scholarly journals A Prospective Observational Study on Treatment Evaluation in Patients Newly Diagnosed with Squamous Cell Carcinoma of Head and Neck in Bangladesh

2019 ◽  
Vol 10 (1) ◽  
pp. 17-22
Author(s):  
MA Hai ◽  
Ehteshamul Haque ◽  
Salim Reza ◽  
Mokhles Uddin ◽  
Kumkum Pervin

Background: Most head and neck cancers are squamous cell carcinomas (SCCHN) that contribute to substantial morbidity and mortality worldwide. The disease is mostly diagnosed at locally advanced stage. Because treatment of head and neck cancers is complex and involves multiple modalities of surgery, radiotherapy and systemic therapy including chemotherapy and molecularly targeted agents; a multidisciplinary approach is needed. The study evaluated the current treatment approaches for patients newly diagnosed with SCCHN in Bangladesh. Methods: This prospective, observational and non-comparative, study enrolled eligible males and females of 18 years newly diagnosed with SCCHN at any stage of disease. No therapeutic intervention was implied rather selection of treatment strategy and dosage of therapy was on discretion of individual oncologist as per routine clinical practice. Results: A total of 64 patients with median age of 55 years were enrolled between August 2008 and July 2011. The majority of patients (42, 65.6%) were males. The major risk factors were betel leaf chewing along with jorda (smokeless tobacco) (62.5%) and cigarette smoking (32.8%), though most of the patients had multiple risk factors. No patient was diagnosed at early stage; all were in locally advanced disease at stage III (52, 81.3%) and IV (12, 18.8%). The oncologists prescribed neoadjuvant chemotherapy in half (32) of the patients, 19 (29.7%) patients received adjuvant chemotherapy and 13 (20.3%) received palliative chemotherapy. Only 3 (4.6%) of the patients received radiotherapy. Chemotherapy combination regimen included docetaxel, cisplatin and 5-fluorouracil (5-FU) and leucovorin was added to 2 patients. The dosage of chemotherapeutic agents was as per routine clinical practice of the oncologists. Neutropenia was the common hematological abnormality reported spontaneously in 16 (25%) patients. No serious adverse event was reported leading the patients to withdraw from therapy. During continuation of therapy 1 patient died due to sudden cardiac arrest who had medical history of previous myocardial infarction. Conclusion: This registry revealed that squamous cell carcinoma of head and neck region are mostly presented in advanced stage in Bangladesh and the majority of the patients are treated with combination chemotherapeutic regimens. Anwer Khan Modern Medical College Journal Vol. 10, No. 1: Jan 2019, P 17-22

Head & Neck ◽  
2010 ◽  
Vol 32 (12) ◽  
pp. 1619-1628 ◽  
Author(s):  
Oleksandr Ekshyyan ◽  
Glenn M. Mills ◽  
Timothy Lian ◽  
Nazanin Amirghahari ◽  
Xiaohua Rong ◽  
...  

2014 ◽  
Vol 47 (3) ◽  
pp. 441-447 ◽  
Author(s):  
Myoung Hee Kang ◽  
Jung Hun Kang ◽  
Haa-Na Song ◽  
Bae Kwon Jeong ◽  
Gyu Young Chai ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS6090-TPS6090 ◽  
Author(s):  
Ravindra Uppaluri ◽  
Nancy Y. Lee ◽  
William Westra ◽  
Ezra E.W. Cohen ◽  
Robert I. Haddad ◽  
...  

TPS6090 Background: Evidence of efficacy and pathological response at the time of surgery was reported in two phase 2 studies (NCT02296684 and NCT02641093) of preoperative pembrolizumab in patients with high-risk, resectable, locally advanced (LA) head and neck squamous cell carcinoma (HNSCC). The randomized, open-label, phase 3 KEYNOTE-689 trial ( NCT03765918) will evaluate efficacy and safety of pembrolizumab as neoadjuvant and adjuvant therapy in combination with SOC (radiotherapy ± cisplatin) in patients with previously untreated, resectable LA HNSCC. Methods: Patients with newly diagnosed LA HNSCC will be randomly assigned 1:1 to two treatment arms. Patients in arm A will receive neoadjuvant pembrolizumab (200 mg Q3W for two cycles) followed by surgical resection then SOC plus adjuvant pembrolizumab (15 cycles). Patients in arm B will undergo only surgical resection followed by adjuvant SOC. Eligibility criteria will include age ≥18 years; newly diagnosed, resectable, stage III/IVA HNSCC (AJCC Cancer Staging Manual, 8th edition); and ECOG performance status 0-1. Randomization will be stratified by primary tumor site (oropharynx/oral cavity vs larynx vs hypopharynx), tumor stage (III vs IVA), and HPV p16 status (oropharynx p16 positive vs oropharynx p16 negative or larynx/hypopharynx/oral cavity). Treatment will continue until disease progression, unacceptable toxicity, or decision to withdraw. Patients in arm A will undergo the first radiologic imaging assessment after two cycles of neoadjuvant pembrolizumab and before surgery. In both arms, postoperative imaging will be performed 12 weeks after SOC, then every 3 months until the end of year 3, and then every 6 months until the end of year 5. Dual primary end points are major pathological response, defined as ≤10% invasive squamous cell carcinoma within resected primary tumor and sampled regional lymph nodes per blinded central pathology, and event-free survival. Secondary end points include overall survival, pathological complete response, and safety and tolerability. Recruitment is ongoing and will continue until ~600 patients are enrolled. Clinical trial information: NCT03765918.


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