Abstract
Patients with metastatic head and neck squamous cell carcinoma (HNSCC) have a poor prognosis, limited treatment options, and median survival of 6 to 9 months. Paclitaxel (TAX) and gemcitabine (GEM) have both shown activity in HNSCC. The optimal combination, dosing, and scheduling of both drugs is, however, unknown. Thus, we investigated the efficacy and safety of biweekly dose-intense GEM/TAX in patients with recurrent locoregional or metastatic HNSCC.
An open-label, single-institution, single-arm, phase II study was conducted for patients (pts) who were previously treated with no more than two cytotoxic regimens. The pts received paclitaxel (150 mg/m2IV) and gemcitabine (3000 mg/m2 IV) on day 1 and 15. The treatments were repeated every 28 days (one cycle), until disease progression or unacceptable toxicity. The primary end point was response rate. RECIST-defined response was evaluated every 2 cycles (8 wks) and toxicities were evaluated after each cycle (4 wks).
Fifty-five pts were enrolled into the trial (M: F 42:13, median age (range): 56 years (23-84), performance status 0-2, 48 pts had previous radiation therapy and 39 had previous surgery), 41 of whom were response evaluable. Of these 41 patients, two pts (4.8%) achieved complete response (CR) and 17 (41.4%) demonstrated a partial response (PR). Thus, the overall response rate was 46%. Thirteen pts (31.7%) had stable disease (SD), resulting in tumor control in 32 of 41 pts (78% with CR, PR or SD), whereas 9 pts (21.1%) had disease progression (PD). Among those pts who achieved objective response or stable disease, the median response duration was 5 months and median time to progression was 4 months. Median overall survival (OS) was 15 months. Myelosuppression was the most common adverse event. Grade 3-4 neutropenia and anemia were observed in 5 (12%) and 11 (26%) pts, respectively. Eight (19%) pts developed grade 3 infection. None of these pts, however, had febrile neutropenia and there were no treatment-related deaths.
The combination of biweekly dose intense GEM/TAX was tolerable and active regimen in patients with recurrent locoregional or metastatic HNSCC. Our findings warrant further investigation in a larger patient population.
All authors have declared no conflicts of interest.