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• W2605355129 abstract "5552 Background: Postoperative radiation with concurrent cisplatin has shown improved efficacy over radiation alone in randomized trials for patients with HRPHNC: ≥2 involved nodes (N), extra-capsular nodal disease (EC), +margins (+M), N3 disease (N3). This phase II trial in HRPHNC evaluates the efficacy and toxicities of postop CR using weekly docetaxel, and with weekly Epo in patients with suboptimal Hgb (≤12 gm/dl). Methods: HRPHNC patients were enrolled 2–8 weeks after surgery with PS 0–1, no distant metastases, and no prior regional radiation or chemotherapy. Treatment consisted of conformal radiation (60Gy in 6 weeks) with weekly Doc 25mg/m2 and Epo 40,000U. Primary endpoints include local/regional control, DFS, and patterns of failure. Secondary endpoints include toxicity and QOL. Results: 15 HRPHNC (11 male, 4 female) ages 22–69 years (median 51) were enrolled. Characteristics include: Oropharynx=6, Oral Cavity=6, Hypopharynx=1, Larynx=1; AJCC stage III=2 pts, IV=13 pts. HRPHNC eligibility included: N=11, EC=8, +M=5. Doc was held for Gr4 mucositis (muc), Gr4 dermatitis, or allergy. Doc was reduced to 20mg/m2/wk after 5 pts had prolonged Gr≥3 muc; however, all 5 received 5 or all 6 weekly doses. At 20mg/m2, the number of Doc doses tolerated/prescribed were: 3/6=1 pt, 4/6=3 pts, 5/6=3 pts, 6/6=3 pts, and most often held for acute Gr4 muc. Median FU is 18 months (3–41): 12 (80%) remain NED, 1 patient died of local recurrence, 1 of distant mets, and 1 with both. No Gr≥3 late toxicities have been observed, although prolonged muc and taste loss (∼3 months) has been observed in a few patients. Only 1 pt requires PEG to date. QOL data will be analyzed at a later date. Conclusions: Postoperative radiation with weekly doc 20mg/m2 (+/- Epo) for HRPHNC is feasible. Early results suggest high locoregional control rates (80%). Weekly Doc doses > 20 mg/m2 appear to result in prolonged Gr≥3 muc. Accrual will continue using this regimen with intensity-modulated radiation therapy, and local/regional control, DFS, and toxicities will be evaluated with this approach. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer Pfizer Johnson & Johnson" @default.
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• W2605355129 date "2004-07-15" @default.
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• W2605355129 title "Early results of a phase II multi-institutional trial of chemoradiation (CR) using weekly docetaxel (Doc) and erythropoetin (Epo) for high-risk postoperative head and neck cancer (HRPHNC) patients" @default.
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