Phase II Study of Gemcitabine and Docetaxel Combination in Patients with Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Purpose. To explore the safety and efficacy of gemcitabine and docetaxel (GEMDOC) in previously treated patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods. Patients with advanced SCCHN previously pretreated with one or two lines of palliative chemotherapy were treated with gemcitabine and docetaxel until disease progression. Results. Thirty-six patients were enrolled, and 29 were response evaluable. 16 (55%) experienced clinical benefit (response or stable disease). Six (21%) patients achieved partial response (PR), none achieved complete response (CR), and the overall response rate (ORR) was 21% (95% CI: 0.10–0.38). Ten (28%) patients had stable disease. The median response duration (RD) for the 6 PR patients was 3.2 months (80% CI: 2.0–6.1 months). Median overall survival was 4.2 months (95% CI: 2.4–7.0 months). Among the 33 treated patients: 13 (39%) patients had grade 3-4 anemia, 10 (30%) had grade 3-4 neutropenia. Conclusion. The study drugs were relatively safe, and the clinical benefit (PR + SD) rate was 55%. However, the efficacy objective for this regimen was not met. Given the good safety profile, further investigation of this regimen with the addition of a targeted agent may lead to better efficacy. 1. Introduction Patients with squamous cell carcinoma of head and neck (SCCHN) who had disease recurrence after primary surgery or chemoradiation therapy or who present with metastatic disease usually have a poor prognosis [1]. The role of chemotherapy in this setting is palliative, complete response is rare, and duration of response is short. Single-agent docetaxel was previously evaluated in four phase II studies involving approximately 160 patients with metastatic or recurrent SCCHN. The overall response rates observed in these studies ranged from 21% to 42% [2–5]. The principal toxicity reported in these studies was grade 3 and 4 neutropenia. Based on these phase II studies, single-agent docetaxel 75–100？mg/m2 IV every 3 weeks was shown to be an active and generally well-tolerated regimen for metastatic or recurrent SCCHN. Docetaxel has also been evaluated as part of a doublet in combination with cisplatin or 5-fluorouracil (5-FU) in patients with recurrent or metastatic SCCHN. In phase I/II trials evaluating the combination of docetaxel and cisplatin the overall response rates were 33% to 40% [6–8]. Studies evaluating the combination of docetaxel and 5-FU yielded response rates from 24% to 27% [9, 10]. Of the two doublets, docetaxel combined with cisplatin appeared to be the more
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