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Journal of Oncology
Volume 2019, Article ID 6273438, 9 pages
Review Article

Efficacy and Safety of Gefitinib in Patients with Advanced Head and Neck Squamous Cell Carcinoma: A Meta-Analysis of Randomized Controlled Trials

1Department of Pharmacy, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
2Department of Pharmacy, The 920th Hospital of PLA, Kunming, Yunnan, China
3College of Pharmaceutical Sciences, Kunming Medical University, Kunming, China
4Advanced Analytics Institute, University of Technology Sydney, Australia
5Department of PET/CT Center, Yunnan Cancer Hospital, The Third Affiliated Hospital of Kunming Medical University, Yunnan, China

Correspondence should be addressed to Juan He; moc.361@naujeehh and Long Chen; moc.liamtoh@3891nehcenol

Received 24 October 2018; Revised 9 March 2019; Accepted 30 April 2019; Published 23 May 2019

Academic Editor: Reza Izadpanah

Copyright © 2019 Xiaoxia Tang et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background. Trials on assessing the benefits of EGFR inhibitors in head and neck squamous cell carcinoma (HNSCC) patients have gradually been published. Nevertheless, the benefits of gefitinib in advanced HNSCC are still unknown. Methods. The Cochrane library, PubMed, and EMBASE databases were systematically searched from the inception dates to 17 July 2017, 18 July 2017, and 19 July 2017, respectively. The keywords “head and neck” and gefitinib were used to retrieve in articles and abstracts. An additional search for recently published randomized trials was performed from July 17, 2017, to April 18, 2018. Then we assessed the risk of bias of the included studies based on the Cochrane “Risk of Bias” tool. Quantitative analysis was carried out to evaluate the overall survival (OS), progression free survival (PFS), overall response rate (ORR), and grade 3-4 adverse effects by Review Manager 5.0.2 and the quality-of-life was analyzed in the included studies. Results. Seven randomized controlled trials and a total number of 1287 patients were involved. There were no significant differences in OS, PFS, or ORR between gefitinib and no gefitinib group (HR 1.07, 95% CI 0.93 to 1.22, and P=0.35; HR 0.84, 95% CI 0.69 to 1.04, and P=0.11; RR 1.04, 95% CI 0.90 to 1.20, and P =0.60, respectively). However, gefitinib alone was equivalent to chemotherapeutics (i.e., methotrexate; methotrexate + fluorouracil) in ORR in patients with recurrent HNSCC, and a trend of improvement in QOL in gefitinib group was showed. Toxicities revealed no differences except for diarrhea and skin toxicity (p=0.0003; p=0.03, respectively). Conclusion. For patients with advanced HNSCC, gefitinib cannot prolong the OS and PFS or improve ORR, and odds of skin toxicity and diarrhea increased. However, gefitinib alone is equivalent to methotrexate or methotrexate + fluorouracil and tends to improve QOL for recurrent patients.