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

• Type of Material: Article
• Authors: Ammar Sukari, Karmanos Cancer Institute; Marwan Al-Hajeili, King Abdulaziz University; Mohamed Salem, Wayne State University; Lance Heilbrun, Karmanos Cancer Institute; Daryn Smith, Karmanos Cancer Institute; George Yoo, Karmanos Cancer Institute; John R Jacobs, Karmanos Cancer Institute; Ho-Sheng Lin, Karmanos Cancer Institute; Omer Kucuk, Emory University
• Language: English
• Date: 2015-04
• Publisher: Medknow Publications
• Publication Version: Final Published Version
• Copyright Statement: © Avicenna Journal of Medicine
• License: Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported
• Final Published Version (URL): http://dx.doi.org/10.4103/2231-0770.154195
• Title of Journal or Parent Work: Avicenna journal of medical biotechnology
• ISSN: 2008-2835
• Volume: 5
• Issue: 2
• Start Page: 36
• End Page: 41
• Grant/Funding Information: This study was partially supported by grants from Eli-Lilly and by NIH Cancer Center Support Grant CA-22453.
• Keywords: Gemcitabine; paclitaxel; head and neck cancer
• Research Categories: Health Sciences, Oncology; Health Sciences, Medicine and Surgery

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 less than 6 months of concurrent chemoradiotherapy with high-dose cisplatin and/or have recurrent/metastatic platinum refractory SCCHN.