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%; N(2)/N(3), 66%) were treated on a regimen of 1-h infusion of paclitaxel (100 mg/m(2)/day, day 1), 120-h infusion of 5-fluorouracil (600 mg/m(2)/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.
RCT Entities:
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%; N(2)/N(3), 66%) were treated on a regimen of 1-h infusion of paclitaxel (100 mg/m(2)/day, day 1), 120-h infusion of 5-fluorouracil (600 mg/m(2)/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.
Authors: Jeri A Logemann; Alfred W Rademaker; Barbara Roa Pauloski; Cathy L Lazarus; Bharat B Mittal; Bruce Brockstein; Ellen MacCracken; Daniel J Haraf; Everett E Vokes; Lisa A Newman; Dachao Liu Journal: Head Neck Date: 2006-01 Impact factor: 3.147
Authors: Barbara Roa Pauloski; Alfred W Rademaker; Jerilyn A Logemann; Muveddet Discekici-Harris; Bharat B Mittal Journal: Head Neck Date: 2014-08-01 Impact factor: 3.147
Authors: Julia Bohlius; Kurt Schmidlin; Corinne Brillant; Guido Schwarzer; Sven Trelle; Jerome Seidenfeld; Marcel Zwahlen; Mike J Clarke; Olaf Weingart; Sabine Kluge; Margaret Piper; Maryann Napoli; Dirk Rades; David Steensma; Benjamin Djulbegovic; Martin F Fey; Isabelle Ray-Coquard; Volker Moebus; Gillian Thomas; Michael Untch; Martin Schumacher; Matthias Egger; Andreas Engert Journal: Cochrane Database Syst Rev Date: 2009-07-08
Authors: Thomas Kuhnt; Axel Becker; Marc Bloching; Johannes Schubert; Gunther Klautke; Rainer Fietkau; Juergen Dunst Journal: Med Oncol Date: 2006 Impact factor: 3.738