Trial reportEndocrine-related cancer2015
Safety and tolerability of sorafenib in patients with radioiodine-refractory thyroid cancer.
Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph
Trial report in Endocrine-related cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00984282 (A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
5.6field-weighted citation impact, top 3% of its field
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 65 citations in OpenAlex.
- Lenvatinib and sorafenib for differentiated thyroid cancer after radioactive iodine: a systematic review and economic evaluation.Health technology assessment (Winchester, England) · 2020Pooled it
- Pooled it
- Body Composition in Patients with Radioactive Iodine-Refractory, Advanced Differentiated Thyroid Cancer Treated with Sorafenib or Placebo: A Retrospective Analysis of the Phase III DECISION Trial.Thyroid : official journal of the American Thyroid Association · 2019Trial
- Optimized Dosing of Regorafenib in Patients With Metastatic Colorectal Cancer: A Practical Guide for Oncologists, Advanced Practice Providers, and Pharmacists.Journal of the advanced practitioner in oncology · 2025Review
- Re-evaluating surgical strategies in Barcelona Clinic Liver Cancer-B hepatocellular carcinoma.World journal of hepatology · 2025Review
- Investigating Drug-Induced Thyroid Dysfunction Adverse Events Associated With Non-Selective RET Multi-Kinase Inhibitors: A Pharmacovigilance Analysis Utilizing FDA Adverse Event Reporting System Data.Clinical epidemiology · 2025Article
- Navigating the complexity of current interventional radiological approaches for distant metastases in thyroid cancer.Frontiers in endocrinology · 2025Review
- Epigenetic modifications in follicular cell-derived thyroid cancer: new dimensions in pathogenesis and treatment.Frontiers in oncology · 2025Review
- Improved guidance is needed to optimise diagnostics and treatment of patients with thyroid cancer in Europe.Endocrine · 2024Review
- Systemic treatments for radioiodine-refractory thyroid cancers.Frontiers in endocrinology · 2024Review
- The potential role of reprogrammed glucose metabolism: an emerging actionable codependent target in thyroid cancer.Journal of translational medicine · 2023Review
- Combination Strategies Involving Immune Checkpoint Inhibitors and Tyrosine Kinase or BRAF Inhibitors in Aggressive Thyroid Cancer.International journal of molecular sciences · 2022Review
- Article
- Audit of Demographics, Treatment Patterns and Outcomes of Differentiated Thyroid Cancers Treated with Tyrosine Kinase Inhibitors.Indian journal of surgical oncology · 2022Article
- RET kinase inhibitors forTherapeutic advances in medical oncology · 2022Review
- Kinase-Inhibitors in Iodine-Refractory Differentiated Thyroid Cancer-Focus on Occurrence, Mechanisms, and Management of Treatment-Related Hypertension.International journal of molecular sciences · 2021Review
- Overview of lenvatinib as a targeted therapy for advanced hepatocellular carcinoma.Clinical and experimental hepatology · 2021Review
- Advancements in the treatment of differentiated thyroid cancer.Therapeutic advances in endocrinology and metabolism · 2021Review
- Article
- Clinical observation of apatinib-related hypothyroidism in patients with advanced malignancies.Experimental and therapeutic medicine · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 6 institutions in 10 countries.
Francis WordenDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA fworden@med.umich.edu.
Martin FassnachtDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA Division of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadioth
Yuankai ShiDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA Division of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadioth
Tatiana HadjievaDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Françoise BonichonDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Ming GaoDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Laura FugazzolaDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA Division of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadioth
Yuichi AndoDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Yasuhisa HasegawaDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Do Joon ParkDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Young Kee ShongDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Johannes W A SmitDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
John ChungDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Christian KappelerDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Gerold MeinhardtDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Martin SchlumbergerDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Marcia S BroseDivision of Hematology/OncologyUniversity of Michigan Comprehensive Cancer Center, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, Michigan 48109, USAEndocrine UnitDepartment of Medicine I, University Hospital, University of Würzburg, Würzburg, GermanyComprehensive Cancer Center MainfrankenUniversity of Würzburg, Würzburg, GermanyDepartment of Medical OncologyCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, ChinaBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing, ChinaRadiotherapy DepartmentMedical University, Sofia, BulgariaInstitut BergonieBordeaux, FranceTianjin Medical University Cancer HospitalTianjin, ChinaFondazione IRCCS Ca' GrandaMilan, ItalyDepartment of Pathophysiology and TransplantationUniversity of Milan, Milan, ItalyNagoya University HospitalNagoya, JapanAichi Cancer Center HospitalNagoya, JapanSeoul National University College of MedicineSeoul, KoreaAsan Medicine CenterSeoul, KoreaDepartment of Internal MedicineRadboud University Nijmegen Medical Center, Nijmegen, The NetherlandsBayer HealthCare PharmaceuticalsMontville, New Jersey, USABayer Pharma AGBerlin, GermanyInstitut Gustave RoussyVillejuif, FranceDepartment of Otorhinolaryngology: Head and Neck SurgeryAbramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Universitätsklinikum Würzburg · DEChinese Academy of Medical Sciences & Peking Union Medical College · CNAcademy of Medical Sciences · GBAichi Cancer Center · JPBayer (United States) · USNagoya University · JP
Funding
No grant is acknowledged in the PubMed record.
Abstract
Effective adverse event (AE) management is critical to maintaining patients on anticancer therapies. The DECISION trial was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 trial which investigated sorafenib for treatment of progressive, advanced, or metastatic radioactive iodine-refractory, differentiated thyroid carcinoma. Four hundred and seventeen adult patients were randomized (1:1) to receive oral sorafenib (400 mg, twice daily) or placebo, until progression, unacceptable toxicity, noncompliance, or withdrawal. Progression-free survival, the primary endpoint of DECISION, was reported previously. To elucidate the patterns and management of AEs in sorafenib-treated patients in the DECISION trial, this report describes detailed, by-treatment-cycle analyses of the incidence, prevalence, and severity of hand-foot skin reaction (HFSR), rash/desquamation, hypertension, diarrhea, fatigue, weight loss, increased serum thyroid stimulating hormone, and hypocalcemia, as well as the interventions used to manage these AEs. By-cycle incidence of the above-selected AEs with sorafenib was generally highest in cycle 1 or 2 then decreased. AE prevalence generally increased over cycles 2-6 then stabilized or declined. Among these AEs, only weight loss tended to increase in severity (from grade 1 to 2) over time; severity of HFSR and rash/desquamation declined over time. AEs were mostly grade 1 or 2, and were generally managed with dose interruptions/reductions, and concomitant medications (e.g. antidiarrheals, antihypertensives, dermatologic preparations). Most dose interruptions/reductions occurred in early cycles. In conclusion, AEs with sorafenib in DECISION were typically grade 1 or 2, occurred early during the treatment course, and were manageable over time.
Indexed as
Adenocarcinoma, FollicularAdenoma, OxyphilicAgedAntineoplastic AgentsCarcinoma, PapillaryDiarrheaDisease-Free SurvivalDrug EruptionsDrug Resistance, NeoplasmDyspneaFatigueFemaleHumansHypertensionHypocalcemiaIncidenceAntineoplastic AgentsIodine RadioisotopesNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsRadiopharmaceuticalsSorafenibadverse eventsdifferentiated thyroid cancersorafenibtargeted therapytyrosine kinase inhibitor
Identifiers
What OpenQuestion holds
Textmetadata
LicenceCC BY
Read underepoch 390
Registered trials
NCT00984282ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.