PARADIGM and DeCIDE Trials in Head and Neck Cancer

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • Background:
    • Both PARADIGM and DeCIDE were phase III randomized trials that evaluated the role of induction chemotherapy (IC) followed by chemoradiation versus chemoradiation alone:
      • In patients with locally advanced head and neck squamous cell carcinoma (HNSCC)
  • Trial Findings:
    • PARADIGM Trial (Haddad et al., 2013):
      • Compared IC (docetaxel, cisplatin, 5-FU) followed by CRT vs. CRT alone
      • No overall survival (OS) benefit was seen for the IC arm
      • The control arm (CRT alone) performed better than expected:
        • Narrowing potential differences
      • Trial closed early due to poor accrual (145 patients instead of 300+ planned)
    • DeCIDE Trial (Cohen et al., 2014):
      • Also tested induction chemotherapy followed by CRT vs. CRT alone in advanced HNSCC with high-risk features
      • It failed to show significant improvement in OS or progression-free survival (PFS)
      • Similar to PARADIGM, poor accrual and favorable outcomes in the control arm limited conclusions
  • Key Takeaways for Surgeons:
    • Negative Results:
      • Neither trial demonstrated a survival advantage for adding induction chemotherapy before CRT
    • Reasons for Negativity:
      • Poor accrual:
        • Underpowered to detect meaningful differences
      • Unexpectedly favorable outcomes in control arms:
        • CRT alone did better than historical benchmarks
    • Clinical Implication:
      • CRT alone remains the standard of care for most patients with locally advanced HNSCC:
        • IC is not routinely recommended outside of select cases:
          • Organ preservation
          • Laryngeal /hypopharyngeal cancers
          • Where rapid tumor shrinkage is needed
    • Ongoing Relevance:
      • These trials highlight the challenges of large cooperative studies in HNSCC and the importance of accrual in detecting real benefits
  • Summary Sentence:
    • The PARADIGM and DeCIDE trials did not demonstrate a survival benefit for induction chemotherapy in head and neck cancer:
      • Largely due to poor accrual and unexpectedly strong results in the control arms:
        • Confirming that CRT alone remains the standard of care for most patients
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Published by Rodrigo Arrangoiz MS, MD, FACS, FSSO

My name is Rodrigo Arrangoiz I am a breast surgeon/ thyroid surgeon / parathyroid surgeon / head and neck surgeon / surgical oncologist that works at Center for Advanced Surgical Oncology in Miami, Florida. I was trained as a surgeon at Michigan State University from (2005 to 2010) where I was a chief resident in 2010. My surgical oncology and head and neck training was performed at the Fox Chase Cancer Center in Philadelphia from 2010 to 2012. At the same time I underwent a masters in science (Clinical research for health professionals) at the University of Drexel. Through the International Federation of Head and Neck Societies / Memorial Sloan Kettering Cancer Center I performed a two year head and neck surgery and oncology / endocrine fellowship that ended in 2016. Mi nombre es Rodrigo Arrangoiz, soy cirujano oncólogo / cirujano de tumores de cabeza y cuello / cirujano endocrino que trabaja Center for Advanced Surgical Oncology en Miami, Florida. Fui entrenado como cirujano en Michigan State University (2005 a 2010 ) donde fui jefe de residentes en 2010. Mi formación en oncología quirúrgica y e n tumores de cabeza y cuello se realizó en el Fox Chase Cancer Center en Filadelfia de 2010 a 2012. Al mismo tiempo, me sometí a una maestría en ciencias (investigación clínica para profesionales de la salud) en la Universidad de Drexel. A través de la Federación Internacional de Sociedades de Cabeza y Cuello / Memorial Sloan Kettering Cancer Center realicé una sub especialidad en cirugía de cabeza y cuello / cirugia endocrina de dos años que terminó en 2016.

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