Home | About us | Editorial board | Search | Ahead of print | Current issue | Archives | Submit article | Instructions | Subscribe | Advertise | Contacts | Login 
  Users Online: 704 Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
ORIGINAL ARTICLE
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

Login to access the Email id

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

Rights and Permissions

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.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed3192    
    Printed63    
    Emailed0    
    PDF Downloaded259    
    Comments [Add]    
    Cited by others 2    

Recommend this journal