Thyroidectomy followed by fosbretabulin (CA4P) combination regimen appears to suggest improvement in patient survival in anaplastic thyroid cancer

Julie A. Sosa, Jai Balkissoon, Shiao Ping Lu, Peter Langecker, Rossella Elisei, Barbara Jarzab, C. S. Bal, Shanthi Marur, Ann Gramza, Frank Ondrey

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1078-1087
Number of pages10
JournalSurgery
Volume152
Issue number6
DOIs
StatePublished - Dec 2012

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Thyroidectomy
Survival
Neoplasms
Carboplatin
Operative Surgical Procedures
Risk Reduction Behavior
Disease Management
Paclitaxel
Anaplastic Thyroid Carcinoma
fosbretabulin
Prospective Studies
Safety

ASJC Scopus subject areas

  • Surgery

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Thyroidectomy followed by fosbretabulin (CA4P) combination regimen appears to suggest improvement in patient survival in anaplastic thyroid cancer. / Sosa, Julie A.; Balkissoon, Jai; Lu, Shiao Ping; Langecker, Peter; Elisei, Rossella; Jarzab, Barbara; Bal, C. S.; Marur, Shanthi; Gramza, Ann; Ondrey, Frank.

In: Surgery, Vol. 152, No. 6, 12.2012, p. 1078-1087.

Research output: Contribution to journalArticle

Sosa, JA, Balkissoon, J, Lu, SP, Langecker, P, Elisei, R, Jarzab, B, Bal, CS, Marur, S, Gramza, A & Ondrey, F 2012, 'Thyroidectomy followed by fosbretabulin (CA4P) combination regimen appears to suggest improvement in patient survival in anaplastic thyroid cancer', Surgery, vol. 152, no. 6, pp. 1078-1087. https://doi.org/10.1016/j.surg.2012.08.036
Sosa, Julie A. ; Balkissoon, Jai ; Lu, Shiao Ping ; Langecker, Peter ; Elisei, Rossella ; Jarzab, Barbara ; Bal, C. S. ; Marur, Shanthi ; Gramza, Ann ; Ondrey, Frank. / Thyroidectomy followed by fosbretabulin (CA4P) combination regimen appears to suggest improvement in patient survival in anaplastic thyroid cancer. In: Surgery. 2012 ; Vol. 152, No. 6. pp. 1078-1087.
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abstract = "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.",
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AU - Sosa, Julie A.

AU - Balkissoon, Jai

AU - Lu, Shiao Ping

AU - Langecker, Peter

AU - Elisei, Rossella

AU - Jarzab, Barbara

AU - Bal, C. S.

AU - Marur, Shanthi

AU - Gramza, Ann

AU - Ondrey, Frank

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N2 - 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.

AB - 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.

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