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

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.