GORTEC-94-01 in Advanced Oropharyngeal Squamous Cell Carcinoma (SCC)

Rodrigo Arrangoiz MS, MD, FACS, FSSO
  • What it asked?
    • Does adding concurrent chemotherapy to definitive RT improve outcomes vs RT alone in stage III to IV oropharyngeal cancer? PubMed
  • Who was enrolled?
    • n=226 adults with stage III to IV oropharynx SCC:
      • No planned primary surgery
    • Arms well balanced by age, sex, stage, PS, site  PubMed
  • Treatment and dosing (the “GORTEC” CRT)
    • RT (both arms): 
      • 70 Gy in 35 fractions
    • CRT arm chemotherapy: 
      • Carboplatin 70 mg/m²/day (IV bolus) + 5-FU 600 mg/m²/day (continuous infusion), days 1 to 4, given during weeks 1, 4, and 7 of RT (total 3 cycles) PubMed+1
  • Endpoints:
    • Primary intent:
      • Improve DFS:
        • Reported OS, DFS, and locoregional control (LRC) at 3 and 5 years; plus acute and late toxicity PubMed+1
  • Key efficacy results
    • 3-year (initial JNCI report, 1999):
      • OS: 51% CRT vs 31% RT (P=.02)
      • DFS: 42% vs 20% (P=.04)
      • LRC: 66% vs 42% (favored CRT) PubMed
    • 5-year (final JCO report, 2004):
      • OS: 22% CRT vs 16% RT (P=.05)
      • DFS: 27% vs 15% (P=.01)
      • LRC: 48% vs 25% (P=.002)
    • Independent adverse prognostic factors: 
      • Stage IV, Hgb < 12.5 g/dL, and RT alone PubMed
    • Toxicity (what to remember)
      • Acute (during treatment):
        • Grade 3 to 4 mucositis: ~ 71% CRT vs 39% RT
      • Higher hematologic toxicity with CRT PubMed
    • Late (5-year assessments):
      • Any late effect common in both arms; organs most affected with CRT:
        • Salivary glands, skin, teeth, mandible
      • In a dedicated late-toxicity paper using LENT/SOMA, RTOG/EORTC, and NCI-CTC scales:
        • Severe late effects differed significantly only for dental complications (higher with CRT)
        • Spinal cord not adversely affected
        • No late-toxicity deaths
        • Scale choice influenced perceived rates PubMed
      • In the JCO final report, “≥ G3 to G4 late complications” were:
        • 56% CRT vs 30% RT (not statistically significant) PubMed
  • Why it still matters:
    • One of the pivotal pre-HPV-era trials establishing concurrent CRT as superior to RT alone for oropharynx SCC:
      • Supporting today’s practice where cisplatin-based CRT is standard for eligible patients:
        • Carboplatin / 5-FU remains a reasonable alternative when cisplatin is contraindicated PubMed+1
  • Fast facts to quote:
    • Site: 
      • Oropharynx only
    • Regimen: 
      • Carboplatin 70 mg / m² day 1 + 5-FU 600 mg/m²/d CI day 1 to 4, weeks 1/4/7 with 70 Gy/35 fx
    • 3-yr OS: 
      • 51% vs 31%
    • 5-yr LRC: 
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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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