A Phase II multi-institutional trial of chemoradiation using weekly docetaxel and erythropoietin for high-risk postoperative head and neck cancer patients.

Abstract

PURPOSE:

To determine efficacy and toxicities of postoperative concurrent chemoradiation using docetaxel in high-risk head and neck cancer.

METHODS AND MATERIALS:

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.

CONCLUSION:

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.

• Authors: Christopher D Willey, Barbara A Murphy, James L Netterville, Brian B Burkey, Yu Shyr, Bashar Shakhtour, Bonnie Kish, David Raben, Changhu Chen, John I Song, Madeleine A Kane, Anthony J Cmelak
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 67 Issue 5 Pg. 1323-31 (Apr 01 2007) ISSN: 0360-3016 [Print] United States
• PMID: 17289289 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Radiation-Sensitizing Agents
• Taxoids
• Erythropoietin
• Docetaxel
• Hemoglobin A

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects)
• Combined Modality Therapy (adverse effects)
• Disease-Free Survival
• Docetaxel
• Dose Fractionation, Radiation
• Erythropoietin (administration & dosage)
• Female
• Head and Neck Neoplasms (blood, drug therapy, radiotherapy, surgery)
• Hemoglobin A
• Humans
• Male
• Middle Aged
• Mouth Mucosa (drug effects, radiation effects)
• Prospective Studies
• Radiation Injuries
• Radiation-Sensitizing Agents (administration & dosage, adverse effects)
• Radiotherapy Dosage
• Stomatitis (etiology)
• Taxoids (administration & dosage, adverse effects)