Concomitant infusional paclitaxel and fluorouracil, oral hydroxyurea, and hyperfractionated radiation for locally advanced squamous head and neck cancer
Ms. Kies et al., Concomitant infusional paclitaxel and fluorouracil, oral hydroxyurea, and hyperfractionated radiation for locally advanced squamous head and neck cancer, J CL ONCOL, 19(7), 2000, pp. 1961-1969
Purpose: To improve local disease control and survival with organ preservat
ion, we conducted ct phase II multi-institutional trial with a concomitant
taxane-based chemotherapy and hyperfractionated radiation regimen.
Patients and Methods: Sixty-four patients with locally advanced squamous ca
ncers (stage IV, 98%; N2/3, 81%) were treated on fin intensive regimen cons
isting of 5-day (120-hour) infusions of paclitaxel 120 mg/m(2)/d) and fluor
ouracil (600 mg/m2/d), oral hydroxyurea 500 mg every 12 hours for 11 doses,
and radiation 1.5 Gy bid (T-FH2X). Chemoradiation was administered concomi
tantly on days 1 to 5 of each 14-day cycle. A full treatment course consist
ed of five cycles during a 10-week period to a total radiation dose of 72 t
o 75 Gy.
Results: The median follow-up for the group is 34 months. At 3 years, progr
ession-free survival is 63%, locoregional control is 86%, and systemic cont
rol is 79%; overall survival is 60%. Seventeen patients died of recurrent c
ancer, two died of second primary cancers, and four died of other causes. S
ide effects observed include anemia (22% required transfusion), leucopenia
(34%, grade 3 to 4), and mucositis (84%, grade 3 to 4). Organ preservation
principles were maintained. At 1 year posttreatment, 61% of patients had re
vere xerostomia and 47% had compromised swallowing. There was little distur
bance of speech quality in 97% of patients at the same follow-up point.
Conclusion T-FH2X is a highly active and tolerable concomitant chemotherapy
and hyperfractionated radiation regimen that induces sustained local tumor
control and holds promise for improved survival with organ preservation in
high-risk patients. Identification of less toxic therapy and improved dist
ant disease control are needed. T-FH2X should be tested in a randomized tri
al and compared with a less intensive concomitant regimen that uses once-da
ily radiation fractionation. (C) 2001 by American Society of Clinical Oncol
ogy.