OR WAIT null SECS
CHICAGO -- Induction therapy with Taxotere (docetaxel), Platinol (cisplatin), and 5-FU (fluorouracil) leading up to chemoradiation improved complete response in patients with inoperable stage III or IV squamous cell carcinoma of the head and neck, researchers reported here.
CHICAGO, Nov. 3 -- Induction therapy with Taxotere (docetaxel), Platinol (cisplatin), and 5-FU (fluorouracil) leading up to chemoradiation improved complete response in patients with inoperable stage III or IV squamous cell carcinoma of the head and neck, researchers reported here.
The complete response rate in a small Phase II-III trial was 46.8% in patients who had neoadjuvant therapy versus 19.2% for patients treated with standard chemoradiation therapy alone, said Maria Grazia Ghi, M.D., of Ospedal SS Giovanni e Paolo in Venice, Italy, and colleagues.
There was no significant difference in the overall objective response rate between the two regimens, but the "difference in complete response justifies a larger phase III trial," Dr. Ghi reported at the International Society for the Study of Lung Cancer symposium on malignancies of the head and neck.
The objective response rate was 72.3% for patients who had neoadjuvant chemotherapy versus 80.9% for the controls, she said. The higher objective response rate in the control group reflects more patients with partial response to treatment-29 versus 12, she said. By contrast, 22 patients in the neoadjuvant treatment group achieved radiologically confirmed complete response versus nine patients in the control group.
The study recruited 96 patients with advanced, inoperable squamous cell carcinoma of the head and neck. Forty-nine patients were randomized to concomitant chemotherapy with Platinol and 5FU and radiation and 47 were randomized to three cycles of neoadjuvant Taxotere/Platinol/5FU followed by standard chemoradiation.
Two patients in the control arm were lost to follow-up after randomization, so Dr. Ghi reported results from 47 patients in each treatment arm.
The primary endpoint was radiological complete response and secondary endpoints were progression-free survival, duration of response, overall survival, time to treatment failure, and toxicities.
In both treatment groups most patients were men-38 men in the control group and 43 in the neoadjuvant therapy group. In both arms most of the cancers occurred in the oral cavity or oropharynx.
During induction therapy, the most common toxicity was neutropenia with nine grade 3 and 14 grade 14 neutropenias.
After induction therapy the observed objective response rate (two complete responses and 28 partial responses) was 63.8%, she said.
During concomitant chemotherapy/radiation therapy eleven patients in the neoadjuvant group developed stomatitis and five reported dysphagia versus 18 stomatitis cases and nine reports of dysphagia in the control group.