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Year : 2015  |  Volume : 5  |  Issue : 2  |  Page : 36-41

Biweekly gemcitabine and paclitaxel in patients with relapsed or metastatic squamous cell carcinoma of the head and neck

1 Karmanos Cancer Institute, Detroit, MI; Department of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi Arabia
2 Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
3 Department of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi Arabia
4 MD Anderson Cancer Center, Houston, TX, USA
5 Karmanos Cancer Institute, Detroit, MI, Saudi Arabia
6 Karmanos Cancer Institute, Detroit, MI, Saudi Arabia; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USA
7 Winship Cancer Institute, Emory University, Atlanta, GA, USA

Correspondence Address:
Ammar Sukari
Karmanos Cancer Institute, 4100 John R Road, Mailcode HW04HO, MI, USA

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Source of Support: This study was partially supported by grants from Eli-Lilly and by NIH Cancer Center Support Grant CA-22453, Conflict of Interest: None

DOI: 10.4103/2231-0770.154195

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Purpose: 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. Patients and 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. Conclusion: 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 <6 months of concurrent chemoradiotherapy with high-dose cisplatin and/or have recurrent/metastatic platinum refractory SCCHN.

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