scholarly journals Hearing evaluation of patients with head and neck cancer: Comparison of Common Terminology Criteria for Adverse Events, Brock and Chang adverse event criteria in patients receiving cisplatin

Head & Neck ◽  
2014 ◽  
Vol 37 (8) ◽  
pp. 1102-1107 ◽  
Author(s):  
A. Dimitrios Colevas ◽  
Ruth R. Lira ◽  
Electra A. Colevas ◽  
Philip W. Lavori ◽  
Cato Chan ◽  
...  
Keyword(s):  
Adverse Event ◽  
Head And Neck Cancer ◽  
Adverse Events ◽  
Head And Neck ◽  
Neck Cancer ◽  
Hearing Evaluation

Defining adverse events of anti-programmed-death-1 (Anti-PD1) agents using FDA adverse event reporting system (FAERS).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14568-e14568
Author(s):  
Kun Xiao ◽  
Zhesi Lian ◽  
Robert Collins ◽  
Anastasios Dimou ◽  
Elizabeth Garrett-Mayer ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Event ◽  
Head And Neck Cancer ◽  
Adverse Events ◽  
Head And Neck ◽  
Kidney Cancer ◽  
Neck Cancer ◽  
Cox Regression ◽  
Adverse Event Reporting System ◽  
Cox Regression Analysis

e14568 Background: Anti-PD1 inhibitors are a promising therapeutic option in oncology. They have received FDA-approval in treating metastatic and relapsed non-small cell lung cancer, kidney cancer, head-and-neck cancer, and melanoma. Yet its adverse event profile is still being defined. The FAERS database contains information on adverse events and medication error reports submitted to the FDA and serves to support the post-marketing safety surveillance program for drug and therapeutic biologic products. Methods: We searched the FAERS database from January 1, 2015 to June 30, 2016. Only initial cases reported by an MD or pharmacist for treatment of cancers of the lung, kidney, head and neck, or melanoma were included. Cases with incomplete starting, ending or event dates were excluded. The primary outcome was time from drug initiation to onset of the event. Cox proportional hazard model was used to evaluate the association between time to AE and age, gender, disease, and time of report. Results: A total of 105 adverse events (AEs) were identified. Of those AEs, 68 were related to nivolumab, 35 to pembrolizumab, and 2 to atezolizumab. Fifty-six AEs were seen in lung cancer patients, whereas 46 were in melanoma, 2 in kidney cancer and 1 in a head and neck cancer patient. Thirty-three AEs involved pulmonary complications, 30 gastrointestinal systems, 17 endocrine, and 9 were constitutional in nature. The median onset of AEs from the start of therapy was 31 days (range: 2 - 459 days). Using a Cox regression analysis, pembrolizumab was associated with a longer time to AEs compared to nivolumab (HR 0.48, 95%CI: 0.26 - 0.89). Also age between 60 and 70 was associated with a longer time to the onset of AEs compared to age < 60 (HR 0.61, 95%CI: 0.37-0.99). Conclusions: FAERS is a vigilance system to monitor AEs from anti-PD1 inhibitors. Pembrolizumab and age between 60 and 70 were associated with less AEs. Ongoing data accrual will increase the statistical power and analysis of AEs from anti-PD1 inhibitors in greater detail.

Effect of Epoetin Alfa on Survival and Cancer Treatment–Related Anemia and Fatigue in Patients Receiving Radical Radiotherapy With Curative Intent for Head and Neck Cancer

2009 ◽  
Vol 27 (34) ◽  
pp. 5751-5756 ◽  
Author(s):  
Peter J. Hoskin ◽  
Martin Robinson ◽  
Nicholas Slevin ◽  
David Morgan ◽  
Kevin Harrington ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Adverse Events ◽  
Cancer Treatment ◽  
Head And Neck ◽  
Neck Cancer ◽  
Functional Assessment ◽  
Radical Radiotherapy ◽  
Epoetin Alfa ◽  
Local Tumor ◽  
Curative Intent

Purpose To evaluate the effect of epoetin alfa on local disease-free survival (DFS), overall survival (OS), and cancer treatment–related anemia and fatigue in patients with head and neck cancer receiving radical radiotherapy with curative intent. Patients and Methods Patients (N = 301) with hemoglobin (Hb) less than 15 g/dL were randomly assigned in a ratio of 1:1 to receive radiotherapy plus epoetin alfa (10,000 U subcutaneously [SC] three times weekly if baseline Hb was < 12.5 g/dL; 4,000 U SC three times weekly if baseline Hb ≥ 12.5 g/dL) or radiotherapy alone. Hb levels were monitored weekly. The primary end point was local DFS, defined as the time from random assignment to local disease recurrence or death. Secondary efficacy end points included OS, local tumor response, and local tumor control. Patients were followed at 1, 4, 8, and 12 weeks postradiotherapy and annually for 5 years. Cancer treatment–related anemia and fatigue were evaluated with the Functional Assessment of Cancer Therapy-Anemia and Functional Assessment of Cancer Therapy-Head and Neck. Adverse events were recorded up to 12 weeks postradiotherapy. Results Hb levels increased from baseline with epoetin alfa. The median duration of local DFS was not statistically different between groups (observation, 35.42 months; epoetin alfa, 31.47 months; hazard ratio, 1.04; 95% CI, 0.77 to 1.41). Groups did not significantly differ in DFS, OS, tumor outcomes, or cancer treatment–related anemia or fatigue. No new or unexpected adverse events were observed. Conclusion Addition of epoetin alfa to radical radiotherapy did not affect survival, tumor outcomes, anemia, or fatigue positively or negatively in patients with head and neck cancer.

Clinical outcome in recurrent and/or metastatic head and neck cancer patients after discontinuation of nivolumab monotherapy due to immune-related adverse events

2020 ◽  
Vol 140 (12) ◽  
pp. 1043-1048
Author(s):  
Ryuji Yasumatsu ◽  
Mioko Matsuo ◽  
Takahiro Wakasaki ◽  
Muneyuki Masuda ◽  
Toranoshin Takeuchi ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Clinical Outcome ◽  
Adverse Events ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer

Examination of the Acute Adverse Event in Cetuximab with Radiotherapy for Head and Neck Cancer

2015 ◽  
Vol 108 (12) ◽  
pp. 945-950
Author(s):  
Hiromi Nagano ◽  
Yumi Miyamoto ◽  
Hiroyuki Iuchi ◽  
Tomohiro Jimura ◽  
Mizuo Umakoshi ◽  
...  
Keyword(s):  
Adverse Event ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Acute Adverse Event

Serious immune‐related adverse events in patients with head and neck cancer after checkpoint blockade: Systematic review

Head & Neck ◽  
2019 ◽  
Vol 41 (11) ◽  
pp. 4036-4050 ◽  
Author(s):  
Mohsin Shah ◽  
Mona K. Jomaa ◽  
Renata Ferrarotto ◽  
Sai‐Ching J. Yeung ◽  
Ehab Y. Hanna ◽  
...  
Keyword(s):  
Systematic Review ◽  
Head And Neck Cancer ◽  
Adverse Events ◽  
Head And Neck ◽  
Neck Cancer ◽  
Checkpoint Blockade
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