Radiation Alone (RT) Versus RT with Concomitant Chemotherapy (CT) in Stages III and IV Oropharynx Carcinoma. Final Results of the 94-01 GORTEC Randomized Study

Diana Stripp, MD
University of Pennsylvania Cancer Center
Last Modified: November 5, 2001

Share article


Presenter: Bourhis, J
Presenter's Affiliation: GORTEC, Tours, France
Type of Session: Reporting

Background

  • This study was designed to test whether the addition of three cycles of chemotherapy during standard radiation therapy would improve disease-free survival in patients with stages III and IV oropharynx carcinoma
  • Preliminary results of this randomized trial for radiation (RT) vs. concomitant chemotherapy and radiation therapy (CTRT) for advanced stage oropharynx carcinoma showed improvement in overall survival for the CTRT arm. Calais, G JNCI 1999

    Materials and Methods

  • 226 patients with locally advanced oropharynx stage III and IV tumors have been entered in this phase III multicentric randomized trial
  • RT alone (arm A) was compared to RT with concomitant CT (arm B).
  • RT was identical in the two arms,delivering 70 Gy in 35 fractions.
  • Arm B patients received Carboplatin and 5FU.
  • 34% were stage III and 66% were stage IV.

    Results

  • RT compliance was similar in the 2 arms.
  • Relative dose intensity in arm B was 78% and 76% for carboplatin and 5FU.
  • With a median follow-up of 63 months, 72 patients have died in arm A vs 49 in arm B.
  • 5 yr actuarial disease-free survival rates were 27% for arm B vs 15% for arm A, p = 0.01.
  • 5 yr overall survival was 23% for arm B vs 16% for arm A, p=0.06.
  • Local and regional control rates were 48% vs 25%, p=0.02.
  • Grade 3 and 4 acute toxicity: mucositis rate was significantly higher in arm B (57% vs 32%, p=0.05). Skin toxicity was not different. Hematologic toxicity was higher in arm B on neutrophil count and hemoglobin level.
  • Grade 3 and 4 late toxicity was 32% in arm A and 49% arm B, p=0.02 ( xerostomia, cervical fibrosis, dental problems).
  • Pattern of failure: Primary tumor bed ? 58% arm A vs 37% arm B, p=0.04. Nodal ? 35% arm A vs 21% arm B, p=0.02. Distant mets ? 12% arm A and 19% arm B, p=NS

    Author's Conclusions

  • Concomitant chemoradiation improves local regional control and disease free survival with a trend toward improved overall survival.
  • Concomitant chemoradiation has no impact on distant metastasis.
  • Both acute and late toxicity were increased with concomitant chemoradiation, however these toxicities were acceptable.

    Clinical/Scientific Implications

  • Findings from this study are consistent with the current trend of using concurrent chemotherapy and radiation therapy for advanced stage Head and Neck cancer patients.
  • Future studies may evaluate ways to decrease toxicities associated with this agressive regimen
  • Studies aimed at decreasing the rate of distant metastasis are also needed.


    News
    ASTRO: Cisplatin Plus RT, HDRB Beneficial for Cervical Cancer

    Oct 4, 2013 - For women with stage IIIB squamous cervical cancer, cisplatin added to radiotherapy plus high-dose-rate brachytherapy is associated with improved disease-free survival, according to a study presented at the annual meeting of the American Society for Radiation Oncology, held from Sept. 22 to 25 in Atlanta.



  • I Wish You Knew

    How cancer patients have changed my life

    View More



    Blogs and Web Chats

    OncoLink Blogs give our readers a chance to react to and comment on key cancer news topics and provides a forum for OncoLink Experts and readers to share opinions and learn from each other.




    OncoLink OncoPilot

    Facing a new cancer diagnosis or changing the course of your current treatment? Let our cancer nurses help you through!

    Learn More