LISBON, Portugal—For patients with locally advanced head and neck cancer, coupling cisplatin(Drug information on cisplatin) (Platinol) with radiotherapy leads to longer survival and fewer recurrences than does radiation alone, according to the first results of EORTC study 22931.
This randomized phase III trial was jointly conducted by the Head and Neck and Radiotherapy groups of the European Organization for Research and Treatment of Cancer (EORTC).
Jacques Bernier, MD, of the Oncology Institute of Southern Switzerland, Bellinzona, presented the results at the 11th European Cancer Conference (ECCO abstract 989). He said that EORTC investigators from 23 centers in 12 countries enrolled 334 patients with cancer of the oral cavity, oropharynx, hypopharynx, or larynx.
Eligible patients had stage T3-T4 disease, or T1-T2 disease with two to three positive nodes and no metastases, or T1-T2 disease with fewer than two positive nodes plus a high risk factor, such as perineural involvement. "Importantly, two thirds of patients were stage T3-T4," Dr. Bernier said.
After undergoing primary surgery performed with curative intent, study participants were randomized to receive either radiotherapy alone, consisting of 66 Gy given in 33 fractions over 6.5 weeks, or the same radiation schedule paired with cisplatin 100 mg/m² on days 1, 22, and 43. Dr. Bernier pointed out that two thirds of surgical procedures achieved tumor-free margins.
Although patients treated with cisplatin experienced significantly more functional mucosal reactions, they showed no significant excess of objective mucosal reactions.
Cisplatin was responsible for grade 3-4 leukopenia in 14% of patients, grade 3-4 granulocytopenia in 11%, grade 3-4 thrombocytopenia in 2%, grade 3-4 nausea in 11%, and grade 3-4 vomiting in 10%. Notwithstanding these side effects, two thirds of patients completed two of the planned three cycles of chemotherapy, and half completed all three cycles.
