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CC BY-NC-ND 4.0 · Avicenna J Med 2015; 05(02): 36-41
DOI: 10.4103/2231-0770.154195
ORIGINAL ARTICLE

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

Ammar Sukari
Karmanos Cancer Institute, Detroit, MI; Department of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi Arabia
,
Marwan Al-Hajeili
Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia
,
Mohamed Salem
Department of Hematology & Oncology, Wayne State University, Detroit, MI, Saudi Arabia
,
Lance Heilbrun
Karmanos Cancer Institute, Detroit, MI, Saudi Arabia
,
Daryn Smith
Karmanos Cancer Institute, Detroit, MI, Saudi Arabia
,
George Yoo
Karmanos Cancer Institute, Detroit, MI, Saudi Arabia; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USA
,
John R Jacobs
Karmanos Cancer Institute, Detroit, MI, Saudi Arabia; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USA
,
Ho-Sheng Lin
Karmanos Cancer Institute, Detroit, MI, Saudi Arabia; Department of Otolaryngology & Head and Neck Surgery, Wayne State University, Detroit, MI, USA
,
Omer Kucuk
Winship Cancer Institute, Emory University, Atlanta, GA, USA
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Abstract

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.

Keywords

Gemcitabine - head and neck cancer - paclitaxel


Publication History

Article published online:
09 August 2021

© 2015. Syrian American Medical Society. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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