Brose, Marcia S, Dr
1Nutting, Christopher M, Prof
2Jarzab, Barbara, Prof
3Elisei, Rossella, Prof
4Siena, Salvatore, MD
5Bastholt, Lars, MD
6de la Fouchardiere, Christelle, MD
7Pacini, Furio, Prof
8Paschke, Ralf, Prof
9Shong, Young Kee, Prof
10Sherman, Steven I, Prof
11Smit, Johannes W A, Prof
12Chung, John, MD
13Kappeler, Christian, PhD
14Peña, Carol, PhD
15Molnár, István, MD
16Schlumberger, Martin J, Prof
aucorp
0on behalf of the DECISION investigators
1DECISION investigators
formatjournal
genrearticle
ristypeJOUR
atitleSorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial
jtitleThe Lancet (British edition)
addtitleLancet
date2014
risdate2014
volume384
issue9940
spage319
epage328
pages319-328
issn0140-6736
eissn1474-547X
codenLANCAO
abstractSummary Background Patients with radioactive iodine (131 I)-refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis because of the absence of effective treatment options. In this study, we assessed the efficacy and safety of orally administered sorafenib in the treatment of patients with this type of cancer. Methods In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (DECISION), we investigated sorafenib (400 mg orally twice daily) in patients with radioactive iodine-refractory locally advanced or metastatic differentiated thyroid cancer that had progressed within the past 14 months. Adult patients (≥18 years of age) with this type of cancer were enrolled from 77 centres in 18 countries. To be eligible for inclusion, participants had to have at least one measurable lesion by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST); Eastern Cooperative Oncology Group performance status 0–2; adequate bone marrow, liver, and renal function; and serum thyroid-stimulating hormone concentration lower than 0·5 mIU/L. An interactive voice response system was used to randomly allocate participants in a 1:1 ratio to either sorafenib or matching placebo. Patients, investigators, and the study sponsor were masked to treatment assignment. The primary endpoint was progression-free survival, assessed every 8 weeks by central independent review. Analysis was by intention to treat. Patients in the placebo group could cross over to open-label sorafenib upon disease progression. Archival tumour tissue was examined for BRAF and RAS mutations, and serum thyroglobulin was measured at baseline and at each visit. This study is registered with ClinicalTrials.gov , number NCT00984282 , and with the EU Clinical Trials Register, number EudraCT 2009–012007–25. Findings Patients were randomly allocated on a 1:1 basis to sorafenib or placebo. The intention-to-treat population comprised 417 patients (207 in the sorafenib group and 210 in the placebo group) and the safety population was 416 patients (207 in the sorafenib group and 209 in the placebo group). Median progression-free survival was significantly longer in the sorafenib group (10·8 months) than in the placebo group (5·8 months; hazard ratio [HR] 0·59, 95% CI 0·45–0·76; p<0·0001). Progression-free survival improved in all prespecified clinical and genetic biomarker subgroups, irrespective of mutation status. Adverse events occurred in 204 of 207 (98·6%) patients receiving sorafenib during the double-blind period and in 183 of 209 (87·6%) patients receiving placebo. Most adverse events were grade 1 or 2. The most frequent treatment-emergent adverse events in the sorafenib group were hand–foot skin reaction (76·3%), diarrhoea (68·6%), alopecia (67·1%), and rash or desquamation (50·2%). Interpretation Sorafenib significantly improved progression-free survival compared with placebo in patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Adverse events were consistent with the known safety profile of sorafenib. These results suggest that sorafenib is a new treatment option for patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Funding Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (an Amgen subsidiary).
copKidlington
pubElsevier Ltd
pmid24768112
doi10.1016/S0140-6736(14)60421-9
oafree_for_read