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Department of Medicine, Section of Hematology/Oncology [F.R.R.], Department of Radiation Oncology, and Department of Otolaryngology/Head and Neck Surgery [L.P.], University of Illinois at Chicago, Chicago, Illinois; Departments of Medicine [M.S.K.], Radiation Oncology [B.B.M.], and Otolaryngology/Head and Neck Surgery [H.P.] and the Cancer Research Center [A.W.R.], Northwestern University, Chicago, Illinois; Department of Medicine, Section of Hematology/Oncology [B.E.B., E.E.V.], Department of Radiation and Cellular Oncology [D.J.H., M.E.W., R.R.W., E.E.V.], Section of Otolaryngology/Head and Neck Surgery [K.S.], Center [M.A.L.], University of Chicago, Chicago, Illinois
Purpose: To expand on our experience with the combination of paclitaxel, fluorouracil, hydroxyurea, and twice daily irradiation (T-FHX) and to assess the impact of weekly administration of erythropoietin (r-HuEpo) on transfusion requirements, we conducted a Phase II multi-institutional trial with a simplified 1-h paclitaxel infusion schedule and randomized patients to receive weekly doses of r-HuEpo.
Patients and Methods: A total of 90 patients with locally advanced head and neck cancers (stage IV, 96%; N2/N3, 66%) were treated on a regimen of 1-h infusion of paclitaxel (100 mg/m2/day, day 1), 120-h infusion of 5-fluorouracil (600 mg/m2/day, days 0–5); hydroxyurea 500 mg p.o. every 12 h for 11 doses; and radiation 150cGy bid, days 1–5 of each 14-day cycle repeated for five cycles over 10 weeks (7200–7500 cGy). Before initiating therapy, patients were randomized to receive r-HuEpo 40,000 IU s.c. once weekly.
Results: At median follow-up of 40 months, 3-year progression-free survival is 62%, locoregional control is 84%, and systemic control is 79%. Overall survival is 59%. Anemia, leucopenia, dermatitis, and mucositis were the most frequent grade 3 or 4 toxicities. Patients randomized to erythropoietin experienced less grade 2/3 anemia (52 versus 77%; P = 0.02), but transfusion requirements were not significantly different.
Conclusions: T-FHX is an active and tolerable regimen inducing local tumor control and promising survival with organ preservation in high-risk patients. One h infusion of paclitaxel simplified the regimen without compromising efficacy. Addition of erythropoietin does not reduce the need for transfusion with this nonplatinum-containing regimen. T-FHX should be advanced to a randomized trial and compared with a cisplatin-based concomitant regimen.
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