Purpose: The objective of this phase II study was to assess the clinical antitumor activity and toxicities of docetaxel and cisplatin chemotherapy, in patients with locally advanced and metastatic, recurrent squamous cell carcinomas of the head and neck (SCCHN).
Materials and methods: All eligible patients with locally advanced and metastatic, recurrent SCCHN had received two courses of chemotherapy followed by repeated head and neck examinations and computed tomography. Patients who had received prior chemotherapy with taxanes were ineligible. If the patients achieved a response (either CR or PR), they received one more course of chemotherapy prior to undergoing definitive local treatment. The combination chemotherapy consisted of docetaxel, 70 mg/m2, and cisplatin, 75 mg/m2, on day 1, with the cycles repeated every 3~4 weeks.
Results: All 32 patients were assessable for response and toxicity analyses. The most common grade 3/4 adverse event was neutropenia, which occurred in 11% of cases. No febrile neutropenia was noticed. The other grade 3/4 adverse events included: anemia (2%) and stomatitis (3%). The response rate in patients with locally advanced cancer was 19/21 (90%). Fifteen patients (71%) achieved a CR and 4 (19%) a PR. Out of the 4 patients presenting with a distant metastatic disease, 1 each achieved CR and PR, with 2 stable disease (SD). Out of the 7 patients with a recurrence at a distant site, 1 each achieved PR and SD, and 5 (71%) had a progression of the disease (PD). The overall response rate was 22/32 (69%).
Conclusion: Docetaxel plus cisplatin is an effective regimen with an acceptable toxicity profile. This regimen may offer high antitumor activity on short outpatient administration, with a low incidence of severe toxicity.
Keywords: Chemotherapy; Cisplatin; Docetaxel; Head and neck neoplasm.