A phase III study of late course accelerated hyperfractionated radiotherapy versus conventionally fractionated radiotherapy in patients with nasopharyngeal carcinoma.

OBJECTIVE

To compare the efficacy and toxicity of late course accelerated hyperfractionated radiotherapy (LCAF) with conventionally fractionated (CF) radiotherapy in the treatment of nasopharyngeal carcinoma (NPC).

METHODS

Between March 1998 and November 2002, 200 eligible patients with NPC were randomized to receive either LCAF (48 Gy in 40 fractions, 2 fractions per day, 1.2 Gy/fraction, with an interval of ≥6 h, 5 d/wk, followed by 30 Gy in 20 fractions using 2 fractions per day, 1.5 Gy/fraction, 5 d/wk) or CF (35 fractions, 2.0 Gy/fraction/d, 5 d/wk, to a total dose of 70 Gy).

RESULTS

All patients completed the treatment. Overall baseline characteristics of the study population of the 2 arms were well balanced. With a median follow-up of 6.9 years, the 5-year local control rate was higher in the LCAF arm (87.6% vs. 75.9%, P=0.044). The 5-year overall survival rates were 74.1% vs. 58.0% (P=0.024) for the LCAF arm and the CF arm, respectively. LCAF patients had a higher occurrence of acute mucositis and a more evident weight loss than CF patients, whereas incidence rates of radiation-induced damage to the central nervous system were similar in the 2 arms.

CONCLUSIONS

LCAF achieved higher local control and overall survival rates than CF radiotherapy, without increasing radiation-related late complications such as cranial nerve palsy.