title: Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  We conducted a Phase II, clinical trial to evaluate the efficacy and safety of a biweekly gemcitabine and paclitaxel (GEMTAX) regimen as second-line treatment in patients with recurrent or metastatic unresectable, squamous cell carcinoma of the head and neck (SCCHN). The primary endpoint was response rate.
  
  
  METHODS
  Patients with recurrent unresectable or metastatic platinum refractory SCCHN, who had performance status ≤2 and adequate organ function, were eligible. Gemcitabine (3000 mg/m(2) intravenous) and paclitaxel (150 mg/m(2) intravenous) was given on days 1 and 15of 4 weeks cycle, until patients had disease progression or unacceptable toxicity.
  
  
  RESULTS
  Disease control (partial response [PR] + complete response [CR] + stable disease [SD]) was noted in 19 patients (54%) and overall response (CR + PR) was noted in 8 patients (23%). However, the most frequent response outcomes were progressive disease in 16 patients (46%) and SD in 11 patients (31%). The most frequent Grade 3-4 adverse events were lymphopenia in 38 patients (75%), anemia in 20 patients (39%), and infection in 16 patients (31%). Median progression-free survival was 3.6 months; median overall survival was 6.3 months.
  
  
  CONCLUSIONS
  The biweekly GEMTAX regimen has statistically significant grade 3 and 4 adverse events and has meaningful clinical activity as a second-line treatment in patients with recurrent or metastatic SCCHN who have received prior chemotherapy. This regimen may particularly be a useful treatment option in patients who progressed in less than 6 months of concurrent chemoradiotherapy with high-dose cisplatin and/or have recurrent/metastatic platinum refractory SCCHN.
authors: Karmanos Cancer Institute, Detroit, MI, Saudi Arabia ; Department of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi Arabia.
authors: Ammar
authors: A
authors: Sukari
authors: Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
authors: Marwan
authors: M
authors: Al-Hajeili
authors: Department of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi Arabia.
authors: Mohamed
authors: M
authors: Salem
authors: Karmanos Cancer Institute, Detroit, MI, Saudi Arabia.
authors: Lance
authors: L
authors: Heilbrun
authors: Karmanos Cancer Institute, Detroit, MI, Saudi Arabia.
authors: Daryn
authors: D
authors: Smith
authors: Karmanos Cancer Institute, Detroit, MI, Saudi Arabia ; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USA.
authors: George
authors: G
authors: Yoo
authors: Karmanos Cancer Institute, Detroit, MI, Saudi Arabia ; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USA.
authors: John R
authors: JR
authors: Jacobs
authors: Karmanos Cancer Institute, Detroit, MI, Saudi Arabia ; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USA.
authors: Ho-Sheng
authors: HS
authors: Lin
authors: Winship Cancer Institute, Emory University, Atlanta, GA, USA.
authors: Omer
authors: O
authors: Kucuk
keywords: Gemcitabine; head and neck cancer; paclitaxel