CHICAGO—Radio- and chemotherapy delivered concurrently produced greater overall and disease-free survival than radiotherapy alone in RTOG 9703, a phase II randomized trial of patients with advanced squamous cell carcinoma of the head and neck. The RTOG 9703 trial compared three treatment approaches using different chemotherapeutic agents, integration strategies, and timing sequences against the results of clinical studies involving radiotherapy alone.
Concurrent combined radio- and chemotherapy achieved overall median 2-year survival rates of 60% to 70%, Adam Garden, MD, reported at the Second International Chicago Symposium on Malignancies of the Chest and Head & Neck.
"What is most striking is that 2-year survival, particularly in two arms of the study, is better than 1-year survival with radiotherapy alone," said Dr. Garden, associate professor of radiation oncology, M.D. Anderson Cancer Center. "Concurrent radio- and chemotherapy produced at least a 50% reduction in death rates, compared with historical controls from the 1970s, and disease-free survival ranging from 34% to 50% at 2 years."
The regimens also had acceptable toxicities. Dr. Garden said that three episodes of grade 5 toxicities secondary to treatment and sepsis occurred in one arm of the study. Grade 4 toxicities occurred at a rate of about 30% in all treatment arms, compared with 8% in previous studies of aggressive radiotherapy alone.
"The RTOG trial has shown in a randomized phase II effort that intensive therapy can be given and given safely," concurred Merrill S. Kies, MD, professor of thoracic/head and neck medical oncology, M.D. Anderson Cancer Center.
Study Protocol
RTOG 9703 analyzed 227 patients out of a total enrollment of 241 patients with stage III or IV M0 squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. Patients were randomized to one of three arms. In the first arm, patients received 70 Gy of radiation therapy for 7 weeks and cisplatin(Drug information on cisplatin) (Platinol) 10 mg/mg² and fluorouracil(Drug information on fluorouracil) (5-FU) 400 mg/m² daily for the last 10 days of the treatment course. Patients in the second arm received 70 Gy of radiation therapy on an alternate-week basis for a total of 13 weeks as well as hydroxyurea (Hydrea) 1 g twice daily and 5-FU 800 mg/m² every day. In the third arm, patients received 70 Gy of radiation therapy for 7 weeks with cisplatin 20 mg/m² and paclitaxel(Drug information on paclitaxel) (Taxol) 30 mg/m² every week.
