Intensity-modulated radiation therapy and doxorubicin in thyroid cancer: A prospective phase 2 trial Journal Article


Authors: Romesser, P. B.; Sherman, E. J.; Whiting, K.; Ho, M. L.; Shaha, A. R.; Sabra, M. M.; Riaz, N.; Waldenberg, T. E.; Sabol, C. R.; Ganly, I.; McBride, S. M.; Fagin, J. A.; Zhang, Z.; Tuttle, R. M.; Wong, R. J.; Lee, N. Y.
Article Title: Intensity-modulated radiation therapy and doxorubicin in thyroid cancer: A prospective phase 2 trial
Abstract: Background: The use of external-beam radiotherapy for locally advanced nonanaplastic thyroid cancer remains controversial. This prospective study evaluated the efficacy and tolerability of intensity-modulated radiation therapy (IMRT) with or without concurrent chemotherapy in patients with locally advanced thyroid cancer. Methods: The authors conducted a nonrandomized phase 2 trial of IMRT with or without concurrent doxorubicin in patients with gross residual or unresectable nonanaplastic thyroid carcinoma (ClinicalTrials.gov identifier NCT01882816). The primary end point was 2-year locoregional progression-free survival (PFS). Secondary end points included overall survival (OS), safety, patient-reported outcomes, and functional outcomes. Results: Twenty-seven patients were enrolled: 12 (44.4%) with unresectable disease and 15 (55.6%) with gross residual disease. The median follow-up was 45.6 months (interquartile range, 42.0-51.6 months); the 2-year cumulative incidences of locoregional PFS and OS were 79.7% and 77.3%, respectively. The rate of grade 3 or higher acute and late toxicities was 33.4%. There were no significant functional differences 12 months after treatment (assessed objectively by the modified barium swallow study). Patient-reported quality of life in the experimental group was initially lower but returned to the baseline after 6 months and improved thereafter. In a post hoc analysis, concurrent chemotherapy with intensity-modulated radiation therapy (CC-IMRT) resulted in significantly less locoregional failure at 2 years (no failure vs 50%; P =.001), with higher rates of grade 2 or higher acute dermatitis, mucositis, and dysphagia but no difference in long-term toxicity, functionality, or patient-reported quality of life. Conclusions: In light of the excellent locoregional control rates achieved with CC-IMRT and its acceptable toxicity profile as confirmed by functional assessments and patient-reported outcomes, CC-IMRT may be preferred over IMRT alone. © 2021 American Cancer Society
Keywords: head and neck cancer; radiation therapy; thyroid cancer; chemoradiation; intensity-modulated radiation therapy (imrt)
Journal Title: Cancer
Volume: 127
Issue: 22
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2021-11-15
Start Page: 4161
End Page: 4170
Language: English
DOI: 10.1002/cncr.33804
PUBMED: 34293201
PROVIDER: scopus
PMCID: PMC9455581
DOI/URL:
Notes: Article -- Export Date: 1 December 2021 -- Source: Scopus
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MSK Authors
  1. James A Fagin
    181 Fagin
  2. Zhigang Zhang
    428 Zhang
  3. Ashok R Shaha
    698 Shaha
  4. Robert M Tuttle
    482 Tuttle
  5. Eric J Sherman
    341 Sherman
  6. Nadeem Riaz
    417 Riaz
  7. Nancy Y. Lee
    876 Lee
  8. Richard J Wong
    415 Wong
  9. Ian Ganly
    431 Ganly
  10. Mona M Sabra
    43 Sabra
  11. Margaret L Ho
    8 Ho
  12. Paul Bernard Romesser
    192 Romesser
  13. Sean Matthew McBride
    295 McBride
  14. Christopher Sabol
    14 Sabol
  15. Karissa A. Whiting
    47 Whiting