Chemo-Radiotherapy, as Compared to Radiotherapy Alone, Significantly Increases Disease-Free and Overall Survival in Head and Neck Cancer Patients After Surgery: Results of EORTC Phase III Trial 22931

Ryan Smith, MD
University of Pennsylvania Cancer Center
Last Modified: November 5, 2001

Presenter: J. Bernier
Presenter's Affiliation: Radio-Oncology, Ospedale San Giovanni, Bellinzona, Switzerland
Type of Session: Plenary

Background

Standard adjuvant therapy for advanced head and neck cancer in the post-operative setting is radiation alone.

This study was designed to determine if there is an advantage of treating patients with advanced head and neck cancer with concurrent chemoradiation with high dose cisplatin compared to radiation alone.

Materials and Methods

This is a prospective, randomized trial of 334 patients assigned to either chemoradiation or radiation alone after primary surgery with curative intent.

All had squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx

Patients had T3-4 any N OR T1-2N2-3 OR T1-2N < 2 with a high risk factor (insufficient margin, perineural invasion, vascular embolism, or extracapsular nodal extension)

Radiation alone group: 66 Gy/33 Fxs/6.5 wks

Chemoradiation group: 66 Gy/33 Fxs/6.5 wks concurrent with cisplatin 80 mg/m2 on days 1, 22, and 43

Approximately 2/3 of patients had T3 or T4 primary tumors in both groups

Approximately 30% of patients had positive margins in both groups

85% of patients received >54 Gy

Results

87% of patients assigned completed 1 cycle of chemotherapy, 65% completed 2 cycles, and 49% completed all 3 cycles of chemotherapy

There was no difference between groups in terms of amount of radiation received or treatment time

Radiation alone group: 20% Grade 3 toxicity, 1.25% Grade 4 toxicity

Chemoradiation group: 36.6% Grade 3 toxicity, 6% Grade 4 toxicity

Objective mucosal reactions (grade 3) were 23% in the radiation alone group compared to 31.5% in the chemoradiation group

Local-Regional control (74% vs 55%), time to progression, DFS (59% vs 41%), and OS (65% vs 49%) were all statistically significantly better in the chemoradiation group compared to the radiation alone group

Metastasis free survival (73% vs 57%) also better in the chemoradiation group, though this did not reach statistical significance

Author's Conclusions

In high risk patients in the post-operative setting, compared to radiation alone, concurrent chemoradiation with high dose cisplatin delivered every 3 weeks resulted in a statistically significant improvement in local control, time to progression, DFS, and OS

The acute toxicities were higher, but acceptable, in the chemoradiation group

More follow up is needed to fully evaluate time to metastases, development of second primaries, and late toxicity profile.

Clinical/Scientific Implications
The majority of patients diagnosed with head and neck cancer present in an advanced stage (III-IV). Standard of care is chemoradiation for organ preservation or surgery with postoperative adjuvant radiation therapy. This study shows a large advantage in treating postoperative patients with concurrent chemoradiation as well. The results obtained for LC, DFS, and OS are all very encouraging. The toxicity profile reported is acceptable with approximately 1/3 of patients in the chemoradiation group experiencing Grade 3 toxicity. 6% had Grade 4 toxicity. These toxicity data are low, when comparing the numbers from other (nonsurgical) chemoradiation trials. With surgery, the toxicity should increase even further. Therefore, these data should be taken with some caution and, if treating patients with this regimen, full support including hydration assessment, nutritional evaluation, pain control, and close monitoring should be employed.

Oncolink's ASTRO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology and Pharmacia Oncology.

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