1043P - Phase II study of biweekly dose-intense paclitaxel plus gemcitabine (GEM/TAX) in patients with recurrent locoregional or metastatic head and neck sq...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anti-Cancer Agents & Biologic Therapy
Head and Neck Cancers
Presenter Ammar Sukari
Authors A. Sukari1, M. Salem2, M. Al-Hajeili3, J. Jacobs4, S. Taylo3, G. Yoo4, H. Lin4, L. Heilbrun3, A. Alousi5, O. Kucuk6
  • 1Karmanos Cancer Center, Wayne State University, 48201 - Detroit/US
  • 2Oncology, Karmanos Cancer Center, Wayne State University, 48201 - Detroit, MI/US
  • 3Oncology, Karmanos Cancer Center, Wayne State University, 48201 - Detroit/US
  • 4Department Of Otolaryngology And Head And Neck Surgery, Karmanos Cancer Center, Wayne State University, 48201 - Detroit/US
  • 52division Of Hematology And Oncolog, MD Anderson Cancer Cente, Houston/US
  • 6Oncology, Winship Cancer Institute, Emory University, 30322 - Atlanta/US

Abstract

Background

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.

Methods

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).

Results

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.

Conclusions

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.

Disclosure

All authors have declared no conflicts of interest.