CHICAGORadio- 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 &
"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
"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
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 (Platinol)
10 mg/mg² and 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 (Taxol) 30 mg/m² every week.