BACKGROUND:Anaplastic thyroid cancer (ATC) is an aggressive neoplasm for which a paucity of data exist about the relative role of operative procedures in disease management. METHODS: The FACT trial was a randomized, controlled phase 2/3 trial assessing the safety and efficacy of carboplatin/paclitaxel with CA4P (experimental arm) or without CA4P (control arm) in ATC, 2007-11. Patients were permitted to have had an operation before enrollment, which was stratified on the basis of exposure to operation. A subpopulation of patients who had a cancer-related operation (thyroidectomy) was compared with those who did not, and 1-year and median survival were estimated. RESULTS: A total of 80 patients were enrolled; 55% had undergone a cancer-related operation, of whom 70% had near-total/total thyroidectomy. Baseline characteristics for operative and nonoperative patients were not substantially different. Median survival for patients who had cancer-related operation was 8.2 months in the CA4P arm versus 4.0 months in the control arm, resulting in a hazard ratio of 0.66 (P = .25) and a suggested associated reduction in risk of death of 35%. 1-year survival was 33.3% in the CA4P arm versus 7.7% in the control arm. CONCLUSION: In this largest prospective study ever conducted in ATC, thyroidectomy followed by CA4P combination regimen showed a nonsignificant trend toward improvement in patient survival.
RCT Entities:
BACKGROUND:Anaplastic thyroid cancer (ATC) is an aggressive neoplasm for which a paucity of data exist about the relative role of operative procedures in disease management. METHODS: The FACT trial was a randomized, controlled phase 2/3 trial assessing the safety and efficacy of carboplatin/paclitaxel with CA4P (experimental arm) or without CA4P (control arm) in ATC, 2007-11. Patients were permitted to have had an operation before enrollment, which was stratified on the basis of exposure to operation. A subpopulation of patients who had a cancer-related operation (thyroidectomy) was compared with those who did not, and 1-year and median survival were estimated. RESULTS: A total of 80 patients were enrolled; 55% had undergone a cancer-related operation, of whom 70% had near-total/total thyroidectomy. Baseline characteristics for operative and nonoperative patients were not substantially different. Median survival for patients who had cancer-related operation was 8.2 months in the CA4P arm versus 4.0 months in the control arm, resulting in a hazard ratio of 0.66 (P = .25) and a suggested associated reduction in risk of death of 35%. 1-year survival was 33.3% in the CA4P arm versus 7.7% in the control arm. CONCLUSION: In this largest prospective study ever conducted in ATC, thyroidectomy followed by CA4P combination regimen showed a nonsignificant trend toward improvement in patient survival.
Authors: Robert I Haddad; William M Lydiatt; Douglas W Ball; Naifa Lamki Busaidy; David Byrd; Glenda Callender; Paxton Dickson; Quan-Yang Duh; Hormoz Ehya; Megan Haymart; Carl Hoh; Jason P Hunt; Andrei Iagaru; Fouad Kandeel; Peter Kopp; Dominick M Lamonica; Judith C McCaffrey; Jeffrey F Moley; Lee Parks; Christopher D Raeburn; John A Ridge; Matthew D Ringel; Randall P Scheri; Jatin P Shah; Robert C Smallridge; Cord Sturgeon; Thomas N Wang; Lori J Wirth; Karin G Hoffmann; Miranda Hughes Journal: J Natl Compr Canc Netw Date: 2015-09 Impact factor: 11.908
Authors: P Jiménez-Fonseca; J M Gómez Saez; J Santamaria Sandi; J Capdevila; E Navarro Gonzalez; C Zafon Llopis; T Ramón Y Cajal Asensio; G Riesco-Eizaguirre; E Grande; J C Galofré Journal: Clin Transl Oncol Date: 2016-04-05 Impact factor: 3.405
Authors: John W Kunstman; C Christofer Juhlin; Gerald Goh; Taylor C Brown; Adam Stenman; James M Healy; Jill C Rubinstein; Murim Choi; Nimrod Kiss; Carol Nelson-Williams; Shrikant Mane; David L Rimm; Manju L Prasad; Anders Höög; Jan Zedenius; Catharina Larsson; Reju Korah; Richard P Lifton; Tobias Carling Journal: Hum Mol Genet Date: 2015-01-09 Impact factor: 5.121