Randomized Phase II Trial of Concomitant Chemoradiotherapy Using Weekly Carboplatin or Daily Low-Dose Cisplatin for Squamous Cell Carcinoma of the Head and Neck

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PURPOSEThis randomized, phase II study aimed to compare concomitant Chemoradiotherapy using weekly carboplatin or daily low-dose cisplatin as a treatment for squamous cell carcinoma of the head and neck.PATIENTS AND METHODSOne hundred nineteen patients with moderate-to advanced-stage disease were eligible for the study. Fifty-three patients had stage II disease, 28 had stage III, and the remaining 38 had stage IV disease. Primary tumor sites included the larynx (N = 63), oropharynx (N = 30), hypopharynx (N = 23), and oral cavity (N = 3). Each patient received either a weekly carboplatin dose (100 mg/m2) in one arm or daily cisplatin (4 mg/m2) in the other arm for the initial 4 weeks of radiotherapy. The radiotherapy dose of 65 Gy was given in 26 fractions over 45 days, dependent on a good tumor response at 40 Gy. Forty-nine (81.7%) of 60 patients treated with carboplatin and 41 (69.5%) of 59 patients treated with cisplatin received the full dose of radiotherapy. Surgical resection was optionally used for the remaining patients.RESULTSThe median follow-up time was 63 months. The local control rate at 5 years was 56.2% for the carboplatin-treated arm and 35.5% for the cisplatin-treated arm, respectively. The 5-year overall survival rate did not significantly differ between treatments: 71.4% for carboplatin and 66.0% for cisplatin. Hematologic toxicity was more frequent in the carboplatin-treated arm. No difference was observed in surgical complications or in radiation-related adverse effects.DISCUSSIONThese findings suggest that weekly carboplatin treatment is preferable to daily low-dose cisplatin. This could be because the total dose of cisplatin was too low to be effective.

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