A Phase II multi-institutional trial of chemoradiation using weekly docetaxel and erythropoietin for high-risk postoperative head and neck cancer patients.
OBJECTIVE
To determine efficacy and toxicities of postoperative concurrent chemoradiation using docetaxel in high-risk head and neck cancer.


METHODS
High-risk patients were enrolled 2-8 weeks after surgery. Treatment included 60 Gy for 6 weeks with weekly docetaxel 25 mg/m(2) and erythropoietin alpha 40,000 U for hemoglobin < or =12 g/dL. Primary endpoints included locoregional control (LC), disease-free survival (DFS), and patterns of failure (POF). Secondary endpoints were toxicity and quality of life.


RESULTS
Eighteen patients were enrolled (14 male, 4 female), aged 24-70 years (median, 55 years). Primary site included oropharynx = 7, oral cavity = 8, hypopharynx = 1, and larynx = 2. Pathologic American Joint Committee on Cancer Stage was III = 3 patients, IV = 15 patients. High-risk eligibility included > or =2 positive lymph nodes = 13, extracapsular extension = 10, positive margins = 8 (11 patients with two or more risk factors). Docetaxel was reduced to 20 mg/m(2)/week after 5 patients had prolonged Grade 3 or higher mucositis. Overall, number of doses delivered was 2 of 6 = 1, 3 of 6 = 2, 4 of 6 = 2, 5 of 6 = 4, 6 of 6 = 9 patients. With median follow-up of 30 months (range, 5-66), 10 (56%) patients are alive and have no evidence of disease (NED); POF: three local recurrences (two with distant) and 1 distant only. One-year survival was 76%, median PFS and DFS had not been reached. Three-year LC was 82%. No Grade 3 or higher late toxicities were observed, although a few cases of prolonged mucositis and taste loss (>3 months) were seen, particularly at 25 mg/m(2)/week.


CONCLUSIONS
Postoperative radiation therapy with weekly docetaxel 20 or 25 mg/m(2)/week for high-risk postoperative head and neck cancer caused intolerable mucosal toxicity, prompting early study termination. Further studies should consider 15 mg/m(2). Actuarial 3-year LC is 82%, similar to cisplatin-based chemoradiation regimens. Distant metastasis remains an important issue requiring additional systemic interventions.
Willey
Christopher D
CD
Department of Radiation Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, USA.
Murphy
Barbara A
BA
Netterville
James L
JL
Burkey
Brian B
BB
Shyr
Yu
Y
Shakhtour
Bashar
B
Kish
Bonnie
B
Raben
David
D
Chen
Changhu
C
Song
John I
JI
Kane
Madeleine A
MA
Cmelak
Anthony J
AJ
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D003131:Combined Modality Therapy / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006258:Head and Neck Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D006441:Hemoglobin A; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000528:radiation effects; D011446:Prospective Studies; D011832:Radiation Injuries; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000209:etiology*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects*
D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D043823:Taxoids; D004921:Erythropoietin; D000077143:Docetaxel; D006441:Hemoglobin A