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

2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Xiaoxia Tang ◽  
Juan He ◽  
Bo Li ◽  
Yi Zheng ◽  
Kejia Li ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Randomized Controlled Trials ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Skin Toxicity ◽  
Risk Of Bias ◽  
Neck Squamous Cell Carcinoma ◽  
Controlled Trials ◽  
Randomized Controlled

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.

Efficacy and tolerance of carboplatin-cetuximab in patients with metastatic or recurrent head and neck squamous cell carcinoma unfit for extreme regimen.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6539-6539
Author(s):  
Charlotte Le Roy ◽  
Dewi Vernerey ◽  
Cecile Evin ◽  
Celine Crespel ◽  
Thomas Samaille ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Univariate Analysis ◽  
Skin Toxicity ◽  
Neck Squamous Cell Carcinoma ◽  
Poor Performance Status ◽  
Hematologic Toxicity ◽  
Frail Population

6539 Background: Head and neck squamous cell carcinoma (HNSCC) is the fourth cause of death by cancer in France. For metastatic patients, the standard first line treatment is the EXTREME regimen. However, a lot of these patients have a poor performance status (PS) and/or several comorbidities making them unfit for this regimen. We have treated them with carboplatin and cetuximab (simplified EXTREME regimen) since 2007. The aim of this study is to assess the efficacy and tolerance of this regimen in this frail population. Methods: We retrospectively reviewed the medical charts of all patients treated with simplified EXTREME regimen for recurrent or metastatic HNSCC in three French academic hospitals between 2007 and 2017. The primary endpoint was overall survival (OS) and secondary endpoints were progression free survival (PFS), overall response rate (ORR), identification of prognostic factors, and toxicity. Results: 103 patients were included with a median age of 63 y.o., 60% had a PS 0-1 and 40% a PS 2-3. With a median follow-up of 30.2 months, median OS was 7.2 months and median PFS 3.7 months. ORR was 39% and 24% of patients had disease stabilization. On univariate analysis, a PS of 2 or more was significantly associated with a worse OS (median OS 10.1 months if PS 0-1 versus 4.6 months if PS 2-3; HR = 1.68; 95%CI = 1.11-2.57; p = 0.01). Acute grade 3-4 hematologic and non-hematologic toxicity rates were 25.2% and 27.2%, respectively, with 11.8% of thrombopenia, 9.7% of neutropenia, 10% of skin toxicity, and 12.6% of asthenia. Patients with grade 1 or more skin toxicity had a higher ORR (HR = 3.44; 95%CI = 1.16-10.23; p = 0.03) and a prolonged OS (HR = 0.37; 95%CI = 0.23-0.58; p < 0.0001) and PFS (HR0.29; 95%CI = 0.19-0.47; p < 0.0001). During treatment, 29% of patients had a pain decrease, 13.5% a gain of weight, and 17.2% an improvement in PS. Conclusions: This is the largest cohort of patients treated with simplified EXTREME for HNSCC. Simplified EXTREME was well tolerated in this frail population with a high ORR. Patients with a good PS had prolonged survival. Interestingly, skin toxicity of any grade was significantly correlated with treatment efficacy.

Sign in / Sign up

Export Citation Format

Share Document