Purpose: Several studies have shown that the concurrent administration of chemotherapy (CHT) and radiotherapy (RT) is superior to RT alone in patients with inoperable non-metastatic squamous cell carcinoma of the head and neck (InSCCHN). We compared the efficacy and safety profile of RT and concurrent cisplatin CHT given in two different schedules to patients with previously untreated InSCCHN.
Methods: Fifty patients with previously untreated InSCCHN admitted to our oncology department were included in the study. Thirty of 50 (60%) patients with a younger age or good performance status (PS) (ECOG 0-1) received cisplatin 100 mg/m(2) on a 21-day schedule (group A). Other 20 (40%) patients with older age or poor PS (ECOG 2) received cisplatin 40 mg/m(2) on a 7-day schedule (group B). Each of the 50 patients received concurrent conventional dose RT according to primer tumor location.
Results: The median follow-up is 12 months for group A and 12.5 months for group B. Twenty-eight (93.3%) patients in group A and 18 (90%) in group B were evaluable for response. The complete response rate was 50% in group A and 40% in group B (P > 0.05). The objective response rate was 92% in group A and 90% in group B (P > 0.05). All grade 3-4 toxic events were seen in 16 (53.3%) of group A patients and 8 (40%) of group B patients (P > 0.05).
Conclusions: Comparison between two treatment modalities appears to result in statistically similar response rates and adverse event profile. A randomized phase III trial is required to confirm the safety and efficacy of weekly cisplatin therapy in patients with poor PS and/or older age at diagnosis.