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Immunotherapy in Head and Neck Cancers
Published in R James A England, Eamon Shamil, Rajeev Mathew, Manohar Bance, Pavol Surda, Jemy Jose, Omar Hilmi, Adam J Donne, Scott-Brown's Essential Otorhinolaryngology, 2022
Several EGFR-targeted MAbs have been tested in clinical practice. Clinical trials confirmed the efficacy of cetuximab in combination with chemotherapy or radiotherapy. Subsequently, research in locally/regionally advanced HNSCC demonstrated that patients receiving radiotherapy and cetuximab have prolonged locoregional control (LRC) and overall survival (OS) when compared to patients receiving radiotherapy alone (Bonner 2006). Cetuximab was associated with a higher incidence of rash and infusion reactions, but supplementary analysis demonstrated that skin reactions represented a biomarker of favourable outcome. Further trials (Table 73.1) have not shown improved outcomes. The data indicate that, in the curative setting, anti-EGFR MAb therapy should be restricted to the use of cetuximab plus radiotherapy.
Antibody-Based Therapies
Published in David E. Thurston, Ilona Pysz, Chemistry and Pharmacology of Anticancer Drugs, 2021
The main adverse events associated with cetuximab are skin reactions including skin rash, acne, pruritus, dry skin, desquamation, hypertrichosis, and nail disorders. However, nausea, vomiting, diarrhea, abdominal pain, headache, asthenia, malaise, fever, urticaria, airway obstruction, hypotension, shock, and infusion reaction are also common. Caution is required in patients with cardiopulmonary and/or pulmonary disease, and treatment should be discontinued if interstitial lung disease develops. It should only be used in pregnancy if benefits outweigh risks, although little data on toxicity to the fetus is available.
Missing Data Analysis
Published in Atanu Bhattacharjee, Bayesian Approaches in Oncology Using R and OpenBUGS, 2020
We consider data of Head and neck cancer conducted by the Tata Memorial Centre. The results of this study were reported by Noronha [58]. The palliative chemotherapy patients were selected in this study. Cetuximab is a costly chemotherapeutic drug. Only a total of 30 patients could afford this drug. The quality of life (QOL) data is presented among those patients. Similarly, another group of the cohort () is treated with cisplatin therapy. Data is filled with European Organisation for Research and Treatment of Cancer(EORTC) QOL questionnaire. The primary objective of this study was to compare the QOL between Cisplatin and Cetuximab arm. Presence of missing data is handled by Bayesian methodology. The imputation technique is performed to obtain the missing data. The comparison between treatment effect on repeated measurements is presented in Chapter 9. This chapter is restricted only on missing data handling technique. Data is presented below.
Advances in pharmacotherapy for head and neck cancer
Published in Expert Opinion on Pharmacotherapy, 2021
Shikhar kumar, Vanita Noronha, Vijay Patil, Amit Joshi, Nandini Menon, Kumar Prabhash
In a phase I dose-finding study by Baselga et al. [7], it was demonstrated that cetuximab could be combined safely with cisplatin and that antibody doses in the range of 200 to 400 mg/m2 were associated with complete saturation of systemic clearance. The recommended phase II dose was 200 mg/m2. A subsequent phase Ib study by Shin et al. [8] showed that a loading dose of 400 mg/m2 with a maintenance dose of 250 mg/m2 achieved a high percentage of saturation of EGFR in the tumor tissue. A phase II study also demonstrated that cetuximab was effective, when given in combination with platinum-based chemotherapy, with an objective response rate (ORR) of 10% and disease control rate of 53%. The most common adverse effect of cetuximab was an acneiform skin rash [9].
Bioanalytical strategies in drug discovery and development
Published in Drug Metabolism Reviews, 2021
Aarzoo Thakur, Zhiyuan Tan, Tsubasa Kameyama, Eman El-Khateeb, Shakti Nagpal, Stephanie Malone, Rohitash Jamwal, Chukwunonso K. Nwabufo
Biologics are a vast class of drugs that include products, such as mAbs, vaccines, growth factors, enzymes, hormones, antibody fragments, antibody-drug conjugates (ADCs), protein diagnostics, etc. (Shi 2014). They are classified into four groups. Group I include protein therapeutics with enzymatic or regulatory activity, like insulin for the treatment of diabetes. Biologics with special targeting activity belong to Group II. Cetuximab, an epidermal growth factor inhibitor, used for the treatment of colorectal cancer and head and neck cancer, belongs to Group II. Group III and Group IV include protein vaccines (like HPV vaccine) and protein diagnostics (like Arcitumomab, Capromab pendetide, etc.), respectively (Leader et al. 2008). During the past few years, a lot of biologics have entered the market. Based on the latest evaluation, by 2022, biologics will overtake small molecules and will contribute to 52% of the top 100 product sales (Eval. Pharma 2017). The cutting-edge research that discovers new biologics offers more effective means to treat a variety of illnesses and conditions (U.S. FDA 2018). Through innovative breakthroughs, such as protein engineering, genomic medicines, etc., biologics have made more progress in healthcare development than small molecules (Makurvet 2021).
Palliative chemotherapy in head and neck cancer: balancing between beneficial and adverse effects
Published in Expert Review of Anticancer Therapy, 2020
Akhil Rajendra, Vanita Noronha, Amit Joshi, Vijay Maruti Patil, Nandini Menon, Kumar Prabhash
The KEYNOTE-048 trial, a randomized phase III trial amongst 882 patients from 200 medical centers in 37 countries consisted of three arms – pembrolizumab single agent (P), pembrolizumab + carboplatin/cisplatin + 5FU (P + C), and the EXTREME regime (cetuximab + carboplatin/cisplatin + 5FU) (E). Pembrolizumab in the P + C and the P group was administered at a dose of 200 mg every 3 weeks and continued till disease progression or intolerable toxicity or physician/participant decision or 35 cycles, whichever occurred first. In the P + C and the EXTREME arm, chemotherapy(Carboplatin AUC5/Cisplatin 100 mg/m2 every 3 weeks, 5-Fluorouracil 1000 mg/m2 D1 – D4 every 3 weeks) was given for a total of 6 cycles. In the P + C and the EXTREME group, Cetuximab was administered at a dose of 400 mg/m2 loading dose followed by 250 mg/m2 every week until disease progression, intolerable toxicity or physician/participant decision.